Acta Med Scand 1984; 215: 97-8 -

EDITORIAL

Science and Society-Are Scientific-Ethical Committees Bridging a Gap?

For the medical sciences, experiments on man are a necessity. Few physiological and biochemical projects, and no clinical investigations, can be procured in tissue cultures or small laboratory animals. These facts are to a large extent accepted by the community, whereas the practical forms of such collaboration between science and society have been discussed repetitively during the last two decades.

The Second Helsinki Declaration introduced the formal demand for setting up indepen- dent scientific-ethical committees for “consideration, comment and guidance” after obligatory submission of biomedical research protocols. The demand has recently been followed up by CIOMS and WHO in their “Proposed International Guidelines for Biome- dical Research Involving Human Subjects” (1).

Two questions are crucial when discussing the necessity and use of scientific-ethical committees (“review boards”). One is the size of the problem in quantitative terms, the other is the knowledge and acceptance of such committees in the general population (2, 3). Unlike many epidemiological studies of disease, the epidemiology of scientific-ethical problems within medicine is clearly linked to specific national conditions. Yet figures from different countries will certainly be applicable within different groups of countries having the same or similar political/economic structure and standards. In this perspective the Danish figures are probably to a large extent representative for the Nordic countries.

The Danish system is based on seven regional committees covering all biomedical research within the areas. The system covers medicine, dental research and pharmaceutics in primary/secondary health care, universities, industry, etc. The members of the commit- tees are scientists and lay people in equal numbers. Based on the annual reports from the committees the following epidemiological figures can be calculated, presupposing a com- plete registration of biomedical projects (2).

In 1982, 850 protocols were sent for registration/evaluation. This means an approximate incidence of 170 biomedical projects with man as a subject per million inhabitants. Of the 850 protocols, 679 comprised patients, usually 50-200 per project, and with a project duration of 1-2 years. In other words, the prevalence of ongoing projects with man as a subject will amount to 17Ck340 per million, and the number of citizendpatients involved on a given day will be 1040000 per million, tentatively. Thus, the ethical aspects of biomedical research are of substantial magnitude, and the implementation of control systems is of corresponding importance.

In the present issue Saurbrey et al. describe their attempt to probe civic attitudes and norms concerning scientific ethics. Their conclusions show that confidence in clinical doctors involved in biomedical projects is still the solid base of citizens, expecting autonomy and security before accepting project participation. Citizens certainly want to be informed, and to be asked personally if they wish to join an investigational project. If satisfied by this introduction, and if confident in the responsible doctor, they seem to feel little need for the extra security made possible through the committee system, especially in

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the majority of rather innocent projects. If, however, patients are prevented from consent- ing due to low age, mental incapacity, etc., and if no relatives can consent on their behalf, the patients interviewed feel a stronger need for an independent committee evaluation.

Considering that patient autonomy was a strong and fundamental motive for recom- mending the establishment of scientific-ethical committees, the relatively low percentage of public demand for committee evaluations can at first sight seem surprising. It might, however, just reflect the breif period-3-4 years-for which a regional committee system has now been active in Denmark. Or, what is more important, perhaps the committee system is going to support patient autonomy and security less directly than originally thought, and more indirectly. By setting professional standards for medicine, dentistry and pharmacy, and by commenting principally on major ethical issues internally towards the professions, and externally towards the public, the committee system will be able to reinforce confidence between citizen and doctor, this fundamental and traditional inter- personal carrier of a multitude of important clinical decisions.

Pod Riis, Copenhagen, Denmark

REFERENCES I . CIOMS/WHO. Proposed international guidelines for biomedical research involving human sub-

2. Lewis PJ. The drawbacks of research ethics committees. J Med Ethics 1982; 8: 61-3. 3 . Weatherall DJ. Commentary. J Med Ethics 1982; 8: 63-4. 4. Central Scientific-Ethical Committee of Denmark. Report for 1982. Copenhagen: Forskningssekre-

jects. Geneva: CIOMS/WHO, 1982.

tariatet. 1983.