Testimony of Harold E. Varmus, M.D., Director, National Institutes of Health Before the Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Reform and Oversight, United States House of Representatives

useful to add higher resolution to that picture. DHHS regulations specify 14 elements of
informed consent. Of these, eight are required and are designed to ensure that research subjects
are fully informed about the studies in which they are to enroll, the risks and benefits, if any, as
well as their rights with regard to participation in DHHS-sponsored research. These are
highlighted below.
1) A statement that the study involves research, an explanation of the purposes of the research
and the expected duration of the subject's participation, a description of the procedures to be
followed, and identification of any procedures that are experimental.
2) A description of any reasonably foreseeable risks or discomforts to the subject.
3) A description of any benefits to the subject or to others that may reasonably be expected from
the research.
4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might
be advantageous to the subject.
5) A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained.
6) For research involving more than minimal risk, an explanation as to whether any
compensation will be paid, whether any medical treatments are available if injury occurs, and, if
so, what they consist of, or where further information may be obtained.
7) An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights, and whom to contact in the event of a research-related injury to the
subject.
8) A statement that participation is voluntary, that refusal to participate will involve no penalty
or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue
participation at any time without penalty or loss of benefits to which the subject is otherwise
entitled.
A researcher who seeks to recruit an individual for research without conveying these
elements of information in language understandable to the potential subject is not obtaining
informed consent.
Implementing informed consent is a dynamic endeavor, and we are always seeking new
perspectives. For example, a June 2. 1997. conference co-sponsored by the National Cancer
Institute. the NIH Office of Research on Women's Health, the National Action Plan on Breast
Cancer, and others, will seek to identify principles and models for prospectively obtaining,
storing, and utilizing stored tissue specimens for research. Also, the National Bioethics Advisory