Ethics Committee Members Research Articles

Two kinds of embryo research: four case examples

There are ethical obligations to conduct research that contributes to generalisable knowledge and improves reproductive health, and this should include embryo research in jurisdictions where it is permitted. Often, the...

Research ethics support during the COVID-19 epidemic: a collaborative effort by South African Research Ethics Committees

The COVID-2019 pandemic caused disruption of health services globally due to increased need for critical care facilities and collateral damage to routine healthcare services. Global and local research into disease pathogenesis and management strategies is central to a public health emergency response. South African legislation mandates that no health research may be conducted without approval from a registered Research Ethics Committee. For results to have maximum impact and relevance in a pandemic situation, ethics review and approval must be rapid and timeous, without compromising rigour and quality of review. This chapter argues that South African Research Ethics Committees were under-prepared for this task, largely due to gaps in national ethics guidance and the critical absence of the National Health Research Ethics Council. Although ethics guidance documents contain enabling clauses, no specified procedures for rapid review in emergencies exist. Consequently, and in an unprecedented initiative, several Research Ethics Committee chairpersons and members formed a spontaneous informal, ad hoc group, ‘Research Ethics Support in COVID-19 Pandemic’ (RESCOP), to share resources and support for managing the review of research related to COVID-19. The chapter outlines the processes put in place and mechanisms introduced by RESCOP in the interest of responsible and accountable, but rapid, ethics review. We describe good practices for rapid full ethics review of COVID-19 health research, including clinical trials. RESCOP’s innovative collaboration enabled rapid but thorough ethics review of research protocols during the epidemic. The processes established can serve as a good-practice model that could be adopted and adapted by other committees and future versions of national research ethics guidelines.

Why Non-Clinicians Should Not Be Doing Clinical Ethics

Why Non-Clinicians Should Not Be Doing Clinical Ethics

The ethical and legal considerations of young people and their parents using a hospital patient portal: Hospital Ethics Committee members perspectives

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal (MyGOSH). MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric Bioethics Centre were recruited ( n = 7). Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee (REC) Approval was granted by London Southeast REC (IRAS Project ID: 248793; REC Reference: 18/LO/1945). Results Four themes, and sub-themes, were identified: (1) granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; (2) inequalities resulting in inequities – complexities of inequity in access; (3) responding to change – providing support and managing expectations; (4) engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit.

The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials

BackgroundA failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention.MethodsThis study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire.ResultsEight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable.ConclusionsThis is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.

Considerations of Autonomy in Guiding Decisions around the Feedback of Individual Genetic Research Results from Genomics Research: Expectations of and Preferences from Researchers in Botswana.

Background The Human Health and Heredity (H3Africa) Consortium continues to generate large amounts of genomic data leading to new insights into health and disease among African populations. This has however generated debate among stakeholders involved in developing, implementing, and applying ethical standards and policies for the return of individual genetic research results. The key questions are about when results must, should, may, or must not be returned and by whom. This study aimed to explore the views on the feedback of individual pertinent and incidental genetic research results of researchers, ethics committee members, and policymakers in Botswana. Methods In-depth interviews were conducted with 16 key stakeholders from academic, research institutions, and regulatory bodies in Botswana. An analysis of the coded data was done through an iterative process of analytic induction to document and interpret themes and patterns. Results Overall, the study indicated that researchers have at least a partial obligation to return individual genetic research results to research participants. Respondents placed emphasis on the ethical principle of autonomy. They felt that it was inappropriate for researchers to make decisions about the return of results on participants' behalf except in situations of avoiding participant self-harm or harm to society. Conclusion Findings helped to highlight the importance of considering participants' autonomy in the development of sustainable and credible guidelines for feedback of findings from genomics research in Botswana, which can be explained during community engagement and consent processes. Such guidelines would ultimately be used to develop policies, guide African genomics research, and promote participant autonomy, transparency, and possibly participant trust in research.

How do Research Ethics Committee Members Respond to Hypothetical Studies with Children? Results from the MESSI Study.

Hypothetical scenarios were used to assess the influence of the sensitivity of the study topic, payments, and study methods on research ethics committee (HREC) members' approval of social research studies involving children. A total of 183 Australian HREC members completed an online survey. The higher the perceived sensitivity of the study topic, the less likely the study would be approved by an HREC member. HREC members were most likely to approve each of the hypothetical studies if no payment was offered. Payment was the most common reason for not approving the low risk studies, while risks were the most common reasons for not approving the more sensitive studies. Face-to-face interviews conducted at home with children elicited substantially higher rates of approval from HREC members with more sensitive study topics. Both HRECs and researchers may benefit from additional guidance on managing risks and payments for children and young people in research.

Perspectives on returning individual and aggregate genomic research results to study participants and communities in Kenya: a qualitative study

BackgroundA fundamental ethical challenge in conducting genomics research is the question of what and how individual level genetic findings and aggregate genomic results should be conveyed to research participants and communities. This is within the context of minimal guidance, policies, and experiences, particularly in Africa. The aim of this study was to explore the perspectives of key stakeholders' on returning genomics research results to participants in Kenya.MethodsThis qualitative study involved focus group discussions (FGDs) and in-depth interviews (IDIs) with 69 stakeholders. The purposively selected participants, included research ethics committee (REC) members (8), community members (44), community resource persons (8), and researchers (9). A semi-structured interview guide was used to facilitate discussions. Six FGDs and twenty-five (IDIs) were conducted among the different stakeholders. The issues explored in the interviews included: (1) views on returning results, (2) kind of results to be returned, (3) value of returning results to participants, and (4) challenges anticipated in returning results to participants and communities. The interviews were audio-recorded, transcribed verbatim, and coded in Nvivo 12 pro. Thematic and content analysis was conducted.ResultsParticipants agreed on the importance of returning genomic results either as individual or aggregate results. The most cited reasons for returning of genomic results included recognizing participants' contribution to research, encouraging participation in future research, and increasing the awareness of scientific progress. Other aspects on how genomic research results should be shared included sharing easy to understand results in the shortest time possible and maintaining confidentiality when sharing sensitive results.ConclusionsThis study identified key stakeholders’ perspectives on returning genomic results at the individual and community levels in two urban informal settlements of Nairobi. The majority of the participants expect to receive feedback about their genomic results, and it is an obligation for researchers to see how to best fulfil it.

Problemas morais e/ou éticos em comitês de ética em pesquisa

Abstract The objective of the study is to analyze moral and/or ethical issues experienced by members of research ethics committees when performing their activities and the strategies used to deal with those issues. This is a qualitative study with 39 individuals that participated in committees in Salvador, Bahia, Brazil. Data were collected in October 2020 using a self-administered online questionnaire developed using Google Forms. Results showed that participants underwent conflicts of interests and values, and also faced dilemmas, and the strategies used to deal with those issues were exchanging of experiences and sharing of ideas and opinions. It is concluded that members of such committees experience moral and/or ethical issues and seek to deal with them via strategies that favor the development of research according to appropriate ethical and methodological criteria.

Prioritise research on vaccines for pregnant and breastfeeding women

Prioritise research on vaccines for pregnant and breastfeeding women

A survey on Biostatisticians Serving in the Italian Ethics Committees


 Background. Italian ethics committees (ECs) have the responsibility for evaluating and monitoring clinical research.
 Methods. An electronic survey targeted to the biostatisticians operating in the 95 ECs in Italy, was launched in November 2016. Several aspects were explored such as education, job title, training in biostatistics and experience in the evaluation of protocols within the EC.
 Results. Seventy case report forms were returned (74%), and the response rate was highest for ECs located in the South (78%) and lowest in the North (51%). The biostatisticians in the respondent ECs were prevalently male, aged 50-60 years, with postgraduate education in medical specialties and statistics. The annual workload varied depending on the type of institution and geographical area, with an annual median number of protocols examined ranging from 80 in hospital ECs to 198 in university hospital ECs, and from 80 to 108, in the South and the Centre, respectively. Of these, 40% were observational study protocols. The EC biostatisticians proposed to reject 5% of protocols and to suspend with the request of clarification or amendments 10%. Only 61% and 79% of these opinions, respectively, were regarded as binding by the other EC members.
 Conclusion. The biostatistician will not be able to play a significant role in the EC as long as the required skill-set remains vague and his/her opinion on a protocol is underrated.

Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees.

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues.

Amending Ethics Committee Sanction Recommendations in the House of Representatives

The Constitution provides Congress with the power to punish and discipline its Members. Since the 90th Congress (1967–1968), the House Ethics Committee has been authorized to investigate allegations of misconduct and recommend punishments. This paper examines seven instances where the House Ethics Committee has recommended punishment and the House has considered an amendment to increase or decrease the proposed sanction. Using a combination of case studies and a roll call vote data, this paper finds that demographic similarities between the accused and the voting Member (race, party, and state delegation), partisanship, and serving on the Ethics Committee influence whether a Member might choose to support an alternative sanction. For amendments that propose an increased penalty, same state delegation (negative effect), co-partisanship (positive effect), race (positive effect), ideology (positive effect), and type of scandal (negative effect) matter. For decreased penalties, same state delegation (positive effect), race (positive effect), and ideology (negative effect) matter. For all amendments, being an Ethics Committee member is a strongly negative predictor. These findings imply that committee members attempt to protect the committee’s recommendation, that demographic similarities matter when Members are making sanction decisions, and that ideology is a driving factor in deciding to support a change in ethics penalty.

Online Training as a Means to Improve the Understanding of Ethical, Legal, and Social Aspects of Biobanking Research: Stakeholder Perspectives from South Africa.

Introduction: The proliferation of biobanking activities demand a review of current training opportunities for service providers and researchers, specifically related to the ethical, legal, and social issues (ELSI) of biobanking research. Such information could be useful for planning and developing an educational course. However, it is equally important to explore the platform for offering such a course. Aim and Objectives: This study explored stakeholder perspectives on training needs in biobanking research and the use of an online training platform for such educational purposes. Methods: An exploratory study design using qualitative data was used. The study sample comprised selected stakeholders (n = 25) including biobankers, clinicians, researchers, postgraduate students, and research ethics committee members. Semi-structured in-person or Skype interviews were conducted and all ethical considerations were upheld. The interview focused on participants' perspectives on the accessibility and applicability of current available courses, and advantages and disadvantages of online biobanking courses. Data were analyzed using thematic analysis. Results and Discussion: The following themes arose from data analysis: inadequate availability of online courses, and advantages and disadvantages of online courses and opportunities for a successful training course. There was general consensus regarding the limited availability of context-specific training opportunities on the ELSI of biobanking. The majority of participants were previously self-taught and therefore relied on existing literature and collaborations with international biobanking groups for ongoing learning. Some respondents indicated that the costs of such available training courses were exorbitant. Some respondents also felt that available courses were not tailored to the specific needs of a diverse audience in biobanking. Apart from access, respondents reported possible challenges with internet connectivity and availability of data. Conclusion: Respondents expressed a need for affordable and focused online educational opportunities in biobanking, but highlighted that these courses need to be contextualized and integrated into other learning activities.

Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval.

Barriers and Facilitating Factors for Conducting Systematic Evidence Assessments in Academic Clinical Trials

A systematic assessment of existing research should justify the conduct and inform the design of new clinical research but is often lacking. There is little research on the barriers to and factors facilitating systematic evidence assessments. To examine the practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. In this qualitative study, individual semistructured qualitative interviews were conducted between February and August 2020 with 48 Swiss stakeholder groups (27 primary investigators, 9 funders and sponsors, 6 clinical trial support organizations, and 6 ethics committee members) and between January and March 2021 with 9 international funders of clinical trials from North America and Europe with a reputation for requiring systematic evidence synthesis in applications for academic clinical trials. The main outcomes were practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. Interviews were analyzed using conventional content analysis. Of the 57 participants, 40 (70.2%) were male. Participants universally acknowledged that a comprehensive understanding of the previous evidence is important but reported wide variation regarding how this should be achieved. Participants reported that the conduct of formal systematic reviews was currently not expected before most clinical trials, but most international funders reported expecting a systematic search for the existing evidence. Whereas time and resources were reported by all participants as barriers to conducting systematic reviews, the Swiss research ecosystem was reported not to be as supportive of a systematic approach compared with international settings. In this qualitative study, Swiss stakeholders and international funders generally agreed that new clinical trials should be justified by a systematic evidence assessment but that barriers on individual, organizational, and political levels kept them from implementing it. More explicit requirements from funders appear to be needed to clarify the required level of comprehensiveness in summarizing existing evidence for different types of clinical trials.

Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

BackgroundThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders.MethodsA total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public.ResultsThe survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data.ConclusionThe recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

Human Research Ethics Committee Experiences and Views About Children's Participation in Research: Results From the MESSI Study.

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members' confidence to judge ethical research with children.

Barriers and Facilitators for Implementing a National Guideline to Foster the Responsible Use of Residual Biospecimens and Data in Health Research.

Residual biospecimens that are stored in hospitals' diagnostic specimen archives can be used for scientific research under strict legal and ethical regulations. In the Netherlands, a Code of Conduct governs responsible secondary use of residual biospecimens. However, implementation of this Code seems to be challenging. This study aims to explore the most important factors that facilitate or hinder the implementation of the Code. In addition, it investigates what is needed to further foster the responsible use of residual biospecimens. A mixed-methods design was used. Questionnaires were sent out to pathologists, patient information centers, physicians, researchers, data protection officers (DPOs), members of research ethics committees, and members of the boards of directors of all hospitals in the Netherlands (81 hospitals). To further investigate the barriers and facilitators, interviews were conducted with pathologists, patient information centers, physician-researchers, DPOs, review boards, research coordinators, and quality managers of pathology departments. In total, 246 respondents filled out the questionnaire and 36 interviews were conducted. Major barriers for implementing were a lack of resources (time, money), a lack of attention for responsible use, and a lack of practical knowledge (knowing what to do, where to go with questions). In contrast, the perception that implementing the Code was necessary, either by the respondent or by colleagues, was considered "a driver" for implementation. Practical instruments such as checklists and roadmaps were considered necessary to foster implementation; however, the creation of such instruments was hindered by a lack of clear-cut answers regarding legal aspects. Therefore, more clarity and harmonization on how to interpret both the Code and legislation regarding secondary use were considered necessary.

A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda

BackgroundOver the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review.MethodsThis was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies.ResultsWe enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29).ConclusionCompetence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.