Function Of Research Ethics Committees Research Articles

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries.

Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative). Overall, 971 queries were identified, of which 407 (42%), 379 (39%), and 135 (14%) were deemed ethical, scientific, and administrative queries, respectively. The most frequent concern was about participants' information. The main influencing factor was the profession of the reporting readers-scientific queries were more frequently raised by a methodologist, whereas ethical queries were more frequently raised by an ethicist. These results indicate that research ethics review is a multidimensional task that should be considered a collaborative effort.

The Impact of Covid-19 Pandemic on the Function of Research Ethics Committees

The Impact of Covid-19 Pandemic on the Function of Research Ethics Committees

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.

Research Ethics Committees (RECs)—or Institutional Review Boards (IRBs), as they are known in the US—were created about 50 years ago to independently assess the ethical acceptability of research projects involving human subjects, their fundamental role being the protection of the dignity and rights of research participants. In this paper we develop some critical reflections about the current situation of RECs. Our starting point is the definition of the role they should ideally play, a role that should necessarily include a collaborative approach and the focus on the ethics component of the review. This ideal is unfortunately quite far from reality: inadequacies in the functioning of RECs have been discussed for decades, along with reform proposals. Both in the US and in the European Union (EU), reforms that aim at the centralization of the review process were recently approved. Even though these reforms were needed, they nonetheless raise concerns. We focus on two such concerns, related in particular to Regulation (EU) No 536/2014: the risk of narrowing the scope of the ethics review and that of disregarding the local context. We argue that the COVID‐19 pandemic paved the way for the transition towards the centralized model and that an analysis of its impact on the research review process could provide some interesting insights into possible shortcomings of this new model. We conclude by identifying three objectives that define the role of a REC, objectives that any reform should preserve.

An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for theoptimization of the trial supervision regime in the EU.Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance.On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis. ethics committees, clinical trials, Regulation on clinical trials, regulatory competition

A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research.

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task.

Current Status of Research Ethics Capacity in Myanmar.

Myanmar has recently surfaced from total military rule and efforts at conducting research to enhance the health of the population has increased during the recent democratization process, both from the military and civil sectors as well as support from international agencies. International guidelines mandate that such research requires prior ethics review in accordance with international standards. Previous commentators have expressed concerns, however, regarding the degree of adequate training in research ethics for investigators, the optimal functioning of Research Ethics Committees (RECs), and the extent of responsible conduct in research in low and middle-income countries. Such concerns might also be applicable to Myanmar, especially since it has recently emerged from a long period of military rule where there has been lack of basic freedoms and human rights abuses. We herein review the current gaps in research ethics capacity in Myanmar, the status of the existing RECs and the current efforts to establish training programs to enhance capacity in research ethics.

The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia

In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1...

A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

Estructura y funcionamiento de los comités de ética en investigación de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires

Given the few existing studies on research ethics committees (RECs) in Argentina, this paper aims to describe the structure and functioning of institutional RECs in the Autonomous City of Buenos Aires and Greater Buenos Aires. A descriptive, qualitative and quantitative research study was carried out using a survey conducted between March and July 2012. The sample was made up of 46 RECs. Forty percent of committee members were doctors and the age and sex distribution met standards. Inadequate numbers of methodologists, community representatives, lawyers and members external to the institution were identified, as well as shortcomings regarding administrative staff, fixed locations for meetings, budgets adequate to expenditures and training in research ethics. Some of those surveyed reported problems in their relationship with the institution and with researchers, in addition to difficulties regarding the time available to perform tasks.

[Structure and functioning of research ethics committees in the Autonomous City of Buenos Aires and Greater Buenos Aires].

Given the few existing studies on research ethics committees (RECs) in Argentina, this paper aims to describe the structure and functioning of institutional RECs in the Autonomous City of Buenos Aires and Greater Buenos Aires. A descriptive, qualitative and quantitative research study was carried out using a survey conducted between March and July 2012. The sample was made up of 46 RECs. Forty percent of committee members were doctors and the age and sex distribution met standards. Inadequate numbers of methodologists, community representatives, lawyers and members external to the institution were identified, as well as shortcomings regarding administrative staff, fixed locations for meetings, budgets adequate to expenditures and training in research ethics. Some of those surveyed reported problems in their relationship with the institution and with researchers, in addition to difficulties regarding the time available to perform tasks.

Research ethics training of trainers: Developing capacity of Bolivian health science and civil society leaders

Program/Project Purpose: The University of San Andres, Faculty of Medicine in La Paz, Bolivia in collaboration with Touro University California, Public Health Program was awarded a NIH Research Ethics Planning Grant in June, 2013 to develop strategies and processes for implementation of a comprehensive national research ethics program for Bolivia. Although the importance of scientific research based on ethical principles is highlighted in the Bolivian constitution and national health legislation, few Bolivian academics, researchers and health professionals have received formal training in the principles and practices of research ethics. A principle aim of the Planning Grant is to develop and implement a Research Ethics Train the Trainers (TOT) course with the goal of training faculty for future implementation of a national research ethics program. Structure/Method/Design: A Project Directors Committee representing public health science universities from four participating Bolivian Departments/States (La Paz; Santa Cruz, Cochabamba & Chuquisaca) was formed to oversee all project activities including implementation of a three day in-personTOT followed by a 10week online training. Training modules utilized materials developed by Bolivian academics and scientists and international research ethics programs at PAHO (PanAmerican Health Organization) and CITI (Collaborative Institutional Training Initiative), University of Miami. TOT University and civil society representatives were selected from each participating Department/State for a total of 26 participants. Upon completion of the training, participants were asked to implement educational research ethics activities in their local communities and institutions. Outcomes & Evaluation: A pre-test/post-test study design was used to assess change in participant knowledge related to research ethics principles and practices. The mean score improved from 73% correct at baseline and 84% at course completion. Participants completed a course evaluation after the in-person and virtual components of the course. Participants highlighted the most useful topics in the course as respect for persons and human rights, principles of bioethics, informed consent and the function of research ethics committees. The most positive aspects of the inperson component of the course were the high level of participation, group work, communication and debate among participants representing different academic disciplines and social sectors. Eighty percent of participants completed the course with five dropping out during the virtual component. Most students reported that the instructions for using the virtual platform were clear and they received sufficient support from the Course Coordinator, however, most stated that some of the teachers provided insufficient academic support. Going Forward: Integrating the group interaction strengths of the inperson TOT component with the flexibility of the virtual component recommends using a mixed methods approach while providing additional training to teachers related to virtual teaching methodologies. Funding: NIH/FIC, International Research Ethics Education and Curriculum Development Award (R25). Abstract #: 01ETC001

Biomedical Research Ethics Committees in sub-Saharan Africa: a collective review of their structure, functioning, and outcomes.

Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs.

Perspectives of Egyptian Research Ethics Committees regarding Their Effective Functioning

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

A European consistency for functioning of RECs? We just lost our chance

On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC....

The Role, Remit and Function of the Research Ethics Committee — 5. Collective Decision-Making and Research Ethics Committees

Part 5, the concluding essay in the series describing and discussing the role, remit and function of research ethics committees, bases an enquiry into the nature of decision-making by research ethics committees on the processes followed by the committees in their deliberations leading to the final outcome.

The Role, Remit and Function of the Research Ethics Committee — 4. Limits to Consent?

This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary.

The Role, Remit and Function of the Research Ethics Committee — 3. Balancing Potential Social Benefits against Risks to Subjects

This is the third in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in balancing the social value of the research it reviews against the risks it imposes on those who take part. The ethics committee's role in assessing the social value of research goes well beyond checking its scientific validity and this assessment may affect the risks ethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work.

What is the function of research ethics committees (RECs)

Carol Levine stated in 1988 that ethics in research was '... born in scandal and reared in protectionism'. To answer the question 'What is the function of RECs?', it would be necessary to understand the notion of ethics in research from the perspective of past tragedies. There are many examples of studies in the health context where vulnerabilities of research participants have been exploited. Violations of participants' rights and dignities have in many instances resulted in morbidity and mortality, costing them their health and even their lives.

The Role, Remit and Function of the Research Ethics Committee — 2. Science and Society: The Scope of Ethics Review

This is the second in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in assessing the science of the research it reviews. While ethics committees are not specifically constituted to review the science of a project, they must nevertheless assess the social benefits of research and, in this context, have an important role in checking that the science has been properly peer-reviewed.