Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards adopt these roles. I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate=55%), and an additional 12 members and administrators. IRBs become involved in a variety of RI problems, broadly defined, and face (...) challenges in deciding how and when to do so. IRBs vary in how they define, discover, and respond to RI problems, and interact with other institutional offices concerning these issues; and what types of RI violations they encountered. While many institutions establish separate Compliance Offices, the boundaries and relationships between these entities and IRBs vary; and many IRBs discover and monitor RI violations, and struggle with how to respond. Larger questions arise of how IRBs decide whether to trust vs. closely monitor individual PIs. IRBs' roles are often indirect, and not fully systematic, raising questions of whether these functions should be enhanced, and if so, to what degree, and how. These areas require heightened investigation and discussion. (shrink)

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: (...) four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees. (shrink)

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings (...) of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic. (shrink)

Aims and background: The present work assessed the impact of two decrees on ethics committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into line with the rest of the EC, and regulating and facilitating not-for-profit research.Material and methods: Prospectively collected data from an Italian multicentre study were examined with respect to the ethics review process. Administrative and time elements of the review process were audited. Main outcome measures were time between the application submission (...) and the ethics committee definitive opinion, type and number of application submission forms, number of ethics committees that refused fee exemption, and time between the ethics committee approval and the administrative authorisation.Results: A total of 134 local research ethics committees were approached. Application submission procedures and application forms varied greatly; paper submission was mandatory. The median time from submission to approval was 72 days. Only two LRECs refused the fee exemption. The median time from LREC approval to administrative agreement was 50 days and only 9.6% of local authorities came to a verbal agreement with the sponsor.Conclusions: Italian LRECs are still not sufficiently efficient in complying with the Directive 2001/20/EC requirement . Better coordination of LRECs work is needed although the optimal level of coordination between them is still not known. In the meantime, national guidelines are needed concerning the application of Directive 2001/20/EC. The behaviour of Italian LRECs towards not-for-profit research was excellent although only the fee exemption was requested. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, (...) such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)

Institutional Review Boards can play vital roles in observing, monitoring, and responding to research integrity issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to (...) best oversee research to protect these participants from harm.For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest, and may interact with IRBs. In 2002, the Institute of Medicine report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research. (shrink)