Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor
To the Editor: Dr Botkin addressed the issue of collecting family history data for research purposes.1 The central issue concerns the definitions of private information and human subjects under the Common Federal Rule.2 Individuals become human subjects when they interact directly with an investigator or when the investigator collects identifiable private information about them.3 Clearly, if personal information is known by others, it is not private. Precisely because of this, information shared with a physician, lawyer, or priest is protected from forced or negligent disclosure by legal, ethical, and professional standards of confidentiality. Botkin dismisses such arguments. However, while the Common Rule recognizes many vulnerable groups, including prisoners, pregnant women, children, minorities, and persons with mental retardation, nowhere is the penumbra of privacy extended to the family. If anamnestic family histories are not private, family members are not experimental subjects even when they are individually identifiable.
Nance WE. Protecting the Privacy of Family Members in Research. JAMA. 2001;285(15):1960-1963. doi:10.1001/jama.285.15.1960