C Paul1. 1. Department of Preventive and Social Medicine, University of Otago Medical School, Dunedin.
Abstract
AIMS: To find out, from the perspective of researchers, how ethics committees are dealing with matters of ethical concern in research on humans and to seek the views of researchers on their role in thinking through the ethical issues in research. METHODS: A sample of researchers was selected from the Health Research Council database of grant recipients. Information was sought, using a mailed questionnaire, in relation to essential elements of concern to ethics committees according to the 1996 National Standard, types of study undertaken, codes of practice, national application forms, multicentre review, aspects of committee function and the role of researchers. RESULTS: The response rate was 35/40 (87.5%). Approximately half the respondents commented favourably on most aspects of ethics committee functioning. Major criticisms were directed at the assessment of risks and benefits, scientific validity and handling of consent procedures. Consistent weaknesses in multicentre review, quality of advice and the composition of committees were noted. Positive aspects were: availability of chairpersons for discussion, the protection of vulnerable participants, the handling of the Health Information Privacy Code and the introduction of a national application form. Most researchers expected to take a major role in thinking through the ethical issues in their work. Half reported occasions where ethics committees had unnecessarily impeded research. CONCLUSIONS: The high level of commitment of researchers to ethics should be acknowledged by involving them more in guideline development and education. Perceived deficiencies in the range of expertise on ethics committees, particularly expertise to judge potential harms in experimental research, should be further investigated and addressed. Recommendations to improve the quality of ethical review include reducing the overload on committees by identifying categories of research which might not require full ethics committee review.
AIMS: To find out, from the perspective of researchers, how ethics committees are dealing with matters of ethical concern in research on humans and to seek the views of researchers on their role in thinking through the ethical issues in research. METHODS: A sample of researchers was selected from the Health Research Council database of grant recipients. Information was sought, using a mailed questionnaire, in relation to essential elements of concern to ethics committees according to the 1996 National Standard, types of study undertaken, codes of practice, national application forms, multicentre review, aspects of committee function and the role of researchers. RESULTS: The response rate was 35/40 (87.5%). Approximately half the respondents commented favourably on most aspects of ethics committee functioning. Major criticisms were directed at the assessment of risks and benefits, scientific validity and handling of consent procedures. Consistent weaknesses in multicentre review, quality of advice and the composition of committees were noted. Positive aspects were: availability of chairpersons for discussion, the protection of vulnerable participants, the handling of the Health Information Privacy Code and the introduction of a national application form. Most researchers expected to take a major role in thinking through the ethical issues in their work. Half reported occasions where ethics committees had unnecessarily impeded research. CONCLUSIONS: The high level of commitment of researchers to ethics should be acknowledged by involving them more in guideline development and education. Perceived deficiencies in the range of expertise on ethics committees, particularly expertise to judge potential harms in experimental research, should be further investigated and addressed. Recommendations to improve the quality of ethical review include reducing the overload on committees by identifying categories of research which might not require full ethics committee review.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Felicity Goodyear-Smith; Brenda Lobb; Graham Davies; Israel Nachson; Sheila M Seelau Journal: BMC Med Ethics Date: 2002-04-19 Impact factor: 2.652