Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study
http://www.100md.com
《英国医生杂志》
1 Centre for Primary Health Care Studies, Warwick Medical School, University of Warwick, Coventry CV4 7AL Hilary.Hearnshaw@Warwick.ac.uk
Introduction
Countries clearly differ in their requirements for approval by a research ethics committee for an identical study. If all countries are meeting the principles of the Declaration of Helsinki, then the striking variations mean we are too careful in some countries or too lax in others. The United Kingdom has an arduous process for gaining ethical approval for a non-invasive intervention study.
The risks of inappropriate requirements include unnecessarily delayed studies and extra costs without any increased protection for participants. Disintegration of study protocols is also a high risk, and, therefore, UK partners may be unwelcome in international studies.
In countries where researchers do not apply for approval of a research ethics committee they are not being unethical. In the Netherlands, guidelines distinguish between studies where approval is and is not necessary.4 Not all medical research needs all the principles of the Declaration of Helsinki—for example, research that requires only answering questions, without risk of psychological distress.5 The sooner this concept is implemented by committeees in all countries, the sooner we can stop unnecessary applications which are both risky and costly.
Editorial by Glasziou and Chalmers
The questionnaire completed by researchers is on www.bmj.com
I thank the research partners from the IMPROVE project who completed the survey questionnaire. I also thank the referee of the first version.
Contributors: HH is the sole contributor to this paper.
Funding: This study was not funded. The study for which the research ethics approvals were investigated—the IMPROVE project—was funded by the European Commission.
Competing interests: HH is an active researcher who has applied for, and will continue to apply for, the approval of research ethics committees in the United Kingdom for studies she leads.
Ethical approval: Not needed.
References
World Medical Association. Declaration of Helsinki. Ferney-Voltaire: WMA, 2002. www.wma.net/e/policy/b3.htm (accessed 16 Oct 2003).
Maskell NA, Jones EL, Davies RJO. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. Q J Med 2003;96: 305-7.
Grol R, Wensing M, Mainz J, Jung H-P, Ferreira P, Hearnshaw HM, et al. Patients in Europe evaluate general practice care: an international comparison. Br J Gen Pract 2000;50: 882-7.
Centrale Commissie Mensgebonden Onderzoek. www.ccmo.nl
Doll R. What are the effects of the fifth revision of the Declaration of Helsinki: research will be impeded. BMJ 2001;323: 1421-2.
((Hilary Hearnshaw, reader )
Introduction
Countries clearly differ in their requirements for approval by a research ethics committee for an identical study. If all countries are meeting the principles of the Declaration of Helsinki, then the striking variations mean we are too careful in some countries or too lax in others. The United Kingdom has an arduous process for gaining ethical approval for a non-invasive intervention study.
The risks of inappropriate requirements include unnecessarily delayed studies and extra costs without any increased protection for participants. Disintegration of study protocols is also a high risk, and, therefore, UK partners may be unwelcome in international studies.
In countries where researchers do not apply for approval of a research ethics committee they are not being unethical. In the Netherlands, guidelines distinguish between studies where approval is and is not necessary.4 Not all medical research needs all the principles of the Declaration of Helsinki—for example, research that requires only answering questions, without risk of psychological distress.5 The sooner this concept is implemented by committeees in all countries, the sooner we can stop unnecessary applications which are both risky and costly.
Editorial by Glasziou and Chalmers
The questionnaire completed by researchers is on www.bmj.com
I thank the research partners from the IMPROVE project who completed the survey questionnaire. I also thank the referee of the first version.
Contributors: HH is the sole contributor to this paper.
Funding: This study was not funded. The study for which the research ethics approvals were investigated—the IMPROVE project—was funded by the European Commission.
Competing interests: HH is an active researcher who has applied for, and will continue to apply for, the approval of research ethics committees in the United Kingdom for studies she leads.
Ethical approval: Not needed.
References
World Medical Association. Declaration of Helsinki. Ferney-Voltaire: WMA, 2002. www.wma.net/e/policy/b3.htm (accessed 16 Oct 2003).
Maskell NA, Jones EL, Davies RJO. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. Q J Med 2003;96: 305-7.
Grol R, Wensing M, Mainz J, Jung H-P, Ferreira P, Hearnshaw HM, et al. Patients in Europe evaluate general practice care: an international comparison. Br J Gen Pract 2000;50: 882-7.
Centrale Commissie Mensgebonden Onderzoek. www.ccmo.nl
Doll R. What are the effects of the fifth revision of the Declaration of Helsinki: research will be impeded. BMJ 2001;323: 1421-2.
((Hilary Hearnshaw, reader )