The Public Health Service (PHS), including the National Institutes of Health, has changed its policies regarding financial conflict of interest (FCOI), effective August 24, 2012. The University has been working on new policies, training programs, and electronic systems since last fall, and the Graduate School's Office of Research Policy has worked diligently to ensure our ability to meet the new requirements by the deadline. This new policy impacts our investigators as well as our subrecipients on PHS-funded sponsored programs.

A very significant change is the new business process related to proposed and current PHS subrecipients. There is new emphasis placed on obtaining certain information about Significant Financial Interests at the proposal state. This memo focuses on those changes, and the information will be available on both the RSP and Graduate School websites.

As of August 24, prior to proposal submission the University must obtain information from each proposed subrecipient about whether the subrecipient (1) has their own PHS-compliant financial conflict of interest policy or (2) does not have a policy and will agree to be subject to UW-Madison's policy on financial conflict of interest. The University currently has about 600 unique subrecipients, and we can anticipate that some of the smaller entities, small business, and foreign entities may need to use our policy. Consequently, we have developed the following guidance.

Submission of a New or Renewal PHS Proposal:
For new and renewal proposals that will be submitted to any PHS agency on or after August 24, 2012 that include one or more subawards, please: Check to see if your proposed subrecipient is listed on the FDP Clearinghouse of PHS FCOI Compliant Institutions. http://sites.nationalacademies.org/PGA/fdp/PGA_070596

Option #1: Subrecipient is in the Clearinghouse. If your subrecipient is on the Clearinghouse list, just add a note in the WISPER comments tab with the name of the subrecipient, such as: University of Minnesota - on the FDP Clearinghouse List. You do not need to do anything else. No other forms are needed.

Option #2: Subrecipient is NOT in the Clearinghouse. If your subrecipient is NOT on the FDP Clearinghouse of PHS FCOI Compliant Institutions, please send out, as early as possible, the attached form packet (Subrecipient Documentation). You can also encourage the subrecipient to sign up on the FDP Clearinghouse if they are eligible: http://sites.nationalacademies.org/PGA/fdp/PGA_070596. If the subrecipient does join the Clearinghouse, then the process under #1 above can be used.

Option #2A: Subrecipient is NOT in the Clearinghouse but will use its own FCOI policies.. If the subrecipient does not sign up with the FDP Clearinghouse but does intend to use its own policies for financial conflict of interest, then the form, Subrecipient FCOI Documentation must be completed and uploaded to the WISPER attachment tab before the proposal is submitted. No other action is necessary.

Option #2B: Subrecipient is NOT in the Clearinghouse and does NOT have its own FCOI policies. If the subrecipient does not have PHS-compliant conflict of interest policies and agrees to use the policies of the University, then the Subrecipient FCOI Documentation form must be completed in addition to the Subrecipient Disclosure of Financial Conflict of Interest Form. The disclosure of Significant Financial Interests that are directly related to the research proposed must be completed for each subrecipient investigator (an "individual responsible for the design, conduct or reporting of the research") before the proposal is submitted.

It is necessary to have the Subrecipient FCOI Documentation and the Subrecipient Disclosure (if applicable) completed before the proposal is routed for final review by RSP or by the College or School. We realize this constitutes a new and sometimes difficult burden for researchers and the staff members who support them. We anticipate the need for flexibility for projects that are under development prior to this notice. However, this requirement for certification and disclosure is unfortunately a mandate of the new PHS policy. Under this option, the subrecipient will be subject to all UW FCOI policies, including training.

Process at the Time of Award
If the proposed subrecipient is using the University's policy and any of its investigators have a positive disclosure of financial interests, the UW COI Committee must complete its review and, if necessary, create a conflict management plan, prior to the subrecipient's expenditure of any grant funds. RSP will coordinate with the Office of Research Policy on monitoring this review, which could begin as early as notification of a Just-in-Time phase if we know of a JIT review. Otherwise, RSP will trigger the COI review at the time a Notice of Grant Award is received. We cannot issue a subaward until all positive disclosures have been reviewed by the UW COI Committee. This applies to new and continuation awards.

Previously Submitted PHS Proposals and Active PHS Awards
RSP is currently contacting all active subrecipients on PHS proposals and awards who are not listed in the FDP Clearinghouse. We will determine their ability either to comply with the new FCOI regulations or to utilize the UW-Madison policy. If any of them need to use the University policy, we will work with them to obtain any missing information and to get their disclosures of Significant Financial Interests. We anticipate this process will extend into the early fall, but we will update information as soon as possible.