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

rate of administration, and/or new route of administration than they would normally use must be
made. Finally and most importantly, investigators must make a serious and concerted effort to
link these individuals to drug abuse treatment and other medical care.
The effects of drug use on adolescents is a major issue in drug abuse research and
children are often involved in drug abuse prevention research. If the hypothesis being tested
requires the involvement of individuals under age 18 and the benefit outweighs the potential
risks, the investigator must: (1) obtain the individual's consent and/or assent to participate in the
study; (2) obtain permission from the parent(s) or guardian for the individual to participate in the
study; and (3) comply with any applicable local laws governing such research.
Assurance of Compliance With Human Subjects Regulations
The DHHS regulations for Protection of Human Subjects are not a set of rules that can be
applied rigidly to make determinations of whether a proposed research activity is ethically
"right" or "wrong." Rather, they are a framework in which investigators, IRB members, and
others can ensure that serious efforts have been made to protect the rights and welfare of research
subjects.
OPRR oversees implementation of the regulations in all DHHS facilities as well as
domestic and foreign institutions or sites receiving DHHS funds. OPRR requires that each
DHHS agency and extramural research institution that conducts research involving human
subjects set forth the procedures it will use to protect human subjects in a policy statement called
an "Assurance of Compliance." An Assurance statement is a formal, written commitment to: 1)
widely-held ethical principles: 2) the DHHS regulations for Protection of Human Subjects; and
3) institutional procedures adequate to safeguard the rights and welfare of human subjects. The
terms of the institution's Assurance are negotiated with OPRR. The detailed, written Assurance
statement becomes the instrument that OPRR uses to gauge an institution's compliance with
human subject protections if there is a problem.
At OPRR's discretion. institutions with large research portfolios and demonstrated
expertise in human subject protection may be granted a Multiple Project Assurance (MPA). An
MPA. as the term implies, is an institutions pledge of full human subject protections for all
federally-funded projects at the institution. More than 450 institutions currently hold an MPA.
As an agency regulated by OPRR. the NIl Intramural Research Program, with 14 Institutional
Review Boards overseeing research conducted at the NIH itself, has a Multiple Project
Assurance from OPRR.
Informed Consent
All present today know how integral, and how crucial, the process of informed consent is
to the protection of human subjects. Many have a general picture of informed consent, and it is