April 20, 1999
TO: Investigators and Research Staff
From: Wyatt R. Hume, Executive Vice Chancellor
Chairperson, Human Research Policy Board (HRPB)
RE: Disclosure of Possible Conflict of Interest to
Human Research Subjects
I would like to clarify our institutional obligations
regarding disclosure of an investigator’s possible
conflict of interest in informed consent forms when (A)
the researcher is responsible for the healthcare of the
subject and/or (B) has a financial interest in the
sponsor of the study. The disclosure requirement also
extends to a financial interest in the manufacturer of
the product being tested in government sponsored
research. A brief statement that explains the background
of these obligations is on the second page of this memo.
A. Health Care Provider/Investigator Disclosure
Please use the following sub-head and statement on the
first page of informed consent forms when the
investigator is also the health care provider for the
subject:
Disclosure Statement
Your health care provider may be an investigator of
this research protocol, and as an investigator, is
interested both in your clinical welfare and in the
conduct of this study. Before entering this study or at
any time during the research, you may ask for a second
opinion about your care from another doctor who is in no
way associated with this project. You are not under any
obligation to participate in any research project offered
by your doctor.
B. Investigator Disclosure of Financial Interest
The Human Research Policy Board (HRPB) and the UCLA
Institutional Review Boards (IRBs) understand that an
investigator’s financial relationship with a sponsor
may be as simple as a one time honorarium for a
presentation or as complex a relationship as officer,
director, paid consultant, stockholder, or a close
relative of a stockholder.
Due to the possible complex and varying interests
investigators may have in sponsors, it is difficult to
create a boilerplate informed consent form statement that
will universally and adequately inform subjects of the
relationship. As a result, the HRPB and the IRBs request
that investigators create their own disclosure statements
for the informed consent form. The IRB support staff in
the Office of Human Research Protection Program would be
happy to help you construct disclosure statements prior
to submission of the project for IRB review.
Background
It is generally recognized that a researcher has an
ethical responsibility to disclose a possible conflict of
interest to potential research subjects as part of the
informed consent process. Our IRBs are required, per
federal regulations and State law, to address an
investigator’s possible conflict of interest and the
manner of disclosure to the potential subject. The above
requirements are the result of a 1990, California Supreme
Court decision, Moore v. The Regents of the University
of California, which addressed the concept of full
disclosure. The Court stated that, "[A] physician
who treats a patient in whom he also has a research
interest has potentially conflicting loyalties. This is
because medical treatment decisions are made on the basis
of proportionality - weighing the benefits to the patient
against the risks to the patient…. The possibility
that an interest extraneous to the patient’s health
has affected the physician’s judgment is something
that a reasonable patient would want to know in deciding
whether to consent to a proposed course of
treatment." The California Association of Hospitals
and Health Systems indicated the Supreme Court ruling
meant that, "prior to consenting to treatment,
patients have the right to be informed of any potentially
conflicting interests (viz., medical research or economic
interests) that a physician may have related to such
treatment."
Please contact Steven Peckman, Associate
Director-Human Subjects Research, at x55344 or
(speckman@research.ucla.edu) if you have any comments,
concerns, or questions regarding the informed consent
form disclosure requirements outlined above.
