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Abstract

An analysis was performed of the ethics section in 134 biomedical research protocols submitted for review to a Danish Research Ethical Committee (REC) in 1990.

The statements made in the ethics sections were identified and classified.

It was found that 20% of the protocols lack an ethics section despite a specific requirement for such a section in the Helsinki-II declaration and the guidelines issued by the REC. The ethics sections have a median length of 6 lines of text and contain a median of 3 ethically relevant statements, thereby comprising 1.13% of the total research protocol.

An analysis of the statements made show that 32% are purely formal and 30% are concerned with the area of information, consent and voluntariness. The remaining 38% are spread over a wide range of considerations.

It is hypothesized that this relatively meager result reflects the researchers perception of the research review procedure as a mostly formal procedure.

Keywords

medical ethics research ethics research ethics committees

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References

1. Lynøe N , Sandlund M , Dahlqvist G , Jacobsson L. , Informed consent: study of quality of information given to participants in a clinical trial. BMJ 1991; 303: 610–3.

2. Mackillop W.J. , Johnston PA. , Ethical problems in clinical research: The need for empirical studies of the clinical trials process. J Chron Dis 1986; 39(3): 177–88.

3. Shapiro M.F. , Charrow RP. , Scientific misconduct in investigational drug trials. N Engl J Med 1985; 312: 731–6.

4. Holm S. , How many lay members can you have in your IRB? – An overview of the Danish system. IRB – A Review of Human Subjects Research 1992; 14(6): 8–11.

5. Riis P. , What a national research ethics committee does. Bull Med Eth 1992; 84: 13–16.

6. Declaration of Helsinki. Légeforeningens Vejviser 1993. Copenhagen: Légeforeningens Forlag, 1993.

7. Holm S. Skriftlig patientinformation: en analyse af danske biomedicinske forsøgsplaner. (Patientinformation sheets: an analysis of Danish biomedical research protocols). Ugeskr Lérger 1992; 36: 2432–5 (in Danish).

8. Mackillop W.J. , Ward GK , O'Sullivan B. , The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer. Br J Cancer 1986; 54: 661–667.

9. Mackillop W.J. , Palmer MJ , O'Sullivan B , Ward GK , Steele R , Dotsikas G. , Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment. Br J Cancer 1989; 59: 388–95.

10.

10. Rest JR. Development in judging moral issues. Minneapolis: University of Minnesota Press, 1979.

11.

11. Anastasi A. Psychological testing (6 ed.). New York: Macmillan Publishing Company, 1990.

Moral Reasoning in Biomedical Research Protocols

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