A European consistency for functioning of RECs? We just lost our chance

Waligóra, Marcin

doi:10.1136/medethics-2012-101228

Cited by 6 publications

(5 citation statements)

References 6 publications

(4 reference statements)

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“…This new directive has unfortunately already come under criticism over several of its aspects (Gøtzsche, 2012; Tuffs, 2012; Waligora, 2012) and seems unlikely to solve the fundamental concerns of the research community.…”

Section: One Step Forwardmentioning

confidence: 99%

The advance of research governance in psychiatry: one step forward, two steps back

Leeson

Tyrer

2013

Epidemiol Psychiatr Sci

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Purpose. To investigate the reasons behind difficulties in recruiting patients to randomized controlled trials (RCTs) in psychiatry and to examine a database of RCTs for differences between studies in mental health and other specialities. Methods. A discussion of recent changes in research governance in the UK and Europe followed by an examination of the database of all trials supported by the Health Technology Assessment programme of the National Institute of Health Research in the UK between 1993 and 2007 to determine if three different measures, (i) time between grant approval and study start date, (ii) percentage of additional time given to extend recruitment and (iii) percentage of planned recruitment achieved, changed over the time period studied and differed between mental health, cancer and other medical disciplines. Findings. Despite attempts in the UK to accelerate the process of clinical trials in recent years, there was a significant increase in the extension time for trials to be completed (p = 0.038) and the percentage of planned recruitment to mental health studies (71%) was significantly less than for cancer (90.3%) and other studies (86.1%) (p = 0.032). Summary. These results suggest that, despite the priority afforded to the advancement of RCTs in healthcare, such studies are encountering increasing difficulty in recruiting to time and target. We suggest that this difficulty can be attributed, at least in part, to the excessively byzantine regulation and governance processes for health research in the UK, and unnecessary bureaucracy in the current National Health Service system. Mental health studies appear particularly vulnerable to delay and better systems to facilitate recruitment are required urgently for the evidence base to be improved and facilitate new cost-effective interventions.

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Section: One Step Forwardmentioning

confidence: 99%

The advance of research governance in psychiatry: one step forward, two steps back

Leeson

Tyrer

2013

Epidemiol Psychiatr Sci

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“…"We just lost our chance"summarizes the concerns of the European Network of Research Ethics Committees (EUREC) and ethics experts across Europe in the article "A European consistency for the functioning of REC?" (Waligora, 2013). Marcin Waligora notes the EUREC's concern regarding the Regulations' "wide discretion in constituting national assessments processes," which may inadvertently facilitate sponsors shopping for countries with the weakest regulatory systems (Waligora, 2013, p. 408).…”

Section: Europementioning

confidence: 99%

“…Waligora highlights Eugenijus Genfenas and Richard Ashcroft's comments that the new EU Regulations represent an "ethics rubber stamp" and "moral figleaf" for research (Waligora, 2013, p. 409). He notes the lost opportunity to address inconsistencies in EU RECs (Waligora, 2013). There was also a call for a "transparency quality and accreditation system for RECs in the EU" (Waligora, 2013, p. 408).…”

Section: Europementioning

confidence: 99%

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Cox

Solbakk

Bernabe

2021

Current Medical Research and Opinion

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BackgroundFor approximately six decades, Research Ethics Committees (RECs), also known as Institutional Review Boards (IRBs), have played an integral part in the identification of ethical issues before the commencement of clinical research globally. The importance and relevance of the REC/IRB prospective review are widely acknowledged, admired, and critiqued. In many jurisdictions, legislative and policy frameworks are in place to prevent clinical research from taking place without prior review and approval by a REC/IRB. It is, therefore, reasonable to assume that research with a favorable opinion of a REC/IRB is ethically sound and scientifically appropriate. There is evidence, however, that researchers may deviate from the approved protocols. Many of these deviations are ethically relevant yet remain unaddressed. These unaddressed deviations form the basis for this interrogative thesis into the post-approval role of RECs/IRBs. It employs the sociological frame of role theory to illuminate concepts such as role expectations, identity, and behavior concerning REC/IRBs in the post-approval oversight of clinical trials. MethodsQualitative research methods were employed to explore the main objectives. The research approach includes hermeneutic content analysis combined with thematic analysis to guide data extraction, reading, interpretation, and reporting. The primary data sources were regional and international normative documents related to clinical research and REC/IRBs in Europe and the USA and US Academic health center IRBs' web page content. Stakeholder engagement included REC representatives in Europe using the European Network for Research Ethics Committee (EUREC) member list. ResultsThe general post-approval role expectations of REC/IRBs are 1) to review significant protocol amendments and issue opinions or approval on these amendments, 2) to receive notification of safety and adverse events reports, and 3) to receive notification of the end of a trial and a final report. There is disagreement between regions on whether RECs ought to conduct continuing reviews. Within the EU and allied countries, continuing review is considered a form of active monitoring delegated to the regulatory authorities. Contrariwise, the law mandates continuing review within the USA, which is also distinguished from active monitoring. There are challenges with the use of and interpretation of clinical trial nomenclature. The authority of US IRBs to suspend and terminate trials is not commonplace in the EU. Conclusion/RecommendationsThe overarching role expectation of REC/IRBs after the approval of clinical trial protocols is to protect research participants. This may be achieved through post-approval activities such as continuing review, active monitoring, ethics support and education to researchers, and the issuance of an opinion on the final reports at the end of clinical trials. There may be hesitancy in European countries to conduct active follow-up of approved trials due to a lack of supporting legislation/policy, types of org...

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“…Similar regulatory harmonisation covering research on biosamples is currently lacking (Ref. 63). In the area of TR, an ambitious programme called the EurocanPlatform aims to create a European infrastructure for translational cancer research and includes modules for early and late TR, including clinical studies.…”

Section: Outlook/future Directionsmentioning

confidence: 99%

Developing translational research infrastructure and capabilities associated with cancer clinical trials

Hall

Brown

2013

Expert Rev. Mol. Med.

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The integration of molecular information in clinical decision making is becoming a reality. These changes are shaping the way clinical research is conducted, and as reality sets in, the challenges in conducting, managing and organising multi-disciplinary research become apparent. Clinical trials provide a platform to conduct translational research (TR) within the context of high quality clinical data accrual. Integrating TR objectives in trials allows the execution of pivotal studies that provide clinical evidence for biomarker-driven treatment strategies, targeting early drug development trials to a homogeneous and well defined patient population, supports the development of companion diagnostics and provides an opportunity for deepening our understanding of cancer biology and mechanisms of drug action. To achieve these goals within a clinical trial, developing translational research infrastructure and capabilities (TRIC) plays a critical catalytic role for translating preclinical data into successful clinical research and development. TRIC represents a technical platform, dedicated resources and access to expertise promoting high quality standards, logistical and operational support and unified streamlined procedures under an appropriate governance framework. TRIC promotes integration of multiple disciplines including biobanking, laboratory analysis, molecular data, informatics, statistical analysis and dissemination of results which are all required for successful TR projects and scientific progress. Such a supporting infrastructure is absolutely essential in order to promote high quality robust research, avoid duplication and coordinate resources. Lack of such infrastructure, we would argue, is one reason for the limited effect of TR in clinical practice beyond clinical trials.

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A European consistency for functioning of RECs? We just lost our chance

Cited by 6 publications

References 6 publications

The advance of research governance in psychiatry: one step forward, two steps back

The advance of research governance in psychiatry: one step forward, two steps back

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Developing translational research infrastructure and capabilities associated with cancer clinical trials

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