Savitz, David A. (2000). Failure to Publish Results of Epidemiological Studies Is Unethical. Epidemiology, 11(3)
An essential component of informed consent for research participants is a careful delineation of risks and benefits associated with the study. Risks in observational epidemiologic studies often include the possible psychological discomfort of disclosing sensitive information, potential breach of confidentiality, the physical discomfort of a needle stick to draw blood, and logistical burdens of participation, such as time and travel. Often, the discussion of benefits indicates that there is no direct health benefit to the participant since no intervention is to be applied. Instead, the benefits are to society, advancing knowledge that may eventually help in the prevention or improved treatment of disease. Institutional review boards sometimes question whether participants fully appreciate that they do not stand to benefit from the study, particularly for research in a clinical setting.
Savitz, David A.