Testimony of Harold E. Varmus, M.D., Director, National Institutes of Health

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Commission (NBAC), which is charged with providing guidance to Federal agencies on the
ethical conduct of current and future human biological and behavioral research, is reviewing all
of the human subject protections for their adequacy and appropriateness today.
Special Considerations in Informed Consent
With any set of regulations, situations arise that require special consideration. DHHS
regulations for Protection of Human Subjects do provide avenues for such occurrences,
recognizing that certain consent procedures with IRB approval may not include or may alter
some or all the elements of informed consent, or that a waiver of the informed consent
requirement may be made. These avenues may only be used in certain narrow circumstances.
The DHHS regulations (45 CFR 46.116(d)) provide for waiver of the requirements to obtain
informed consent when all four of the following circumstances pertain:
N the research involves no more than minimal risk to the subjects;
("Minimal risk" means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests [45 CFR 46.102(i)].)
N the waiver, or alteration, of consent will not adversely affect the rights and welfare of the
subjects;
C! the research could not practicably be carried out without the waiver or alteration; and
9 whenever appropriate, the subjects will be provided with additional pertinent information
after participation.
IRBs are required to make and document these judgments.
Research on Informed Consent
Despite the specificity of Federal regulatory language on informed consent, its endurance
through many years, and the enthusiasm with which we all adhere to it, there is little empirical
work in existence to document the degree of understanding achieved by research participants.
There is a paucity of data that bear upon. for example: 1) research subjects' comprehension of a
study's methods and procedures; 2) subjects' understanding of relative risks and benefits of
participation: 3) subjects' understanding of confidentiality and any exceptions to confidentiality;
and 4) subjects' understanding of the implications of withdrawal from a study. Such data are
needed to aid in designing informed consent procedures that are readily comprehended by
prospective participants and, at the same time. impart all critical information.
In this vein, the NIH has joined with the Department of Energy and the Department of

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