Office of the Assistant Secretary for Planning & Evaluation
	Office of SciencePolicy

Human Subject Protection and Financial Conflicts of Interest

Background Materials for a Conference to be held August 15-16, 2000 at the
Natcher Center, National Institutes of Health, Bethesda, Maryland.

National Institutes of Health and Public Health Service documents

42 CFR Part 50, Subpart A. Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science

42 CFR Part 50, Subpart F. Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
"This subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator."

Frequently Asked Questions Concerning the Department of Health and Human Services' Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy as published in the Federal Register: July 3, 1996 Volume 61, Number 129, p. 34839.

Required Education in the Protection of Human Research Participants. NIH Guidance, June 5, 2000

Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards. NIH Guidance, June 5, 2000.

Terms and Conditions of NIH Grant Awards

Food and Drug Adminstration

FDA Guidance for Institutional Review Boards and Clinical Investigators (9/98) including

1. List of Selected FDA Regulations
2. 21 CFR PART 50 Protection of Human Subjects
3. 21CFR Part 54 Financial Disclosure by Clinical Investigators
4. 21 CFR PART 56 Institutional Review Boards
5. Significant Differences in FDA and HHS Regulations

FDA Guidance For Industry:  Financial Disclosure by Clinical Investigators (October 25, 1999).

FDA Press Release:   "FDA Announces Financial Disclosure Rules" (February 2, 1998).

Office of the Inspector General

Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (OEI-01-97-00195; 6/00) Available only in PDF. 1237 Kb

Recruiting Human Subjects: Sample Guidelines for Practice (OEI-01-97-00196; 6/00) Available only in PDF.

FDA Oversight of Clinical Investigators (OEI-05-99-00350; 6/00) Available only in PDF. Kb

Protecting Human Research Subjects: Status of Recommendations (OEI-01-97-00197; 4/00) Available only in PDF.

Other

Conference Announcement in the Federal Register

Secretary's Announcement of initiatives to further strengthen protections of human research subjects in clinical trials, including those involving gene transfer.

45 CFR Part 46, Subpart A. Basic HHS Policy for Protection of Human Research Subjects.

HHS Debarment Regulations - 45 CFR Part 76

For more information please contact coi@osaspe.dhhs.gov

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Last revised 6/15/00.