Bowman-Smart et al. (2023) argue for a framework to examine the ethical issues associated with genetic screening for non-medical traits in the context of noninvasive prenatal testing (NIPT). Such s...

The European Medical Information Framework project, funded through the IMI programme, has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice to ensure the privacy protection of data subjects, (...) protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board, to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective (...) review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion. (shrink)

This study assessed the attitudes and needs of physicians and health professional staff at a tertiary care hospital in Canada regarding the introduction of physician assisted dying (PAD) during 2015–16. This research aimed to develop an understanding of the wishes, concerns and hopes of stakeholders related to handling requests for PAD; to determine what supports/structures/resources health care professionals (HCP) require in order to ensure high quality and compassionate care for patients requesting PAD, and a supportive environment for all healthcare (...) providers across the moral spectrum. This study constituted a mixed methods design with a qualitative descriptive approach for the study’s qualitative component. A total of 303 HCPs working in a tertiary care hospital completed an online survey and 64 HCPs working in hospital units with high mortality rates participated in 8 focus group discussions. Both focus group and survey data coalesced around several themes to support the implementation of PAD following the decriminalization of this practice: the importance of high quality care; honoring moral diversity; supporting values (such as autonomy, privacy, beneficence); and developing resources, including collaboration with palliative care, education, policies and a specialized team. This study provided the foundational evidence to support the development of the PAD program described in other papers in this collection, and can be a model for gathering evidence from stakeholders to inform the implementation of PAD in any healthcare organization. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Artificial intelligence (AI) is increasingly relied upon by clinicians for making diagnostic and treatment decisions, playing an important role in imaging, diagnosis, risk analysis, lifestyle monitoring, and health information management. While research has identified biases in healthcare AI systems and proposed technical solutions to address these, we argue that effective solutions require human engagement. Furthermore, there is a lack of research on how to motivate the adoption of these solutions and promote investment in designing AI systems that align (...) with values such as transparency and fairness from the outset. Drawing on insights from psychological theories, we assert the need to understand the values that underlie decisions made by individuals involved in creating and deploying AI systems. We describe how this understanding can be leveraged to increase engagement with de-biasing and fairness-enhancing practices within the AI healthcare industry, ultimately leading to sustained behavioral change via autonomy-supportive communication strategies rooted in motivational and social psychology theories. In developing these pathways to engagement, we consider the norms and needs that govern the AI healthcare domain, and we evaluate incentives for maintaining the status quo against economic, legal, and social incentives for behavior change in line with transparency and fairness values. (shrink)

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We (...) argue that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations. (shrink)

BackgroundThe use of a Community Advisory Board is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified.MethodsAll studies approved by the University of Zambia Bioethics Research Committee from 2008 – (...) 2012 were reviewed to identify those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013.ResultsIdentification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings.ConclusionsSelection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making. (shrink)

An analysis of current biomedical research misconduct policy that proposes a new approach emphasizing the context of misconduct and improved oversight. Federal regulations that govern research misconduct in biomedicine have not been able to prevent an ongoing series of high-profile cases of fabricating, falsifying, or plagiarizing scientific research. In this book, Barbara Redman looks critically at current research misconduct policy and proposes a new approach that emphasizes institutional context and improved oversight. Current policy attempts to control (...) risk at the individual level. But Redman argues that a fair and effective policy must reflect the context in which the behavior in question is embedded. As journalists who covered many research misconduct cases observed, the roots of fraud “lie in the barrel, not in the bad apples that occasionally roll into view.” Drawing on literature in related fields—including moral psychology, the policy sciences, the organizational sciences, and law—as well as analyses of misconduct cases, Redman considers research misconduct from various perspectives. She also examines in detail a series of clinical research cases in which repeated misconduct went undetected and finds laxity of oversight, little attention to harm done, and inadequate correction of the scientific record. Study questions enhance the book's value for graduate and professional courses in research ethics. Redman argues that the goals of any research misconduct policy should be to protect scientific capital (knowledge, scientists, institutions, norms of science), support fair competition, contain harms to end users and to the public trust, and enable science to meet its societal obligations. (shrink)

The national ethical guidelines relevant to assisted reproductive technology have recently been reviewed by the National Health and Medical Research Council. The review process paid particular attention to the issue of non-medical sex selection, although ultimately, the updated ethical guidelines maintain the pre-consultation position of a prohibition on non-medical sex selection. Whilst this recent review process provided a public forum for debate and discussion of this ethically contentious issue, the Victorian case of JS and LS v (...) Patient Review Panel [2011] VCAT 856 provides a rare instance where the prohibition on non-medical sex selection has been explored by a court or tribunal in Australia. This paper analyses the reasoning in that decision, focusing specifically on how the Victorian Civil and Administrative Tribunal applied the statutory framework relevant to ART and its comparison to other uses of embryo selection technologies. The Tribunal relied heavily upon the welfare-of-the-child principle under the Assisted Reproductive Treatment Act 2008. The Tribunal also compared non-medical sex selection with saviour sibling selection. Our analysis leads us to conclude that the Tribunal’s reasoning fails to adequately justify the denial of the applicants’ request to utilize ART services to select the sex of their prospective child. (shrink)

As we approach the end of the twentieth century, the ways in which knowledge--scientific, social, and cultural--is produced are undergoing fundamental changes. In The New Production of Knowledge, a distinguished group of authors analyze these changes as marking the transition from established institutions, disciplines, practices, and policies to a new mode of knowledge production. Identifying such elements as reflexivity, transdisciplinarity, and heterogeneity within this new mode, the authors consider their impact and interplay with the role of knowledge in social relations. (...) While the knowledge produced by research and development in science and technology is accorded central focus, the authors also outline the changing dimensions of social scientific and humanities knowledge and the relations between the production of knowledge and its dissemination through education. Placing science policy and scientific knowledge within the broader context of contemporary society, this book will be essential reading for all those concerned with the changing nature of knowledge, with the social study of science, with educational systems, and with the correlation between research and development and social, economic, and technological development. "Thought-provoking in its identification of issues that are global in scope; for policy makers in higher education, government, or the commercial sector." --Choice "By their insightful identification of the recent social transformation of knowledge production, the authors have been able to assert new imperatives for policy institutions. The lessons of the book are deep." --Alexis Jacquemin, Universite Catholique de Louvain and Advisor, Foreign Studies Unit, European Commission "Should we celebrate the emergence of a 'post-academic' mode of postmodern knowledge production of the post-industrial society of the 21st Century? Or should we turn away from it with increasing fear and loathing as we also uncover its contradictions. A generation of enthusiasts and/or critics will be indebted to the team of authors for exposing so forcefully the intimate connections between all the cognitive, educational, organizational, and commercial changes that are together revolutionizing the sciences, the technologies, and the humanities. This book will surely spark off a vigorous and fruitful debate about the meaning and purpose of knowledge in our culture." --Professor John Ziman, (Wendy, Janey at Ltd. is going to provide affiliation. Contact if you don't hear from her.) "Jointly authored by a team of distinguished scholars spanning a number of disciplines, The New Production of Knowledge maps the changes in the mode of knowledge production and the global impact of such transformations. . . . The authors succeed . . . at sketching out, in very large strokes, the emerging trends in knowledge production and their implications for future society. The macro focus of the book is a welcome change from the micro obsession of most sociologists of science, who have pretty much deconstructed institutions and even scientific knowledge out of existence." --Contemporary Sociology "This book is a timely contribution to current discussion on the breakdown of and need to renegotiate the social contract between science and society that Vannevar Bush and likeminded architects of science policy constructed immediately after World War II. It goes far beyond the usual scattering of fragmentary insights into changing institutional landscapes, cognitive structures, or quality control mechanisms of present day science, and their linkages with society at large. Tapping a wide variety of sources, the authors provide a coherent picture of important new characteristics that, taken altogether, fundamentally challenge our traditional notions of what academic research is all about. This well-founded analysis of the social redistribution of knowledge and its associated power patterns helps articulate what otherwise tends to remain an--albeit widespread--intuition. Unless they adapt to the new situation, universities in the future will find the centers of gravity of knowledge production moving even further beyond their ken. Knowledge of the social and cognitive dynamics of science in research is much needed as a basis of science and technology policymaking. The New Production of Knowledge does a lot to fill this gap. Another unique feature is its discussion of the humanities, which are usually left out in works coming out of the social studies of science." --Aant Elzinga, University od Goteborg. (shrink)

The semantic confusion in Europe about the term “anthropology” has of late been considerable. On the one hand there is meant by it, and quite justifiably, human biology and medical anthropology. On the other hand, the work of some contemporary thinkers, under the name of “philosophical anthropology,” has recently gone beyond the narrower compass. This has been noticeable at both the German and the international European philosophical conventions since the last war. In addition to this, there appeared the (...) term “Kulturanthropologie,”—for the first time probably as the title of E. Rothacker's contribution to Systematische Philosophie, a collection of essays edited by Nicolai Hartmann and published in 1942. But “Kulturanthropologie,” in Rothacker's sense, is not a translation of “cultural anthropology,” which has in recent years grown to such eminence among scholarly fields in England and America. In the United States, “anthropology” designates a group of scholarly fields ranging on the one hand from biological anthropology to archaeology and the study of the beginnings of history on the other, often including history, linguistics, and other realms of research; it is neither one of the natural sciences nor of the humanities but one of the social sciences; and the actually new results of this young discipline, especially at Harvard, Yale, and the University of Chicago, are arrived at by means of team work by anthropologists, psychologists, and sociologists, which in Germany has not been the case so far. (shrink)

BackgroundResearch proactively and deliberately aims to bring about specific changes to how societies function and individual lives fare. However, in the ever-expanding field of ethical regulations and guidance for researchers, one ethical consideration seems to have passed under the radar: How should researchers act when pursuing actual, societal changes based on their academic work?Main textWhen researchers engage in the process of bringing about societal impact to tackle local or global challenges important concerns arise: cultural, social and political values and institutions (...) can be put at risk, transformed or even hampered if researchers lack awareness of how their ‘acting to impact’ influences the social world. With today’s strong focus on research impacts, addressing such ethical challenges has become urgent within in all fields of research involved in finding solutions to the challenges societies are facing. Due to the overall goal of doing something good that is often inherent in ethical approaches, boundaries to researchers’ impact of something good is neither obvious, nor easy to detect. We suggest that it is time for the field of bioethics to explore normative boundaries for researchers’ pursuit of impact and to consider, in detail, the ethical obligations that ought to shape this process, and we provide a four-step framework of fair conditions for such an approach. Our suggested approach within this field can be useful for other fields of research as well.ConclusionWith this paper, we draw attention to how the transition from pursuing impact within the Academy to trying to initiate and achieve impact beyond the Academy ought to be configured, and the ethical challenges inherent in this transition. We suggest a stepwise strategy to identify, discuss and constitute consensus-based boundaries to this academic activity. This strategy calls for efforts from a multi-disciplinary team of researchers, advisors from the humanities and social sciences, as well as discussants from funding institutions, ethical committees, politics and the society in general. Such efforts should be able to offer new and useful assistance to researchers, as well as research funding agencies, in choosing ethically acceptable, impact-pursuing projects. (shrink)

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them (...) better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

Mindfulness has come to be considered an important approach to help individuals cultivate transformative capacity to free themselves from stress and suffering. However, the transformative potential of mindfulness extends beyond individual stress management. This study contributes to a broadening of the scope of contemplative science by integrating the prominent, individually focused mindfulness meditation literature with collective mindfulness scholarship. In so doing, it aims to illuminate an important context in which mindfulness interventions are increasingly prevalent: workplaces. Typically, the intended effect (...) of workplace mindfulness training is to help workers manage stress better. Since mindfulness in organizations impacts individual and collective processes, the study blends the above literatures to create a cross-level “next-generation” Team Mindfulness Training pilot. Its potential in helping individuals and teams to manage work stress better is investigated via a two-phase mixed-methods research study in high-stress military work populations, and compared to a conventional 8-week mindfulness meditation program based on mindfulness-based stress reduction. Results suggest that compared to the “first-generation” mindfulness program, TMT seems no less effective in raising individual stress management skills, and may hold more promise in generating collective capacity to manage stress and unexpected difficulty, linked to an apparent interdependence between collective and individual mindfulness capacity development. Based on these empirical results, the study contributes to theory in three important ways: first, it outlines how individual and collective mindfulness in workplaces may be interdependent. Second, it explains why “next-generation” workplace training interventions should apply a cross-level approach. And third, it illustrates how its transformative potential for people at work, individually as well as collectively, can be extended by moving beyond an inward-looking meditation focus in mindfulness training. The study contributes to practice by providing a detailed outline of the pilot TMT program, and offers a series of follow-up research opportunities to inspire further scientific innovation in workplace mindfulness training, especially for high-stress work populations. The study’s ultimate aim is to prompt a shift away from adapting clinically oriented, self-focused “first-generation” mindfulness training protocols, and towards mindfulness as team sport: a more prosocially oriented mindfulness science intent on generating wisdom and compassion, for one and all. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of (...) important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

During the past decades, research collaboration between researchers from different disciplines has become more frequent. However, there is a need to look into the generic modalities and challenges. The article explores a series of potential obstructions to cross-disciplinary collaboration of methodological and epistemological nature. Furthermore, a number of contextual, inhibiting factors are outlined. As means of overcoming the obstacles, the importance of mutual knowledge, allocation of adequate time and conducive research management is emphasised. New teams may benefit from (...) tutoring by facilitators, who can help to make problem areas explicit and negotiate solutions. Owing to the training background of the author, most of the examples are drawn from the interface between biomedicine/natural science and applied medical anthropology. However, the issues raised basically apply to all sorts of cross-disciplinary research collaboration in various combinations. (shrink)

We have followed with interest the commentaries arising from Moore and Donnellys1 argument that authorities in charge of research ethics committees should focus primarily on establishing code-consistent reviews.1 We broadly agree with Savulescu’s2 argument that ethics committees should become more expert, but in a different way and for a different reason. We have recently been working with the UK Health Research Authority analysing the outcomes of their ‘Shared Ethical Debate’ exercises.3 Each ShED exercise involves the circulation of a (...) single research project to a number of RECs. The resulting minutes from each REC are compared along with the final decisions made by each REC on the project under consideration. This process was originally an administrative exercise designed to promote greater consistency among the 60 or so ethics committees that were brought under the HRA ) umbrella within the UK National Health Service. Over 20 ShEDs have been run, and although the process has significant weaknesses and has not always been run consistently, the results of the exercises are fascinating. Broadly speaking, NHS RECs have been getting more consistent over time in terms of their decision-making, but the reasons for the final decisions as described in the committee minutes continue to vary widely. Qualitative research now needs to be done to understand why different committees can have such different discussions in relation to exactly the same research project and yet come to essentially the same conclusion. As part of our analysis of the ShED data, we looked at …. (shrink)

BackgroundBreakthroughs in animal studies make the topic of human application of ectogenesis for medical and non-medical purposes more relevant than ever before. While current data do not yet demonstrate a reasonable expectation of clinical benefit soon, several groups are investigating the feasibility of artificial uteri for extracorporeal human gestation.Main textThis paper offers the first comprehensive and up to date discussion of the most important pros and cons of human ectogenesis in light of clinical application, along with an examination (...) of crucial ethical (and legal) issues that continued research into, and the clinical translation of, ectogenesis gives rise to. The expected benefits include advancing prenatal medicine, improving neonatal intensive care, and providing a novel pathway towards biological parenthood. This comes with important future challenges. Prior to human application, important questions have to be considered concerning translational research, experimental use of human fetuses and appropriate safety testing. Key questions are identified regarding risks to ectogenesis’ subjects, and the physical impact on the pregnant person when transfer from the uterus to the artificial womb is required. Critical issues concerning proportionality have to be considered, also in terms of equity of access, relative to the envisaged application of ectogenesis. The advent of ectogenesis also comes with crucial issues surrounding abortion, extended fetal viability and moral status of the fetus.ConclusionsThe development of human ectogenesis will have numerous implications for clinical practice. Prior to human testing, close consideration should be given to whether (and how) ectogenesis can be introduced as a continuation of existing neonatal care, with due attention to both safety risks to the fetus and pressures on pregnant persons to undergo experimental and/or invasive procedures. Equally important is the societal debate about the acceptable applications of ectogenesis and how access to these usages should be prioritized. It should be anticipated that clinical availability of ectogenesis, possibly first as a way to save extremely premature fetuses, may spark demand for non-medical purposes, like avoiding physical and social burdens of pregnancy. (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike (...) in, for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

Recently, the author of this paper and his research team have extended the orthodox quantum theory of atoms in molecules (QTAIM) to a novel paradigm called the two-component QTAIM (TC-QTAIM). This extended framework enables one to incorporate nuclear dynamics into the AIM analysis as well as performing AIM analysis of the exotic species; positronic and muonic species are a few examples. In present paper, this framework has been reviewed, providing some computational examples with particular emphasis on origins and (...) applications, in a non-technical language. The main questions, enigmas and basic ideas that finally yielded the TC-QTAIM are considered in chronological order to help the reader comprehend the intuition behind the math. Finally, it is demonstrated that the TC-QTAIM and its more refined versions are able to tackle problems inaccessible to the orthodox QTAIM. (shrink)

The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in‐depth interviews using an unfolding case vignette with probes. A shared view among most was (...) that individual research results which are ‘actionable’ or have ‘clinical significance’ should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to “give back” to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of ‘ownership’ appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for “two way altruism” where the researcher in return for the altruistic ‘valuable contribution’, shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of “giving back” which goes beyond individual rights and ensures reciprocity and distributive justice. (shrink)

Drawing on and extending the Foucaultian philosophical framework that Jeffrey Bishop develops in his masterful book, The Anticipatory Corpse: Medicine, Power, and the Care of the Dying, we undertake a sociological analysis of the neurological procedure—deep brain stimulation —which implants electrodes in the brain, powered by a pacemaker-like device, for the treatment of movement disorders. Following Bishop’s work, we carry out this analysis through a two-fold strategy. First, we examine how a multidisciplinary team evaluates candidates for this implant at (...) a major medical center. We present excerpts from an ethnographic study of the “case conference” where disease entities are presented, contested, ratified, and made objects for intervention with this technology. The case conference becomes the key site in the transition from “person-with-illness” to “person-with-brain-implant” as a team of health professionals determines a plan of action by interpreting both statistical and “quality of life” data regarding their patients. Second, this article explores these decision-making processes through Bishop’s conceptualization of evidence-based medicine, which relies on statistical approaches as the ultimate authority in knowledge production and medical decisions. We then reflect on Bishop’s critique of the social sciences and the methodological, analytical, and substantive ramifications that The Anticipatory Corpse can offer future sociological work. (shrink)

Background Research ethics boards exist for good reason. By setting rules of ethical behaviour, REBs can help mitigate the risk of researchers causing harm to their research participants. However, the current method by which REBs promote ethical behaviour does little more than send researchers into the field with a set of rules to follow. While appropriate for most situations, rule-based approaches are often insufficient, and leave significant gaps where researchers are not provided institutional ethical direction. Results Through a (...) discussion of a recent research project about drinking and driving in South Africa, this article demonstrates that if researchers are provided only with a set of rules for ethical behaviour, at least two kinds of problems can emerge: situations where action is required but there is no ethically good option and situations where the ethical value of an action can only be assessed after the fact. These dilemmas highlight and help to articulate what we already intuit: that a solely rule-based approach to promoting ethical research is not always desirable, possible, effective, or consistent. Conclusions In this article, I argue that to better encourage ethical behaviour in research, there is a need to go beyond the rules and regulations articulated by ethics boards, and focus more specifically on creating and nurturing virtuous researchers. (shrink)

In the slipstream of several large-scale corporate scandals, the board of directors has gained a pivotal position in the corporate governance debate. However, due to an overreliance on particular methodological (i.e. input–output studies) and theoretical (i.e. agency theory) research fortresses in past board research, academic knowledge concerning how this important governance mechanism actually operates and functions remains relatively limited. This theoretical paper aims to contribute to the promising stream of research which focuses on behavioural perspectives and processes (...) within the corporate board, by delving into one of the research areas perhaps plagued most by these predominant approaches: board leadership. In adopting a team perspective on the board of directors our study goes beyond traditional board leadership research, which has turned a blind eye on actual leadership dynamics, by examining leadership processes and behaviours inside the board team. Specifically, we develop a conceptual framework addressing a novel and ethical approach to team leadership within the board, i.e. shared leadership, which has previously been demonstrated to result in performance benefits in various other team settings. (shrink)

As reproductive freedoms in the U.S. undergo significant rollbacks, vital reproductive health services — and the care teams delivering them — face escalating legal threats and complexity. This qualitative case-control community-based participatory research study describes how legal problem-solving supports for reproductive care teams serving mothers with opioid use disorder are protective for both patients and care team members. We describe how medical legal partnerships (MLPs) can promote Reproductive Justice and argue for wider adoption of care-team facing (...) legal supports. (shrink)

The welfare of the child is the prevailing principle and concern regarding access to assisted reproduction in Western countries today, and there is a wish to avoid harm to future children. New research fields have developed in order to provide scientific evidence on the welfare of children living with different “types” of parents. Assisted reproductive technologies (ART) seems to be heading in a responsible direction where the care and concern for future children is vital. However, the claim of this (...) article is that the principle of the welfare of the child confuses the ethical framing of ART. Several philosophers in the past have argued that potential people must be regarded as outside the moral domain, and therefore cannot be harmed or benefitted. This message has not reached the policymakers, probably because the welfare of the child principle seems to fit so elegantly with common sense. In this article a different ethical framing of ART is proposed. The author argues that “futile care” and not “the welfare of the child” should be the guiding principle for eventually rejecting access to ART. The desired goal of ART treatment should be understood to be the production of functional families. Assisted reproduction is primarily about us, actual people in an actual society, and how potential children may affect us. (shrink)

An ongoing collaborative project between art and science, Taming the Forest (2022) was implemented by a team of students, artists and researchers charting an interdisciplinary project among bioeconomics, environmental history, policy and artistic practice. In this article, the project acts as a case study for researching the conflicting narratives of history and economics about biodiversity in general, and specifically about forests. It shows how different blends of methodologies in artistic-cum-scientific research can become relevant for both realms, opening new (...) creative pathways and pedagogical registers while repeatedly returning to a specific forest’s microhistory. Moreover, the article stresses the need for a new sensibility and complex knowledge, moving beyond an objective study and becoming attentive to different dimensions of research and its outputs that emerge through the introduction of artistic thinking and methodologies. This kind of transdisciplinary approach becomes necessary in order to tackle the manifold large-scale problems such as the climate and biodiversity crises, which call for both acting decisively and transforming radically, above all with regard to how humans perceive, relate to and manage nature. (shrink)

Photo ID 279661800 © Sidewaypics|Dreamstime.com ABSTRACT Decolonization is complex, vast, and the subject of an ongoing academic debate. While the many efforts to decolonize or dismantle the vestiges of colonialism that remain are laudable, they can also reinforce what they seek to end. For decolonization to be impactful, it must be done with epistemic and cultural humility, requiring decolonial scholars, project leaders, and well-meaning people to be more sensitive to those impacted by colonization and not regularly included in the discourse. (...) INTRODUCTION Decolonization is complex. To successfully achieve decolonization, projects should incorporate the voices of those subjugated or silenced. Including such voices requires sincerely exploring who has been affected by colonialism or neocolonialism and how, as well as cultural sensitivity. In its basic use, decolonization refers to countries under colonial rule gaining independence or freedom from forms of subjugation. Additionally, scholars use the term to refer to efforts to dismantle neocolonialism and vestiges of colonialism. The process includes de-silencing subjugated voices.[1] I use decolonization in the latter way to refer to countries with technical independence. While arguably colonization ended formally with independence from colonizing powers, neocolonialism is the indirect, informal, and sometimes subtle control of the people, their economy, and political life despite formal independence from colonizing authorities. I conceptualize neocolonialism as a system that involves direct and involuntary control of another’s political, economic, or social life, impacting their worldview and ways of encountering the world. Decolonization may target actions, places, or systems like health care or AI to overcome the ills of colonialism and neocolonialism. It also may target knowledge and require rethinking how people develop their knowledge base. For example, if people grew up seeing an outside colonizer as superior, they would need to change their knowledge of superiority. Decolonization may target power, for example, changing who owns and distributes COVID-19 vaccines and who distributors exclude in the distribution of vaccines. Decolonization could require looking at those disempowered in the distribution process. Additionally, decolonization may target autonomy of persons by freeing people, ensuring human and individual rights, and respecting cultural traditions. Decolonization projects that try to de-silence by including the voices of those affected by colonialism and neocolonialism must examine inclusiveness in the context of the culture of the subrogated individuals. Examples of decolonization projects include making datasets inclusive of diverse peoples and places, returning to traditional food and eating practices, making sure hospitals in developing countries are led by locals and respectful of cultural traditions, returning unethically obtained artefacts or objects. Another project would be laying the groundwork for equality in formerly colonized countries to ensure that business ownership, education, and financial success will flow fairly to those previously victimized by colonization. Summarily, there are many strategies for decolonizing. However, it is worth asking whether the strategies have risks that undermine the goal of decolonization. I. Understanding Decolonization Discourses Many fields, from AI to politics, economics, health care, aviation, and academia, discuss decolonization. The content of the discourse on decolonization depends on the region and field discussing it. Rather than just reporting on decolonization, the discussions may be calls to action. For example, decolonization discourses reflect activism for cognitive justice, such as equal consideration of Indian or African knowledge systems in global health discourses.[2] In politics and political science, some scholars frame decolonization as an anti-western, anti-colonial movement by Africans to emancipate Africa/ns from subjugation or shift the continent to postcolonialism and post-neo-colonialism. This framing walls off non-African participants and may undermine their capacity to benefit the conversation.[3] There are other political scientists who actively support decolonization and see it as a field of activism in support of anyone and countries where colonization harmed people and development.[4] The point is that two ways of conceptualizing decolonization in politics and political science are discernible. One conceptualization is less inclusive since it alienates scholars and professionals from Western, high-income, or developed countries. The other is more inclusive. In humanitarian studies, including philosophy, some decolonization articles and conversations are efforts to end the destructive force of colonization. They focus on either the form, such as ecocide, genocide, and many others, or the geographic location, such as Africa, Asia, Latin America, and Oceania.[5] Finally, the feelings one brings into this conversation can adversely impact how one engages in them and who they listen to or are willing to hear from. For example, anger, rage, bitterness, and hatred are emotions that are not uncommon in spaces of decolonization conversations. Decolonization conversations that originate from a place of negativity risk deepening the psychological state of victimhood and prevent people from disrupting constructively or critically engaging in the conversation.[6] II. Understanding Decolonization Strategies Decolonization strategies mainly aim to de-silence victims of domination or subjugation. People have proposed many strategies for decolonizing. These strategies may be informed by what the target is for decolonization. Decolonization can target power relations in global health. For example, during the COVID-19 pandemic, public health organizations noted the power imbalance in vaccine distribution. Decolonization could involve de-silencing those affected by neocolonialism to bring about a more balanced distribution of power and a more fair distribution of the vaccine. By analyzing who was adversely impacted by the distribution and who ought to wield power, those engaged in decolonizing advocated for positive change and equitable power relations. Equally, when being is the target of decolonization, the language of unlearning or relearning and mental decolonization take centre stage in the decolonization discourse. For example, the quest to decolonize colonized minds aims to demythologize African inferiority and Western superiority. Demythologizing African inferiority enables those engaged in the decolonization discourse to cultivate and foster African agency.[7] Finally, when knowledge production is the target of decolonization, scholars use inclusion and cognitive justice. For example, they try to alter the knowledge that underlies global health ethics.[8] “[D]decolonizing researchers aim to respectfully understand and integrate theory from Other(ed) perspectives, while also critically examining the underlying assumptions that inform their Western research framework.”[9] One common strategy that scholars use in decolonization is inclusion. It is worth asking, does including people who have been subrogated foster decolonization? Whether that is effective depends on whether included people are more heard or whether the strategies to include them create new forms of silencing. III. Inclusion and the Quest to Decolonize Evaluating how effective inclusion is in the quest to de-silence subjugated voices is important. First, inclusive strategies are not neutral. They are epistemically situated. This situatedness constrains meaning-making in different ways: how and what questions are asked, how social roles are constructed, organized or assigned, and who is admitted to the room where these conversations occur.[10] Inclusion strategies may reinforce (unchallenged) assumptions. For example, to address prejudices and stereotypes in global health images, Arsenii Alenichev and his colleagues[11] successfully inverted “one stereotypical global health image” by prompting a generative AI to produce “an image of a traditional Indian or African healer healing a White Child.” Although there were some problems with the image of the White child, this innovation is a significant, useful effort to de-embed or strip global health images of problematic pictures that mythologize White superiority and Black inferiority. Yet it is possible that using categories like traditional Indian or African reinforces unchallenged assumptions, raising key questions regarding how language and words create new stereotypes. It is common to define traditional as non-conventional, unorthodox, and informal. Yet studies continue to reveal that non-scientifically appraised healing approaches in India or Africa are not only effective but also real, meaningful, fundamental, and primary care-seeking behaviours in many communities in these regions.[12] Suppose inclusive strategies are not un-situated. These conversations may be had within the structures, language, and spaces built by or connected to colonialism. The spaces, language, places, and structures in which these conversations occur can limit who can participate and how they participate. Importantly, some conditions are not conducive to participation as equals. The allocated time for the discussion could also constrain how individuals express themselves. It is unclear who is ultimately heard. Furthermore, epistemic situatedness of inclusion can impact decolonization conversations when participants are beneficiaries of, products of, and trained by structures and systems they seek to dismantle. To enhance the decolonization project and its goals, a pressing task is to unveil and question how the circumstances may inhibit activism. If the vestiges of colonialism continue to structure the decolonization discourse invisibly, the vestiges may undermine decolonization. For example, a public health discussion that includes white Western doctors and Western pharmaceutical executives in Africa may have many local Africans at the table but could still effectively devalue their input based on built-in assumptions and biases that are vestiges of colonialism. Second, exclusion and inclusion are also not binary. Individuals may experience exclusion, even while included (the phenomenon called internal exclusion). In other words, inclusion can fail to be substantial or become a means of enhancing optics, “a way of (un)consciously weakening the radical claims being pursued.”[13] For example, in South Africa, many institutions have made significant efforts to diversify their faculties due to the promulgation of the Employment Equity Act 55.[14] The act requires South African institutions to implement employment equity that redresses the history of harmful discrimination in the country. The act further requires transforming departments and institutional administrations. Although many recognize and support the need to transform departments in South Africa, the rhetoric of transformation departs sharply from the lived experiences.[15] This misalignment between the plan and practice is evident in the underrepresentation of black people and females in senior management teams, professorships in many universities and health departments, and positions of power in some South African institutions. Those selected in the transformation of the departments have also complained of being overworked. The burden of extra work undermines their ability to develop agency and voice in the space they now occupy or fulfil key requirements that have implications for their career trajectory.[16] This is called the minority tax. Notably, "the minority tax… is the burden of extra responsibilities [placed] on faculty of colour to achieve diversity and inclusion and contributes to attrition and impedes academic promotion."[17] One challenge for decolonializing projects will be for decolonial scholars and those selected for decolonization objectives to have the humility to decline invitations, requests, roles, and platforms for which they are either unqualified or lack the capacity to fulfil. At its heart, decolonization strategies must empower those included rather than weaken them. Finally, inclusion can lead to a phenomenon known as elite capture.[18] Elite capture occurs when socially advantaged individuals in a group monopolize or exploit activism to their own benefit at the expense of the larger, struggling group. Elite capture weakens decolonization efforts from within, revealing that those likely to benefit from global inclusive efforts are those who fulfil globally constructed standards, those “already present in the room.” There is no better strategy to weaken decolonial movements than weakening the project from within by strategically positioning individuals who share physical properties with the victims of exclusion and silencing but intellectually, behaviourally, psychologically, and emotionally share more common ground with the colonizer. Such insiders may be unaware they are furthering neocolonial conditions rather than decolonizing. In relation to decolonization, particularly in global health, elite capture reveals that those whose voices are loudest in the room are not necessarily those more impacted by colonialism. They may benefit more from reinforcing colonialism. Opportunism weakens meaningful activism from within, preventing good initiatives and strategies from having their intended impact or taking substantive root.[19] This paper cannot do justice to elite capture, but it is worth noting its negative impacts. IV. Improving the Impact of Decolonization To end neo-colonialism, it is important to understand how it manifests and what to do at each level. Beyond the academic discourse, many tangible efforts exist to decolonize through de-silencing. Examples of these efforts include the ME2 movement that seeks to centre the concerns and experiences of sexually abused or harassed victims in the public discourse. At the funding level, many grant-awarding agencies like Wellcome Trust have dedicated huge budgets to studies that help them understand how they may have perpetrated colonialism or neocolonialism and what they can do differently going forward.[20] In South Africa, promulgating the Employment Equity Act 55 was a tangible attempt to entrench decolonization concerns in a country's regulatory framework. Yet, these decolonization efforts could fail to be substantive if they do not reflect cultural sensitivity. Two key components of cultural sensitivity are worth highlighting here: epistemic and cultural humility. Epistemic humility is an intellectual virtue described as knowing one’s limitations and the limitations of the learning methods employed. At its simplest, it is the ability to admit when one is wrong. Cultural humility includes genuine attempts to learn about and embrace other cultures. Epistemic and cultural humility are signs of academic excellence and strength. Epistemic and cultural humility seriously acknowledge how the state of our knowledge, cognitive limitations, experiences, and backgrounds, while constraining us, also invite us to listen, learn, grow, and change. The limitations-owing account of epistemic and cultural humility suggests that “a person who is aware of her cognitive limitations and owns them is much better positioned to achieve such epistemic goods as true beliefs and understanding than someone who… simply has insight into the epistemic status of her beliefs.”[21] Epistemic and cultural humility may help prevent decolonization projects that unintentionally reinforce what they seek to dismantle. Epistemic humility calls on decolonizers to defer tasks for which they are not qualified to suitably qualified persons. Beyond this, humility supports brave scholarship that imagines and reimagines how featuring the same voices, faces, and perspectives possibly introduces new forms of domination or silencing. Cultural knowledge can lead to a more intentional way of seeking out the right people or a more diverse group than those frequently featured in decolonization conversations. This would give others more opportunities to navigate these spaces and should do so in ways that are familiar to them. One ought to be more sensitive to those who would ordinarily not be included in these conversations. Unless we radically and boldly reimagine these discussions, we risk alienating those most negatively impacted by neocolonialism. CONCLUSION Decolonization conversations are complex and the subject of academic debate. The strategies employed to decolonize can harm or help the victims of neo-colonialism. Inclusion of previously silenced individuals may not be enough to overcome the vestiges of colonialism, leading to a false inclusion, where those included feel excluded or contribute in ways reflecting their own biases and circumstances. Inclusion of an elite or people who do not truly represent the subjugated can lead to elite capture. For decolonization strategies to be impactful, for example, in the context of global health, project leaders and participants must engage in conversations employing epistemic and cultural humility. In many ways, epistemic and cultural humility can help us demythologize our assumptions of any cultural superiority or cognitive authority, allowing for diverse voices, cultures, and perspectives to emerge without domination. - [1] Caesar Atuire & Olivia Rutazibwa. 2021. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization [Online]. Available from: https://law.yale.edu/yls-today/news/african-reading-covid-19-pandemic-and-stakes-decolonization [Accessed July 29, 2021 2021]. [2] Bridget Pratt & Jantina De Vries 2023. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. Journal of Medical Ethics, medethics-2022-108291. [3] Anye-Nkwenti Nyamnjoh 2023. Is decolonisation Africanisation? The politics of belonging in the truly African university. Social Dynamics, 1-20. [4] Rianna Oelofsen 2015. Decolonisation of the African mind and intellectual landscape. Phronimon, 16, 130-146. [5] Caesar Atuire & Olivia Rutazibwa. 2021. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization [Online]. Available from: https://law.yale.edu/yls-today/news/african-reading-covid-19-pandemic-and-stakes-decolonization [Accessed July 29, 2021 2021]. [6] Pedro Alexis Tabensky 2008. The Postcolonial Heart of African Philosophy. South African Journal of Philosophy, 27, 285-295. [7] Nicholas M. Creary 2012. African Intellectuals and Decolonization, Ohio, Ohio University Press. [8] Bridget Pratt & Jantina De Vries 2023. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. Journal of Medical Ethics, medethics-2022-108291. [9] Vivetha Thambinathan & Elizabeth Anne Kinsella 2021. Decolonizing Methodologies in Qualitative Research: Creating Spaces for Transformative Praxis. International Journal of Qualitative Methods, 20, 16094069211014766. [10] Abimbola Seye 2023. Knowledge from the global South is in the global South. Journal of Medical Ethics, 49, 337. [11] A. Alenichev, P. Kingori & K. P. Grietens 2023. Reflections before the storm: the AI reproduction of biased imagery in global health visuals. Lancet Glob Health. [12] Jonathan K. Burns & Andrew Tomita 2015. Traditional and religious healers in the pathway to care for people with mental disorders in Africa: a systematic review and meta-analysis. Social Psychiatry and Psychiatric Epidemiology, 50, 867-877. [13] Anye-Nkwenti Nyamnjoh & Cornelius Ewuoso 2023. What type of inclusion does epistemic injustice require? Journal of Medical Ethics, jme-2023-109091. [14] 1998. Employment Equity Act. In: GOVERNMENT, S. A. (ed.) 19370. [15] Dina Zoe Belluigi & Gladman Thondhlana 2019. ‘Why mouth all the pieties?’ Black and women academics’ revelations about discourses of ‘transformation’ at an historically white South African university. Higher Education, 78, 947-963. [16] Juliet Ramohai & Khomotso Marumo 2016. Women in Senior Positions in South African Higher Education: A Reflection on Voice and Agency. 231, 135-157. [17] J. Trejo 2020. The burden of service for faculty of color to achieve diversity and inclusion: the minority tax. Mol Biol Cell, 31, 2752-2754. [18] Olufemi Taiwo 2020. Being-in-the-Room Privilege: Elite Capture and Epistemic Deference. The Philosopher, 108, 7. [19] Margarita Kurbatova & Elena Kagan 2016. Opportunism of University Lecturers As a Way to Adaptate the External Control Activities Strengthening. Journal of Institutional Studies, 8, 116-136. [20] Jeremy Farrar. 2022. An update on Wellcome's anti-racist programme. An update on Wellcome's anti-racist programme [Online]. Available from: https://wellcome.org/news/update-wellcomes-anti-racism-programme [Accessed August 10, 2022 2022]. [21] Katherine Dormandy 2018. Does Epistemic Humility Threaten Religious Beliefs? Journal of Psychology and Theology, 46, 292-304. (shrink)

Recently, creative deviance has been lauded to be an innovation-enhancing approach with applications in many new and high-tech domains. Previous study on antecedents to creative deviance remains scattered and vague. Our research conceptualizes creative deviance from the perspective of independent innovation and explores its antecedents, mechanisms, as well as conditions. Team authoritarian leadership is conceptualized as a contradictory unity as it mixes advantages and disadvantages. However, it is surprising to find that there are very few researches that have (...) examined its relevant influence mechanisms and boundary conditions for authoritarian leadership. Contributing to an advanced understanding of authoritarian leadership in research and development teams, we investigated whether team authoritarian leadership is positively or negatively related to creative deviance. Drawing on social information processing theory and regulatory focus theory, we supposed that team authoritarian leadership facilitates creative deviance when the degree is low and inhibits it when the degree is high; dual occupational stress and prevention regulatory focus play mediation roles between team authoritarian leadership and creative deviance respectively, both variables play a chain mediation role in that relationship; and the mindfulness characteristic of an individual moderates the inverted-U team authoritarian leadership-creative deviance association, such that this association is weaker with low individual mindfulness. With two-phase questionnaire data collected from 433 members in 82 R&D teams of high-tech enterprises in electronic information technology, new material technology, new medical technology, resource and environment technology and advanced manufacturing technology randomly selected from five provinces in eastern China, these hypotheses are supported empirically. Overall, we find that, our study broadens antecedents and the relevant occurrence mechanisms of creative deviance when studied through a leadership management lens. Moreover, our research enriches the cognate studies on authoritarian leadership by empirically demonstrating that team authoritarian leadership may function as an double-edged sword of creative deviance in the R&D workplace. These above findings offer insightful thoughts to scholars in the field of authoritarian leadership and bring practical suggestions for team superiors who seek to implement best innovation practice. (shrink)

After the ‘empirical turn’ in bioethics, few specific approaches have been developed for doing clinical ethics research in close connection with clinical decision-making on a daily basis. In this paper we describe the ‘committed researcher’ approach to research in clinical ethics that we have developed over the years. After comparing it to two similar research methodological approaches, the ‘embedded researcher’ and ‘deliberative engagement’, we highlight its main features: it is patient-oriented, it is implemented by collegial and multidisciplinary (...) teams, it uses an ethical grid to build the interview guide, and it is geared towards bringing the results to bear on the public debate surrounding the issue at stake. Finally, we position our methodological approach with respect to the ‘is vs. ought’ distinction. We argue that our ‘commitment researcher’ approach to clinical ethics research takes concerned people’s life-building values as the main data, and compares them to the larger normative framework underlying the medical practice at stake. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Subjective Experiences of Tourette SyndromeBeyond the Premonitory UrgeThe authors report no conflicts of interest.There is an evolving recognition in healthcare that the patient's subjective experience needs to be privileged both in understanding clinical phenomena and also ensuring the salience of outcomes used to evaluate the impact of treatment interventions. This is reflected in the expansion of patient-reported outcome measures to capture a person's perception of their own health, and (...) the increasing requirement of involving people with lived experience in the co-design of research studies (National Health and Medical Research Council, 2016) and care improvement initiatives. In mental health it has been long understood that observable behavioral phenomena can only partially inform clinical understanding of the experience of the patient living with the condition. However, capturing the patient's subjective experience faithfully remains a challenge.Tourette syndrome (TS) is a complex condition in which there are clearly observable behavioral phenomena (vocal and motor tics, compulsive and socially inappropriate behaviors), but also a broad and varied range of subjective phenomena reported by different individuals. These may include sensory phenomena such as the premonitory sensory urge preceding a tic, compulsions to touch things a certain number of times or do something repeatedly until it feels "just right," or bothersome intrusive thoughts or images. To further complicate the picture most patients with TS have one or more co-occurring conditions such as attention deficit hyperactivity disorder, obsessive-compulsive disorder, and anxiety, which may actually cause a greater burden of dysfunction and distress than the Tourette symptoms.In their paper, Curtis-Wendlandt et al. (2024) challenge the dependence of current psychiatric diagnostic criteria (e.g., the Diagnostic and Statistical Manual of Mental Disorders, 5th edition) on observable tics, and propose a broader and more dimensional approach to nosology which incorporates sensory, cognitive and affective phenomena. [End Page 47] Data from interviews they conducted identified that premonitory phenomena and urge experiences in tic disorders are more complex and diverse than what is currently reflected in the literature and clinical scales. They also interviewed participants who reported "no urges" or "no premonitory sensations." They commented that the literature generally treats reports of urge absences at face value, and does not address the likelihood that such reports may be ambiguous or problematic. Overall, they concluded that their research suggests that premonitory urges in TS are a complex and diverse phenomenon that requires further study. This reflects with our clinical experience in working with TS patients. Although a large proportion of older patients describe sensory-based premonitory urges, descriptions are not homogenous, with many describing other experiences preceding their tics.When evaluating a patient's response to an intervention (either behavioral or pharmacological) clinicians incorporate a range of information. This includes the severity of their tics (number, type, frequency, intensity, and associated impairment), as well as their mood, participation and performance in study, work, and social activities, and overall quality of life. Standard clinical practice would not typically include assessment of some of the subjective experiences which precede tics. If it was accepted that these subjective phenomena are indeed salient to the patient's well-being, then a challenge would be how to consistently and reliably capture these feelings to operationalize a comprehensive patient-centered assessment.The primary evidence-based treatment for tic disorders, comprehensive behavioral intervention for tics (CBIT), involves training to increase the awareness of premonitory urges (Woods et al., 2008). Furthermore, successful 'blocking' of tics during the course of CBIT requires the patient to be aware of premonitory urges. Clinicians having a better understanding of the complexity and diversity of experiences which precede tics, as well as using open-ended questioning styles, may assist with improving CBIT outcomes. [End Page 48]Related ArticlesFeature Article: Dimensions, Not Types: On the Phenomenology of Premonitory Urges in Tourette SyndromeCommentary: Priming and Narrative Habits in the Phenomenological Interview: Reflections on a Study of Tourette SyndromeCommentary: Subjective Experiences of Tourette Syndrome: Beyond the Premonitory UrgeResponse: Phenomenological Interviews and Tourette’sDaryl EfronThe Royal Children's Hospital MelbourneIvan MathiesonThe Laneway ClinicDaryl Efron Daryl Efron is a Consultant Pediatrician, Royal Children's Hospital Senior Research Fellow, Murdoch... (shrink)

In this paper, we consider how the four key team emergent states for team learning identified by Bell, Kozlowski and Blawath (2012), namely psychological safety, goal orientation, cohesion, and efficacy, operate as a system that produces the team’s learning climate (TLC). Using the language of systems dynamics, we conceptualize TLC as a stock that rises and falls as a joint function of the psychological safety, goal orientation, cohesion, and efficacy that exists in the team. The systems (...) approach highlights aspects of TLC management that are traditionally overlooked, such as the simultaneous influence of and feedback between the four team emergent states and the inertia that TLC can have as a result. The management of TLC becomes an issue of controlling the system rather than each state as an independent force, especially because changing one part of the system will also affect other parts in sometimes unintended and undesirable ways. Thus the value is to offer a systems view on the leadership function of team monitoring with regards to team emergent states, which we term team state monitoring. This view offers promising avenues for future research as well as practical wisdom. It can help leaders remember that TLC represents an equilibrium that needs balance, in addition to pointing to the various ways in which they can influence such equilibrium. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber (...) education program of research ethics” in KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

This article aims to clarify the epistemological foundations of the Freudian energetics model, starting with a historical review of the 19th century scientific context in which Freud's research lay down its roots. Beyond the physiological and anatomical references of Project for a Scientific Psychology, the physiology Freud makes reference to is in reality primarily anchored in an epistemological model derived from physics. Whilst across the Rhine, the autonomy of physiology in relation to physics was far from being accomplished, (...) as a counterpoint, in France, the revolution in physiology driven by Claude Bernard established itself autonomously from physics,. In contrast, Freud's scientific landscape is entirely dominated by the physics elevated to the rank of an ideal science. The influence of Helmholtz, who is both a medical doctor and a physicist, has a determining influence on Freud's training. The discoveries in physics at that time, in particular the formulation of the principle of 'conservation of force' - first principle of thermodynamics - will constitute the points of reference upon which Freud will elaborate his energetics model, then subsequently, the idea of economy in his metapsychology. In this way we can trace both the historic and epistemological path that led Freud from a concept based on physics, and more specifically thermodynamic energy, to an idea of nervous energy that constitutes the basis of the concept of "quantity" as it is stated as 'first fundamental idea' in Project for a Scientific Psychology. This notion will subsequently evolve, and lead Freud to the introduction of the concept of 'psychical energy,' this time in a purely metapsychological sense. (shrink)

Burnout is a well-documented entity in Care Workers population, affecting up to 50% of physicians, just as it is equally well established that managing an infectious disease outbreaks, such as confirmed in the COVID-19 pandemic, increases Post-Traumatic Stress Disorder and the psychological burden. Mental health support, in the form of formal or remote sessions, has been shown to be helpful to health care staff, despite the organizational difficulties in an emergency. During the first emergence of COVID-19 in Italy, the Scientific (...) Institute for Research, Hospitalization and Health Care Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo Foundation, the Italian hospital that treated “patient 1,” has activated an agreement with the Soleterre Foundation, an international Non-Governmental Organization that manages health emergency projects, to provide psychological support. A task force of psychologists was created with the aim of designing and administering a Therapeutic Mental Health Assessment for COVID-19 Care Workers to evaluate and support health care workers’ mental health. The assessment battery was developed to evaluate symptoms and behaviors associated with trauma and the corresponding maladaptive behaviors. Once the TMHA COVID-19 CWs had been developed, the team of psychologists regularly visited healthcare staff in the ward to administer it. One hundred seven care workers across Intensive Care Units, the emergency room and medical ward were administered the TMHA COVID-19 CWs. PTSD symptoms were reported as severe by 13% of the population. Depressive symptoms as severe for 7% and Anxiety symptoms as severe for 14%. Severe psychotic symptoms were experienced by 2% and severe suicidal thoughts by 1% of the population. The possibility of acting upon the results of the TMHA COVID-19 CWs allowed an early intervention through individual session beyond the cut-off level for PTSD in NSESSS. In fact, 280 individual support sessions were offered. Therefore, we considered our project a protective and support factor for healthcare workers’ mental well-being and we recommend implementing a mental health screening program in ward involved in COVID-19 patients’ care. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...) RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

The Concussion in Sport Group guidelines have successfully brought the attention of brain injuries to the global medical and sport research communities, and has significantly impacted brain injury-related practices and rules of international sport. Despite being the global repository of state-of-the-art science, diagnostic tools and guides to clinical practice, the ensuing consensus statements remain the object of ethical and sociocultural criticism. The purpose of this paper is to bring to bear a broad range of multidisciplinary challenges to the (...) processes and products of sport-related concussion movement. We identify lacunae in scientific research and clinical guidance in relation to age, disability, gender and race. We also identify, through multidisciplinary and interdisciplinary analysis, a range of ethical problems resulting from conflicts of interest, processes of attributing expertise in sport-related concussion, unjustifiably narrow methodological control and insufficient athlete engagement in research and policy development. We argue that the sport and exercise medicine community need to augment the existing research and practice foci to understand these problems more holistically and, in turn, provide guidance and recommendations that help sport clinicians better care for brain-injured athletes. (shrink)

ArgumentThis article uses four historical case studies to address epistemological issues related to the animal model of human diseases and its use in medical research on human diseases. The knowledge derived from animal models is widely assumed to be highly valid and predictive of reactions by human organisms. In this contribution, I use three significant historical cases of failure (ca. 1890, 1960, 2006), and a closer look at the emergence of the concept around 1860/70, to elucidate core assumptions (...) related to the specific practices of animal-human knowledge transfer, and to analyze the explanations provided by historical actors after each of the failures. Based on these examples, I argue that the epistemological status of the animal model changed from that of a helpful methodological tool for addressing specific questions, but with precarious validity, to an obligatory method for the production of strong knowledge on human diseases. As a result, there now exists a culture of biomedical research in human disease that, for more than a century, has taken the value of this methodological tool as self-evident, and more or less beyond question. (shrink)

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and (...) mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. (shrink)

Friedrich Nietzsche has emerged as one of the most important and influential modern philosophers. For several decades, the book series Monographien und Texte zur Nietzsche-Forschung (MTNF) has set the agenda in a rapidly growing and changing field of Nietzsche scholarship. The scope of the series is interdisciplinary and international in orientation reflects the entire spectrum of research on Nietzsche, from philosophy to literary studies and political theory. The series publishes monographs and edited volumes that undergo a strict peer-review process. (...) The book series is led by an international team of editors, whose work represents the full range of current Nietzsche scholarship. (shrink)

Though assumptions about language underlie all bioethical work, the field has rarely partaken of theories of language. This article encourages a more linguistically engaged bioethics. We describe the tacit conception of language that is frequently upheld in bioethics—what we call the representational view, which sees language essentially as a means of description. We examine how this view has routed the field’s theories and interventions down certain paths. We present an alternative model of language—the pragmatic view—and explore how it expands and (...) clarifies traditional bioethical concerns. To lend concreteness, we apply the pragmatic view to a pervasive concept in bioethics and adjacent fields: decision making. We suggest that problems of the decision-making approach to bioethical issues are grounded in adherence to the representational view. Drawing on empirical work in surgery and critical care, we show how the pragmatic view productively reframes bioethical questions about how medical treatments are pursued. (shrink)

Purpose Medical students receive a varying amount of training in medical ethics and are expected to navigate clinical ethical dilemmas innately. There is little literature on attempts to navigate ethical dilemmas experienced during early clinical experiences and whether current curricula prepare students for these dilemmas. This study explores the different ethical dilemmas experienced by medical students on their third-year clerkships and analyzes the factors, sources, and resolutions proposed by them.Methods From 2016 to 2018, third-year medical students (...) completed a written assignment to describe, analyze, and reflect on a clinical situation in which they experienced an ethical dilemma. They identified specific ethical dilemmas present, potential preventative and aftermath solutions, and reflected on their professional development from their experience. The research team utilized applied thematic analysis to identify themes and patterns in the data. A thematic matrix was utilized to examine similarities and differences across medical students.Results Of the 162 reflections, 144 (88.9%) students indicated an ethical dilemma that included issues related to autonomy and beneficence. Of these, 116 (71.6%) students found the two ethical principles in direct conflict. Students identified three common sources of this conflict: lack of communication; unclear understanding of clinical policies regarding family authority and psychiatric capacity; and medical negligence. Lastly, students suggested different solutions for dealing with and preventing this conflict.Conclusion Our findings suggest that an overwhelming number of students face ethical challenges when confronted with medical situations that raise conflicts between autonomy and beneficence. Their recommended solutions reveal an appeal among students to have tools and strategies in place to ease the need to make difficult decisions. Medical students might be better served by learning about the complexities of ethical decision-making and the likelihood of experiencing moral distress when they feel an inability to implement what they envision as the best solution. (shrink)

This paper reports on an action research project about organizational change by a regional food bank in New York State’s southern tier. While the project team initially included a sociologist, food bank leadership and staff, it expanded to involve participants in food access programs and area college students. This paper combines findings from qualitative research about the food bank with findings generated through a collaborative inquiry about a ten-year process of organizational change. We ask how a regional (...) food bank can change its approach to address root causes of hunger. Acknowledging that narrow, pragmatic definitions of hunger promote charitable responses, our collaboration is grounded in structural understandings of poverty that refuse to blame the poor or treat poverty as an accident. Decades-long economic restructuring, deindustrialization and a rise in the service economy have resulted in growing inequality and long-term demand for “emergency” food in New York State. We outline critiques by scholars and practitioners of the emergency food regime. Description and analysis of the organizational change efforts of the Food Bank of the Southern Tier combine discourse analysis, collaborative inquiry, interviews, and participant observation. Discourse analysis of the agency’s strategic plans documents changes in aspirations, exposure to new epistemic communities and repertoires of actions. Interviews with participants evidence impacts of the organization’s advocacy and education programs on people with lived experience in poverty. Through a participatory process, we developed a collaborative chronology of phases of organizational change. Collaborative analysis of organizational changes demonstrates new definitions of the problem, a shift in service focus, changing outcomes and increased funding for advocacy. While recognizing substantial constraints, this project contributes to evidence that food banks may shift their discourse and practices beyond charity. (shrink)

In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment (...) distinction, pervasive in regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. (shrink)

Military Medical Ethics for the 21st Century is the first full length, broad-based treatment of this important subject. Written by an international team of practitioners and academics, this book provides interdisciplinary insights into the major issues facing military-medical decision makers and critically examines the tensions and dilemmas inherent in the military and medical professions. In this book the authors explore the practice of battlefield bioethics, medical neutrality and treatment of the wounded, enhancement technologies for war (...) fighters, the potential risks of dual-use biotechnologies, patient rights for active duty personnel, military medical research and military medical ethics education in the 21st Century. (shrink)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a (...) duty to participate. The current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

Background Medical aid in dying (MAID) is legal in a number of countries, including some states in the U.S. While MAID is only permitted for terminal illnesses in the U.S., some other countries allow it for persons with psychiatric illness. Psychiatric MAID, however, raises unique ethical concerns, especially related to its effects on mental illness stigma and on how persons with psychiatric illnesses would come to feel about treatment and suicide. To explore those concerns, we conducted several focus groups (...) with persons with lived experience of mental illness.Methods We conducted three video-conference-based focus groups involving adults residing in the U.S. who reported a prior diagnosis of any psychiatric illness. Only participants who reported thinking that MAID for terminal illness was morally acceptable were included. Focus group participants were asked to respond to a series of four questions. Groups were facilitated by a coordinator who was independent of the research team.Results A total of 22 persons participated in the focus groups. The majority of participants had depression and anxiety disorders; no participants had psychotic disorders such as schizophrenia. Many participants strongly favored permitting psychiatric MAID, generally on the basis of respect for autonomy, its effects on stigma, and the severe suffering caused by mental illness. Others expressed concerns, typically related to difficulties in ensuring decision-making capacity and to the risk that MAID would be used in lieu of suicide.Conclusions Persons with a history of psychiatric illness, as a group, have a diverse array of views about the permissibility of psychiatric MAID, reflecting nuanced consideration of how it relates to the public perception of mental illness, stigma, autonomy, and suicide risk. (shrink)