Overview

Ethical issues related to the collection and use of human specimens for research purposes have been the subject of considerable discussion. Although the human subjects regulations detailed in the “Common Rule” (45CFR46) have not changed, application of the regulations are complicated by a variety of legal and social implications. The National Bioethics Advisory Commission’s report entitled “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance” addresses many of the issues currently under discussion. The National Cancer Institute has worked with other NIH institutes and centers and with a variety of other groups to help clarify these issues and to provide education and models to assist the research community. The NIH has developed a brochure to help researchers understand how the human subjects regulations apply to the use of specimens for research.

For more information, please visit:

• Federal Regulations on the Protection of Human Subjects (45CFR46) (“Common Rule”)
  http://ohsr.od.nih.gov/mpa/45cfr46.php3
• National Bioethics Advisory Commission
  http://www.georgetown.edu/research/nrcbl/nbac/
• Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
  http://www.georgetown.edu/research/nrcbl/nbac/pubs.html
• NIH brochure: How the Human Subjects Regulations Apply to the Use of Specimens for Research
  • HTML Version
  • PDF Version
    • Adobe Acrobat Reader is required to view the PDF file. If you do not have Acrobat Reader, you can download it free of charge from the Adobe Web site.

Several models exist for protecting subjects whose specimens are used for research, including the honest broker model, in which a tissue bank trustee ensures strict control of information flows associated with research using banked tissues, and a model developed by the former Office of Protection From Research Risks (now the Office of Human Research Protection).

• Merz, J.F., Sankar, P., Taube, S.E., LiVolsi, V.A., “Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows,” Journal of Investigative Medicine, Vol. 45, No. 5, June 1997.
• Issues to Consider in the Research Use of Stored Data or Tissue, Office of Protection from Research Risks, November 7, 1997. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm