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

the research study. Having the IRB at the research site is the cornerstone of our system of
protection of human subjects. IRB review is a prospective and continuing review of the research
by an impartial group of individuals, who are in the best position to know the resources of the
institution, the capabilities and reputations of the investigators and staff, and the prevailing
values and ethics of the community and, thus, the likely subject population. No federallyfunded human subjects research may be initiated, and no ongoing federally-funded research may
continue, in the absence of an IRB approval. The NIH cannot provide funds for human subjects
research unless an IRB approves the protocol for such studies.
Once research is initiated that involves human subjects, IRBs have continuing
responsibilities. These include the conduct of continuing review at intervals appropriate to the
degree of risk, but not less than once per year; the authority to observe or have a third party
observe the consent process and the research; prompt reporting of any unanticipated problems
involving risks to subjects or others, or any serious or continuing noncompliance with the IRB's
requirements or determination, or with the regulations; and authority to suspend or terminate IRB
approval of research that is not being conducted in accord with the IRB's requirements or that
has been associated with unexpected serious harm to subjects.
Data and Safety Monitoring Boards
An additional layer of review that is sometimes employed is an independent Data and
Safety Monitoring Board, or "DSMB," appointed to oversee and to evaluate the research
investigation. Size and make-up of DSMBs vary; however, most include physicians with
expertise in the disease under study, gained either through patient care or in the conduct of
research, statisticians, and experts in scientific specialities. A patient advocate also may be
included among the members of a DSMB. At periodic intervals during the course of a research
study, the Data and Safety Monitoring Board reviews the accumulated data and makes
recommendations on the continuation, or modification, of the study.
Institutional Officials
The final responsible party at the applicant/grantee institution is the institutional official,
who signs-off on the research project when the application is submitted to the funding agency
and assumes responsibility for the research project on behalf of the institution when the award is
accepted.
Those directly involved with the protection of human subjects on behalf of the NIH are
the members of peer review groups. the Director and other staff of the funding institute or center,
and the Office for Protection from Research Risks (OPRR). Located administratively at the NIH,
OPRR exerts extensive oversight of the entire process of human subject protection for HHSsupported research. Among its many responsibilities, the OPRR develops and monitors, as well
as exercises compliance oversight relative to. DHHS regulations; establishes criteria and
negotiates Assurances of Compliance with institutions engaged in DHHS-supported research