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

involving human subjects in research; conducts programs of clarification and guidance for both
the Federal and non-Federal sectors with respect to the involvement of humans; and evaluates the
effectiveness of DHHS policies and programs for the protection of human subjects. OPRR plays
a major role in ensuring that human subjects of research are informed and protected and that
thorough investigations of human subjects concerns are conducted. OPRR also investigates
complaints from research subjects and others concerned with their welfare, and conducts a
national program to educate the research community about human subject protections.
Members and staff of NIH scientific review groups and advisory councils evaluate the
proposed involvement of human subjects in the research and identify questions, suggestions or
concerns regarding protection of human subjects in the activity. These are communicated
directly to the applicant before an award decision is made. If "concerns" are expressed by the
review body, NIH program staff, with assistance from OPRR, work with the principal
investigator and the institution to resolve any human subject "concerns" before a project is
eligible for award. Grants management staff confirm that an applicable Assurance of
Compliance and IRB approval have been obtained prior to award. Once these steps are
completed, the Institute or Center Director makes the decision whether or not to fund the
research project.
A Perfect System?
While I have emphasized the multiple layers of protection inherent in this system, I
know you are most concerned about the possibility that this system can somehow fail. We
acknowledge that despite our best efforts, there are occasions when the systems for protection are
not perfect or the individuals charged with ensuring adequacy of these protections are unable to
foresee potential problems--that is. there is always room for improvement in any system,
including human subject protections. There have been research studies that have required further
evaluation for human subjects concerns. To give you a sense of the kinds of problems we have
encountered. I will relate brief accounts of selected research studies involving human subjects
concerns and highlight actions taken to address them.
In one well-publicized instance, concern was raised about the proper explanation of
research procedures and risks in the informed consent process for a study involving research
subjects with schizophrenia at the University of California at Los Angeles (UCLA). After
extensive OPRR review of concerns voiced, and of the institution's informed consent practices in
general. it was determined that the IRB did not exercise sufficient oversight of the informed
consent process. The institution was directed to revise the informed consent process. In
addition. OPRR instituted close monitoring of the institution's human subjects activities, and
issued a report on the investigation of UCLA activities relative to this protocol. As a result of
this occurrence, the Acting Director of the National Institute of Mental Health (NIMH), the
funding entity for the study. sent letters to over 200 clinical investigators to provide each with a
copy of the OPRR report and to request that they carefully scrutinize all informed consent
documents for full compliance with the OPRR recommendations. In 1995, the Institute released