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Incidental/Secondary Findings

An incidental finding is "a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of research but is beyond the aims of the study." (SM Wolf, et al. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics 2008;36(2):219-248. "A secondary finding. . . is an additional result actively sought by the practitioner." ("Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Directto-Consumer Contexts." Presidential Commission for the Study of Bioethical Issues, Bioethics Commission. Accessed May 8, 2018). Incidental findings are sometimes call "additional" or "ancillary" findings. See also Return of Results. 

Informed Consent

"Before a person has a genetic test, it is important that he or she fully understands the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results. The process of educating a person about the test and obtaining permission to carry out testing is called informed consent. 'Informed' means that the person has enough information to make an educated decision about testing; 'consent' refers to a person's voluntary agreement to have the test done." ("What is Informed Consent?" Genetics Home Reference, US National Library of Medicine. Accessed April 18, 2018).

Insurance Coverage for Genomics

"One challenge insurers face is the difficulty of deciding when to reimburse for genetic tests that health care providers have offered their patients. The reason this is difficult is that insurers may not be able to easily evaluate what type of genetic test was performed, whether the test was appropriate to perform and whether the test is scientifically valid. . . . NHGRI hopes to serve as a resource for advancing genomic medicine by assisting all types of payers in their efforts to evaluate emerging genetic tests for reimbursement, and by promoting research into the health benefit and cost-effectiveness of genetic testing." ("Coverage and Reimbursement of Genetic Tests." National Human Genome Research Institute. Accessed April 18, 2018).


An Institutional Review Board. IRBs are "formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB typically has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects." The Common Rule established requirements for IRB membership, authority, review procedures, records and criteria for approval. ("Institutional Review Boards Frequently Asked Questions - Information Sheet." US Food and Drug Administration. Accessed April 18, 2018). See also Common Rule.