Federal guidelines strongly advise IRBs to consider specific issues when reviewing clinical genetic research and to alert investigators engaged in such research to address these issues in their application for IRB approval. Unlike the risks presented by biomedical research, the primary risks of genetic research are risks of social and psychological harm rather than risks of physical injury. Genetic studies that generate information about subjects' personal health risks can provoke anxiety and confusion, damage familial relationships, and compromise subjects' insurability and employment opportunities. Although these genetic studies may be limited to a collection of family histories or blood draws, the IRB does not necessarily consider them to be minimal risk.
Genetic research does not mean only research that involves looking for mutations in DNA. Research that involves looking at the differences between proteins in individuals with or without a certain disease can also qualify as genetic research. Records research involving information that was derived from a previous genetic test can also qualify as genetic research. See definitions below.
Disclosure of genetic research findings to a research subject or the subject's physician through use of personal identifiers should not occur unless:
IRB approval is required before disclosure of research results can occur. In the event these conditions are met, the results may only be released to the subject or any other party with the subject's permission, and appropriate medical advice and referral must be provided.
Re-contact of a research subject or a patient from whom samples or information was obtained originally for clinical purposes should not occur unless the subject was informed during the initial treatment or research consent and authorization process, that re-contact may occur under specified circumstances. Reasons for re-contacting research subjects can include re-contact for release of clinically relevant research results. If this is desired, precautions must be taken both to minimize the potential harm to subjects of receiving bad news and to guard against the unintended release of the information. The precautions needed in conveying genetic research results depend on the age at onset of the disorder, the burden of illness, and the availability of treatment or prevention. The communication of genetic information carries with it the responsibility to interpret the results and provide care for the individual; and, thus, it is ideally done in the setting of a clinical rather than research relationship with the subject. Because of the complexity of the results of most genetic tests, subjects cannot be required to inform relatives of the results of the research