Ethical, Legal, and Policy Issues

In growing recognition of the importance of human specimens and data to clinical research, the NIH CRpac program is coordinating a high priority effort to address the legal, ethical and policy issues related to such research.  The goal is to facilitate research using human specimens while protecting subjects.  CRpac is working to promote more consistent policies across the NIH by developing a trans-NIH policy framework for NIH funded research with human specimens and data; and across the Department of Health and Human Services, through an inter-agency taskforce (the HELPS Taskforce). The CRpac initiative covers the legal, ethical and policy issues related to collection, storage, use of, and access to human biological materials and associated data for research.  The specific plans of the CRpac initiative include:

• Identifying legal, ethical and policy challenges to research using human specimens and data and strategies for overcoming those challenges while protecting human subjects;

• Developing an NIH-wide policy framework to facilitate the collection, storage, use of, and access to, these materials in research;

• Coordinating the efforts of a trans-HHS HELPS Task Force to review agencies’ existing policies and regulations related to specimens and data to determine where harmonization is needed and to develop strategies to achieve greater consistency;

• Promoting more uniform interpretation of existing regulations and policy guidance related to human specimens and data; and

• Guiding the development of NIH positions on international policy instruments and guidances and coordinating with other federal agencies to advance international harmonization.

CRpac plans to engage all of the various stakeholders in discussions to help inform these efforts.  Stakeholder input will be critical to help shape rational policies and initiatives that will facilitate the collection, storage, distribution and use of human biological materials for research while protecting subjects.

Pertinent Resources, Policies, and Regulations

Department of Health and Human Services:

• Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46

• HIPAA Privacy Rule (Standards for Privacy of Individually Identifiable Health Information) at 45 CFR Parts 160 and 164

Food and Drug Administration:

• Protection of Human Subjects. Code of Federal Regulations, 21 CFR Parts 50 and 56

• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff

National Institutes of Health:

• Guidance on "Protecting Personal Health Information in Research:  Understanding the HIPAA Privacy Rule" (April 14, 2003; revised 7/13/04)

• Guidance on "Research Repositories, Databases and the HIPAA Privacy Rule" (July 2, 2004)

• Guidance on "Institutional Review Boards and the HIPAA Privacy Rule" (July 8, 2004)

Office for Human Research Protections:

• Guidance on "Issues to Consider in the Research Use of Stored Data or Tissues" (November 1997)

• Guidance on "Engagement of Institutions in Research" ( January 26, 1999)

• Guidance on "Research Involving Coded Private Information or Biological Specimens" ( August 10, 2004)

• International Compilation of Human Subject Research Protections

Other Resources

• Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group