Research ethics committees: values and power in higher education

The rise of research governance structures in universities has created huge disquiet amongst academic researchers. The unquestioning adoption of a medical model of ethical review based upon positivist methodological assumptions has created for many a mismatch between their own ongoing ethical research practice and the process of obtaining clearance from Research Ethics Committees (REC). This paper examines the issues that have contributed to dissatisfaction with the ethical review model that is prevalent within the modern university. Using examples from the authors’ own experiences, the dynamics of values, interests and power in research governance is examined from multiple perspectives including that of REC member and applicant; lecturer/student supervisor; researcher; and
university administrator. The paper reveals a rift between the values and objectives of the key players in research governance within the modern university and concludes by asking whether differences can be resolved so that a collaborative approach to ethical review may be incorporated into a renewed academic research culture. It is suggested that the alternative is increasing alienation from anything to do with ‘ethics’, with potentially serious consequences for the ethical standards of social research.

Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries

BACKGROUND: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. METHODS AND FINDINGS: Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%-52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%-65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2-3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6-2.5). The probability of publication within two years after study completion ranged from 7% to 30%. CONCLUSIONS: A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.

Access to death certificates: What should research ethics committees require for approval?

PURPOSE: To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval Of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death. METHODS: A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s). RESULTS: Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol. RECOMMENDATIONS: Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which Voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Ethics in Research with Children

Widespread scholarly interest in ethics in research with children, as an extant field of inquiry and practice, is a relatively new phenomenon. The discipline of ethics can be traced back to the Hippocratic school, but its contemporary applications in the everyday worlds of children and those around them are gaining greater attention from theorists, practitioners, and those involved in policy. Heightened international awareness of the United Nations Convention on the Rights of the Child (1979) gave significant impetus to increasing international awareness of children’s rights to provision, protection, and participation in everyday contexts, including those in which research occurs. Understandings of research ethics and of children’s involvement in research relate to broader understandings of children and childhood drawn from developmental science, sociology, human geography, health sciences, and children’s human rights to participation and protection. Key understandings pertain to children’s competence to participate in research, to operate as reliable informants with respect to their own lives, to provide voluntary informed consent and dissent in research, and to make meaningful decisions about the nature and extent of their participation. The field is international and interdisciplinary, although bounded by legislative, policy, and jurisdictional requirements governing research—its conduct and dissemination. So, too, the burgeoning work of ethics committees, whether in relation to health research or social research, is evidence of a sharpened focus on governance of child research. Oxford Bibliographies offers a suite of perspectives, resources, and strategies to guide the researcher, practitioner, and policymaker and serves to challenge readers to interrogate conceptual understandings, methodologies, and dissemination of research with and about children. Exploration of the suite opens up new possibilities for considering children’s rights to participation in matters that affect their lives and for children to be seen and heard in research.

Introduction - research ethics : women, sex, and gender in biomedical research

The ethical governance of biomedical research is an area of intense international debate. Scholars argue about who should regulate and how, the appropriate role for ethics committees, what kind of research should be included, and who should be involved in monitoring compliance. A particular aspect of these debates concerns the inclusion of women as research participants and the efforts to ensure that researchers consistently investigate questions of sex and gender in health research. There is increasing evidence of the role of sex in the manifestation and course of some illnesses and their treatment. Moreover, evidence suggests that gendered expectations also affect health outcomes. This special issue investigates how researchers are addressing these issues and debates the appropriate roles of policy makers, ethicists, and lawyers in ensuring that sex and gender differences are taken into account in the development, conduct, and reporting of health research.

Progress in animal experimentation ethics. A case study from a brazilian medical school and from the international medical literature

PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Progress in animal experimentation ethics: a case study from a Brazilian medical school and from the international medical literature

PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Clinical ethics revisited

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems.

The ethics of paying drug users who participate in research: a review and practical recommendations

THE PAYMENT OF RESEARCH PARTICIPANTS raises ethical and empirical questions that have special importance in addictions research involving drug-dependent participants. Despite a now large literature on human subjects payment, what is still needed is practical guidance for investigators and ethics committees. This paper reviews the literature on: current payment practices and guidelines; defining features of undue and due incentives and fair reimbursement; and the significance of risks and harms that may arise from paying drug using participants. We conclude that research payments are ethically acceptable in most circumstances of addictions research, but should be closely scrutinized in situations where these may exacerbate existing harms or create additional risks for participants and investigators. General principles, key questions and procedural options are highlighted for an applied approach to ethical research payments. Future research directions are identified.