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FCOI - New COI requirements for PHS funded researchers

New federal regulations governing financial conflicts of interest (FCOI) related to PHS-funded research went into effect on August 24, 2012 (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).  As required by the regulations, Penn has posted its revised policy, the University of Pennsylvania Policy on Conflicts of Interest Related to Research (the FCOI Policy), http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/090412-Supplement-ConflictsInterest.pdf. The FCOI policy reflects many new regulatory requirements, including expanded disclosure requirements.  Each Investigator (any person responsible for the design, conduct or reporting of such research) must now disclose to his/her School all of his/her Significant Financial Interests (SFIs) and those of his/her family members that reasonably appear to be related to the Investigator’s Penn responsibilities(regardless of whether such SFIs are related to research). In addition, Investigators must disclose travel reimbursed or paid on the Investigator’s behalf within the most recent 12 months.Investigators must also receive FCOI training from the University prior to engaging in research at Penn and at least every four years thereafter. The PI certification in PD has been revised to reflect the new FCOI requirements.

A new web-based disclosure, the PHS Financial Interest and Travel Statement (PHS-FITS) will now be required at the time of every PHS proposal submission for every Investigator (as defined above) listed on the proposal. If and when PHS funding is likely to occur for a specific proposal and prior to establishing or updating a fund number, Investigators will be required to update their PHS-FITS and answer additional questions in order to assess whether any disclosed SFIs or Travel are related to the proposal. Depending on the Investigator’s responses to the PHS-FITS questions and their School’s review, an additional, more detailed disclosure may be required in the Financial Interest Disclosure Electronic System (FIDES) for that proposal.
Investigators must update their PHS-FITS annually with respect to each PHS award, as well as: (1) when a grant is transferred from another institution, (2) at the  time of an IRB protocol submission if PHS-funded, (3) upon being added as an Investigator to an ongoing project, (4) within 30 days of discovering or acquiring a new SFI, (5) within 30 days of a change in an SFI such that it will require Conflict of Interest Standing Committee review, or (6) as otherwise required by the Office of the Vice Provost for Research (OVPR), the Investigator’s School, or the University.
Please consult the Office of the Vice Provost for Research website for more detailed information regarding the new FCOI policy, including (1) comparison of different disclosure requirements at Penn, (2) the special disclosure process for PHS-funded projects, (3) the disclosure process in FIDES and, (4) other relevant topics at: http://www.upenn.edu/research/compliance_training/conflicts_of_interest_in_research_program/
Additionally, the PHS regulations set forth a number of negative consequences that could result from a failure to comply with the regulations. For example, an Investigator’s failure to timely disclose an SFI may require the University to conduct a retrospective review of the  Investigator’s activities and the research project to determine whether any portion of the research con­ducted during the time period of the noncompliance was biased. In addition, violations of the FCOI Policy may result in sanctions and / or the initiation of proceedings under other University policies.

  • Awards issued on or after August 24th, 2012

At the time of award, Pre-award will confirm the final FCOI status for each Investigator (e.g., that all required PHS-FITS disclosures have been submitted, that any additional required disclosures in FIDES have been submitted, and that any identified conflicts have been managed or eliminated and all required reports have been filed). ORS will also confirm that Investigators have completed FCOI training.

  • Proposals  - Subawards

 

As of August 24, 2012, all proposed subrecipients (subcontractors) must demonstrate compliance with the new FCOI regulations.  Please make sure your subrecipients have completed the required documentation (i.e. a signed Letter of Intent certifying that the subrecipient has a compliant FCOI policy) prior to submitting a proposal to ORS.

The Federal Demonstration Partnership (FDP) has now launched a national website where the subawardee/susbrecipient can voluntarily allow the FDP to record the names (and DUNS numbers) of institutions that have certified PHS-compliant Financial Conflict of Interest policies. That list is available at: http://sites.nationalacademies.org/PGA/fdp/PGA_070596. Please feel free to tell your proposed subrecipients about the opportunity to join the list. An invitation to join the FDP list is available on the FDP web site at thefdp.org (the process takes about 2 minutes).  If your proposed subrecipient is on the FDP FCOI Compliant list, you do NOT need to have the subrecipient complete a Letter of Intent.

The greatest impact of the new regulations will likely be on smaller subrecipients or foreign entities that do not already have their own, compliant FCOI policies. The FDP web page includes a model FCOI policy that subrecipients may consider adapting for their own local implementation if they do not already have a compliant policy in place. As a rule, the University will require subrecipients to have their own FCOI policies and will only in excep­tional circumstances permit the subrecipient to be covered by Penn’s FCOI Policy.

What Happens when Penn is the Subrecipient?

  • It is Penn’s policy that the University’s FCOI Policy always applies.
  • We do not agree to use another entity’s FCOI policy, forms or procedures.
  • PHS-FITS disclosures are required for all Investigators performing work on the subaward.
  • Any request for written certification of Penn’s FCOI policy should be directed to your Pre-award contact for official institutional signature, or for PSOM, to ORSS.

 
Please don't hesitate to contact your FCOI Liaison or ORS representative if you have any questions.
Guidance Documents:
University of Pennsylvania Policy on Conflicts of Interest Related to Research
Effective: August 24, 2012
http://www.upenn.edu/research/pdf/policy_on_conflicts_of_interest_related_to_research.pdf

Office of the Vice Provost for Research

http://www.upenn.edu/research/compliance_training/conflicts_of_interest_in_research_program/

 

Research Sponsors That Require Compliance with PHS Regulations
U.S. Public Health Services Agencies include:
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry
• Centers for Disease Control (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Services (IHS)
• National Institutes of Health (NIH)
• Office of Global Affairs
• Office of the Assistant Secretary for Health, including

- Office of Minority Health Resources Center (OMH)
- Office of Population Affairs (OPA)
- Office of Research Integrity (ORI)
- Office of Research on Women’s Health (OWH)
• Office of the Assistant Secretary for Preparedness and Response, including

- Biomedical Advanced Research and Development Authority (BARDA)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

This list of PHS agencies is taken from the US Department of Health and Human Services Organizational Chart. Because there may be changes, if the agency you are interested in is not on this list and you are unsure if it is a PHS agency, check with your Pre-award contact.

Non-PHS organizations which have adopted the PHS regulations:
• Alliance for Lupus Research
• American Cancer Society
• American Heart Association
• Arthritis Foundation
• Susan G. Komen for the Cure

 

 

 


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