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

Whose Responsibility Is The Protection of Human Subjects of Research?

Who is involved in protecting human subjects? The architecture of the current system
involves at least half a dozen levels of protection. Ultimately, protection depends on several
factors. First, the clinical investigator must be scientifically well-trained and also aware of his or
her ethical responsibilities as a researcher, and committed to both the advancement of knowledge
and the welfare of research participants. The initial planning of the research protocol is a vital
part of the protection of human subjects, during which time the researchers perform a thorough
review of the literature in order to develop a research plan and also to identify and articulate any
potential risks associated with the research. The investigators must consider both benefits and
risks associated with the research, build in safeguards for research participants, and formulate an
extensive process to inform potential participants, to obtain informed consent for participation,
and to document the consent.
Second, there is review and approval of the research protocol by a local IRB, a
requirement of the DHHS regulations for Federally-supported research. Although non-Federal
research is not covered by these regulations, you should be aware that the DHHS regulations are
in general use by others as well. Many institutions voluntarily follow DHHS regulations for all
their research. Following IRB review, additional review responsibilities rest with 1) the
executive official of the research site; 2) the scientific review group at the NIH (generally,
within the Division of Research Grants, or within an NIH Institute or Center [IC]); 3) the
Advisory Council or Board of the funding IC; and 4) the executive official of the funding entity.
Each has the authority to raise concerns about human subjects issues and to request further
evaluation and correction of any problems found.
Once multiple review of the proposed study design and informed consent documents has
been accomplished, and the proposal is funded, there is the crucial interaction between the
research volunteer and the research investigator. It is at this point that the informed consent
process begins -- when the research volunteer is apprised of what will be required for his/her
participation in the study, including known associated risks. The informed consent document is
only one component--the written component--of the informed consent process. I will describe
the particulars of informed consent later. There also may be several individuals involved with
the research volunteer during the process of obtaining informed consent, and throughout the
course of the study, such as the nursing and scientific staff, as well as a physician. There also
may be a consent auditor or monitor, or an advocate for the research subject to ensure that
research subjects understand and are kept informed of any risks or proposed changes.
Role of the IRB
The role of the IRB is to protect the rights and safeguard the welfare of human research
subjects. As I mentioned earlier. IRB review is required by DHHS regulations. The IRB must
be established at the local level and have a minimum of five people, including at least one
scientist, one nonscientist, and one person not otherwise affiliated with the institution conducting

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