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

a program announcement--Informed Consent in Clinical Mental Health Research--to expand
upon previously funded research on informed consent. NIMH also has sponsored, and cosponsored with advocacy groups, a number of workshops and conferences aimed at addressing
issues specific to mental illness in clinical research.
In a second instance, concern was expressed about the misuse of an expedited IRB review
process. OPRR identified failure of leadership within the IRB as the root of the problem,
resulting in resignation of the IRB chairman. Sometimes, an OPRR review leads to a finding
that the concerns were unfounded as in the case of another institution. OPRR followed up on
concerns that were raised about whether a particular IRB was properly conducting the required
annual review of continuing research. The institution demonstrated to OPRR that some 2,000
research protocols involving human subjects had, indeed, received continuing review by the IRB
in accord with DHHS regulations.
Protection of Vulnerable Populations
Let me return briefly to the specific responsibilities of the IRB and the concerns IRBs
must address. IRB review assures that risks are minimized; risks are reasonable in relation to
anticipated benefits; selection of subjects is equitable; there is proper informed consent; and the
rights and welfare of subjects are maintained in other ways, as well. This is particularly
important when subjects are likely to be vulnerable to coercion or undue influence.
What populations are judged to be vulnerable? IRBs pay careful attention to research
involving children, prisoners, pregnant women, individuals with mental disabilities, individuals
who are economically disadvantaged, and individuals who are educationally disadvantaged.
The DHHS regulations provide extra protection for vulnerable subjects in several ways.
If an IRB regularly reviews research that involves a vulnerable category of subjects,
consideration must be given to including as IRB members one or more individuals who are
knowledgeable about and experienced in working with the vulnerable population. When some or
all of the subjects are likely to be vulnerable to coercion or undue influence, IRBs must see that
additional safeguards are included in the study protocol. Specific, detailed protections are
actually written into DHHS regulations pertaining to pregnant women, fetuses, human ova
fertilized in vitro, prisoners, andchildren. I would like to highlight some of the additional
protections in place for several of these vulnerable groups.
Children
Recognizing the need for special attention to pediatric subjects of research, it is assumed
that children are incapable of providing informed consent. As such, special protections are
mandated for this vulnerable population. As required by regulation, parents or legal guardians
must give proxy consent, termed "'permission." for their children to participate in research
protocols. and in most cases the children must agree ("assent") to their participation. In