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Human Subjects Division (HSD)

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Genetics Research

Investigators applying to do any genetics research involving human subjects should be prepared to demonstrate to the Institutional Review Board that:

  • Adequate provision has been taken to protect the privacy of subjects and maintain the confidentiality of data. 
  • Any potential risk to subjects is reasonable in relation to the anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result from the study.  
  • In cases where the findings may have significant implications for the subject’s health or the health of the subject’s family, a plan for disclosure of test results to those subjects who want to be informed of their genetic status is in place. Subjects have the right to decline to be informed of their genetic status.

Investigators conducting genetic research sponsored by the Department of Health and Human Services (DHHS) should consider the protections provided by the Genetic Information Non-Discrimination Act (GINA) when developing their consent processes. For more information, see http://www.hhs.gov/ohrp/policy/gina.html.

Change Notes

  • Noted 08/26/2010 @ 04:03pm
    Keyword newly added.
    - selsayed