Capron A M
Law Center, University of Southern California, Los Angeles 90089-0071.
J Clin Epidemiol. 1991;44 Suppl 1:81S-89S. doi: 10.1016/0895-4356(91)90180-h.
Epidemiological studies raise somewhat different ethical issues than those that usually confront IRBs in their review of biomedical research. Although epidemiologic research seldom risks direct harm to subjects, it may still wrong them if it invades their interests (such as privacy) or treats them merely as means. Review by an IRB is thus justified if it improves the benefit-risk ratio; even more important, in most circumstances, informed consent should be obtained in advance from subjects, to promote subjects' autonomy, to improve the quality of research, to regularize the relationship of investigators and potential subjects, and to protect subjects' privacy. Nonetheless, in certain circumstances-illustrated here by considering three hypothetical studies-alternatives to the usual consent rules are acceptable.
流行病学研究引发的伦理问题与机构审查委员会（IRB）在审查生物医学研究时通常面临的问题略有不同。尽管流行病学研究很少对受试者造成直接伤害，但如果侵犯了他们的利益（如隐私）或仅仅将他们当作手段对待，仍可能对他们造成伤害。因此，如果IRB的审查能改善利益风险比，那么这种审查就是合理的；更重要的是，在大多数情况下，应提前获得受试者的知情同意，以促进受试者的自主性，提高研究质量，规范研究者与潜在受试者的关系，并保护受试者的隐私。尽管如此，在某些情况下——这里通过考虑三项假设研究来说明——可以接受偏离通常同意规则的替代方案。
