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What is group consent?

Group consent is a new ethical issue that has arisen in genetic research. An individual's genetic information is shared by his/her biological relatives as well as by members of his/her ethnic group(s). Group consent applies to families and to ethnic groups. For families, once an individual consents to genetic research on his/her biological material, does he/she reveal anything about others, and if so, should the consent be required? One important question is whether or not others (e.g., relatives) can be identified by the human subject's family history and associated clinical information.

Group consent applies to ethnic groups as well as families. The issue of whether members of genetically isolated groups, such as Australian Aborigines, need to consent to genetic research before it can proceed on any voluntary individual member of the group is controversial. In general, it is good practice for researchers to include group leaders in the research plans and other members of the group to prevent the group from feeling exploited (e.g., "mined" for their DNA) by researchers.

NBAC and the Working Group of HHS agree that when research poses harm to groups, representatives of the relevant groups should be consulted in the planning phase of the research. Methods are needed for appropriate group consultation. Risks of harm to groups should be disclosed during the informed consent process and whenever possible, minimized.

Similar ethical issues related to group consent for genetic research arise in tissue collection for repositories that may have end-users conducting ethnic-based genetic research. This particularly applies to repositories that collect tissue internationally in genetically isolated regions of the world. Groups may have sensitivity about being "data mined", particularly when U.S. repositories, with some end-users interested in developing commercial products, seek to collect in remote and/or impoverished regions for instance, in Eastern Europe, or parts of Asia and Africa. It is good practice for repositories to consider ways in which potential donors in such regions may benefit from donating tissue. It is also important to consider involving group leaders in the region and to carefully evaluate appropriate conditions for informed consent procedures which may be hampered by illiteracy, among other issues.