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COI FEDERAL REGULATIONS

Public Health Service Regulations

Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50. Subpart F)

Responsible Prospective Contractors (45 C.F.R. Part 94)


NSF Regulations

Guidance for Financial Conflict of Interest


FDA Regulations

FDA Guidance: Financial Disclosure by Clinical Investigators


Resources

NIH Financial Conflicts of Interest Page

NIH Frequently Asked Questions Regarding PHS Funding and COI (July 29, 2009)

NIH FCOI Web-based Tutorial (July 29, 2009)

NIH Guide on Objectivity in Research (July 14, 1995)

AAMC Financial Conflicts of Interest in Academic Medicine

Recognizing and Managing Personal Financial Conflicts of Interest (COGR – Winter 2002)

DHHS Office of Technology Transfer Policies and Reports


COI Updates

On May 21st, 2010, the Department of Health and Human Services issued an Advance Notice of Public Rule Making regarding changes proposed for the financial conflict of interest regulations. The proposed rules, as well as a summary of the significant changes, are included below.

Notice of Proposed Rulemaking regarding COI Regulations in NIH Proposals

Summary of Major Proposed Changes to the Financial Conflict of Interest (FCOI) Regulations

The comment period to allow the HHS to seek public comment on the proposed rules was extended to August 19, 2010. Included below are the AAMC/AAU/ACE/APLU and COGR responses are included below:

AAMC/AAU/ACE/APLU response to the 2010 NIH Notice of Proposed Rulemaking

The Council on Governmental Regulations (COGR) response to the 2010 NIH Notice of Proposed Rulemaking

American Society of Clinical Oncology (ASCO) response to the 2010 NIH Notice of Proposed Rulemaking


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