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Research Compliance

 
 
 

Outside Interest Reporting and COI Management

Regulation and Guidance


GOVERNMENT REGULATIONS

DHHS/PHS/NIH
NIH Objectivity in Research 1995
NIH Subcontractor Regulations 1995
42 CFR 50 Subpart F 2000
NIH Regulatory Burden Report 2000
NIH Grants Policy Statement 2001
NIH Pilot Compliance Program 2007 
NIH FCOI Tutorial 2008
PHS/NSF Frequently Asked Questions
NIH Terms and Acronyms

DHHS/OIG
OIG Report on NIH Oversight of COIs 2008
OIG Report on Institutional COI 2011

NSF
NSF COI Policies 2002

OHRP
OHRP COI Guidance 2004

FDA
FDA Financial Disclosure by Investigators 2009
2010 COI and FDA Advisory Panels

PROFESSIONAL GUIDANCES

American Psychiatric Association
Policies and Procedures to be Developed and Followed in All APA Organizational Relationships

Council of Medical Specialty Society
2010 Code for Interactions with Companies

University Associations
AAMC home page for COI in research
AAMC principles for individual COI 2001
AAMC Principles for Institutional COI
AAMC mentoring post-docs 2006
AAMC industry funding in medical education 2008
AAMC / AAU joint COI report 2008
AAMC Clinical Care 2010
AAU individual & institutional COI guidelines 2001
COGR individual COI guidelines 2002
COGR institutional COI guidelines 2008

Industry Codes of Ethics
PhRMA code 2008
AdvaMed Code 2009

Powerpoint Presentations
2009 Managing COI in Research - Maureen Landies and Phil Cola

SCHOLARLY PUBLICATIONS

ICMJE Uniform Requirements for Manuscripts: Conflict of Interest

“The ICMJE’s Editorial on “Uniform Format for Disclosure of Competing Interests in ICMJE Journals,” as well as the “ICMJE Uniform Disclosure Form for Potential Conflicts of Interest” and a “Sample ICMJE Uniform Disclosure Form for Potential Conflicts of Interest” can all be downloaded here.

 


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