NEW COI REGULATIONS FOR PHS (INCLUDING NIH) DEADLINES
PHS Proposals (Including NIH) for Upcoming Submission Cycles:
The automated disclosure system is not currently available. New rules have gone into effect related to conflicts of interest. For PHS (including NIH) submissions, all disclosures must be current at TIME OF PROPOSAL for all personnel named in the proposal. The new disclosure form, the ADF, is REQUIRED. To get the form, send a request to COIOFF@louisville.edu. Questions regarding this requirement can be directed to Allison Ratterman, PhD at 852-2453.
The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulation effective August 24, 2012. Accordingly, the University of Louisville has put into effect revised policies on Conflict of Interest posted at: http://louisville.edu/conflictofinterest.
In order to fully comply with PHS’s new regulation, UofL has developed the Attestation and Disclosure Form (ADF). If you plan to apply for funding from a PHS agency (directly or flowing thru another entity), you must comply with the new FCOI regulations. Please note that some non-federal sponsors have chosen to follow PHS regulations and therefore require compliance.
Before a PI can submit a proposal to any of the PHS agencies, all named project personnel must have a completed ADF on file. To request the ADF form, please send an email to COIOFF@louisville.edu
Questions regarding this requirement can be directed to Allison Ratterman, Director, Research Integrity, email@example.com or 852-2453.
List of PHS Funded Agencies
The following is a list of the 8 PHS-funded agencies and the 3 PHS-funded offices that are PHS-funded and covered under the new regulation. Each link will take you to the agency or office’s website, where you can find a list of all centers, institutes and sub-offices that are also covered.
- National Institutes of Health (NIH)
- Food and Drug Administration (FDA)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
Additional organizations following PHS regulation which require compliance include:
- Administration for Children and Families (ACF)
- Alliance for Lupus Research (ALR)
- American Cancer Society (ACS)
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- California Breast Cancer Research Program (CBCRP)
- California HIV/AIDS Research Program (CHRP)
- Centers for Medicare and Medicaid Services (CMS) [formerly HCFA]
- Juvenile Diabetes Research Foundation (JDRF)
- Susan G. Komen For the Cure
- Lupus Foundation of America (LFA)
Changes to PHS FCOI Policy
The FCOI regulation, effective August 24, 2012, requires that all persons applying for, receiving or being supported on PHS funds must be compliant with PHS rules on training, disclosure, and establishment of conflict of interest management plans.
The major changes to the PHS Financial Conflict of Interest Policy include:
- Lower financial disclosure thresholds
- Increased transparency for travel reimbursement
- New conflict of interest training
- New public accessibility requirements
Lower Financial Thresholds
Covered Individuals must disclose the following as a significant financial interest:
- The value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $5,000.
- Please note that assets in or income from investment vehicles such as mutual funds and retirement accounts are not considered significant financial interests and do not need to be disclosed as long as you do not directly control the investment decisions made in these vehicles.
- The value of any remuneration received from any non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000, or any equity interest in non-publicly traded entities. Intellectual property rights and interests count toward the $5,000 received from the entity upon receipt of income related to such rights and interests.
Increased Transparency for Travel Reimbursement
Any reimbursed travel or sponsored travel related to Institutional responsibilities if paid directly on behalf of the Investigator (including purpose of trip, sponsor/organizer, destination, and duration) must be disclosed as a Significant Financial Interest.
Please note that you are not required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. For example, if travel is reimbursed or paid by U of L as part of a gift or sponsored project, it is not considered a significant financial interest and does not need to be disclosed.
Financial Conflict of Interest Training for PHS Investigators
Please note that effective August 24, 2012, each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the following circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements; An Investigator is new to UofL; or
- U of L finds an Investigator noncompliant with COI policy or management plan.
Public Accessibility Requirements
U of L must make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible website. At a minimum, U of L must provide the following information:
- Covered Individual’s name;
- Covered Individual’s title and role on the PHS research project;
- Name of the entity in which the significant financial interest is held; and
- Approximate dollar value of the significant financial interest.
- These can be reported in a dollar range: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.