Research ethics committees

Savulescu J. Two deaths and two lessons Is it time to review the structure and function of research ethics committees J Med Ethics 2002 28 1-2. 

Bayer A and Tadd W (2000) Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval descriptive study. BMJ 321(7267) 992-993... 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

Centrai Office for Research Ethics Committees (COREC)... 

Department of Health (UK). Governance Arrangements for NHS Research Ethics Committee. London Central Office for Research Ethics Committees (COREQ, 2001. 

Clinical trials in which registered or listed medicines (or medical devices) are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence. 

Research Ethics Committees (RECs) should be invited to review all materials used to recruit subjects for all phases of clinical trials, including, but not limited to ... 

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

The clinical part of the study was conducted with participation of 116 adolescent patients aged from 10 to 18 years hospitalized by the Department of Pediatrics for examination and treatment of chronic dyspeptic complaints. The control group comprised 38 age matched healthy volunteers. The Regional Research Ethics Committee of Ukraine approved the study. 

Proposing this new criterion in a document like the Declaration of Helsinki implies a policy that should rule all research being done. Note that the Declaration of Helsinki is "the" ethical code. It morally binds all researchers and should be abided by research ethics committees when evaluating protocols and sustained as a requirement when publishing an article. Hence, changing the standard of care in such a document would have a profound impact on research. It would imply a new normative criterion for all research. 

At the societal level, they imply an anemic view of justice, as London pointed out. They rebuff any commitment to a substantive theory of justice. They only require procedures such as the approval by the community and/or the local research ethics committee. What is more, they do not commit themselves to basic conditions for such procedures to be acceptable. They naturalize the extreme and desperate situation of such communities as the baseline. Furthermore, they do not recognize the influence this baseline condition may have in the bargaining process. They force people to expose themselves in order to achieve or protect such basic goods as health or life. This fact seems to put the research subject in an unfair position or, as Ballantyne (2004) has argued, in a situation of exploitation a mutually advantageous exploitation. This means that research (or any transaction) can be simultaneously mutually beneficial and yet also unfair. 

The key to the ethics of such studies is informed consent from patients, efficient scientific design and review by an independent research ethics committee. The key interpretative factors in the analysis of trial results are calculations of confidence intervals and statistical significance.The potential clinical significance needs to be considered within the confines of controlled clinical crials.This is best expressed by stating not only the percentage differences, but also the absolute difference or its reciprocal, the number of patients who have to be treated to obtain one desired outcome.The outcome might include both efficacy and safety... 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

Usually, if, in the course of a trial, a substantial amendment to the protocol becomes necessary, then a repeat opinion of the ethics committee must be sought before implementing any change. Substantial amendments are defined as amendments to the terms of the research ethics committee s (REC s) application, or to the protocol or any other supporting documentation that is likely to affect to a significant degree... 

COREC New Operational procedures for NHS RECs, guidance for applicants to Research Ethics Committees. 

IRBs are increasingly requiring payment to evaluate protocols when a single IRB can be used, this fee is likely to be insignificant. However, in Europe and the United States, multiple local research ethics committees often have to be consulted and, even if their individual fees are modest at rarely more than 2000 per protocol, the effect of dozens of such committees can be quite substantial. In Germany, there are usually two ethics committees that review each protocol - one local and one at the state level. 

Acknowledgments The authors would like to thank all University of Sydney students who agreed to participate in this study. Data collections described in this work were authorised by the University of Sydney Human Research Ethics Committee, project reference numbers 04-2004/7353 and 08-2005/4/8461. 

Marshall M, Lockwood A, Bradley C et al. Unpublished rating scales a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry 2000 176 249-52 Pocock SJ. Clinical Trials A Practical Approach. Chichester John WUey, 1983 Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically Some suggestions for improving performance and accountabihty. BMJ 1996 313 1390-3... 

Ethical approval for the 1998—1999 and 2000—2001 surveys was granted by the University of Tasmania Human Research Ethics Committee and for the post-intervention surveys in 2003, 2004, 2005 and 2007 by the Southern Tasmanian Health and Medical Human Research Ethics Committee and the Department of Educations Office of Educational Review. Individual informed consent was obtained from a patent/guardian of each child for all surveys. 

Blunt J, Savalescu J, Watson AIM (1998) Meeting the challenges facing research ethics committees. Br Med/316 58-61. 

Some research based on observation, collating information from notes and tests already performed for therapeutic purposes, may be permissible without consent because it does not involve direct contact with the child. Researchers must be careful in this matter and consult the Central Office for Research Ethics Committees (COREC) to ascertain this requirement. Non-therapeutic research can be validly consented only when the research can be reasonably said not to go against the child s interests. Even though it is not legally required, research should seek assent from school-age children and should always ensure that the child does not object. 

COREC (Central Office for Research Ethics Committees) (2006). Guidelines for researches patient information sheet and consent form. http //www.corec. org.uk (accessed 13 August 2006). 

Approval from the Southern Derbyshire Local Research Ethics Committee, where the study was conducted, was obtained before the study got underway. 

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