In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the (...) research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Hospital ethics committees are common, but not universal, in small hospitals. A needs assessment was completed at a 155-bed community hospital in order to adapt an academic tertiary center model for a clinical ethics committee to fit the needs of the small hospital community. Of 678 questionnaires distributed, 209 were completed. Data suggested that clinical staff frequently experienced ethical dilemmas. Significantly more nonphysicians indicated that they would utilize a consultation service, if available, compared to physicians (p = (...) 0.0067). The data also indicated that the majority of staff (>80 percent) desired more education in clinical ethics. Physicians preferred annual or bi-annual hospital-wide grand rounds, compared to nonphysicians, who preferred more frequent department-based teaching (p < 0.001). The data presented in this article were used to subsequently develop a clinical ethics support committee, the process of which is also described. (shrink)

Background:Emergency care providers are frequently faces with situations in which they have to make decisions quickly in stressful situations. They face barriers to ethical decision-making and recognizing and finding solutions to these barriers helps them to make ethical decision.Objectives:The purpose of this study was to identify barriers of ethical decision-making in Iranian Emergency Medical Service personnel.Methods:In this qualitative research, the participants (n = 15) were selected using the purposive sampling method, and the data were collected by deep (...) and semi-structured interviews. Finally, the data are analyzed using the content analysis approach.Ethical considerations:Permission to conduct the study was obtained from the Ethics Committee of the Shahid Beheshti University of Medical Sciences. The objectives of the study were explained to the participants and written consent was received from them. Also, participants were assured that necessary measures were taken to protect their anonymity and confidentiality.Findings:The results of the analysis are classified in five main categories. It encompasses the following areas: perception of situation, patient-related factors, input and output imbalance, uncoordinated health system, and paradoxes.Conclusion:Emergency Medical Service personnel make ethical decisions every day. It is important that prehospital personnel know how to manage those decisions properly so that clients’ moral rights are respected. Hence, by identifying the dimensions and obstacles of ethical decision-making in Emergency Medical Service personnel, it is possible to enhance the moral judgment and ethical accountability of the personnel and develop the strategies necessary for ethical decision-making in them. (shrink)

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They (...) also reported, however, that tendencies to evade moral disagreement, conflict, and ‘outsiders’ are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well‐known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. (shrink)

Hospitals in many countries have had clinical ethics committees for over 20 years. Despite this, there has been little research to evaluate these committees and growing evidence that they are underutilized. To address this gap, we investigated the question ‘What are the barriers and facilitators nurses and physicians perceive in consulting their hospital ethics committee?’ Thirty-four nurses, 10 nurse managers and 31 physicians working at four Canadian hospitals were interviewed using a semi-structured interview guide as (...) part of a larger investigation. We used content analysis of the interview data related to barriers and facilitators to use of hospital ethics committees to identify nine categories of barriers and nine categories of facilitators. These categories as well as their subcategories are discussed and those specific to nurses or physicians are identified. The need to increase health professionals' use of clinical ethics committees through reducing barriers and maximizing facilitators is discussed. (shrink)

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, (...) the American Society for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of (...) two workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

BackgroundThe last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries.MethodsSemi-structured interviews were conducted (...) from July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs.ResultsAcross the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding.ConclusionThe broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture. (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the (...) National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

In Canada, all institutions that conduct publicly funded, animal-based research are expected to comply with the standards of the Canadian Council on Animal Care (CCAC). The CCAC promotes the use of animal alternatives, and uses the “3Rs” principles of Replacement, Reduction, and Refinement as a guiding ethical framework. To ensure these standards are strictly enforced, internal ethics committees at each institution are tasked with creating “Animal Use Protocol” (AUP) forms to be filled out by researchers and evaluated by (...) the committees. In this paper, we assess AUP forms from Canada’s top research universities to identify the extent to which they conform to, or advance, the 3Rs framework. Our results show various deficiencies that call into question the quality of information elicited by these forms. To remedy this, we recommend that the CCAC assume responsibility for creating a standardized 3Rs section to be used on all AUP forms. In addition, proposal forms and experimental results for all research at CCAC-certified institutions should be digitized and uploaded into a national database. We argue that this would offer higher quality information for researchers at the experimental design stage, while strengthening the CCAC’s mandate to be accountable to the Canadian public. (shrink)

Personal data protection is an ethical issue. In this study we analyzed how research ethics committees (RECs) and data protection officers (DPOs) handle personal data protection issues in research protocols. We conducted a mixed-methods study. We included heads (or delegated representatives) of RECs and DPOs from universities and public research institutes in Croatia. The participants provided information about data protection issues in research and their mutual collaboration on those issues through structured interviews that contained closed and open-ended questions. (...) Qualitative description was used to analyze open-ended questions. The results showed that 55% of the REC representatives were not aware who was DPO in their institution. Among RECs, 65% never contacted the DPO. There were 61% of RECs who reported that they received no training from the organization on personal data protection. When asked about barriers to personal data protection in their institutions, 26% of REC members highlighted the lack of a clear protocol for assessing personal data protection issues, while 30% of DPOs mentioned lack of knowledge among researchers about personal data. In conclusion, we found that when it came to protecting personal data in research protocols, RECs and DPOs hardly ever worked together. When developing future personal data protection policies for academic and scientific research institutions, it is essential that RECs and DPOs should collaborate and both continue to expand/update their knowledge on personal data protection procedures. (shrink)

BackgroundThe COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, (...) we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa.MethodsTwenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses.ResultsKenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking.ConclusionsThis study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs. (shrink)

The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a (...) sample without the donor's consent. In this study, we present the results of 36 semistructured qualitative interviews with Swiss biobanking stakeholders regarding these options and the role of ethics committees in the process of authorizing sharing. Our results show that despite a lack of legal or guideline-based barriers to general consent, some stakeholders and ethics committees have reservations about this method of consent. In most cases, however, a general consent form is already in use. Many interviewees describe processes involving the ethics committees as time-consuming and cumbersome and their requirements as too demanding for donors/patients. Greater awareness of donors' opinions and preferences and the content of guidelines and recommendations could therefore be helpful for a better justified perspective of biobanking stakeholders and ethical committee members, equally. Finally, it may be necessary to differentiate between procedures governing future samples, where general consent is clearly desirable, and the use of old yet still relevant samples, where the option of using them without consent can be highly beneficial for research. (shrink)

Background People who are at elevated risk of suicide stand to benefit from internet-based interventions; however, research in this area is likely impacted by a range of ethical and practical challenges. The aim of this study was to examine the ethical issues and practical barriers associated with clinical studies of internet-based interventions for suicide prevention. Method This was a mixed-methods study involving two phases. First, a systematic search was conducted to identify studies evaluating internet-based interventions for people at risk (...) of suicide, and information pertaining to safety protocols and exclusion criteria was extracted. Second, investigators on the included studies were invited to complete an online survey comprising open-ended and forced-choice responses. Quantitative and qualitative methods were used to analyse the data. Results The literature search identified 18 eligible studies, of which three excluded participants based on severity of suicide risk. Half of the 15 suicide researchers who participated in the survey had experienced problems obtaining ethics approval, and none had encountered adverse events attributed to their intervention. Survey respondents noted the difficulty of managing risk in online environments and the limitations associated with implementing safety protocols, although some also reported increased confidence resulting from the ethical review process. Respondents recommended researchers pursue a collaborative relationship with their research ethics committees. Conclusion There is a balance to be achieved between the need to minimise the risk of adverse events whilst also ensuring interventions are being validated on populations who may be most likely to use and benefit from them. Further research is required to obtain the views of research ethics committees and research participants on these issues. Dialogue between researchers and ethics committees is necessary to address the need to ensure safety while also advancing the timely development of effective interventions in this critical area. (shrink)

Research on research ethics—regarding both the governance and practice of the ethical review of human subjects research—has a tumultuous history in North America and Europe. Much of the academic literature focuses on issues to do with regulating the conduct and quality of ethics review of research protocols by ethics committees (research ethics boards (REBs) in Canada and institutional review boards (IRBs) in the United States). In addition, some of the literature attends to issues particular to (...) the review of qualitative research, and still other literature addresses the challenges posed by and the need for research on REBs/IRBs. It is this third group of literature within which our article is situated. (shrink)

When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to (...) the trial intervention, unplanned financial liabilities for NHS Trusts forced to fund this, negative press and potential to undermine public trust.1–3,iOne reason for the lack of clarity is controversy over whether and when participants should have access, after the study, to the study intervention. At one extreme is the view that continued access should be ensured when the intervention has benefited the participant or when it has proven safe and effective for the participant population, irrespective of the cost and burden of ensuring continued access. At the other extreme is the view that continued access need never be provided so long as non-availability of the study intervention post-trial was adequately disclosed when participants were invited to participate.6 There is also disagreement about when poststudy access to the study intervention should be considered beneficial for participants. The spectrum ranges from the view that the intervention should be regarded as beneficial for a proposed use only after the …. (shrink)

Over the past 15 years, ethics committees have become common within the acute care hospital setting. Their development within long-term care settings has evolved more slowly and has been confined primarily to nursing homes. In this paper, I describe the development of an ethics committee in a residential center for the mentally retarded and developmentally disabled. I describe how the committee has progressed and some of the ethical issues in this setting.

Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18‐year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the science of HGT (...) itself. We will evaluate the latest preclinical research, especially data on the viruses that are used as vectors and on modes of administration of vectors. We will put forward new arguments concerning the toxicity assessment of so‐called ‘gene drugs‘, the tissue and cell type specificity of the vectors, and the duration and on‐set of gene expression. Secondly, we will look at procedural aspects of applied research ethics on the way to clinical application of HGT. There, informed consent (IC) and the patient‐researcher relationship are of utmost concern. Furthermore, we will explore the problem of expertise in risk assessment and will show how current regulations foster conflicts of interests that create dilemma situations even for those researchers who act in the best interest of the patients. We will conclude the article with a set of questions for ethicists who have to decide about the quality of HGT protocols. This may contribute to the safety of patients participating in HGT trials and to achieving the aim of efficient application of HGT. (shrink)

For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia’s voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research (...) institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals. (shrink)

Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and ...

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

Background Several ethical issues are associated with providing living organ transplantation services, and there is limited information on these issues faced by the teams providing service to refugees or asylum seekers. Aim To determine the challenges healthcare professionals face in organ transplant centers providing services to Syrians under temporary protection status and discern whether these difficulties align with ethical issues in living organ transplantation. Research design This study employed a qualitative design and conducted individual semi-structured, in-depth interviews with 18 transplant (...) team members in Istanbul between September and November 2022. Data analysis was based on Braun and Clarke’s thematic analysis. Participants and research context The participants comprised 18 healthcare professionals, including 6 physicians and 12 nurses working in organ transplant teams in Istanbul. Ethical considerations The University’s Ethics Committee provided approval. Participants were informed regarding confidentiality and signed an informed consent form. Results Three themes emerged from the data on ethical issues faced by organ transplantation services to Syrians: (a) beneficence or double equipoise, (b) autonomy, and (c) justice. Transplant teams experience problems related to preserving double equipoise in the provision of living donor organ transplantation because of language barriers, poor socioeconomic conditions, and cultural factors, which increases transplant teams’ individual and indirect social burden. Although problems arise from the language barrier when obtaining informed consent in the autonomy theme, institutional and national policies in preventing donor abuse have a comforting effect. Health workers had the least problems with the justice theme, wherein national health policies are determined. Conclusion Fewer issues related to autonomy and justice were reported in providing organ transplantation services to Syrians, with the most intense reported issues being maintaining double equipoise. The results revealed the need to develop institutional, national, and international policies with individual solutions to prevent difficulties healthcare professionals face in this process. (shrink)

BackgroundImplementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.DiscussionImplementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design (...) and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict requirements of ethics committees were developed for a purpose – to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally and informally ; without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada. (shrink)

Background The aim was to explore how the clinical ethics committees in Norway have worked and functioned within mental health care and addiction treatment services. Methods Analysis of 256 annual reports from clinical ethics committees from 2003 to 2012 and a survey to clinicians who had used a clinical ethics committee. Results Dilemmas related to coercion, confidentiality, information, and patient autonomy dominated. The committees established only for psychiatric hospitals, had received more cases from mental (...) health and addiction services than the committees also serving somatic services. Many of the case discussions involved both somatic and mental health care, complicated legal issues as well as ethical dilemmas. Mental health care professionals that have used the clinical ethics committees evaluated the clinical ethics committees deliberation as useful. Conclusion Given the many difficult ethical dilemmas in mental health care ethics work need to be strengthened. The complexity of the cases requires varied and interdisciplinary competence and training among the clinical ethics committee members. (shrink)

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review (...) processes. We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (shrink)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the (...) complex ethical issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)

This study explored the perceptions of ethics among long-term care employees (N275) in order to test two hypotheses. A cohort cross-sectional survey examined employees’ perceptions of an ethics environment, racial-ethnic, and position disparities (HO1; ANOVA), and, secondarily, ethics in relationship to select, research-grounded work features measured as manage disagreements, effectiveness, work satisfaction, and opinions of care, the latter including intention to remain (HO2; Pearson Correlations). Established questionnaires with robust psychometrics were employed. Response rate was 51%. Non-significant differences (...) between sample and population on key variables supported extrapolation of results. Statistically significant differences between racial–ethnic (p < 0.03; F 2.42) and work positions (p <0.0001; F 6.24) were revealed on ethics (3.16; HO1). Statistically significant relationships (p <0.0001; r = 0.26–0.68; HO2) between ethics and employees’ work features also were found, confirming both hypotheses. Perceptions of ethics based on racial-ethnic and position disparities, as well as the robust links with employee work features, offered potential avenues for decreasing disparities at work and improving the quality of long-term care. Noted further on ethics item scoring were relatively low scores indicating less involvement in, and access to, ethics discussions and decisions. In contrast, the literature review substantiated the importance of empowerment and retention, which were enhanced by employee involvement in work, notably, discussions and decisions. Thus, implications of ethics committees in long-term care sites as ways to potentially enhance employees’ work and quality of care, especially work satisfaction and retention, were explored; relevant concerns raised by the Covid pandemic were, briefly, discussed. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...) with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects. (shrink)

This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics committees (...) and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)

Few ethics committees were in place when the New Jersey Supreme Court announced its ruling on the Quinlan case in 1976. Today, the vast majority of hospitals have formed ethics committees and their use in nursing homes and other healthcare facilities is growing. Given the increasing commitment to the use of ethics committees and their increasing influence on healthcare decision making, the careful evaluation of committee performance should be a high priority. Yet to date (...) ethics committees appear to have undergone relatively little scrutiny. While professional articles on ethics committees do appear and at least one journal sets aside a regular section for the discussion of “Ethics Committees at Work” articles to date have primarily been limited to essays, philosophical inquiries, reports, case studies, and, occasionally, surveys. The use of more structured research methodologies has been lacking. As a result, it is not yet clear, for example, what characteristics describe the best functioning ethics committee. Indeed, what constitutes best functioning lacks careful definition as well. Committee impact on medical decision making and patient outcomes, while discussed, has not been systematically measured and analyzed. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs (...) involving exchange of biospecimens and data and in monitoring compliance. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in (...) Ethics Committees in Japan. Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees. The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitoring Quality in Health System. The study was conducted by the survey method. There were 56 hospitals that responded to the survey. The number of (...) HECs members fluctuated between 3 and 16 members, where usually 5 members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized. Only 55 % of HECs had a professional set of standards. 98 % of HECs had specific tasks. 62 % of HECs were asked for their expertise, and 55 % prepared <6.88 % of the opinions were related to interpersonal relations between hospital personnel, patients and their families with emphasis on the interactions between superiors and their inferiors or hospital staff and patients and their families. Only 12 % of the opinions were reported by the respondents as related to ethical dilemmas. In conclusion, few Polish hospitals have HECs, and the structure, services and workload are not always adequate. To ensure a reliable operation of HECs requires the development of relevant legislation, standard operating procedures and well trained members. (shrink)

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to (...) these concerns, the Drugs for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They (...) had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (shrink)

In the Philippines, all transplant centers are mandated by the Department of Health (DOH) to have a Hospital Transplant Ethics Committee (HTEC) to ensure that donations are altruistic, voluntary and free of coercion/commercial transactions. This study was undertaken primarily to describe the organizational and functional profile of existing HTECs and identify areas for improvement. This is a descriptive cross‐sectional study. There was variation in their logistical arrangements (support from hospital, filing systems, office spaces), operations (length and frequency of meetings, (...) number of referrals) and membership (composition, qualifications, occupation, training). The approval rate for donor‐recipient pairs is high with the majority of cases made by living non‐related donors. Appropriate reasons were cited for rejection. The perception of HTECs is that they are competent and confident in their decision‐making. However, there is a need to standardize HTEC composition, provide operating procedures and additional training which can be done by the DOH. (shrink)

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the (...) organizational context in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of “alibi ethics”. CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs. (shrink)