PHS Conflict of Interest
Conflict of Interest Requirements for All Investigators on PHS Grants
New requirements for disclosure of financial interests, and for management and reporting of resulting conflict of interest associated with research projects funded by NIH and other Public Health Service (PHS) agencies become effective August 24, 2012. While most of the new requirements will impact investigators when they submit new proposals to NIH and other PHS agencies, investigators on existing projects funded by PHS will be required to complete a brief online training, as well as the filing of the required disclosure forms.
“Investigators” are the Project director or Principal Investigator and any other individual, regardless of title or position, that the Principal Investigator identifies as independently responsible for the design, conduct or reporting of research which may include collaborators or consultants. This includes, but is not limited to, Senior/Key Personnel named in a proposal.
The University of Tulsa Financial Conflict of Interest Policy for Research Conducted Under the Public Health Service can be found here (.pdf file). The full text of the new regulation titled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors,” which was published in the Federal Register (Vol. 76, No. 165, August 25, 2011) is available via a link from the NIH Conflict of Interest homepage (http://grants.nih.gov/grants/policy/coi/index.htm). A FAQ link can also be found at this site.
TU Disclosure of Significant Financial Interest form (SFI form):
TU Principal Investigator Summary of Investigators Related to Applications Submitted to and Funded by PHS (PI Form):
Online training: www.citiprogram.org
Primary changes in the policy include (but are not limited to):
1. a modification to the definition of “Significant Financial Interest” and resulting expansion of the information that must be disclosed by investigators,
2. an increase in the information that must be reported to the PHS agency sponsor and made accessible to the public when a conflict of interest is identified,
3. an increase in T.U.’s responsibilities for oversight of subgrantee disclosure of Significant Financial Interest and management of conflicts of interest, and
4. more explicit requirements for institutional response to investigator non-compliance.
List of PHS Agencies to which this policy applies:
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of Global Affairs (OGA)
- Office of the Inspector General (OIG)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
The Principal Investigator (PI) for a new or existing award or a new request for funding must complete the Principal Investigator Summary of Investigators Related to Applications Submitted to and Funded by PHS. When completing this form, the PI will designate the individuals who are considered Investigators on the project/proposal. Each of these individuals will be considered an Investigator and will be required to complete the necessary forms and complete the training. This form must be completed in a timely manner to allow other Investigators under the project to complete the necessary forms and complete the training before expenditures will be allowed or the proposal will be submitted.
A summary of Investigator requirements are below:
Investigators on existing PHS awards must file a Disclosure of Significant Financial Interest and complete the online training:
1. Upon submission of an annual progress report or upon receipt of continuation funding if the annual progress report was filed prior to August 25, 2012;
2. Upon submission of a request for supplemental funding or upon receipt of supplemental funding if the submission of a request was submitted prior to August 25, 2012; or
3. Upon request of a no-cost extension or upon receipt of a no-cost extension if the request was submitted prior to August 25, 2012.
Expenditure of supplemental funds, continuation funds, or existing funds beyond the ending date in place prior to receipt of a no-cost extension will not be allowed until all Investigators have completed the form and training.
Investigators in receipt of a new PHS award who submitted the proposal prior to August 25, 2012 must file a Disclosure of Significant Financial Interest form prior to expenditure of funds.
Investigators submitting a new proposal requesting PHS funds must file a Disclosure of Significant Financial Interest form prior to submission of the proposal.
Investigators on existing PHS awards must submit a revised Disclosure of Significant Financial Interest form within thirty (30) days of acquiring or discovering any new Significant Financial Interest.
Investigators new to an existing PHS award must submit the Disclosure of Significant Interest form and complete the online training before joining the project.
Investigators who are found to not be in compliance with this policy or have failed to comply with an approved management plan must repeat the training immediately.
The Disclosure of Significant Financial Interest form must be submitted to Debbie Newton, Director of Research and Sponsored Programs. This may be submitted via email (firstname.lastname@example.org) or submitted via campus mail in a sealed envelope marked “Confidential.” If it is determined that an Investigator may have a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of the PHS research activity, this Financial Conflict of Interest must be addressed prior to the expenditure of funds or submission of the proposal.
Questions regarding CITI Training may be directed to Carmen Schaar-Walden, Coordinator of Research Compliance at 631-3310 or email@example.com.
Questions regarding the policy or completion of the forms may be directed to Debbie Newton at 631-2192 or firstname.lastname@example.org.