Ethical issues in the interaction with subjects and disclosure of results.
Ethics and epidemiology, Coughlin SS, Beauchamp TL, eds. New York: Oxford University Press, Inc., 1996 Apr; :178-196
In a review of the ethical issues involved with full disclosure of the benefits and risks of participation in experimental biomedical research procedures, the ethics of disclosure of research results was discussed. The components of full disclosure were subject recruitment and informed consent; privacy and confidentiality; interpretation of results; and communication of results. Results meant individual data as well as epidemiologic findings. Coercion and manipulation were important ethical issues in the consent process. Participants needed to gain an understanding of the study purpose and benefits and risks involved. Unwarranted disclosure of personal information was interpreted as a violation of privacy and confidentiality; individuals, groups, or communities could be stigmatized by disclosure of personal information. Interpretive issues included whether surviving subjects were at the same risk as the overall group; whether group data could be used as the basis of individual risk notification; and whether the assessment of outcomes required a greater threshold for statistical significance. The goal of communicating test results was to provide informative and understandable information. Researchers and participants needed an equal partnership built on the dignity of both. The authors conclude that research participants can now expect to be told of risks and benefits of studies and the findings derived from them.
Humans; Epidemiology; Worker-health; Medical-research; Safety-research; Sociological-factors; Occupational-medicine; Psychological-processes; Psychological-effects
Book or book chapter
Ethics and epidemiology