Report/Document

National Human Research Protections Advisory Committee (NHRPAC)

The charter of the National Human Research Protections Advisory Committee expired in July 2002. These materials are presented for archival and reference purposes. The Secretary's Advisory Committee on Human Subject Protections (SACHRP) was chartered on October 1, 2002

REPORTS/DOCUMENTS

The National Human Research Protections Advisory Committee (NHRPAC) is a Secretarial advisory committee subject to the provisions of the Federal Advisory Committee Act.

NHRPAC advisory documents are the result of considerable Committee effort, deliberation and consensus building. Once the Committee achieves consensus on an issue, its recommendations are posted on this website and transmitted by the Chair to the Secretary of Health and Human Services, Assistant Secretary for Health, and to the Director of OHRP for their consideration. The content of these documents is exclusively advisory and does not represent the official views or policies of OHRP or the Department of Health and Human Services.

Comment letter to the FDA on 45 CFR 46 Subpart D (408)c [August 2001] - Letter transmitted from the Chair to the FDA commenting on Docket #00N-0074 April 24, 2001 Interim Rule:"Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products". This letter pertains to provision (408c) of 45 CFR 46 Subpart D, which provides for limited exceptions that waive the requirement for parental permission for participation in research of certain minors and allows the minor to give informed consent given certain safeguards are in place to protect the interests of the minor.

Comment letter to HHS on 45 CFR 46 Subpart B -- September 2001

NHRPAC Recommendations on HHS's draft Interim Guidance on Financial Relationships in Clinical Research [October 2001]� - NHRPAC's Final Recommendations on the Department's: Draft Interim Guidance: Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators and IRBs To Consider When Dealing with Issues of Financial Interests and Human Subject Protection (posted on both the OHRP and NHRPAC websites for comment last December/January). NHRPAC's document reflects the thinking of the entire Committee and draws from the advice of the Working Group on Financial Relationships/Financial Conflicts of Interest chaired by Committee member Mark Barnes. The document will be forwarded by the Department to the OHRP for it's review and consideration.

Clarification of the Status of Third Parties -- Revised April 24, 2002
NHRPAC Comment Letter on HIPAA NPRM -- April 2002
Report to NHRPAC from Social and Behaviorial Science Workgroup on Public Use Data Files -- April 2002
Draft Work product from Genetics Workgroup (July, 2002)
Final Report to NHRPAC from Children's Workgroup
Final Report to NHRPAC from Workgroup on Decisional Incapacity on Informed Consent and the Decisionally Impaired
Final NHRPAC Recommendations on Confidentiality and Research Data Protections (Part 1) and Illustrative Overview of Federal Confidentiality Statues and Codes (Part 2)

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