1. Why is a conflict of interest policy necessary?
Since 1995, federal regulations require that institutions have policies to ensure the design, conduct, or reporting of Public Health Service (PHS) funded research is not biased by financial interests of investigators. Under the regulations, investigators must disclose significant financial interests that might be affected by their proposed research by the time PHS applications are submitted, and institutions must review the disclosures and take appropriate steps to manage, reduce, or eliminate the conflicting interests prior to expending PHS funds.

In recent years, scrutiny by regulatory agencies and the public at large has continued to increase, and many of the concerns have focused on the impact of financial interests on the safety of human research subjects. These concerns were heightened by high profile cases such as the Jesse Gelsinger gene transfer trial at the University of Pennsylvania in 1999 and the clinical trials during the 1980s and 90s at the Fred Hutchinson cancer center in Seattle where investigators held significant financial interests. While the conduct of the trials might not have been affected, the perception that they might have was certainly suggested. Effective policies can help re-establish trust in the scientific community and alert investigators to possible situations in which questions could be raised, hoping to avoid them.

The potential risks of ineffective conflict of interest policies are several: damage to investigators' reputation; closure of research programs; harm to human subjects; damage to research integrity; damage to public image; fines; and lawsuits. UTHSCH seeks to minimize the likelihood of any of these through the implementation of effective policies and procedures to identify and address significant financial interests that might cause research conflicts of interest, and openness and transparency are major themes in their application.

2. Isn't disclosure and review of research related financial interests just one more burden for investigators to bear in getting research underway?
For most investigators, there is no added work, and in fact, in many situations, there will be less. In the past, all UTHSCH faculty were annually required to submit to the Executive Vice President for Research a financial disclosure identifying significant financial interests whether or not they were related to the faculty members' research. With UTHSCH's new policy (HOOP 23.10), certification, and if applicable, disclosure are requested only for specific projects, and disclosures are limited to financial interests related to an investigator's research. Updates are required during the award or contract period only if there are new reportable interests.

3. Won't UTHSCH's Research Conflicts of Interest Policy inhibit rather than facilitate research?
Hopefully, not. This concern was raised as the policy was being developed and was one reason why the task force developing the policy included several experienced investigators. It is hoped that researchers will find issues discussed in the Policy (HOOP 23.10) helpful when designing projects and applying for funding, and that it will alert them to financial interests that the public or an investigative reporter might perceive as causing conflicts. The perception issue is particularly important in human subjects research.

Investigators may seek advice from the Research Conflicts of Interest Committee which is an advisory body to the Executive Vice President for Research rather than a compliance or regulatory body. Just as one might consult the Committee for the Protection of Human Subjects on a human subject issue, so should one freely seek advice from the Research Conflicts of Interest Committee which seeks to prevent problems, not create them

4. Isn't disclosure of personal financial information an invasion of my privacy?
By restricting disclosure of financial interests to specific research projects, UTHSCH's Research Conflicts of Interest Policy (HOOP 23.10) limits the numbers of individuals who must disclose interests and the specific financial holdings that are reportable. The Research Conflicts of Interest Committee considers the information requested confidential, just as for any scientific submission that has not yet been publicly disclosed (e.g. manuscript under review, protocol under IRB review, etc). Investigators with significant financial interests may be required to disclose them (e.g. informed consent documents, publications, presentations), but up front disclosure is typically preferable to having to respond to an outside critic once the project is underway. The information may also be available under the Texas Public Information Act which entitles people to complete information about the affairs of government and the official acts of public officials and employees unless otherwise expressly provided by law.

5. What are investigator conflicts of interest in research?
Investigator conflicts of interest in research are "situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods" (Association of American Medical Colleges Guidelines, 1990). The potential conflict is particularly of concern in research involving human subjects, and in settings in which individual safety could be jeopardized. These conflicts typically occur when investigators have financial interests or business relationships with entities that sponsor their research, license their intellectual property, or may otherwise benefit financially from the results of their research. The financial or business interest could exist with an entity that is not the sponsor of the study, but might, for example, have a competing product.

6. What are institutional conflicts of interest in research?
Institutional conflicts of interest "occur when the institution, any of its senior management or trustees, or a department head, school or other sub-unit, or an affiliated foundation or organization, has an external relationship or financial interest in a company that itself has a financial interest in a faculty research project" (Association of American Universities Report, 2001). "Two major of categories of such conflicts are potential conflicts involving university equity holdings or royalty arrangements and research programs; and potential conflicts involving university officials who make decisions with institution-wide implications, which can include department heads and leaders of laboratories."

7. How do I know if I have a significant financial interest that should be disclosed because of its potential for creating conflicts of interest in my research?
Significant financial interests that must be disclosed are defined in UTHSCH's Research Conflicts of Interest Policy (HOOP 23.10). Note that this refers to the aggregate interests of both the investigator and his/her spouse and any dependent children. Some exceptions are noted. It is possible that this definition and list of exceptions might not address your specific situation. For example, you may have a close personal relationship with someone other than a spouse or child who holds a significant financial interest and which could create the perception of influence were it to be disclosed. Contacts/resources are listed in Question 17 if you have questions about a specific situation.

8. What is the first step in applying UTHSCH's Research Conflicts of Interest Policy?
The basis for this policy is self-reporting. When you submit research contracts or grants you must certify that you do/do not have significant financial interests related to the proposed research. The Certification is a one page form that is self-explanatory and is part of UTHSCH's Review and Approval Form. If you have no significant financial interests, you sign and date the form, and no further action on your part is required. Please note, however, that this policy also applies to other key research personnel - that is, any member of the research team that has substantive professional responsibilities in the conduct of the project. Therefore you must also identify those individuals, and have them complete Certification forms to submit with your research grant/contract. More details about this process are found in UTHSCH's Research Conflicts of Interest Policy (HOOP 23.10).

9. What happens if I have significant financial interests that must be disclosed?
Disclosure forms (3 pages each) should then be completed and submitted with the Review and Approval form. Investigators submitting contracts to for-profit entities complete the Disclosure for Research Contracts/Grants involving For-Profit Entities, and investigators submitting grants to the federal government or other non-for-profit entities complete the Disclosure for Federal Grants and Proposals to other Non-Profit Entities. The Offices processing your grant/contract (Sponsored Projects or Legal Affairs and Risk Management) forward the Disclosures to the Executive Vice President for Research for review, and, in most cases, the Disclosures are then reviewed by the Research Conflicts of Interest Committee. Details about the review process are provided in the Research Conflicts of Interest Policy.

10. What should I do if my significant financial interests change during the award or contract period?
If you obtain new reportable financial interests during the award/contract period that were not disclosed during the initial submission of a grant/contract, you must submit an updated financial disclosure to the Executive Vice President for Research within 30 days of obtaining the financial interests.

11. How does UTHSCH's Research Conflicts of Interest Committee interface with the Committee for the Protection of Human Subjects (CPHS)?
For projects that require review by both Committees, by virtue of having a significant financial interest in research that also involves human participants, the process will go forward concurrently. Mechanisms have been established to foster good communications between the two Committees with some members serving on both Committees. The final review/approval of the CPHS will not however occur until the review of significant financial interests involving clinical research is complete, and the Executive Vice President for Research notifies the CPHS of the outcome of the review. If the CPHS determines the actions/plans approved by the Executive Vice President to address conflicts due to investigator or institutional financial interests do not adequately protect human subjects, it may request modifications of the plans or disapprove the research. All efforts are made to ensure the project is allowed to go forward, and investigators' concerns are carefully considered.

12. Who has the final say in whether a project goes forward or not?
The UTHSCH's Research Conflicts of Interest Committee is advisory to the Executive Vice President for Research, and, as such, it is the latter who makes the final determination as to whether the project goes forward with any steps needed to reduce, eliminate, or manage a potential conflict. Regardless of the decision of the Executive Vice President for Research, if the project involves human subjects, the Committee for the Protection of Human Subjects (IRB) is the final arbiter as it is in all clinical projects, independent of the existence of a potential conflict

13. What if I do not agree with the Executive President for Research's decision about how conflicts of interest with my research should be addressed?
An appeals process is in place to ensure due process in the review of potential research conflicts of interest, and is detailed in UTHSCH's Research Conflicts of Interest Policy (HOOP 23.10). It requires that a written appeal be submitted to the Executive Vice President for Research within 30 days of the determination of actions to address potential conflicts and the appeal process may include an external review. During the appeal investigators have an opportunity to clarify information in the disclosure that may have been misinterpreted and provide additional information that might impact the decision.

14. What are the ways in which a conflict might be managed?
Strategies to address potential research conflicts are often individualized and depend on the specific issues raised. In many cases, in the interest of transparency, public disclosure of significant financial interests is fundamental, and, in studies involving human subjects, this would occur in the informed consent. The research plan could also be modified so the investigator with significant interests did not participate in subject recruitment, or analysis of data. Distancing oneself from the interest could also be accomplished through divestiture or prohibiting buying or selling of the equity while the research is ongoing. In some instances the only realistic option may be to sever the relationship that created the potential conflict.

15. How much should research subjects be told about any financial interest?
Assuming that the project goes forward with the significant financial interest in place, the first question to ask yourself is what information would be embarrassing to you were it not disclosed but was revealed later. Consider also the perception of an outsider not connected with the study. Being up front with subjects and outside reviewers pays dividends. The Committee for the Protection of Human Subjects has suggested wording for the consent document, but in general it would state that a financial interest exists, and there might be personal profit (e.g. intellectual property with a royalty agreement) for the investigators and/or the institution. It should provide assurance that an oversight body has reviewed the work and will monitor it. Finally, one would also offer an opportunity to answer questions, including the details of the financial interest. Many research participants may not know how to use the information provided, others will be satisfied with the disclosure and reassurance, while others may view the interest as a plus that signifies the investigator's commitment to the project.

16. If the project has been reviewed and approved by both the UTHSCH's Research Conflicts of Interest Committee and the the Committee for the Protection of Human Subjects, why add to the burden of information that a potential research participant has to assimilate?
If a significant financial interest exists, and the project is approved, disclosure will likely be the first element of any management plan, so it will be necessary on this basis alone. Independent of this, however, it is probably best to provide too much rather than too little information, and let the participant decide what he/she wishes to use. The problem of perception comes into play here; if something is revealed later that had not previously been disclosed, its significance could be distorted, even though it might have had no impact on the conduct of the study.

17. What should I do if my invention or intellectual property is patented?
Because most patents have the potential for commercial value, if licensed, a patent is considered a significant financial interest if the invention or intellectual property is being evaluated or used in your research; as such, a disclosure form should be completed. Usually the patent is owned not by you but the institution, or perhaps the sponsor. Nonetheless, the perception can arise that even the potential for royalties paid to you as inventor could influence you as the investigator in the conduct of the research study. There have been several well publicized cases in clinical research in which this issue has been raised; thus, dealing with this possibility up front will avoid problems in the future. Both the Office of Research and the Committee for the Protection of Human Subjects are advised when patents are issued and you may receive a reminder regarding this need from one or both offices, as applicable.

18. What resources are available to help answer questions I have about UTHSCH's policy/process for addressing research conflicts of interest?
Resources that may be useful if you have questions about UTHSCH's policy/process for addressing research conflicts of interest include the following.