Learning System of Research Ethics for EC Members in Bangladesh

While large multicentre trials (MCTs) helps in timely recruitment of participants and gives generalizable results, fragmented ethics approval processes delay trial initiation. This study explored the perspectives of ethics committee (EC) members and researchers on ethics review processes in MCTs, and approaches to streamline ethics approval. A cross-sectional survey with semi-structured and open-ended questions gathered perspectives (August-October 2024) from researchers and EC members across India using a non-probability, network-based sampling strategy. Survey items were developed based on study objectives and relevant literature, and organised into key domains on EC functioning, operational challenges, EC communication and alternative ethics review processes: joint, designated, and national/ regional ECs. Participants shared their perspective regarding the current and three hypothetical ethics review processes. Quantitative data were analysed descriptively; and open-ended responses underwent qualitative content analysis. Of the respondents with MCT experience (106 researchers and 136 EC members), 21% of researchers and 31% of EC members supported the current model of independent EC review at each site. Less than half of respondents viewed the current process as very effective, and only about a quarter considered them efficient in avoiding delays. While researchers perceived designated ECs (30%) to have better efficiency, many EC members (32%) perceived joint reviews would ensure collaborative decision-making. National/ regional models were perceived to have challenges (16% EC members and 22% researchers) due to accountability concerns. Key challenges identified include absence of guidelines for joint review, conflicting decisions, need for training, prolonged timelines, resource constraints, and poor inter-EC communication. While there was no clear consensus for any of the proposed ethics review processes, consensus emerged regarding the need to optimise and reform the current process. These perspectives regarding operations of ECs could provide exploratory insights, although gathered using a non-probabilistic sample of potentially highly engaged respondents. These insights may inform further empirical research and discourse on contextually appropriate models to improving ethics review efficiency while safeguarding participant welfare. Not applicable.

Ethics of healthcare research in developing countries

Ethics in medical research

ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. cross-sectional survey. the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

THIS SPECIAL SECTION OF THE Journal of Empirical Research on Human Research Ethics (JERHRE) is based upon the assumption that much of the best empirical data relevant to research ethics is hidden from the view of Research Ethics Committee (REC) members and others who are interested in research ethics. There are at least three different senses in which ethics-relevant empirical research may be hidden: (1) it may be published in a journal that ethics committee members would not regularly read, (2) it may not use key words that would guide one to its ethics-relevant content, or (3) it may be sequestered in part of a research article that is about something else. This special section of JERHRE reviews all of these types of "hidden ethics" articles on the following issues: What is the relative frequency of hidden ethics articles in journals that focus on vulnerable populations? What does the non-ethics literature in clinical research and experimental economic decision theory teach us about ways of improving subjects' comprehension of risk information? How satisfied are parents and children with their experience with pediatric psychotrophic medication trials? And, how can retention rates be improved in longitudinal studies of difficult regimens such as drug rehabilitation? There is a major amount of ethics-relevant literature that is hidden. Without better ways of communicating the existence of this literature through use of key words, or recasting of the information to highlight its relevance to research ethics in journals that ethics committee members read, the benefits of evidence-based ethical problem solving will be lost.

Strengthening clinical and research ethics in Nigeria—an agenda for change

There has been a concern about the quality of clinical trials conducted in terms of data integrity, accuracy or ethical conduct. This study aimed to assess the tangible gap existing in knowledge and application of rules and guidelines among the Researcher, Research staff (RS) and Ethics Committee (EC) members - the three research stakeholders at the study sites. A validated e-questionnaire with details for demography, role, years of experience, affiliation and questions on knowledge and understanding about their clinical research functions based on the New Drugs and Clinical Trials (NDCT) Rules 2019, including: 'Role and responsibility, Regulations, Reporting timelines, Documentation, Conflict of interest and Miscellaneous' was circulated among the seven research sites of one organization with their fourteen Institutional ECs, as part of planned annual survey. Responses with >60% correct answers were arbitrarily considered to represent adequate knowledge. Of 201 participants, there were 27.4% Researchers, 50.2% were from the EC and 22.4% RS. A greater proportion of the Researchers (43.6%) had >5 years of experience. The mean ± SD of correct answers obtained was 66.9 ± 14.77 and was statistically significant (p<0.05) among the groups, highest for the EC members (71.4 ± 11.51), those with 2-5 years of experience (68.4 ± 14.40), and least for the RS (56.8 ± 11.93). Researchers (> 90%) were aware of their role in the clinical trial agreement and the importance of the trial registration in the Clinical Trials Registry India. There were gaps in the knowledge on Informed Consent (IC) process and post-trial access. Awareness regarding the IC process was adequate among the RS (84%). Awareness that the responsibility of all delegation at the site finally lies with the Researchers was adequate (60%), but 20% incorrectly believed that the sponsor can have access to subject identification details. Deficiencies were noted regarding documentation, NDCT rules -2019 and serious adverse event (SAE) reporting process. Five percent answered that Data Clarification Forms were generated after reviewing the case report forms. The awareness that NDCT rules-2019 was not for medical devices, student projects or Investigator Initiated Studies was inadequate (56%). The EC members' awareness of roles and responsibilities was adequate (≥ 90%). Knowledge gaps were noted in EC monitoring of the ongoing trials (32%) and SAE reporting on the SUGAM portal (8.8%), where stakeholders can access the regulator's web services using a single window interface for clinical trial related activities. There are gaps in the knowledge of the 3 stakeholders at the site. Identifying and rectifying the gray areas will improve the site's performance. There is a need for regular training and assessments.

Good Clinical Practices (GCP) are essential for patient-centric research. The standard bioethics and GCP training emphasizing a "one-size-fits-all" approach may not adequately equip ethics committee members, especially the lay and social scientist members, towards their critical role in reviewing clinical trials and related documentation. This article explores a patient-centered, patient advocates-driven training program focused on raising awareness about research ethics and GCP among patients, advocates and ethics committee members. A patient advocates-driven program called Patient Advocates for Clinical Research (PACER) conducted trainings focused on GCP for patient-centric research for patients, advocates and ethics committee members. Pre- and post-workshop questionnaires were used to assess the participants' knowledge of GCP. The workshop was attended by 116 participants. Of these 91 consented to participate in questionnaire evaluation that assessed participants' knowledge on ethics committee (EC) functionality, research ethics and data confidentiality. Pre-workshop evaluations highlighted knowledge gaps. Only 16.5% were familiar with the primary ethical consideration for vulnerable populations and 69.2% were knowledgeable about data governance. Post-workshop evaluations demonstrated significant overall response improvement of 5.4% (𝜒2=13.890; p<0.001). The understanding of ethical considerations for vulnerable populations rose by 15.4% (p=0.007), and knowledge of data privacy regulations improved by 11.0% (p=0.041). The workshop under PACER initiative highlighted the knowledge gaps in understanding the EC functionality, research ethics and data confidentiality. The workshop effectively fostered participants' understanding of ethical research practices.

Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

Are Ethics Committees in Tune With the “Epidemiology of Ethical Issues”?

Researchers increasingly use social media (SM) to recruit, retain, and trace participants, yet empirical literature investigating the ethics of engaging participants via SM is lacking. We conducted a survey of 401 Australian researchers and human research ethics committee (HREC) members to examine their experience, attitudes, and ethical concerns toward engaging participants via SM. Data revealed that researchers and HREC members share similar concerns and attitudes about using SM in general and in research. We identified a strong demand for additional support, training, and guidance on SM research ethics. This need reflects researchers' and HREC members' limited confidence and knowledge of ethical issues in this context and a lack of awareness of available SM-specific ethical guidelines.

Obtaining 'informed consent' from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require 'informed consent form' as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.

BackgroundGiving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about how trialists can develop suitable communication materials. There is limited evidence about what research ethics committees think of this issue, and limited guidance about what level of oversight they should have over the proposed communications, or post-consent participant communications generally. We conducted a survey of UK ethics committee members to address these points.MethodsThe survey was co-developed by public contributors and trialists who had previously worked together on the communications guidance. We asked respondents if they agreed with the general idea of informing participants who stop taking part, if they had ever been requested to review similar communications, and what level of ethics committee review they might recommend. The survey was primarily conducted online. It was reviewed by three ethics committee members before finalisation and shared directly with all UK ethics committee members. We analysed quantitative questions descriptively and used inductive analysis for open questions to identify common themes.ResultsNinety-one ethics committee members participated (nearly 10% of all UK members). The sample was similar to reported data about all members in terms of several personal characteristics. Most respondents (83%) agreed with our project’s rationale. Only 23% of respondents reported having been asked to review an end-of-participation information sheet before. Respondents gave various answers about the level of ethics committee review required, but most supported a relatively proportionate review process. Common concerns were about the risk of coercion or making participants feel pressured.ConclusionsOur survey suggests that ethics committee members generally support providing information to trial participants who stop taking part, if risks to participants are mitigated. We believe our guidance already addresses the main concerns raised. Our respondents’ lack of prior experience with end-of-participation information sheets suggests that participants are not getting information they want or need when they stop participating. Our results help clarify how ethics committee should oversee post-consent participant communications, but further guidance from research regulators could be helpful.

Ethical oversight is essential since clinical research involves animal and human participants. Despite being established to uphold moral standards, the effectiveness of ethics committees (ECs) in protecting participants remains uncertain. This scoping review examines EC members’ competency and operational performance. We searched PubMed, Scopus, and Web of Science for papers assessing EC members’ competence and operational performance from 2013 to May 2024 in compliance with PRISMA guidelines. After removing duplicates and irrelevant studies, 16 publications were reviewed. Findings were compared across countries and institutions to identify patterns and areas requiring improvements in EC. Out of 16 articles, 6 (37.5%) exclusively assessed the competency in knowledge, attitude, skills, and practices, while 10 (62.5%) papers evaluated the competencies related to EC members’ structure, functioning, and procedural performance. The current study report shows that knowledge scores range from 11.3% to 62.5% across the six studies. Most studies suggested that standardized, periodic training should be for EC members. Proficiency in reviewing complex study designs ranged from 14% to 53%, and substantial gaps were noted in understanding ethical principles, particularly among ECs with heavier workloads despite accreditation. On-site monitoring identified frequent ethical breaches, including missing documentation and incomplete serious adverse event records. Access to formal ethics education was limited to approximately 25% of members, with 20% of ECs reporting inadequate staffing and limited resources. In addition, delays in the communication of EC decisions are observed. The findings highlight the need for standardized ethics training, national oversight mechanisms, and adequate resources to improve the effectiveness of ECs in making the right decisions and enhancing their competency in execution.

The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in-depth interviews using an unfolding case vignette with probes. A shared view among most was that individual research results which are 'actionable' or have 'clinical significance' should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to "give back" to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of 'ownership' appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for "two way altruism" where the researcher in return for the altruistic 'valuable contribution', shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of "giving back" which goes beyond individual rights and ensures reciprocity and distributive justice.