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Procedures for Reporting Individual Financial Conflicts of Interest in PHS Research

UMBC has created the below procedures to assist implementation of UMBC’s interim policy on financial conflicts of interest involving PHS-funded research.  Investigators are encouraged to disclose any situation that could conceivably be viewed as a conflict of interest or a reportable financial interest; such disclosures should be made at the earliest possible time to afford the best protection of an investigator’s interests. When in doubt, it is safer to disclose.

The Public Health Service (PHS) requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via subaward. Other funding organizations, such as the American Cancer SocietyAmerican Heart Association, Alliance for Lupus Research, and Arthritis Foundation, have also adopted the PHS requirements.

PHS procedures

In essence, PHS funded individuals must follow two steps – 1) take required training and 2) disclose potential conflicts if they are:

AND
  • Have a “significant financial interest” that is related or similar to university responsibilities (or if an individual’s spouse, domestic partner or dependent children has a “significant financial interest”). These include salary or payment of services* from the previous 12 months, plus the value of equity interest, plus any income related to intellectual property rights that exceeds $5,000 or equity interests in a non-publicly traded entity**.
OR

Notes:
* – does not include income from or equity in investment vehicles such as mutual funds and retirement accounts, as long the individual does not directly control the investment decisions.
**– stocks, stock options, or other ownership interests. ANY equity interest in a non-publicly traded entity, no matter how small, constitutes an equity interest
***-excludes travel reimbursement from UMBC department funds, a grant or contract to UMBC, a U.S. federal, state or government agency, or other U.S. institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with a U.S. institution of higher education.

Disclosing conflicts

The disclosure will indicate that the investigator either has no Significant Financial Interests (SFIs) or includes a listing of known SFIs (and those of the spouse and dependent children) in entities whose financial interests would reasonably appear to be affected by the research for which PHS funding is sought.

All conflict disclosures must be submitted (see the below processes) to the UMBC Institutional Official, the Vice President for Research, via the Office of Research Protections and Compliance (ORPC) for review. According to the regulations, ALL potential conflicts, as described above, must be reported by investigators.  

Training

Each individual who is identified as an investigator is required complete FCOI training. This training must be repeated at least every four years. Training must also be completed when UMBC revises this policy, when an individual is new to UMBC, or if UMBC finds an individual is not in compliance with the policy or an approved Conflict of Interest COI Management Plan.

Disclosure Process

New Proposals

At the time a proposal is submitted, an Investigator must complete and sign a PHS Conflict of Interest Assessment Form  for each proposal. The Office of Sponsored Programs will not submit a proposal until this disclosure has been submitted to the Office for Research Protections and Compliance (ORPC)  and all investigators on the project have completed the PHS-compliant training.

Organizations or institutions who are subawardees to UMBC in a proposal will certify, via the Subrecipient Commitment Form, whether they are following their own active and enforced conflict of interest policy that is consistent with the PHS regulations (including certification of COI training and documented disclosures) or if they will abide by UMBC’s policy. In the latter case, such investigators must complete the UMBC PHS Conflict of Interest Assessment Form to include with the UMBC proposal prior to Office of Sponsored Programs submission.

If and when a proposal receives a JIT request or some other indication from the funding agency that indicates it is likely to be funded, an investigator will have an Assessment Form on file. No further action is required unless there are changes (additional investigators, completion of COI training, etc.) made to the award or to previously submitted information.

Non-Competing Continuation Proposals/Progress Reports, No-Cost Time Extensions, Requests for Supplements that also Extend the Period of Performance

Investigators are responsible for updating disclosure forms annually (the anniversary of the original disclosure) during the period of the research or within 30 days of identifying or acquiring a new financial interest. In cases of changes, an updated PHS Conflict of Interest Assessment Form  must be completed and submitted to the ORPC.

Proposal Re-submission

When a proposal is re-submitted to a PHS agency, a previously submitted PHS Conflict of Interest Assessment Form  may be used to satisfy the university’s disclosure process for this submission process if no changes occurred on the prior submission. Contact the ORPC at complaince@umbc.edu if an investigator requires a copy of the disclosure.

Travel

Investigators must disclose ALL external entity sponsored reimbursed or paid travel that appears related to university responsibilities using the PHS Conflict of Interest Assessment Form.   Travel by spouses, domestic partners, and dependent children must also be disclosed if it appears related to the investigator’s university responsibilities. Travel information includes the purpose of the trip, the identity of the sponsor/organizer, the destination, and duration.

Travel does not have to be disclosed if reimbursed by:

  • UMBC department funds;
  • a grant or contract to UMBC;
  • a U.S. federal, state or government agency;
  • other U.S. institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with a U.S. institution of higher education.

Travel paid for by foreign institutions, such as universities and governments, must be disclosed.

Review Process

Upon submission, the ORPC will screen the disclosure information in the PHS Conflict of Interest Assessment for applicability and completeness. As neccesary, the form is then submitted to the Assistant Vice President for Research (AVPR) for review to determine if any action is required and if necessary, create a COI Management Plan to manage, reduce or eliminate the Conflict of Interest. This review may also require a meeting of a Conflict of Interest Committee to decide certain activities may be prohibited when potential Conflicts of Interest are too difficult to manage, reduce, or eliminate.

Once the AVPR has developed an appropriate COI Management Plan, a copy will be provided to the individual and his/her department chair or supervisor for review and comment. Once finalized, COI Management Plans are submitted to University Counsel for review and to the UMBC President for the final decision to accept or reject a COI Management Plan.

Continuing obligations concerning conflict of interest

Investigators are responsible for updating disclosure forms annually (the anniversary of the original disclosure) during the period of the research or within 30 days of identifying or acquiring a new financial interest. In cases of changes, an updated PHS Conflict of Interest Assessment Form  must be completed and submitted to the ORPC.

Retrospective Review

Retrospective review is required by PHS regulations if UMBC has not managed a FCOI or where a researcher has failed to comply with a management plan. UMBC must, within 120 days, complete a retrospective review of research to determine whether the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research.

If bias is identified, the UMBC must develop a mitigation report that outlines a plan of action to eliminate or mitigate the effect of the bias. The results of that determination and the mitigation report must be reported to the PHS. Documentation of the retrospective review will include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.

A report of retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.

The Vice President for Research, via the AVPR, will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.  If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.

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