Recent Modifications of Conflict of Interest Guidelines in Privately Sponsored Research
New UC Policy on Disclosure of Financial Interest and Management of Conflicts of Interest in Private Sponsors of Research and Proposed Changes to UCSF Rule 11 are expected to Streamline the COI Process
New UC Policy on Disclosure of Financial Interest and Management of Conflicts of Interest in Private Sponsors of Research
Conflict of interest (COI) in research concerns financial disclosures that may compromise, or have the appearance of compromising, an investigator’s judgement through possible gain.
It is important to note that conflict of interest is not conflict of commitment. The main distinction between the two is that the former’s focus is financial, while the latter is focused on time and effort. Conflict of commitment refers to situations in which outside professional activities may have the potential to interfere with a faculty’s primary commitment to the mission of the University.
UC addresses the various aspects of financial conflicts of interests in research through a number of principles, guidelines and policies intended to promote the conduct of research without bias and with the highest scientific and ethical standards. Each campus is responsible for implementing the conflict of interest policies and developing review procedures.
APM 028 governs the disclosure and review of a principal investigator’s finanacial interest in private sponsors of research. A critical component of the disclosure is Form 700-U, the “Statements of Economic Interests for Principal Investigators,” through which the investigators disclose they have a financial interest in the sponsor company. In October 2018, UC President Napolitano enacted the new Policy COI 700, the Policy on Disclosure of Financial Interests and Management of Conflicts of Interest in Private Sponsors of Research, which replaced that component of APM 028 in which compliance to Form 700-U is assessed, and expanded it to include all University employees. The policy allows for greater local flexibilty and speed in this process, allowing Designated Campus Reviewer (DCR) more breadth to conduct the review, rather than pass it on to the Independent Substantive Review Committee (ISRC). The UCSF ISRC is the Chancellor’s Conflict of Interest Advisory Committee (COIAC).
APM 028 was subsequently revised in April of 2019. It now includes the Presidential Policy, which defines continued compliance with Fair Political Practices Commission (FPPC) regulations and review of Forms 700-U for all University employees, while the remainder of APM 028 describes the additional important principles guiding the conduct of sponsored research for academic appointees.
UCSF Proposed Changes to Rule 11
On the UCSF Conflict of Interest website under the section titled COI Disclosure for Research there is a subsection titled previously titled Compliance with Rule 11 which provides:
Faculty who have, or participate in, a privately sponsored clinical study shall not concurrently receive any compensation from the sponsor, including honoraria and consulting fees, during the course of the study. In addition, they shall not have any investment in, or serve in a decision-making capacity for (such as service on the Board of Directors or management committee), or be an officer or employee of the company sponsoring the study.
In response to concerns raised by several members of the faculty, the Academic Senate Committee on Research (COR) asked the Office of Ethics and Compliance (OEC) to examine Rule 11 and recommend if it should be revised.
In particular, these faculty members have reported that Rule 11 has caused them to decline professional activities such as attending conferences or acting on advisory boards for companies with which they are performing clinical trials. Note that the Academic Senate had advocated to have the name “Academic Senate” removed from the description of the rule on the OEC website because the Senate had neither recommended nor endorsed the rule.
The UCSF COIAC, which is primarily composed of faculty, invited faculty stakeholders to attend its meeting when the rule was reviewed and accepted written feedback. The COIAC determined that Rule 11 is essential to the substantive review of conflict of interest but that it should be clarified, which would eliminate many of the faculty’s concerns. Most importantly, COIAC believes that eliminating travel payments from the definition of “compensation” would remove most of the faculty’s problems with Rule 11.
In addition to removing travel payments from “compensation,” COAIC is recommending further clarifications in the rule, such as defining the “course of a study,” and noting that payments incorporated into an agreement are not a personal payments, and that contracts are now signed by the individual faculty and not on behalf of the Regents.
Noting that travel payment is not “compensation,” COIAC still advises that it is preferable for the sponsor cover the investigator’s travel costs by paying the vendors (e.g., the airline, the hotel) directly, which will avoid the appearance of a concurrent personal payment.
The proposed revision will be forwarded to the Executive Vice Chancellor and Provost for review, after which, the other proposed revisions will be revisited. The Academic Senate will notify faculty of any additional updates.