Medical Research Ethics

The suffering of nonhuman animals has become a noted factor in deciding public policy and legislative change. Yet, despite this growing concern, skepticism toward such suffering is still surprisingly common. This paper analyzes the merits of the skeptical approach, both in its moderate and extreme forms. In the first part it is claimed that the type of criterion for verification concerning the mental states of other animals posed by skepticism is overly (and, in the case of extreme skepticism, illogically) demanding. (...) Resting on Wittgenstein and Husserl, it is argued that skepticism relies on a misguided epistemology and, thus, that key questions posed by it face the risk of absurdity. In the second part of the paper it is suggested that, instead of skepticism, empathy together with intersubjectivity be adopted. Edith Stein’s take on empathy, along with contemporary findings, are explored, and the claim is made that it is only via these two methods of understanding that the suffering of nonhuman animals can be perceived. (shrink)

Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle (...) income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees, and developed a template for expediting review of research protocols in epidemic and emergency conditions. (shrink)

Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to receive a new drug outside of a study, receive a new drug as (...) part of a study and participate in a randomised controlled trial for a new drug. Patients were also asked about participation in studies of invasive procedures.Results: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug . Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter . Willingness to participate was not associated with trust in the doctors.Conclusions: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent. (shrink)

In this article we address the social value of bioethics research and show how a participatory approach can achieve social impact for a wide audience of stakeholders, involving them in a process of joint moral learning. Participatory bioethics recognizes that research co-produced with stakeholders is more likely to have impact on healthcare practice. These approaches aim to engage multiple stakeholders and interested partners throughout the whole research process, including the framing of ideas and research questions, so that outcomes are tailored (...) to the interests and context, and the type of impact stakeholders envisage. There is an emphasis on realizing social change through the conduct of the research, and it is believed that the engagement of stakeholders in the research process will promote their intrinsic motivation to change their practice. Another distinctive feature of participatory bioethics research is that its central normative commitment is to reflection and dialogue, not to a particular substantive ethical approach. In reflection and dialogue there is an emphasis on inclusion and the co-production of knowledge. Furthermore, empirical and normative research are combined, and there is a deliberate attempt to give voice to otherwise marginalized positions. This provides a model of social impact which is relevant not only for bioethics research, but also for other areas of health care research. We will show the merits of a participatory approach to bioethics research with a case example. It concerns the reduction of coercion and in particular seclusion in Dutch mental healthcare. (shrink)

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that their data analyses (...) will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. (shrink)

A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not be upset (...) if the children refused. In contrast, other studies found that children were much more likely to stop their participation if the experimenter said explicitly that she would not be upset if they stopped. We suggest that experimenters should pay more attention to describing the possible risks and benefits of participation in research, and that they should also make it clearer to children that they are free to stop once they have begun. (shrink)

ABSTRACTA needs assessment survey of ethics review committees across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% , and committees surveyed were located in 18 African countries. The majority of the responding committees have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national or regional .In terms of the ethical review (...) process, nine of the 31 committees that responded did not have standard operating procedures , and seven of the 22 that did have SOPs had never revised them after their initial development . Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper‐based data management and archiving systems.Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation‐funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four‐year longitudinal project. (shrink)

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...) how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

Basson's commentary on my proposals regarding the structure and function of research in bioethics provides a welcome opportunity for extended comparison of standard approaches with the suggestions made in ‘What Bioethics Should Be.’ I begin by noting a common assumption underlying our respective views. I then address points of fundamental difference, indicating why the experimental method proposed in my original essay presents a potentially more productive strategy for examining moral issues in biomedicine. In the latter respect, I certainly disagree with (...) Basson's contention that "we are unable to test" metaethical hypotheses "against reality" (Basson, p. 185) – a proposition which seems no more defensible than the equally untenable claim that we cannot refine methods of natural science research through examination of their usefulness in advancing our understanding of the correlation of events in nature. CiteULike Connotea Del.icio.us What's this? (shrink)

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...) how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

Objectives: To investigate whether different methods of obtaining informed consent affected recruitment to a study of delirium in older, medically ill hospital inpatients.Design: Open randomised study.Setting: Acute medical service for older people in an inner city teaching hospital.Participants: Patients 70 years or older admitted to the unit within three days of hospital admission randomised into two groups.Intervention: Attempted recruitment of subjects to a study of the natural history of delirium. This was done by either a formal test of capacity, followed (...) by either a request for consent or an attempt at obtaining assent from a proxy, or a combined informal capacity/consent process.Main outcome measures: Prevalence and severity of delirium, and, as case mix measures, length of hospital stay and destination on discharge.Results: Recruitment of subjects through establishing formal capacity and then informed consent was less successful and, compared with those recruited through the usual combined capacity/consent approach, yielded a sample with less cognitive impairment, lower severity of delirium, lower probability of case note diagnosis of delirium and lower rate of entering a care home.Conclusions: Methods of obtaining informed consent may significantly influence the case mix of subjects recruited to a study of delirium. Stringent testing of capacity may exclude patients with delirium from studies, thus rendering findings less generalisable. A different method is necessary to achieve an ethical balance between respecting autonomy through obtaining adequate informed consent and avoiding sample bias. (shrink)

ABSTRACTIn recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the standard (...) of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care.Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

ABSTRACTIntroduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research.Methods: A survey of developing country researchers, involved in human subject research, was (...) conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in‐depth interviews and 78 responses to open‐ended questions in the questionnaire provided qualitative data.Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent.Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. (shrink)

Freely given informed consent to participation is the ethical cornerstone of research in health care. However, in mental health settings, there are many patients who lack the capacity to give such consent to participate in research. There is an abundance of guidance now available on how researchers might think about this issue and the Royal College of Psychiatrists has also recently reviewed its guidance to members about the ethics of research. In this piece, I will discuss some of the issues (...) that were raised during the revision process, and add some reflections of my own. (shrink)

Funding agencies in Canada are attempting to break down the organizational boundaries between disciplines to promote interdisciplinary research and foster the integration of the social sciences into the health research field. This paper explores the extent to which biomedical and clinician scientists’ perceptions of social science research operate as a cultural boundary to the inclusion of social scientists into this field. Results indicated that cultural boundaries may impede social scientists’ entry into the health research field through three modalities: (1) biomedical (...) and clinician scientists’ unfavourable and ambivalent posture towards social science research; (2) their opposition to a resource increase for the social sciences; and (3) clinician scientists procedural assessment criteria for social science. The paper also discusses the merits and limitations of Tom Gieryn’s concept of boundary-work for studying social dynamics within the field of science. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Una mirada a la historia de la investigación con seres humanos nos revela que la ética (al menos entendida como el ethos de una comunidad) ha estado siempre presente de uno u otro modo. No obstante, también son numerosas las situaciones en las que las pautas morales son sistemáticamente transgredidas.

Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.

Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...) we approach the question of therapeutic justification for phase 1 trials from the viewpoint of five different stakeholders: the drug regulatory authority, the IRB, the clinical investigator, the referring physician, and the patient. Our analysis shows that the question of therapeutic justification actually raises multiple questions corresponding to the roles and responsibilities of the different stakeholders involved. By attending to these contextual differences, we provide more coherent guidance for the ethical negotiation of risk in phase 1 trials involving patients. We close by discussing the implications of our argument for various perennial controversies in phase 1 trial practice. (shrink)

(2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information (...) sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time. (shrink)

The National Commission for the Protection of Human Subjects of Bio-medical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the commission's researcher-dominated composition which permitted it to assume that(1) research is good;(2) experimentation is almost never harmful to subjects; and (3) researcher-dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can learn much by reexamining (...) these premises. (shrink)

Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.Methods: In-depth (...) interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

The primary purpose behind effectiveness research is to determine whether a treatment with demonstrated efficacy has utility when administered to the general population. The main questions these studies are meant to answer are these: Can the typical patient respond to treatment? Is the treatment acceptable to the typical patient? Can the treatment be administered safely and in its entirety in the typical treatment setting? Is the treatment under study significantly better than the community standard of care both from a cost (...) and outcome perspective? Answering these questions is meant to provide sufficient information to providers and policymakers so that effective interventions can be adopted and become the new community standard. For this research to make a meaningful impact on a provider and policymaker's decision to change the status quo, study interventions should be compared to the existing community standard of treatment, often referred to as treatment as usual (TAU). From an ethical perspective, this decision may not always be the safest choice. In some populations, TAU may mean no treatment at all, and in others TAU may be worse than withholding treatment. The effectiveness researcher is then caught between the pull to do no harm and the need for research to have an impact on change. The purpose of this article is to highlight certain conditions when TAU is ethically acceptable and to discuss alternatives when TAU may be an unethical treatment condition. For purposes of precision, we focus exclusively on psychotherapy effectiveness research rather than system-intervention research or medication-intervention research. (shrink)

A placebo is a substance or intervention believed to be inactive, but is administered by the healthcare professional as if it was an active medication. Unlike standard treatments, clinical use of placebo usually involves deception and is therefore ethically problematic. Our attitudes toward the clinical use of placebo, which inevitably includes deception or withholding information, have a tremendous effect on our practice regarding truth-telling and informed consent. A casual attitude towards it weakens the current practice based on shared decision-making and (...) mutual trust between patients and healthcare professionals. Issues concerning the clinical use of placebo are thus intimately related to patient-provider relationships, the public's trust in medicine, and medical education. A review of recent survey studies suggests that the clinical use of placebo appears to be fairly well accepted among healthcare professionals and is common in clinical settings in various countries. However, we think that an ethical discussion is urgently needed because of its controversial nature. If judged to be ethically wrong, the practice should end. In the present paper, we discuss the ethicality of the clinical use of placebo with deception and argue against it, concluding that it is unethical and should be banned. We will show that most arguments in favor of the clinical use of placebo can be refuted and are therefore incorrect or weak. These arguments will be presented and examined individually. Finally, we will briefly consider issues relevant to the clinical use of placebo without deception. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (shrink)

This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.

Background The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light (...) of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. Methods We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. Results The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. Conclusion Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment. (shrink)

The return of individual research results to participants raises many socio-ethical issues and is even more challenging when the participant is a child. The objective of this article is to present an overview of the few ethical guidelines and relevant literature addressing the return of individual results in pediatric research. By reviewing policies and the literature, we present some overarching considerations and delineate contextual issues in order to propose a framework.

Behavior analysis, a rapidly growing profession, began with the use and application of conditioning and learning techniques to modify the behavior of children or adults presenting severe management problems, often because of developmental disabilities. Now behavior analysts work in a variety of settings, from clinics and schools to workplaces. Especially since their practice often involves aversive stimuli or punishment, they confront many special ethical challenges. Recently, the Behavior Analysis Certification Board codified a set of ten fundamental ethical guidelines to be (...) followed by all behavior analysts and understood by all students and trainees seeking certification. This book shows readers how to follow the BACB guidelines in action. The authors first describe core ethical principles and then explain each guideline in detail, in easily comprehensible, everyday language. The text is richly illuminated by more than a hundred vivid case scenarios about which the authors pose, and later answer questions for readers. Useful appendices include the BACB Guidelines, an index to them, practice scenarios, and suggested further reading. Practitioners, instructors, supervisors, students, and trainees alike will welcome this invaluable new aid to professional development. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...) Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)