Some patients, for reasons of their own, distrust research. Health care professionals pledge to do no harm to patients and to maximize the possible benefits for patients. These ethical obligations are no less applicable to unsolicited telephone contacts with patients than to other, more dramatic, invasions of patients' interests. The risk of loss of confidentiality is considered to be a risk worthy of significant protective efforts and IRB review. Such concerns exist when the subject can reasonably expect that the information will not be made public, and the federal regulations speak specifically of medical records as an example of such a situation.
Patient information is a prominent subject of protection in all regulations governing research.
Medical intervention for some patients in some circumstances is a matter of sensitivity, and when an inquiry is made about the procedure some time after the intervention, by someone the patient does not know, it can produce strong reactions. The risk of contacts based upon inaccurate information should be eliminated prior to implementing the plan, and those who are given the responsibility to make the contact should know how to deal with persons who have been contacted erroneously. The burdens and benefits of research should be fairly and equitably distributed among patients. Investigators should select classes of subjects based upon reasons that are directly related to the purpose of the study. Patients who can be classified as persons with diminished capacity are entitled to protection commensurate with the diminishment.