Research Ethics Committee Members Research Articles

The contribution and attitudes of research ethics committees to complete registration and non-selective reporting of clinical trials: A European survey

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees (RECs) are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some (often unsystematic) mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

BackgroundResearch conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.MethodsWe used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.ResultsThrough this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.ConclusionBoth the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that ethics review of disaster research remains diligent and thorough.

Beneficence as a principle in human research.

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

BackgroundThe aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries – England, Canada, the United States of America (USA) – in the late 2000s.MethodsSeveral approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized.ResultsIn Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland.ConclusionsThe work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-016-0078-3) contains supplementary material, which is available to authorized users.

A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

BackgroundIn pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship.AimWe performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent.MethodsWe conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer.ResultsProfessionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person.ConclusionsAlthough the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.Electronic supplementary materialThe online version of this article (doi:10.1007/s40272-015-0158-9) contains supplementary material, which is available to authorized users.

Are Research Ethics Committees Prepared for Community-Based Participatory Research?

Community-based participatory research (CBPR) is challenging to research ethics committees (RECs). We reviewed the REC preparedness when reviewing CBPR projects. We searched the MEDLINE database and included qualitative studies of CBPR researchers or REC members about their experiences with RECs. The search yielded 107 studies, of which 10 met our criteria. Barriers were that the community is not prepared to conduct research, the reluctance of RECs to work outside the university, the difficulty RECs have understanding CBPR, and that REC forms evaluate individual rather than community risk. Facilitators were having a CBPR expert as an REC member and educating RECs. Therefore, RECs are not prepared to evaluate CBPR projects leading to unnecessary delays in the approval process.

Real-time Responsiveness for Ethics Oversight During Disaster Research.

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained.

Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

BackgroundMalaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand.MethodsProposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members’ reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk–benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population.ResultsAll 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design.ConclusionsThis study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies.

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications – US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.

Addressing ethical issues in H3Africa research – the views of research ethics committee members

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context.

Redundant, secretive, and isolated: when are clinical trials scientifically valid?

Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated. Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. According to a recent editorial in the BMJ, bioethicists and members of research ethics committees have been "notable by their absence" among those exposing persistent problems with clinical research and proposing solutions (Chalmers, Glasziou, and Godlee, BMJ 346, 2013, f105). In this paper I offer a theoretical diagnosis for the complicity of bioethicists and research ethics committees in these ongoing problems, as well as a partial solution in the form of a modified ethical requirement of scientific integrity.

The value of respect in human research ethics: a conceptual analysis and a practical guide.

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials.

BackgroundSouth Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.MethodsSite staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: “Familiarity with”, “Ease of Understanding”, “Ease of Implementing”, “Perceived Protection”, and “Agreement with” each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups.ResultsBoth care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was “Ease of Implementing,” and the least problematic was “Agreement with,” suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations.ConclusionsWe propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for “Ease of Implementing”, and/ or “Ease of Understanding” in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.

Prisoners as research participants: current practice and attitudes in the UK

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them...

Informed consent: towards improved lay-friendliness of patient information sheets.

Regional research ethics committee (REC) members have voiced a need for the linguistic improvement of informed consent documents to ensure duly informed consent and to ease committee deliberation. We have little knowledge of what elements of language use hamper comprehension, or of the extent of medical researchers' appreciation of this problem and their willingness to accept intervention. This qualitative, explorative study proposes an intervention design and tests its feasibility and acceptability. Semi-structured interviews with potential REC applicants informed a linguistic intervention benchmarked against existing guidelines, mandated locally and nationally, and then evaluated quantitatively in a semi-controlled set-up and qualitatively via questionnaires. Potential applicants professed the psychological acceptability of linguistic intervention. The intervention comprised a downloadable Microsoft Word template outlining information structure, a detailed guideline offering advice for each move and self-selected linguistic screening. It was used by 14 applicants and had a measurable effect on REC deliberation time and approval rates. The intervention instruments overall made it easier for applicants to produce informed consent documents meeting prescribed ethical standards concerning lay-friendliness. In conclusion, it was found that linguistic intervention is relevant, feasible and psychologically acceptable to REC applicants; it aids their text production process and seems to enhance the lay-friendliness of these texts.

Ethical considerations of research policy for personal genome analysis: the approach of the Genome Science Project in Japan

As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project—the Genome Science Project—this article presents a novel approach to conducting a specific policy for personal genome research in the Japanese context. In creating an original informed-consent form template for the project, we present a two-tiered process: making the draft of the template following an analysis of national and international policies; refining the draft template in conjunction with genome project researchers for practical application. Through practical use of the template, we have gained valuable experience in addressing challenges in the ethical review process, such as the importance of sharing details of the latest developments in genomics with members of research ethics committees. We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology.

“It’s my blood”: ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants

BackgroundThe use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research sites in the Western Cape and Gauteng, South Africa.MethodsData were collected using a semi-structured questionnaire that captured both quantitative and qualitative information at 6 research sites in South Africa. Interviews were conducted in English and Afrikaans. Data were analysed both quantitatively and qualitatively.ResultsOur study indicates that while the majority of participants were supportive of providing samples for research, serious concerns were voiced about future use, benefit sharing and export of samples. While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing. Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples. Interesting opinions were expressed with respect to export of samples.ConclusionsEliciting participant perspectives is an important part of community engagement in research involving biological sample collection, export, storage and future use. A tiered consent process appears to be more acceptable to participants in this study. Eliciting opinions of researchers and research ethics committee (REC) members would contribute multiple perspectives. Further research is required to interrogate the concept of ownership and the consent process in research involving biological samples.

A breach in patients' safety in randomized controlled trials of antibiotic drugs

In a number of randomized controlled trials of antibiotic drugs the pathogens cultured from patients and their in vitro susceptibilities to the study drugs were not disclosed to the physicians during the whole course of the disease. These trials included patients with sepsis and bacteraemia. In clinical practice the information on the pathogen and its susceptibilities serves to re-evaluate the antibiotic treatment on the second or third day. As there is strong evidence that antibiotic treatment (empirical and definitive) matching the in vitro susceptibility of the pathogen reduces fatality rates in severe infections, withholding these data is a breach in patient safety. Sponsors and investigators of clinical trials of antibiotic drugs should ensure that the susceptibility of pathogens to the trial drugs are made available to clinicians in real time and taken into account when considering change in patient management, as would be the case in routine clinical practice. Members of research ethics committees should make sure that the protocols provide for this, while journals considering publication of clinical trial results should ask that details on the availability of susceptibilities to the trial antibiotics are disclosed in the methods section.

The relevance of relevance in research

A new Swiss law requires that any research involving humans must aim to answer "a relevant research question". This paper explains the relevance of the relevance criterion in research, analyses the Swiss and British guidelines on relevance, and proposes a framework for researchers and research ethics committee (REC) members that enables a clearer conception of the role of relevance in research. We conclude that research must be either scientifically or societally beneficial in order to qualify as relevant, and RECs therefore cannot avoid reviewing the scientific aspects of proposed studies. Normally only scientifically relevant studies can be of benefit to society, but research of low scientific relevance can nonetheless be relevant to society if it forms part of the education of new doctors and scientists.

Lay REC members: patient or public?

In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered...