Disclosure Policies for Gifts From Industry to Academic Faculty

The relationships between academic institutions and bioscientific companies are common, complex, and under increasing scrutiny. In this issue of JAMA, Campbell and colleagues¹ present the latest article in their series of studies that have explored university-industry relationships. In earlier studies, this group discussed potential conflicts of interest related to receipt of grants and contracts from industry.^{2 - 3} About one half of the companies surveyed in these previous studies supported research at universities through grants.² In their present article, Campbell and colleagues report on gifts received by faculty at 50 universities. Types of gifts include discretionary funds, biomaterials, support for students, research equipment, and trips to professional meetings.¹ Almost half of the faculty surveyed received gifts. The faculty perceived that these gifts were frequently accompanied by restrictions, including prepublication review of manuscripts and loss of university patent rights. Considering that gifts are often not subjected to the same university oversight as grants or contracts, the authors suggest that general guidelines concerning gifts are necessary.

Multiple policies regarding conflicts of interest can be difficult to understand, and perhaps even more difficult to enforce. Accordingly, a uniform policy is preferred and should help establish guidelines and clarify interpretation for all involved. Policies in place at the University of California, San Francisco (UCSF), where I am a member of the faculty and the Chancellor's Advisory Panel on Relations With Industry, represent an example of how one institution handles gifts. The University of California, San Francisco, is a major recipient of both government and private research funding. Other institutions may have different approaches for dealing with potential conflicts related to gifts.

Two issues relevant to developing a uniform policy are loopholes in university conflict-of-interest policies and the differing perceptions of basic and clinical researchers regarding what constitutes a conflict.

In their article, Campbell et al¹ conclude that industry, faculty, or both may be using the gift mechanism as a way to bypass university administrative structures, namely the contracts and grants office, which is designed to manage university-industry relations. At UCSF, the loophole for avoiding administrative scrutiny is quite small. Faculty at all University of California campuses who receive research funding of $250 or more during a year (including gifts) from a nongovernmental entity must adhere to the State of California's Political Reform Act of 1974 by completing a financial disclosure form.⁴ The Political Reform Act grew out of concerns that university faculty, who are state employees, might be using public resources to make financial gains through their relationships with private industry.

The UCSF financial disclosure form, which each faculty member signs under penalty of perjury, asks a number of questions about the faculty member's relationship with the sponsoring company. If the faculty member, a spouse, or a dependent child receives income, including gifts, honoraria, loans, or other compensation of more than $250; has stocks, stock options, or other investments valued at more than $1000; or serves on the board of directors or other decision-making body of the company, then the faculty member is considered to have a positive disclosure of financial interest.⁵ If a disclosure is positive, the faculty member must complete another form that gathers additional information, including information on biomaterial transfer, patent, and intellectual property rights. All positive disclosures are reviewed by the Chancellor's Advisory Panel on Relations With Industry. A financial interest is considered acceptable by the panel only if the following conditions are met: there are no restrictions on publication or dissemination of information, the licensing of new technologies is fair, the openness of the academic environment is maintained, the research is appropriate to the university, and the use of university resources and facilities is appropriate.⁶ Therefore, the UCSF procedure for reviewing positive disclosures should prevent some of the restrictions on gifts that were perceived by the faculty in the study by Campbell et al,¹ such as publication restrictions and loss of ownership of patentable research.

While the UCSF policy offers some degree of university oversight for gifts compared to other universities, it still leaves several loopholes. Noncash gifts, such as equipment, trips, and biomaterials, do not have to be reported, nor do cash gifts of less than $250 per year. In addition, if the faculty member who receives the gift has no relationship with the sponsoring company, additional information is not collected and the disclosure form is not reviewed by the Chancellor's Panel. However, these negative disclosures should still encourage faculty accountability for gifts as the disclosure forms are kept on file for a minimum of 7 years. Moreover, these disclosure statements are public documents that can be obtained through the Freedom of Information Act.

Disclosures made under the Political Reform Act⁴ can help the university administration regulate gifts, but they can also be confusing to faculty. Disclosures made under the act are in addition to those that are required for all universities that accept federally sponsored research.⁷ When submitting an application for funding from the Public Health Service or the National Science Foundation, the principal investigator and all participants in the research project who have responsibility for the design, conduct, or reporting of research must disclose any financial interests that would appear to be reasonably related to the research and that exceed $10000 in value or 5% equity interest.^{8 - 9} Understandably, faculty can be confused. Why are disclosure limits $250 in one case and $10000 in another? Why are the disclosure guidelines different for federally sponsored and privately sponsored research? These inconsistencies in disclosure policies could suggest to faculty that the policies are arbitrary and could lead faculty to consider these policies less than seriously. For example, some UCSF faculty with clearly defined and substantial financial conflicts of interest have described their relationships to sponsoring companies as inconsequential or trivial. On the other hand, other faculty members err on the side of caution and completeness; for example, some even report the receipt of free coffee cups on their disclosure form.

The UCSF policy regarding acceptance of honoraria illustrates the differing perceptions that preclinical and clinical faculty have about what constitutes a conflict of interest. One of UCSF's most contentious guidelines states that faculty who participate in a sponsored clinical study cannot concurrently receive any compensation from the sponsor, including honoraria, during the course of the study.¹⁰ In contrast, faculty conducting preclinical research can accept honoraria from the sponsoring company during the course of their study. Supporters of the UCSF policy regarding honoraria and clinical studies argue that, since human subjects are involved, the policy is necessary to ensure that faculty do not appear to be receiving remuneration for promoting a clinical product. Opponents of the policy have argued that it creates a double standard for preclinical and clinical researchers, can be easily bypassed (for example, by accepting the honoraria after the study is completed), and prevents faculty from fulfilling their public service and educational commitments to share information about new treatments. Moreover, supporters of the policy feel that researchers are unable to promote a product because they are precluded by their sponsors from talking about the results of a trial. Debate over the clinical honoraria policy has occurred on the Chancellor's Panel and among the Committees of the Academic Senate. Although the faculty remain divided on the issue, the current policy still stands.

Campbell et al¹ suggest a general set of guidelines concerning gifts that would encourage the sharing of resources, ensure the timely dissemination of research results while protecting the interests of the sponsor, and protect university intellectual property rights. The data of Campbell et al¹ on faculty perceptions of restrictions on their gifts offers a compelling argument for such guidelines. However, my experience at UCSF suggests that policies regarding acceptance of gifts should be closely coordinated with policies for accepting grants and contracts, including federal grants, as well as other university policies on conflicts of interest. A uniform policy for financial conflicts of interest should include a definition of the purpose of the policy, a definition of what constitutes a financial interest, a definition of what constitutes a conflict, and strategies for managing the conflict. To avoid faculty confusion and arguments over inconsistencies, a uniform policy should start with a clear description of its purpose. Is the purpose to protect the integrity of the research, avoid the appearance of financial gain by the faculty, protect the intellectual property rights of the university, or all of the above? In addition, a uniform policy should clearly define whether an interest is determined by the amount of money exchanged, whether a conflict is determined by the match of the topic of a research project with a company's mission, or other criteria. In all cases, strategies for managing conflicts should be consistent, regardless of the source of the money.