Regulations & Policies

Institutional Policies

Boston University and Boston Medical Center have several policies relating to potential conflicts of interest of academic officials, faculty, and investigators. The following policies address conflicts of interest affecting different types of activities in which these individuals may be involved in at our institutions:

Related to research integrity, research oversight, research transactions, technology transfer and BU non-research transactions:

Related to continuing medical education and clinical interactions:

(10/20/2010) Policy for Interactions with Industry by Faculty/Clinicians at the Boston University School of Medicine

Related to External activities and professional commitment:

Boston University Policy on External Compensated Activity

Federal Regulations

DHHS/PHS/NIH

NIH Office of Extramural Research – COI Resources
NIH FAQs about the above regulations
42 CFR Part 50 Subpart F: Regulations on Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
45 CFR Part 94: Responsible Prospective Contractors
NIH Grants Policy Statement
(05/2004) Dept of Health and Human Services guidance entitled, “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection“
(06/2004) Report of the NIH Blue Ribbon Panel on Conflicts of Interest Policies

Revision Process for NIH Regulations

(08/25/2011) Final Rule (This regulation will affect awards issued after 8/24/2012)
(05/20/2010) Notice of Proposed Rulemaking for Promoting Objectivity in Research
(05/08/2009) NIH Seeks Comments on Regulations for Financial Conflicts of Interest in Federally-Funded Research

National Science Foundation

(06/30/1994) NSF Policy entitled “Investigator Financial Disclosure Policy”
(01/2010) NSF Policy on Investigators’ Conflicts of Interest

Other Federal/State Regulations

Reports of Professional Associations and Societies

(02/2008) Association of American Medical Colleges Report, Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research
(12/2001) Association of American Medical Colleges Report, “Protecting Subjects, Preserving Trust, Promoting Progress- Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research”
(10/2002) Association of American Medical Colleges Report, “Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research”
(10/2001) Association of American Universities Report on Individual and Institutional Financial Conflicts of Interest.
(07/2006) Federation of American Societies for Experimental Biology (FASEB) “Shared Responsibility, Individual Integrity: Scientists Addressing Conflicts of Interest in Biomedical Research
International Committee of Medical Journal Editors guidance on COI disclosure