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Federal guidance for HHS-supported repositories

The National Bioethics Advisory Commission Report on Human Biological Materials (NBAC)

This 1999 report by an appointed committee under President Clinton reviewed issues pertaining to human biological materials research. NBAC's goals were: to present a schema for the type of information stored with samples, clarify federal regulations, ensure appropriate oversight and IRB review, and provide guidance on informed consent for investigators and IRBs. NBAC concluded that the Common Rule was "not entirely responsive", that occasionally, regulatory language was "ambiguous" and specifically, it left "unclear whether research on human tissue makes the people from whom it came "human subjects." The Report made 23 recommendations. It resulted in no new regulations but influenced the following list of new guidelines. NBAC set out to examine the extent to which the Common Rule could address ethical issues involving research on human biological material.

Recent Federal Guidance after NBAC (1999):

• Issues to Consider in the Research Use of Stored Data or Tissues OPRR (1997)
• Research on Human Specimens (NIH)
• Guidance on the Research Use of Stored Samples or Data, Office of Human Subjects Research, (NIH) 2000
• Human Tissue Repository Guidelines National Heart, Lung, and Blood Institute (NHLBI) (2000)
• Suggested Language for Informed Consent for Future Use of Biological Specimens Collected Under Clinical Protocols, [Guidance for Clinical Protocol Development, Hepatitis C Recovery Research Network] National Institute of Allergy and Infectious Diseases (NIAID) (2000)
• Report on Population Based Samples for the NIGMS Human Genetic Cell Repository, National Institute of General Medical Sciences (NIGMS) 1999