Specific provisions applicable to public health service (PHS)-funded or PHS-submitted research
(effective August 24, 2012)
PHS Agencies include:
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control & Prevention (CDC)
- Food & Drug Administration (FDA)
- Health Resources & Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Substance Abuse & Mental Health Services Administration (SAMHSA)
In addition to the requirements of the Missouri State University Conflict of Interest in Research policy (Op4.02-1), the University will apply the following specific provisions to research submitted to and/or funded by PHS:
Prior to the investigator's submission of a PHS-grant application, each investigator is required to submit a disclosure form describing any financial interest held by an investigator, the investigator's spouse, or any dependent child of the investigator that the investigator determines to be reasonably related to the investigator's institutional responsibilities. The disclosure form must be submitted to the OSRP. If the investigator becomes funded by the PHS, the investigator is also required to provide updates to the disclosure at least annually during the period of the award and within 30 days of discovering or acquiring a new significant financial interest. Disclosures will be reviewed and managed as stated in the MSU COI in Research policy.
Prior to engaging in a PHS-funded research project, investigators must complete University-required COI training. This training must be repeated at least every four years and must be completed immediately if the COI policy is revised to affect the requirements for investigators, if an investigator is new to the University, and if an investigator is not in compliance with this policy or a management plan.
3. Public Access of Disclosed Significant Financial Interest
The University will make available to the public upon request information concerning any significant financial interest disclosed to the University that meets the following criteria:
- The disclosed significant financial interest is still held by the senior/key personnel of the active PHS project; [NOTE: Senior/key personnel means a PHS project director or principal investigator and any other individual who contributes to the scientific development or execution of a project in a substantive, measurable way, and who is included in the grant application, progress report, or any other report submitted by the institution, whether or not they receive salaries or compensation under the grant]
- The University determines that the significant financial interest is related to the PHS-funded research; and,
- The University determines that the significant financial interest is a financial conflict of interest.
The information request must be made to the Custodian of Records who will respond within five (5) business days of receipt of the request. Disclosed information will be provided to the extent required by applicable PHS regulations and state law.
If the University carries out the PHS‐funded research through a subrecipient, the University will incorporate as part of a written agreement with the subrecipient terms that establish whether the University’s or the subrecipient’s policy on conflict of interest in research will apply to the subrecipient investigators. If the subrecipient’s policy will apply, the subrecipient will certify as part of the agreement that its policy complies with the PHS regulations on Objectivity in Research. Additionally, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the University to enable the University to provide timely reports to PHS. Alternatively, if the University’s policy on conflict of interest will apply, the agreement shall specify time period(s) for the subrecipient to submit all subrecipient investigator disclosures of significant financial interests to the University. Such time periods shall be sufficient to enable the University to comply with timely review, management, and reporting obligations under the PHS regulations.
For PHS-funded research, the investigator’s management plan will be monitored on an ongoing basis until the completion of the research project.
6. Retrospective Review
In the event the University identifies a significant financial interest that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by the University during an ongoing research project, and where the Director of Research Compliance has determined that the undisclosed significant financial interest constitutes a financial conflict of interest related to a PHS‐funded research project, the University will implement a management plan for the project within 60 days of identification of that interest. In addition, the Director of Research Compliance will, within 120 days of determination of noncompliance, complete a retrospective review of the investigator's research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research.
7. Mitigation Plan
If the Director of Research Compliance determines in the conduct of the retrospective review of PHS‐funded research that the research or any part of it was biased, the Director will recommend a mitigation plan to the Vice President for Research & Economic Development to address any such issues. The University will notify the PHS Awarding Component of its determination and subsequently follow up with the mitigation report for the project.
8. Ongoing Research
- When in the course of an ongoing research project an investigator new to the project discloses a significant financial interest or an existing investigator discloses a new or changed significant financial interest, and where the Director of Research Compliance has determined that the disclosed significant financial interest constitutes a financial conflict of interest subject to management under this policy, the University will implement a management plan for the project within 60 days of the submission of the disclosure to the University.
- In the case of either (a) or “Retrospective Review” above, and depending on the nature of the financial conflict of interest, the University may determine that additional interim measures are necessary with regard to the investigator’s participation in the research project between the date of disclosure and the implementation of the University’s management plan. Particular consideration will be given to any additional interim measures that the University’s Institutional Review Board views as necessary for the protection of human participants in any ongoing research.