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)

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,...

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)

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)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the research, we used a deductive (...) qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and (...) decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members (...) supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

BackgroundMany studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.MethodsThe data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n (...) = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.ResultsThe researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.ConclusionThe written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. (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 aimed to explore postgraduate students’ lived experiences of managing research ethics committee processes. Whilst there is a wide range of research that explores ethics principles/guidan...

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)

OBJECTIVES: To report the outcome of applications to 43 research ethics committees. SETTING: Four regional health authorities in England. FINDINGS: The research ethics committees varied considerably in their practices. The time lapse until notification of the outcome of the approval ranged from just under one week to 23 weeks with a mean of 8.6 weeks. Four research ethics committees failed to notify the research team of an outcome of their request for approval. CONCLUSION: A national research (...) class='Hi'>ethics committee is needed to review national and multi-location research studies in the light of the fragmented and variable practice of local research ethics committees. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of (...) research participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

What should authorities establish as the job of ethics committees and review boards? Two answers are: review of proposals for consistency with the duly established and applicable code and review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad (...) code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. (shrink)

BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting an (...) end of study declaration to the Hampshire A research ethics committee between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.ResultsOut of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 of the published studies.ConclusionsThis study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research. (shrink)

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, (...) ensuring broad representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material. (shrink)

The current system of ethical review for medical research in the United Kingdom is changing from the current system involving large committees of 7–18 members reviewing every individual application to a system involving pre-review by small sub-committees of National Research Ethics Officers , who have a remit to approve studies if they believe there are no material ethical issues imposed by the research. The reliability of this new system depends on the reliability of the NREAs and in particular (...) the ability of small groups to effectively identify and appropriately assess the seriousness of all the material ethical issues that may be posed by an application. There is anecdotal evidence to suggest that many individual research ethics committee members have had experience of believing that a study presents no material ethical concerns, then on reaching the committee and discussing the application they realise that the committee feels it does present significant ethical concerns. If this is the case then this casts doubt on the reliability of NREAs or small groups to effectively identify ethically problematic research and appropriately respond to this to protect research participants. In this paper we describe a small questionnaire based piece of research carried out to assess how common this and other relevant experiences are. (shrink)

OBJECTIVES: To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN: Postal questionnaire. SETTING: Clinical research by one doctor during one year. SUBJECTS: Eleven patients entered in clinical trials. MAIN OUTCOME MEASURES: Success in ethics committee obtaining data. Achievement of ethical standards in recruitment of subjects (...) and in obtaining consent. RESULTS: The audit was successfully carried out and standards were partly met. CONCLUSIONS: Local Research Ethics Committees can carry out audits of the conduct of research projects which they have approved. Provision for possible audits can be made at the time of application to the committee. Our committee thought the ethical standards in the research which we audited were acceptable. (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 (...) class='Hi'>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)

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of (...) setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields. (shrink)

Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only.1 They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed. The first flawed argument is the argument related to the separation of powers. Moore and (...) Donnelly proceed from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement. This is because any understanding of ethics-consistency standards themselves and of their implications for any case is fallible and improvable in …. (shrink)

Ethical review of applications to conduct research projects continues to be a focus of scrutiny and controversy. We argue that attention to the actual practices of ethical review has the potential to inform debate. We explore how research ethics committees (RECs) establish their position and authority through the texts they use in their correspondence with applicants. Using a discursive analysis applied to 260 letters, we identify four positions of particular interest: RECs positioned as disinterested and responsible; as representing the (...) interests of potential participants; as facilitating ethically sound, high-quality research; and as engaged in dialogue. These positions are used strategically to deflect criticism or complaint. This analysis has implications for reducing contestation between researchers and RECs, suggesting that more dialogic rather than hierarchical approaches to positioning might be helpful. (shrink)

Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own committees to focus on or approve activities that have ethical impact. In contrast, lesser-developed countries are trying to set up these (...) committees to govern their academia and research. As the first European consortium established to assist academic integrity, European Network for Academic Integrity, we felt the importance of guiding those institutions and communities that are trying to conduct research with ethical principles. We have established an ethical advisory working group within ENAI with the aim to promote ethics within curriculum, research and institutional policies. We are constantly researching available data on this subject and committed to help the academia to convey and conduct ethical behaviour. Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications of research projects among peers. Therefore, this short paper preliminarily aims to critically review the available information on ethics, the history behind establishing ethical principles and its international guidelines to govern research.The paper is based on the workshop conducted in the 5th International conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019. During the workshop, we have detailed a) basic needs of an ethical committee within an institution; b) a typical ethical approval process ; and c) the ways to obtain informed consent with some examples. These are summarised in this paper with some example comparisons of ethical approval processes from different universities. We believe this paper will provide guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes. (shrink)

This project is based on the unique ‘Shared ethical debate’ between NHS RECs in the UK in which one research application is reviewed by several research ethics committees. This programme is now in its 6th cycle. In the fifth cycle a prison- based research project was reviewed by each of three NHS RECs that are ‘ flagged’ for such research and their debate and discussions were observed directly by one researcher who recorded the committee processes and the (...) issues raised in committee. Subsequently a focus group of REC members from all three committees was constituted to consider the ethical importance of these issues. The three RECs were consistent in both process and identifying ethical issues. The focus group formulated a basic framework that will further contribute to ensuring a consistent and balanced approach to ethical review within this area of research. (shrink)

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from (...) all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees. (shrink)

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.Objective: To assess training needs for biomedical research ethics evaluation among targeted countries.Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. (...) Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need. (shrink)

Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative (...) and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict. (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: In view of the increasing complexity of research ethics committee applications and thus the time and expense involved in completing the forms, continual monitoring of outcome of clinical research studies for which ethics applications have been submitted is essential in determining whether resources are being effectively used, or alternatively whether significant numbers of research proposals are abandoned because of lack of funding or manpower. Previously published surveys for which data are available examined outcome of studies receiving (...) REC approval 10 or more years ago.Methods: A prospective questionnaire-based survey sent out in July 2006 to all 506 principal investigators who submitted research ethics applications to nine Greater Manchester RECs between April 2004 and March 2005. Data on the outcome of REC applications, and the status of the research study were collected and analysed.Results: 288 of the 506 questionnaires were returned. 97% of REC applications were approved, and 87% of studies were in progress or had been completed 1–2 years after approval had been granted. Researchers employed by universities, healthcare and the pharmaceutical industry had similar rates of success in initiating research studies.Conclusions: This survey suggests that most research studies submitted to RECs in Manchester, UK are approved and initiated. (shrink)

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China’s HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested (...) measures include mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China’s HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China’s HEI. (shrink)

The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we (...) provide a structured approach to the ethical review of on-sharing of data and tissue for research purposes. (shrink)

Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were (...) studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Background Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Method Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Results Three hundred thirty-nine reports from (...) 38 CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. Discussion In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. Conclusions The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Healthcare ethics committees (HEC) have emerged as institutional forums for addressing bioethical dilemmas. Psychiatrists have important roles to play on these committees. Their skills in group process assessment, mental status examination, and character assessment have diverse applications. Psychiatrists can facilitate communication within the committee and as HEC-based clinical ethics consultants. HECs must be concerned with how they arrive at ethical decisions, guarding against political influence or individual monopolization. Psychiatrists can assist these efforts as organizational consultants to HECs. (...) The perception of psychiatrists as reflective, tolerant of ambiguity, humanizing, and approachable about ethical aspects of health care suggests they would make excellent committee leaders. Psychiatrists also have important committee roles to play as ethics educators and policy makers. More demographic data is needed to investigate psychiatrist participation on HECs. Studies of how they are perceived by their ethics committee colleagues may reveal new roles and potential pitfalls for HEC psychiatrists. (shrink)

ABSTRACT Objective: To describe how local research ethics committees (LRECs) consider and apply research ethics in the evaluation of biomedical research proposals. Design: A qualitative study was conducted using purposeful sampling, focus groups and a grounded theory approach to generate data and to analyse the work of the LRECs. Setting and participants: 11 LRECs of the Mexican Institute of Social Security (IMSS). Results: LRECs considered ethics to be implicit in all types of research, but that ethics (...) reviews were only necessary for projects that included the direct participation of human beings. The LRECs appeared to understand the importance of consent, as in the completion of a consent form, but did not emphasise the importance of the process of acquiring ‘informed’ consent. The committees considered their main roles or functions to be: (a) to improve the methodological quality of research and to verify – if applicable – the ethical aspects; (b) to encourage personnel to undergo research training; (c) to follow‐up research to oversee the adherence to norms and compliance with a specified research timetable. Conclusions: This study provides a valuable insight into how these LRECs understand the ethical review process. The emphasis of the committees was on rules, regulations, improving research methodology and research training, rather than a focus on efforts to protect the rights and well being of research subjects. The results encourage further normative and descriptive lines of investigation concerning education and the development of LRECs. (shrink)

There has been longstanding interest in the consistency of decisions made by research ethics committees in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. (...) An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of κ = 0.286 , indicating a level of agreement that, although probably better than chance, may be described as “slight”. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was (...) analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

The aim of this article is to take relational ethics concepts and apply them to the context of application to research ethics committees for approval to carry out research. The process of a multinational qualitative research application is described. The article suggests that a relational ethics approach can address two issues: how qualitative proposals are interpreted by research ethics committees and how this safeguards potentially vulnerable respondents. In relational terms, the governance of a research (...) project may be enhanced by shared ownership and willingness to engage in mutual dialogue. This challenges both researchers and research ethics committees to reframe their understanding of roles and functions in the assessment of research protocols, particularly those of a qualitative nature and those that address end-of-life issues. (shrink)

Aims and background: The present work assessed the impact of two decrees on ethics committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into line with the rest of the EC, and regulating and facilitating not-for-profit research.Material and methods: Prospectively collected data from an Italian multicentre study were examined with respect to the ethics review process. Administrative and time elements of the review process were audited. Main outcome measures were time between the (...) application submission and the ethics committee definitive opinion, type and number of application submission forms, number of ethics committees that refused fee exemption, and time between the ethics committee approval and the administrative authorisation.Results: A total of 134 local research ethics committees were approached. Application submission procedures and application forms varied greatly; paper submission was mandatory. The median time from submission to approval was 72 days. Only two LRECs refused the fee exemption. The median time from LREC approval to administrative agreement was 50 days and only 9.6% of local authorities came to a verbal agreement with the sponsor.Conclusions: Italian LRECs are still not sufficiently efficient in complying with the Directive 2001/20/EC requirement . Better coordination of LRECs work is needed although the optimal level of coordination between them is still not known. In the meantime, national guidelines are needed concerning the application of Directive 2001/20/EC. The behaviour of Italian LRECs towards not-for-profit research was excellent although only the fee exemption was requested. (shrink)

BackgroundSuicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees (HRECs) in dealing with suicide-related study applications.MethodsThis qualitative study entailed a thematic analysis using an inductive approach. We conducted (...) semi-structured interviews with a purposive sample (N = 15) of HREC Chairs or their delegates from Australian research-intensive universities. The interview guide included questions regarding the ethical concerns and challenges in suicide-related research raised by HREC members, how they dealt with those challenges and what advice they could give to researchers.ResultsThe analysis identified four main themes: (1) HREC members’ experiences of reviewing suicide-related study applications, (2) HREC members’ perceptions of suicide, suicide research, and study participants, (3) Complexity in HREC members’ decision-making processes, and (4) HREC members’ relationships with researchers.ConclusionsReliance on ethical guidelines and dialogue with researchers are crucial in the assessment of suicide-related study applications. Both researchers and HREC members may benefit from guidance and resources on how to conduct ethically sound suicide-related studies. Developing working relationships will be likely to help HRECs to facilitate high quality, ethical suicide-related research and researchers to conduct such research. (shrink)

The current practice for UK Research Ethics Committees is to invite researchers to attend meetings at which their applications are to be considered and the National Research Ethics Service strongly recommends researchers to attend. There are no available data, however, to substantiate the value of researchers' attendance and particularly on the extent to which their attendance may influence the initial decision of the committee. This study attempts to address whether it is in the researchers' interest to commit (...) substantial time and resource to attend a REC meeting through using the REC decision on the research proposal as the main outcome measure. (shrink)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of (...) which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (shrink)

In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee . A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging (...) research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network and HREC members in Australia. (shrink)

A previous research ethics article by the authors provided evidence to support the claim that the New Zealand Ethics Committee was a powerless ethics committee. Ethics review applicants were not formally obliged to seek ethics review, and any committee recommendations were given on a ‘take it or leave it’ basis. One year later, the capacity of applications has doubled, and NZEC finds its core assumptions challenged as funders and government agencies now compel (...) contracted researchers to make use of this free service. Moreover, NZEC has expanded into research areas inhabited by market researchers, long shy of ethics review. Review requirements and remit expansion challenges some, but not all, aspects of NZEC’s assumption of powerlessness as NZEC remains committed to research ethics, not research governance, and it adheres to the principles of the New Brunswick Declaration to respect applicants the same way it expects applicants to respect participants. This annual survey of applicants makes NZEC accountable to its applicants, providing evidence once more that NZEC’s expeditious and cordial review of applications is considered different from traditional ethics review. (shrink)

The current practice for UK research ethics committees is to invite researchers to attend meetings at which their applications are to be considered and for student-based research the National Research Ethics Service recommends supervisors to attend. This study aims to identify the extent to which students and their supervisors attend NHS REC meetings and whether attendance is associated with the initial outcomes of RECs.

BackgroundThere are numerous challenges in the consultation services of the Hospital Ethics Committees (HEC) that can impact the means of providing healthcare. This review aimed to identify the main challenges in the application of consultation services of the HEC and propose possible solutions.MethodsThis systematic review was conducted through searching electronic databases including PubMed, Scopus, Science Direct, ProQuest, and Embase. Inclusion criteria included studies published in English language in a peer-reviewed journal, from 2000 to 2019 were identified, which clearly (...) defined the design, method, and results of the study. Study selections, quality assessments, data extraction, and analysis were completed by two researchers, independently. The thematic analysis was used to analyze the data.ResultsThe search yielded 1204 articles and 6 of these, included the analyses. Challenges were categorized into 9 themes: (a) personal views and believes in healthcare professionals, (b) sense of fear in the healthcare professionals, (c) medical culture, (d) environmental factors, (e) managerial and structural factors, (f) characteristics of the HEC members, (g) factors related to the HEC, (h) problematic process for HEC consultations, and (i) weakness of knowledge about HEC. Accordingly, proposed solutions were organized according to five themes: reforming the HEC executive processes, creating the appropriate communications, developing awareness about HEC, improving the competencies of HEC members, and (e) receiving support from HEC consultations.ConclusionsThis review highlights that proposed solutions serve as examples of strategies, which attempt to solve challenges related to the application of the consultation services of HEC by healthcare professionals. (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)

Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees. We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost (...) 30% of letters; sometimes wording was impolite and demonstrated a lack of respect towards applicants; and there was often lack of clarity about the nature of a revision and whether the revision was compulsory or optional. The analysis provides messages for RECs about how they can improve their practices to establish a more cooperative relationship between researcher and committee through the careful use of language and attention to detail in decision letters. (shrink)

Members of the Student Clinical Ethics Committee discussed the ethical and legal issues arising in a case referred for consideration – a female patient in her mid-60s, who had a very long history of multiple sclerosis, withdrew her previous consent to treatment following discussion with her son. The case study summarises the reflections of the Committee and focusses on: the meaning and practical application of respect for patient autonomy; whether a refusal of clinically indicated treatment may (...) challenge the notion of capacity; the role of others in the process of decision-making; if the current decision to refuse treatment was the patient’s own and whether, in the circumstances, it should be respected. (shrink)