Information is the fourth core element of public health legal preparedness and of legal preparedness for public health emergencies specifically. Clearly, the creation, transmittal, and application of information are vital to all public health endeavors. The critical significance of information grows exponentially as the complexity and scale of public threats increase.Only a small body of organized information on public health law existed before the 21st century: a series of landmark books published beginning in 1926 by Tobey, (...) Grad, and Wing ; model public health laws published as early as 1907; systematic reviews of original research studies published in the 1990s; and a small but growing number of articles published in public health journals and law reviews.With the new century came new public health law programs and activities at the Centers for Disease Control and Prevention, in public health professional associations, and in numerous non-profit and academic organizations. (shrink)

Information is the fourth core element of public health legal preparedness and of legal preparedness for public health emergencies specifically. Clearly, the creation, transmittal, and application of information are vital to all public health endeavors. The critical significance of information grows exponentially as the complexity and scale of public threats increase.Only a small body of organized information on public health law existed before the 21st century: a series of landmark books published beginning in 1926 by Tobey, (...) Grad, and Wing ; model public health laws published as early as 1907; systematic reviews of original research studies published in the 1990s; and a small but growing number of articles published in public health journals and law reviews.With the new century came new public health law programs and activities at the Centers for Disease Control and Prevention, in public health professional associations, and in numerous non-profit and academic organizations. (shrink)

In 2008, Representative John Read of Mississippi recently co-sponsored state legislation that would ban restaurants from serving obese customers. He later admitted that the bill was a publicity stunt,meant to “shed a little light on the number one problem in Mississippi.” Although controversial, Read’s bill exemplifies both the current perception of obesity as a national public health problem and the general sentiment underlying the types of interventions that are being considered to address this issue. The proposed legislation also demonstrates how (...) policymakers can use or, in this case misuse, information about obesity to generate significant discussion on an issue along with ill-conceived legal interventions.Information sharing and the methods used to share best practices are components of the fourth core element of public health legal preparedness. (shrink)

In 2008, Representative John Read of Mississippi recently co-sponsored state legislation that would ban restaurants from serving obese customers. He later admitted that the bill was a publicity stunt,meant to “shed a little light on the number one problem in Mississippi.” Although controversial, Read’s bill exemplifies both the current perception of obesity as a national public health problem and the general sentiment underlying the types of interventions that are being considered to address this issue. The proposed legislation also demonstrates how (...) policymakers can use or, in this case misuse, information about obesity to generate significant discussion on an issue along with ill-conceived legal interventions.Information sharing and the methods used to share best practices are components of the fourth core element of public health legal preparedness. (shrink)

This article is concerned with the relationship between assessment information and teacher planning. In the UK, although planning used to be central to characterisations of formative assessment, the most recent government proclamations under the 'Assessment for Learning' banner offer no clear role for teachers making decisions about what to do based on assessment information. In this article, the reasons behind the shift will be examined. 'Contingent planning' will be proposed as a mechanism for using (...) assessment information in a planning context. (shrink)

This article is concerned with the relationship between assessment information and teacher planning. In the UK, although planning used to be central to characterisations of formative assessment, the most recent government proclamations under the 'Assessment for Learning' banner offer no clear role for teachers making decisions about what to do based on assessment information. In this article, the reasons behind the shift will be examined. 'Contingent planning' will be proposed as a mechanism for using (...) assessment information in a planning context. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults.Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected for (...) review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties.Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making.Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union law and (...) a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an effective and efficient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other contexts. (shrink)

Fear of cancer is mostly related to cancer recurrence, metastasis, additional cancer, and diagnostic tests. Its legacy as a lethal disease has raised fear of approaching death. Currently, cancer’s total suffering and the worsening phenomena have raised fear, especially among female patients. Family caregivers (FCGs) who are responsible for the day-to-day cancer care at home need to help the patients deal with this fear frequently. Due to the limited care competencies, they need supportive care from healthcare professionals in cancer fear (...) management. This study aims to assess how types of demanded healthcare information affect the FCG’s role in reducing the fear of female cancer patients. The mindsponge theory was used in conceptual development and interpretation. Bayesian Mindsponge Framework (BMF) analytics were used for statistical analysis on a dataset of 48 spouses (husbands) and 12 other family members in five congested communities of Surabaya, Indonesia. Results showed that among the six types of healthcare information, FCGs with higher demand on cancer-specific information and information on cancer physical needs were more likely to need support in reducing the fear of female cancer patients. Meanwhile, FCGs with a higher demand for information on support services were less likely to need support to reduce cancer patients’ fear. Other types of healthcare information have ambiguous effects on the need for support in reducing cancer-induced fear. This study reveals that the demanded cancer-specific information, e.g., cancer’s prognosis or likely outcome and information on cancer physical needs, need to be met in priority to assist FCG’s role in cancer fear management. (shrink)

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.Returning the locus of capacity assessment to the attending, the primary care (...) doctor, and even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation. (shrink)

The Cognitive Reflection Test (CRT; Frederick, 2005) is designed to measure the tendency to override a prepotent response alternative that is incorrect and to engage in further reflection that leads to the correct response. It is a prime measure of the miserly information processing posited by most dual process theories. The original three-item test may be becoming known to potential participants, however. We examined a four-item version that could serve as a substitute for the original. Our data show that (...) it displays a.58 correlation with the original version and that it has very similar relationships with cognitive ability, various thinking dispositions, and with several other rational thinking tasks. Combining the two versions into a seven-item test resulted in a measure of miserly processing with substantial reliability (.72). The seven-item version was a strong independent predictor of performance on rational thinking tasks after the variance accounted for by cognitive ability and thinking dispositions had been partialled out. (shrink)

In 2004, prenatal risk assessment (PRA) was implemented as a routine offer in Denmark, in order to give all pregnant women an informed choice about whether to undergo prenatal testing. PRA is a non-invasive intervention performed in the first trimester of pregnancy and measures the risk of a fetus having Down's syndrome or other chromosomal disorders. The risk figure provides the basis for action, i.e. the decision about whether or not to undergo invasive fetal testing via the maternal route (...) (amniocentesis or chorionic villus sampling), which, however, involves the risk of inducing a miscarriage. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, this paper investigates how ideals such as autonomy and non-directiveness are practised in processes of decision-making. We view such ideals as forming social practice rather than neutral instruments to reach a certain goal. Focusing on one couple's trajectory through the clinical practices of PRA and the process through which a decision is reached, we call into question the assumption that more choice and more objective information is a source of empowerment and control. We make evident how decisions are made through a complicated process of meaning-making, which emerges through the relationship between professionals, the clinical setting and the social life of the couples. In the face of complex risk knowledge, PRA users are reluctant to make choices and seek to re-install authority in the health professionals. However, when assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the fetus. It is argued that PRA performs a form of government that works not through compulsion or persuasion but through choice. An ethic of a shared responsibility for PRA and its outcome between pregnant women and health professionals would be more in agreement with how decisions are actually made. (shrink)

BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, (...) ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient (...) subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

Concerns with improper collection and usage of personal information by businesses or governments have been seen as critical to the success of the emerging electronic commerce. In this regard, computer professionals have the oversight responsibility for information privacy because they have the most extensive knowledge of their organization's systems and programs, as well as an intimate understanding of the data. Thus, the competence of these professionals in ensuring sound practice of information privacy is of great importance to (...) both researchers and practitioners. This research addresses the question of whether male computer professionals differ from their female counterparts in their self-regulatory efficacy to protect personal information privacy. A total of 103 male and 65 female subjects surveyed in Taiwan responded to a 10-item questionnaire that includes three measures: protection (protecting privacy information), non-distribution (not distributing privacy information to others), and non-acquisition (not acquiring privacy information). The findings show (1) significant gender differences exist in the subjects' overall self-regulatory efficacy for information privacy, and, in particular, (2) that female subjects in this study exhibited a higher level of self-regulatory efficacy than males for the protection and non-acquisition of personal privacy information. The identification of the factorial structure of the self-regulatory efficacy concerning information privacy may contribute to future research directed to examining the links between privacy efficacy and psychological variables, such as ethical attitude, ethical intention, and self-esteem. Studies can also be extended to investigate how different cultural practices of morality and computer use in men and women may shape the different development patterns of privacy self-efficacy. Understanding the different cultural practices may then shed light on the social sources of privacy competence and the appropriate remedies that can be provided to improve the situation. (shrink)

In 2004 prenatal risk assessment was implemented as a routine offer to all pregnant women in Denmark. It was argued that primarily the new programme would give all pregnant women an informed choice about whether to undergo prenatal testing. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, we call into question the assumption underlying the new guidelines that more choice and more objective information is a source (...) of empowerment and control. We focus on one couple's experience of PRA. This case makes it evident how supposed choices in the context of PRA may not be experienced as such. Rather, they are experienced as complicated processes of meaning-making in the relational space between the clinical setting, professional authority and the social life of the couples. PRA users are reluctant to make choices and abandon health professionals as authoritative experts in the face of complex risk knowledge. When assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the foetus. It is argued that al-though the new programme of prenatal testing in Denmark presents itself in opposition to quasi-eugenic and paternalistic forms of governing couples' decisions it represents another form of government that works through the notion of choice. An ethics of a shared responsibility of PRA and its outcome would be more in agreement with how decisions are actually made. (shrink)

A multi-method, multi-informant method was used to collect data from diverse stakeholders about school climate to inform school improvement efforts as part of the Positive Behaviour Intervention Supports framework. Teachers, administrators, school staff and students completed surveys and parents participated in focus groups to gather perspectives about school climate. Respondents identified safety as a strength at the school, staff and student results suggested interpersonal relationships as an area for improvement and staff identified parent involvement as an area for growth. Both (...) positive and negative perceptions of school climate emerged from the parent focus group. While there are limitations to the generalisability of the results, this case study provides a useful approach for schools to assess their school climate and establish goals for improvement. (shrink)

Objective: To assess the adequacy of the process of informed consent for surgical patients at the University Hospital of the West Indies. Method: The study is a prospective, cross-sectional, descriptive study. 210 patients at the University Hospital of the West Indies were interviewed using a standardised investigator-administered questionnaire, developed by the authors, after obtaining witnessed, informed consent for participation in the study. Data were analysed using SPSS V.12 for Windows. Results: Of the patients, 39.4% were male. Of the surgical procedures, (...) 68.6% were scheduled, 7.6% urgent and 23.8% emergency, 35.2% were minor and 64.8% major. Information imparted/received was acceptable in 40% of cases, good in 24% and inadequate (unacceptable) in 36% of cases. Almost all (97.6%) patients stated that they understood why an operation was planned and 93.3% thought that they had given informed consent. Most (95.2%) thought that they had free choice and made up their own mind. A quarter (25.2%) of all patients were told that it was mandatory for them to sign the form. There was a discussion of possible side effects and complications in 56.7% of patients. Conclusions: This study clearly indicates that surgical patients at the University Hospital of the West Indies feel that they have given informed consent. However, it also suggests that more information should be given to patients for consent to be truly informed. (shrink)

BackgroundData processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union General Data Protection Regulation. We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health.MethodsComputerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal (...) investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results.ResultsA total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage, access and accuracy of personal data and anonymisation procedures. A high variability was noted in the application of privacy principles.ConclusionsA comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy. (shrink)

Concerns with improper collection and usage of personal information by businesses or governments have been seen as critical to the success of the emerging electronic commerce. In this regard, computer professionals have the oversight responsibility for information privacy because they have the most extensive knowledge of their organization's systems and programs, as well as an intimate understanding of the data. Thus, the competence of these professionals in ensuring sound practice of information privacy is of great importance to (...) both researchers and practitioners. This research addresses the question of whether male computer professionals differ from their female counterparts in their self-regulatory efficacy to protect personal information privacy. A total of 103 male and 65 female subjects surveyed in Taiwan responded to a 10-item questionnaire that includes three measures: protection, non-distribution, and non-acquisition. The findings show significant gender differences exist in the subjects' overall self-regulatory efficacy for information privacy, and, in particular, that female subjects in this study exhibited a higher level of self-regulatory efficacy than males for the protection and non-acquisition of personal privacy information. The identification of the factorial structure of the self-regulatory efficacy concerning information privacy may contribute to future research directed to examining the links between privacy efficacy and psychological variables, such as ethical attitude, ethical intention, and self-esteem. Studies can also be extended to investigate how different cultural practices of morality and computer use in men and women may shape the different development patterns of privacy self-efficacy. Understanding the different cultural practices may then shed light on the social sources of privacy competence and the appropriate remedies that can be provided to improve the situation. (shrink)

The article analyses information exchange agreements between competitors. The article aims to reveal the cases where the exchange of information between competitors might be considered as a prohibited agreement, violating Article 101 of the Treaty on the Functioning of the European Union or Article 5 of the Law of the Republic of Lithuania on Competition. The article analyses the legal nature of the information exchange agreements between competitors, with utmost regard to the criteria, according to which an (...) agreement on the exchange of information could be acknowledged as prohibited or violating the rules of competition law. In the article it is presumed that information exchange agreements do not aim at restricting competition, however in certain cases they might have the effect of restriction of competition. (shrink)

ObjectiveThis study aims to investigate the lived experience in patients with obstructive sleep apnea syndrome and comorbid obesity following after continuous positive airway pressure therapy made with the disease the device, and to identify barriers and facilitators to the use of CPAP to improve rehabilitation provision and aid in disease self-management.MethodsQualitative research was conducted using three focus groups with a representative sample of 32 inpatients undergoing a 1-month pulmonary rehabilitation program at the IRCSS Istituto Auxologico Italiano San Giuseppe Hospital, Verbania, (...) Italy. The focus groups were recorded on tape, and contemporaneous notes were made. The tapes were transcribed verbatim, and Interpretative Phenomenological Analysis was used to develop themes.ResultsSix main themes were extracted: Living the diagnosis as a shock; You should not sleep on it: the importance of prevention; The adjustment to CPAP; Barriers and facilitators to the use of CPAP; Three in a bed; and The relationship with the healthcare system.ConclusionResults of this study suggest potential avenues for interventions to increase adherence to CPAP, including the provision of information and continued support. Individual counseling providing strategies aimed at helping the person to cope with the emotional problem and relational difficulties associated with the use of CPAP, and at strengthening self-efficacy and self-management skills are also encouraged for optimal care during the rehabilitation program. (shrink)

Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent involved in cosmetic (...) surgery resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT. (shrink)

It has been reported by some studies that the desire to be involved in decisions concerning one’s healthcare especially with regard to obtaining informed consent is related to educational status. The purpose of this study, therefore, is to assess the influence of educational status on attitude towards informed consent practice in three south-eastern Nigerian communities.

Purpose This paper aims to seek to ascertain the corporate social responsibility information needs of customers of microfinance institutions. It also ascertains their media preferences for CSR disclosure. Design/methodology/approach The study adapted Wilson’s concept of information needs as the conceptual basis of this study. Case study research design was used. The respondents consisted of customers of MFIs in Ghana. Semi-structured interview was used to collect the data. Data were analysed using thematic analysis technique. Findings The study found that (...) the CSR information needs of MFIs’ customers relate to moral disclosure, business survival disclosure, financial and business terms and conditions disclosure, donations disclosure and capacity building and training disclosure. The study also found that family and friends are the most reliable sources of CSR information for MFIs’ customers. Originality/value There is a great deal of literature available on CSR disclosure. However, limited studies have investigated the information needs of customers regarding CSR disclosure. Again, CSR disclosure in the Microfinance sector has received limited attention in the existing literature. This study expanded the existing literature by investigating the CSR information needs of MFIs’ customers. (shrink)

INTRODUCTION[|]The practice of medicine has evolved from old approach, in which all decisions for the patient are taken by physician, to a new approach, which includes patients to the medical decision-making process and endorses informed consent of the patients. In addition to healthcare professionals and patients, parents or legal representatives are stakeholders in the informed consent process of children. The knowledge and attitudes of physicians and medical school students about the informed consent period in children are important for the effectiveness (...) of the medical intervention and the biopsychosocial development of children. In this study, it was aimed to understand involvement of medical students and physicians in the informed consent process of children and their level of knowledge on children's rights and their attitudes in daily clinical practice.[¤]METHODS[|]The study is a descriptive study and n = 150 participants, who were randomly selected from senior medical school students working in medical school campus or university hospital and physicians serving pediatric patients, were included to this study. Questionnaires were applied for the measurement of participants' socio-demographic characteristics, education on pediatric patient rights, and legal provisions. The data were evaluated using SPSS 20.00 software.[¤]RESULTS[|]Of participants, 62% (n = 93) were phase 6 medical students, while 29.33% (n = 44) were resident physicians and the rest were faculty members (8.67%; n = 13). The proportion of physicians, who didn't received training on child rights, was 80.7% (n = 46) and statistically significantly higher than medical students (49.45%; n = 45) (p <0.001). However, participants who were not educated about the children's rights stated with higher ratio (44.83%; n=65), that informed consent should be obtained before medical intervention from individuals under 18 years of age, when they are compared to the the participants who received education (20.69%; n=30) (p = 0,019). The majority of participants (59.5%; n = 88) find the intervention in individuals under the age of 18 years in emergencies without consent of legal representatives ethically and legally appropriate (p <0.001). The participants believe that it is ethically and legally appropriate to conduct an intervention on an individual under the age of 18 years without the legal representative (36. 7%; n=54) (p <0.001).[¤]DISCUSSION AND CONCLUSION[|]This study compared the levels of knowledge and attitudes of participants, who were previously trained in or didn't received any training about children's rights and informed consent of children. However, the quality of the training of the participants on children's rights, was not questioned. This study showed that education on children's rights does not significantly increase the level of legal knowledge on children's rights. Having well-designed a subject focused on this theme in medical deontology and ethics education can increase the knowledge levels and improve the attitudes of medical students. This study sheds light on the issues that need to be focused in the medical faculties and the trainings of physicians and showed lack of information and need for development of attitudes regarding children's rights and informed consent in children.[¤]. (shrink)

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

This chapter develops criteria of work and failure implicit within the Prisons Information Group (GIP). Reading the group’s documents in conjunction with the thought of Michel Foucault, the chapter asks: How did the GIP characterize work or attribute failure and how did Foucault understand both in this period? By analyzing these discursive practices together, the essay first identifies five criteria of failure: discursive, structural, systemic, deconstructive, and productive failure. Second, it tests the GIP against each criterion, marking where it (...) does and does not fail. The chapter therefore offers an internal assessment of the GIP, one that is sensitive to the movement’s own discourse and development. In closing, the chapter draws several implications from this analysis of failure for contemporary prison activism and analysis. (shrink)

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...) 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (shrink)

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members’ attitudes; none (...) reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies. (shrink)

Given the increasing need for solid organ and tissue transplants and the decreasing supply of suitable allographic organs and tissue to meet this need, it is understandable that the hope for successful xenotransplantation has resurfaced in recent years. The biomedical obstacles to xenotransplantation encountered in previous attempts could be mitigated or overcome by developments in immunosuppression and especially by genetic manipulation of organ source animals. In this essay we consider the history of xenotransplantation, discuss the biomedical obstacles to success, explore (...) recent developments in transgenic sourcing of organs and tissues, and analyze the problem of infectious disease resulting from xenotransplantation (xenosis). We then apply a model of risk analysis to these risks. The conclusions of this risk analysis are used in an ethical evaluation of informed consent in xenotransplantation, with an ethical foundation in Kantian autonomy and Levinasian heteronomic alterity. Our conclusion is that individual and collective informed consent to the infectious disease risks of xenotransplantation requires an open, participatory and dialogical public policy process not yet seen in the United States and Europe. Until that process is created, we propose caution in xenotransplantation in general and a postponement of solid organ xenotransplants in particular. (shrink)

Research participants may not adequately understand the research in which they agree to enroll. This could be due to a myriad of factors. Such a missing link in the informed consent process contravenes the requirement for an.

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

El Ministerio de Salud Pública cubano ha otorgado especial importancia al tema relacionado con el desempeño profesional evaluativo de la información estadística en los profesionales de la salud, pero una revisión bibliográfica permitió constatar el insuficiente debate pedagógico encaminado a diagnosticar su estado actual para proponer alternativas que permitan su formación y desarrollo en los estudiantes. Este artículo tiene como objetivo caracterizar el desempeño profesional evaluativo de la información estadística en estudiantes de Medicina. Los resultados obtenidos con la aplicación de (...) métodos y técnicas de investigación, tales como encuestas, test de conocimientos permitieron confirmar que ese desempeño actualmente se expresa a un nivel insatisfactorio de actuación. Se concluyó buscar formas más efectivas para su logro en estudiantes de Medicina. The Cuban Ministry of Public Health has given special importance to the subject of professional assessment of statistical information in the area of public health; however, a bibliographic review allowed authors to prove pedagogical debate unsatisfactory. The review was aimed at diagnosing its current state and therefore provide alternatives that allow its formation and development in medical students. The objective of the article is to characterize the assessable professional performance of statistical information in medical students. The results achieved through the application of research methods and techniques such as surveys and knowledge tests enabled to confirm that, nowadays, professional performance is below satisfactory performance levels. As a result, newer and more effective ways of achieving it in medical students will be searched for. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for (...) risk–benefit assessment and informed consent. (shrink)

This paper proposes a framework for an ethical impact assessment which can be performed in regard to any policy, service, project or programme involving information technology. The framework is structured on the four principles posited by Beauchamp and Childress together with a separate section on privacy and data protection. The framework identifies key social values and ethical issues, provides some brief explanatory contextual information which is then followed by a set of questions aimed at the technology developer (...) or policy-maker to facilitate consideration of ethical issues, in consultation with stakeholders, which may arise in their undertaking. In addition, the framework includes a set of ethical tools and procedural practices which can be employed as part of the ethical impact assessment. Although the framework has been developed within a European context, it could be applied equally well beyond European borders. (shrink)