In August 2011, the U.S. Department of Health and Human Services (HHS) published its final rule on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R., Part 50, Subpart F) covering the requirements for disclosure, review, management and reporting of financial interest in PHS-funded research (see Financial Conflict of Interest from the National Institutes of Health). These regulations apply to any research and any activity for which research funding is available from PHS via grant or cooperative agreement, including career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program project awards, research resource awards, conference grants, Phase II SBIR or STTR awards (but excluding Phase I SBIR/STTR) with an issue date on the Notice of Award on or after August 24, 2012. These regulations change the disclosure requirements for investigators and the review, management, and reporting requirements for institutions.

The regulations pertain to all investigators and institutions that apply for or receive funding from the following agencies. Note: This list may not be all inclusive and is subject to change; see the List of Agencies Using the PHS FCOI Regulations maintained by the FDP, and consult the proposal application instructions for the sponsor’s COI requirements.

PHS and Other HHS Agencies

  • National Institutes of Health (NIH)
  • Administration for Children and Families (ACF)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • Office of Global Affairs (OG)
  • Office of Public Health and Science (OPHS)
  • Office of the Assistant Secretary for Health (OASH)
  • Office of the Assistant Secretary for Planning and Evaluation (ASPE)
  • Office of the Assitant Secretery for Preparedness and Response (ASPR)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Other Organizations Following PHS Regulations

  • Alliance for Lupus Research (ALR)
  • Alpha-1 Foundation
  • American Asthma Foundation (AAF)
  • American Cancer Society (ACS)
  • American Heart Association (AHA)
  • American Lung Association (ALA)
  • Arthritis Foundation (AF)
  • CurePSP
  • Juvenile Diabetes Research Foundation (JDRF)
  • Lupus Foundation of America (LFA)
  • Patient-Centered Outcomes Research Institute (PCORI)
  • Susan G. Komen for the Cure

To meet the new requirements, all University of California campuses must have revised policies in place and publicly posted no later than August 24, 2012.


Why did the HHS develop revised regulations?

The new regulations were revised for the stated purpose of “providing a reasonable expectation that PHS-sponsored research will be conducted free of bias resulting from Investigator financial conflicts of interest.” Federal conflict of interest regulations have been in place since 1995. Most of you are familiar with the process of disclosing financial interests related to your NIH and NSF research. The new regulations retain the basic framework for disclosure, review and management of financial interests, but include a number of significant changes in the breadth and scope of disclosure. By increasing the disclosure requirements for investigators and the reporting requirements for institutions, the PHS and other funders that have adopted the PHS model, hope to increase transparency and accountability from their grantees to ensure that research results are not biased or unduly influenced by any outside financial interests of Investigators.

The NIH has posted FAQs, tutorials, webinars, and additional information on the Financial Conflict of Interest page.

Who must disclose?

Any personnel, including those of any subrecipient, who are responsible for the design, conduct or reporting of the research. This would include the principal investigator, project director, senior and key personnel and any others who contribute to the scientific development or execution and reporting of a project in a substantive, measurable way whether or not they request or receive salary or compensation. Under the regulation, these individuals are defined as “Investigator.”


When must disclosure be made?

Investigators must disclose any Significant Financial Interests (SFI) related to their Institutional Responsibilities at the time a new proposal is submitted for funding, at least annually at the time of the non-competing continuation/progress report, and within thirty (30) days of acquiring or discovering any new SFI at any time during the award.


What must be disclosed/What is a “Significant Financial Interest”?

  • With regard to any publicly-traded entity: the value of any remuneration received from the entity in the 12 months preceding financial disclosure and any equity interest owned or acquired as of the date of financial disclosure, which exceeds $5,000 when aggregated for an Investigator, spouse, registered domestic partner and dependent children. Included are salary, consulting fees, honoraria and the value of equity interest (stock, stock options or other ownership interest) as determined by public prices or other reasonable measure of market value as of the date of disclosure.
  • With regard to any non publicly-traded entity: the value of any remuneration received in the 12 months prior to the date of the disclosure, which when aggregated exceeds $5,000 or any equity interest (includes stock, stock option or other ownership interest) held by the Investigator (or their spouse, registered domestic partner or dependent children)regardless of value.
  • Any payments exceeding $5,000 received within the past 12 months for any intellectual property rights and interests assigned or licensed to a party other than the University of California.
  • Any travel reimbursement or payment in excess of $5,000 per entity made by any entity (profit or non-profit) other than those listed below within the past 12 months, regardless of value made to or on behalf of the Investigator related to their Institutional Responsibilities.

What is excluded from disclosure/What is not a “Significant Financial Interest”?

  • Payments (salary, royalties, honoraria, expense reimbursement or other remuneration) made by the University of California to a University of California Investigator who is currently employed or otherwise appointed by the University of California.
  • Income from seminars, lectures, teaching engagements or service on advisory committees or review panels, e.g., NIH peer review, sponsored by a U.S. Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
  • Income from investment vehicles, such as mutual or pension funds or other investment over which the Investigator does not exercise investment decisions.
  • Travel reimbursed or sponsored by U.S. Federal, state, or local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or research institute affiliated with a U.S. institution of higher education.

What is “Institutional Responsibility”?

Institutional Responsibility is defined as teaching/education, research, outreach, clinical service, training, University and public service done on behalf of UC and directly related to those credentials, expertise and achievements upon which the Investigator’s UC position is based. This will generally include consulting, expert witness testimony, and the like.


What is an “Entity”?

Entity is any domestic or foreign, public or private organization (excluding a U.S. Federal agency) from which an Investigator (and their spouse, registered domestic partner or dependent children) receives remuneration or in which that individual has an ownership or equity interest.


What is a Financial Conflict of Interest?

A Financial Conflict of Interest (FCOI) is defined under the regulation as a SFI that is related to the PHS-funded research activity and that could directly and significantly affect the design, conduct or reporting of that activity.


What else is required?

Training:

All Investigators are required to take PHS-compliant training prior to engaging in PHS-funded research for new awards or no later than the due date of the next subsequent progress report/non-competing continuation proposal for ongoing projects, whether receiving remuneration or not, and at least every four years while engaging in PHS-funded research. Training is also required immediately if an Investigator is new to the institution, if the UC policies change in a way that affects Investigator requirements or if UC finds that an Investigator is noncompliant with any policy or management plan. This training requirement applies equally for those funding agencies that have adopted the PHS regulations. The institution must be able to verify that training has been completed. The training requirement must be met as follows:

  • University of California Conflict of Interest Training for Researchers (COIR) is available for UC Berkeley researchers with a Calnet ID through the UC Learning Center on the campus Blu portal. Note that UC extramurally funded researchers (PHS and non-PHS funded) must complete this COIR training (whether or not they have also completed other PHS-specific training) to satisfy Regentally mandated COI training.
    • Go to Blu, login with your Calnet ID, click UC Learning (near bottom left), and search for COIR.
    • Go through the training slides to complete the course.
    • After you have completed the training, you will receive a certification email. Keep this email for your records.
  • Additional training is available via CITI, and can augment but not substitute for COIR training.

Subrecipients:

Subrecipients are also subject to the requirements of the regulation. The prime awardee institution is responsible for ensuring that any of its subrecipients are in compliance with the regulation and for reporting any identified FCOI of a subrecipient Investigator to NIH. In most cases, a subrecipient will be a U.S. educational institution or other non-profit that has a PHS-compliant policy. However, in some cases the subrecipient will be a foreign entity or small non-profit organization that does not have a PHS-compliant policy. Such entities must develop and have in place a PHS-compliant policy before the issuance of any subaward.

If a subrecipient has a PHS-compliant FCOI policy in place, then they are required to follow that policy for financial disclosure review, training and reporting of subrecipient FCOI’s to the prime awardee so that the prime awardee can meet its reporting obligations to the NIH.

Financial disclosures from all Investigators, both UCB and any subrecipient must be provided to the Sponsored Projects Office before the proposal can be submitted to the funding entity and exceptions cannot be granted.

Institutional Reporting to NIH:

The institution must determine if any disclosed SFI is related to the PHS-funded research and, if so, whether that SFI rises to the level of a Financial Conflict of Interest (FCOI). If such a determination is made, the institution must report the FCOI to NIH, along with details about the SFI and its management. The regulation also now requires that the public be provided, upon request, certain details of the SFI as reported to NIH.

Public Access to FCOI Information:

The institution must make certain FCOI information for senior/key personnel available within five business days of the request. The response must be postmarked or dated (if replying by electronic means) within five days of receipt of a written request. All written requests must be sent to: coiphsrequest@berkeley.edu

All information provided as a result of such requests will be current as of the date of the correspondence to the requester and will be updated at least annually and within 60 days of any subsequent request.
 Any information in such requests which falls outside of the 2011 regulations will be responded to in accordance with the requirements of the California Public Records Act.


How is the University of California responding to the final rule?

The Office of the President has posted a new systemwide policy on Conflict of Interest with an effective date of August 24, 2012 that includes the expanded definitions and rules compelled by the new regulations. This policy applies only to PHS investigators and investigators applying for and receiving funding from other funding entities, which have adopted the PHS regulations. In addition, the campus COI Coordinators are working to implement streamlined systems intended to reduce the burden on investigators and minimize redundant reporting requirements.

Despite the efforts of all involved, we are well aware that these new regulations will increase bureaucratic burden on some PHS investigators. We are committed to minimizing that burden to the greatest extent possible and appreciate your patience and cooperation as we work through the process.

Any questions regarding the final rule, UC policies or campus implementation of those policies should be addressed to COI Coordinator Jyl Baldwin at jbaldwin@berkeley.edu or 642-8110. The COI Committee website (http://researchcoi.berkeley.edu/phs.html) will have the latest information, disclosure forms, procedures, policies, and related links posted.