Conflict of Interest
The PHS Regulation
NIH Reminds Investigators to Disclose All Financial Interests.
The 2011 revised PHS regulations:
In response to increased public scrutiny and concern about conflicts of interest at research Institutions, the Public Health Service (PHS) has redrafted its conflict of interest regulations (42 CFR Part 50 Subpart F, 45 C.F.R. Part 94). This increased public scrutiny is a result of both the increase in relationships between researchers and industry and the increased rate at which research is brought from the bench to the market place. Strengthening the existing regulation on managing financial conflicts of interest is key to assuring the public that the institutions PHS supports are taking a rigorous approach to managing the essential relationship between the government, federally funded research institutions, and the private sector. These revised regulations were effective August 24, 2012.
Who is covered by this regulation?
The regulation is applicable to each institution that applies for grants or cooperative agreements for research or submits a proposal for a research contract and all Investigators participating in that research with any of the following offices/agencies:
- NIH – National Institutes of Health
- FDA – Food & Drug Administration
- AHRQ – Agency for Healthcare Research and Quality
- ATSDR – Agency for Toxic Substances & Disease Registry
- ASPR – Office of the Assistant Secretary for Preparedness and Response
- CDC – Centers for Disease Control
- HRSA – Health Resources & Services Administration
- IHS – Indian Health Services
- OASH – Office of the Assistant Secretary for Health
- OGA – Office of Global Affairs
- SAMHSA – Substance Abuse & Mental Health Services
Other organizations may elect to adopt the PHS regulations or similar conflict of interest regulations. Some other sponsors that have conflict disclosure requirements are, but are not limited to:
- National Science Foundation
- American Heart Association
- American Cancer Society
- Arthritis Foundation
- Susan G. Komen Foundation
- Alliance for Lupus Research
- Juvenile Diabetes Research Foundation
What are the responsibilities of investigators under the PHS regulation?
PHS Investigators must disclose as directed under the policy of their institution. The revised PHS regulations are applicable to all Investigators who will participate in research funded under PHS grants or cooperative agreements.
- Disclose outside interests: All Investigators must submit an annual Outside Interest Disclosure Form (OIDF) in eCompliance prior to submitting any proposals for PHS-funded research and each year thereafter. Proposals will not be submitted if all Investigators do not have a current OIDF on file.
- Disclose sponsored travel: Investigators participating in PHS-funded projects are required to disclose travel expenses funded by an outside entity, including reimbursed travel, when such expenses exceed $5000 when aggregated over the last 12 months. Once the $5000 threshold for sponsored travel from a single entity has been reached, a Sponsored Travel Report must be submitted through eCompliance describing the travel sponsored by that entity.
- Complete training: Prior to engaging in any PHS-funded projects, all Investigators must complete conflict of interest training in eCompliance. Investigators may also be required to renew their training when they have failed to properly disclose outside interests or when they are noncompliant with the regulation, including any necessary management plans.
- Update: While participating in a PHS-funded project, Investigators must update their Outside Interest Disclosure Form (OIDF) within 30 days of acquiring or discovering new outside interests or sponsored travel not previously disclosed.
- New Investigators: Before a Principal Investigator (PI) can add any new Investigators to an on-going PHS-funded project, the Investigator must file an OIDF and complete training.
Will disclosures be publically available?
Consistent with the PHS regulations, for senior/key personnel only, the University of Missouri must ensure public accessibility of interests which are identified as a Financial Conflict of Interest (FCOI) by the Conflict of Interest Committee. An FCOI exists when the Committee determines that an Investigator’s financial interest is related to a PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded research. The public must submit a written request to the University of Missouri System Custodian of Records before the information will be released. The University will respond to written requests within five business days. The Conflict of Interest Office will notify Investigators of any requests that involve their disclosure so they will know when and to whom that information was given.
Where can I find additional information?
The National Institutes of Health (NIH) has compiled answers to the most frequently asked questions regarding the implementation of the revised regulations for grants and cooperative agreements. The questions are arranged by topic and can be found on NIH’s website.