Notice Number: NOT-OD-12-079
Key Dates
Release Date: March 21, 2012
Issued by
National Institutes of Health (NIH), Office of Extramural Research (https://grants.nih.gov/grants/oer.htm)
Purpose
This Notice announces the availability of new and updated Frequently Asked Questions (FAQs) that cover a variety of topics, including Investigator disclosure of reimbursed or sponsored travel, related to the 2011 revised regulation, Promoting Objectivity in Research at Title 42, Code of Federal Regulations, Part 50, Subpart F for grants and cooperative agreements.
Background
To address the increasing complexities of the financial interests held by biomedical and behavioral researchers and the resulting interactions among Government, research Institutions, and the private sector, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) published revised regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors (commonly known as the Financial Conflict of Interest (FCOI) regulations). The regulations establish new standards and clarify previously established standards to be followed by Institutions that apply for or receive research funding from PHS Awarding Components, including the NIH, for grants, cooperative agreements, and research contracts. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.
As part of NIH’s continuing efforts to provide useful resources for extramural recipients, we compiled additional FAQs covering a variety of topics and updated some existing FAQs. The purpose of the FAQs is to clarify issues that may arise and will assist Institutions as they develop and/or revise their FCOI policy that meets or exceeds the requirements of the regulation; the FAQs pertain only to grants and cooperative agreements. Questions regarding the applicability and/or compliance with the revised contract regulation provided at 45 CFR Part 94 should be directed to [email protected].
The FAQs may be accessed on the Office of Extramural Research, Financial Conflict of Interest Page at: https://grants.nih.gov/grants/policy/coi/index.htm.Inquiries
For general inquiries on this Notice or other FCOI-related matters, contact:
Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration
Office of Extramural Research
National Institutes of Health
Telephone: (301) 435-0949
FAX: (301) 435-3059
Email: [email protected]
and Human Services (HHS)
