Subcontractors and PHS Sponsored Research Responsibilities
Effective August 24, 2012, the Public Health Service (PHS) including the National Institute of Health (NIH) and other funding organizations that have adopted the PHS policy and regulations, changed its policies regarding financial conflict of interest (FCOI). The University is now required to obtain information related to proposed and current PHS-sponsored research subrecipients, which includes subcontractors and consortium members.
The Principal Investigator (PI) must obtain written documentation from each proposed subrecipeint that the organization, their investigators, and their key personnel are in compliance with the PHS FCOI regulations. The subrecipient has two options available:
- Abide by their own PHS-compliant FCOI policy, or
- Will abide by the Universities’ policy on FCOI if they do not have their own policy.
Documentation of compliance with this part of the regulations will need to be submitted with the Internal Clearance Form (doc) as the proposal is being routed for approval.
To assist Universities and subrecipients to document compliance with PHS FCOI rules and regulations, the Federal Demonstration Partnership (FDP) Institutional Clearinghouse has created an Institutional Clearinghouse where Universities and subrecipients can register their respective institutions and organizations as compliant with the regulations. The PI can access the List of Compliant Institutions and Entities. If the subrecipient is on the list, then the PI can document on the Internal Clearance Form that the subrecipient is listed and certified in the FDP Institutional Clearinghouse.
If the subrecipient organization is not on the list with the FDP Institutional Clearinghouse the PI will send out the Subrecipient Financial Conflict of Interest Documentation Form (doc), Notice to Subrecipient (doc), and the Subrecipient Disclosure of Financial Conflict of Interest Form (doc) to the authorized organizational official for completion.
Financial Disclosure for Investigators
Health and Human Services (HHS) has issued regulations, 42 CFR Part 50 Subpart F, on financial disclosure for Public Health Service (PHS)-funded investigators. Additional financial disclosure and training is required for anyone involved in the design, conduct, and analysis of PHS-funded research. This includes the Principal Investigator (PI), co-PIs, academic professional research staff, postdoctoral research associates, and graduate research assistants. If your research or employment at UIS is funded by the Department of Health and Human Services, Public Health Services, or the National Institute of Health (NIH) you will be required to update your Report of Non-University Activities (RNUA) and complete mandatory training. The RNUA process is designed to assist the investigator(s) to properly disclose any potential significant conflict of interest (SFI) that is related to the investigator, the investigators ’s spouse, and dependent children that reasonably appear to be related to the investigator’s institutional responsibilities. This disclosure must occur:
- no later than at the time of application for PHS-funded research;
- within thirty (30) days of discovering or acquiring (through purchase, marriage, or inheritance) a SFI; and
- at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
Prior to initial award or renewal, the PI will be required to certify that financial disclosures, travel disclosures, and required training are current for all investigators participating in the project.
Travel Disclosure for PHS Funded Researchers
Investigators of Public Health Services (PHS) funded grants are required to disclose each occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. This disclosure does not apply to travel that is reimbursed or sponsored by sources excluded by Department of Health and Human Services (HHS) regulations. Excluded sources include federal, state, or local government agencies; and Institute of Higher Education as defined by 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research facility affiliated with an Institution of Higher Education. Travel associated with significant financial interests such as consulting, paid service on a Board of Directors or Advisory Committee, or other paid outside activities should generally be reported in conjunction with disclosure of the financial interest or paid outside activity. The disclosure form for Travel Related to PHS Sponsored Research (doc) can be used to disclose each travel event. Please remember that the PHS regulation has a $0 de minimis and the reporting requirement is for the previous 12 months.
Required Training for Investigators
Investigators must complete training on the PHS regulations. Required training is available through the Collaborative Institutional Training Initiative (CITI) and must be accessed by following the links and procedures available through the UIS Research webpage. Upon completion of the required training all investigators must submit the transcript from the CITI Program for completion of the Financial Disclosure and Conflicts of Interest for PHS Investigators course to the Office of Sponsored Programs and Research Office, MS PAC 525. The transcripts may be emailed to the Office of Research Administration at ORA@uis.edu.
Core required education and training will be completed through the Collaborative Institutional Training Initiative (CITI).
UIS and UIUC have a collaborative agreement for all UIS investigators, students, and research staff conducting research to access the CITI training modules through the UIUC registration.
- Go to the CITI website
- Register as a new user by scrolling down to “New Users” and click on Register Here.
Select the University of Illinois Urbana-Champaign, and complete the registration as directed.
The National Institutes of Health has developed their own Financial Conflict of Interest training module.
Public Access to Disclosure
The regulations require certain information to be made publically available on the Financial Conflict of Interest of senior/key personnel in response to written requests from any requestor within five (5) business days of receiving a request in the Office of the Vice Chancellor for Academic Affairs and Provost. Requests may be submitted by U.S. mail to:
FCOI Information Request
Office of the Vice Chancellor for Academic Affairs and Provost
University of Illinois at Springfield
One University Plaza, MS PAC 525
Springfield, Illinois 62703-5407
Please click on the link below for the form. A separate request for information is required for each senior/key researcher.