Maintaining the privacy and confidentiality of the donors, Gaining scientific knowledge about the heredity of thyroid disease in order to facilitate diagnosis and therapy. By current rules, the study should have been submitted to the IRB because it involved human tissue. Dr. Gomez' intent to render the samples identifiable by tracing the samples to the operative schedule makes his protocol require informed consent. Dr. Gomez' discoveries could save a patient's life and protect his family from disease such as medullary thyroid carcinoma, or the discoveries could be potentially damaging to a patient's family, employment status, and insurability, for example. In either case, informed consent is required.
Patients have the right to decide if they want information about their genetic susceptibilities.
They need to know that their personal lives could be negatively impacted by worry and anxiety about developing a genetic disease, and possibly their choice whether or not to have children. On the other hand, they might benefit by knowing their genetic susceptibilities so as to make appropriate, rational choices and perhaps improve their lives and that of their descendants. Although the patients may have previously indicated that their tissues could be used in any type of medical research, the publication of pedigrees could result in identification that they did not anticipate at the original time of consent. Dr. Gomez should have submitted his protocol to the IRB for their guidance and approval before the study began. Methods of ensuring anonymity of the data can be established but that will make it impossible for the patients to learn about their heredity.