[Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study]. / Die Rolle von Ethikkommissionen für die nationale Versorgungsforschung - eine Querschnittsstudie des Aufwandes zur Erlangung von Sekundärvoten anhand der DACAPO-Studie.

BACKGROUND: Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). METHODS: Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. RESULTS: The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). CONCLUSION: Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed.

HoMER - an opportunity or threat to general practice research?

The National Health and Medical Research Council (NHMRC) Harmonisation of Multicentre Ethical Review (HoMER) project aims to implement a 'single ethical review', where the outcome of an ethical and scientific review by a single recognised Human Research Ethics Committee (HREC) will enable multiple institutions to decide whether or not to participate in a given study. The desired process will include agreement on time frames, authority of the reviewing HREC, respect among the jurisdictions, verification by independent organisations, and compliance with the national statement and relevant statutory and administrative frameworks. However, there appears to be little discourse on the implications for general practice research in the research community.

Variation among institutional review boards in evaluating the design of a multicenter randomized trial.

OBJECTIVE: The objective of the study was to examine the variation among institutional review boards (IRBs) in evaluation of the study design of a multicenter trial. STUDY DESIGN: We assessed the first written response of local IRBs to each site investigator for a multicenter trial of vitamin A supplementation in extremely low birth weight (ELBW) infants performed by the National Institute of Child Health and Human Development Neonatal Research Network. Each author of this paper independently reviewed and categorized IRB concerns as major, minor or none, according to the predefined criteria. RESULT: Initially, 9 of 18 IRBs withheld approval because of at least one major concern. These concerns reflected difficulties in evaluating specific scientific issues for the design of the trial, including its justification, enrollment criteria, control and experimental therapies, co-interventions, toxicity assessment, outcome monitoring and informed consent. CONCLUSION: The difficulty in assessing appropriate trial design for the specific hypothesis under investigation resulted in considerable variability in the evaluation by local IRBs.

New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest.

This paper examines the UK's response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We examine the new arrangements and argue that though they go a long way toward addressing the uncertainty surrounding ethics committee function, the system favours the facilitation of research over the protection of the dignity and welfare of research participants.

Research governance in health and social care.

In all aspects of our professional, personal and social life we will be faced with issues that need clear authority. Governance is about having a well-defined agreed set of standards by which we work. The purpose of this article is to raise the level of awareness of research governance in health and social care in the UK and to encourage colleagues to look at their local research governance framework critically.