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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

INVESTIGATOR CONFLICTS OF INTEREST AND CHR REVIEW


Guiding Principles and Background

Guiding Principles: The term “conflict of interest in research” refers to 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. A conflict of interest depends on the situation, and not on the actions or character of an individual investigator.

It is important that researchers involved in the conduct of human research do not have or appear to have a conflict of interest, including a financial interest, related to any of the studies in which they participate. The welfare and safety of the research participant is paramount.

Background: On May 5, 2004, DHHS issued revised guidance of Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection. This guidance proposes establishment of an Institutional Conflict of Interest Committee (a committee that has been in place since the mid-1980s at UCSF) and it also includes some recommendations for the Institutional Review Board (IRB), that is, the Committee on Human Research at UCSF. These CHR guidelines in conjunction with the information and requirements posted on the UCSF Conflict of Interest Advisory Committee (COIAC) will help investigators comply with the DHHS guidance and the federal regulations, state laws, and University of California policies governing the disclosure and management of potential or actual financial interests in human research.


CHR Application Procedures

The CHR application includes a “Statement of Financial Interest” section in which Investigators are asked to respond “yes” or “no” to the following statement:

The Principal Investigator and/or one or more of the key personnel has financial interests related to this study.

Financial interests include the interests of the research team members' spouses, registered domestic partners, and dependent children. Additional information on financial interests is available on the UCSF Conflict of Interest Advisory Committee (COIAC) web site.

If the answer is affirmative, the investigator should take the following two actions:

  • All financial interest disclosures must be kept current with the COIAC office. The COIAC Office may contact you for additional information.



  • Briefly describe this financial interest in the "Why is this study being done?" or "What are the costs?" section of the consent form. See the Recommended Consent Form Language below for examples of wording.

Recommended Consent Form Language

Since the Moore v. Regents decision was rendered by the California Supreme Court, informed consent for University of California research projects require that “(a) a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment; and (b) a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of confidentiality.”

Two Types of Required Disclosures:

  • The CHR requires that all consent forms disclose which agencies or institutions (e.g., National Institutes of Health, Department of Defense, Center for Disease Control, State agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors are funding the research or providing study drugs or equipment for the study. If the study is not being funded by an external agency, then the internal funding source, i.e., Department funds, personal funds, should be identified. This information should be included either in the "Why is this study being done?" or "What are the costs?" section of the consent form.


  • Investigators must also disclose the nature of any financial or proprietary interests, though this disclosure can be in general terms.

Examples of recommended standard wording for the consent form:

  • (to identify the study sponsor) The National Institutes of Health (NIH) (or Industry Sponsor or Private Foundation) pays for the conduct of this study, including part of the Dr. Smith’s and Dr. Chang’s salary (if the latter is the situation).

  • Commercial company name, the manufacturer of the investigational drug being used in this study, is providing the study drug [or device or assay] at no cost [or at cost] to the researcher or research participant.
  • Dr. Smith is an unpaid member of the Scientific Advisory Board of the company that is sponsoring this study.
  • Dr. Wright is a paid [or an unpaid] member of the Scientific Advisory Board of a related company [or foundation] [or a company or foundation that is performing research in the same area as this study].
  • Dr. Wu has stock in a company that is performing research in the same area as this study.
  • (If the PI is listed on a patent) Dr. Cohen developed the Y device that is used in this study and he has a personal interest in the device. Dr. Cohen and the University of California may benefit financially if the device does what they hope it will do.
  • Dr. Jones has received an honoraria [or travel reimbursement] during the past 12 months from the study sponsor.

You may also add,

  • This disclosure is [these disclosures are] made so that you can decide if this relationship will affect your willingness to participate in this study.

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Referral to the UCSF Conflict of Interest Advisory Committee

Federal Requirements for Financial Disclosure: Federal regulations, state laws, and University policies require that faculty members submit financial disclosure forms at the time that a proposal is submitted for funding. In those cases in which a financial interest and possible conflict of interest are disclosed, the laws provide for the review of each situation by an impartial review committee. At UCSF, that committee is the Conflict of Interest Advisory Committee (COIAC).

Charge of the COIAC: The COIAC reviews potential financial conflicts of interest and makes recommendations to the Executive Vice Chancellor for acceptance, acceptance with conditions, or disapproval of the gift, grant or contract. Such review and recommendation must be completed before the University accepts the funding. The committee copies its recommendations to the PI, to the CHR, and to other appropriate individuals. The COIAC may recommend, for example, that additional disclosure of financial interests be made in the consent form.

IMPORTANT NOTE: When a financial interest may affect the protection of human subjects, disclosure to potential human subjects and/or the public cannot be used as the sole method of management of the conflict of interest. The COIAC with the concurrence of the Executive Vice Chancellor will determine the appropriate management strategy for the research.

Coordination between the COIAC and the CHR: The two oversight groups will coordinate with the PI to make sure that the study incorporates the recommendations to manage any potential conflicts of interest.

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Avoidance of CHR Member or Consultant Conflicts of Interest

It is important that the members or expert consultants of the Committee on Human Research do not have or appear to have a conflict of interest, including a financial interest, related to any of the studies in which they participate in the review process.

A CHR member is provided guidelines for considering the actual or potential conflicts of interest and determining whether a particular role or relationship could affect his or her objectivity before reviewing, participating in the panel discussion or deliberation, and voting on a protocol. Members who have a conflict of interest on a particular protocol are required to recuse themselves from reviewing or voting on a particular protocol. Procedures are in place to make sure that this occurs at every meeting and for the review of every protocol.


References

UCSF Conflict of Interest Advisory Committee

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” May 5, 2004

“Objectivity in Research,” 42 CFR Part 50; 45 CFR Part 94, Federal Register: July 11, 1995

“Objectivity in Research,” NIH Guide, Vol.24, No.5, July 14, 1995

“Investigator Disclosure Policy,” National Science Foundation, Federal Register, July 19, 1995

Political Reform Act of California of 1974

UC Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects, April 1984