Specific Guidance on Special Issues Privacy and Confidentiality Issues When Conducting Genetic Research and Research With Stored Biological Samples

Whenever possible, investigators should remove all identifiers from biological samples. When this is not possible, it is important for investigators performing genetic research to accurately describe to potential subjects (during the consent process) of all persons, typically listing their job titles, and institutions that will have access to their data, where the data will be placed or stored, and the potential adverse consequences that could result if the confidentiality of their individual genetic information is compromised (such as being accessed by an employer or insurer). If the genetic analysis will include confirming a genetic diagnosis of disease, subjects should also be informed about how the privacy of other family members, who share their genetic information, may be compromised and about any potential adverse consequences. If the subject’s tissues will be stored for potential secondary research, or identifiers will be maintained for follow-up studies, these uses and links must be sufficiently disclosed to potential subjects during the consent process so that subjects, armed with adequate knowledge of the risks to their privacy and confidentiality, can provide a valid consent at the time of recruitment. When in doubt as to whether a potential secondary use of a subject’s tissues was adequately disclosed during the subject’s recruitment, investigators should consult their IRB and if necessary, go back to the subject and obtain consent to use their tissues for these secondary purposes. The greater the harm that the subject might experience if the data developed from the secondary use of his/her tissue are disclosed, the more important it is to ensure that the secondary use was adequately disclosed during the informed-consent process.