THE COMMITTEE ON HUMAN RESEARCH
INVESTIGATOR CONFLICTS OF INTEREST AND CHR
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
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
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.
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.
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,
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.
must also disclose the nature of any financial or proprietary interests,
though this disclosure can be in general
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
- 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
- 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
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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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
recommendations to the PI, to the CHR, and to other appropriate
individuals. The COIAC may recommend, for example, that additional
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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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.
UCSF Conflict of Interest Advisory Committee
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