Guidelines for accepting volunteers: consent, ethical implications and the function of a peer review.

Abstract

Concern for both human and legal rights of volunteers used in scientific research is a recent phenomenon. Abuses of the past were justified by the traditional “greater good for the greater number.” Peer review boards were established to approve the manner in which volunteers are sought and selected, the information given them, and the rewards offered. They pass on the protocol of the study, with particular attention to the safeguards assured the volunteers, probable value of the study, and the ability of the investigator. And finally they must protect the volunteer from an all‐inclusive coment form which, in effect, denies him his human rights. The effectiveness of the board obviously rests upon the character of its members. Certain categories of patients may be impossible to protect from exploitation. Patients with chronic diseases who enioy a close personal relationship with their doctors are most vulnerable, as are prison volunteers. The “internal duress” factors in the prison setting seem to make true evaluation of motive impossible. The need for a prisoner to choose between neglected boredom and significant research is particularly deplored. Unless other attractive alternatives are offered to the dull life, negative motivation may well tip the scales in favor of inappropriate research participation.