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

Veterans' Affairs in a Request for Applications (RFA) for original research proposals in the area
of "Informed Consent in Research Involving Human Participants." The sponsoring organizations
are jointly issuing this RFA because voluntary informed consent is the defining aspect of
interactions between researchers and participants, and is integral to the conduct of the scientific
research funded by all of these organizations. One of the goals of this RFA is to bring together
perspectives of these different agencies, since their different research foci reflect a diversity of
issues relating to informed consent. Of course, many facets of understanding the informed
consent process are shared, and hence a combined effort is efficient for the agencies and
scientists alike. Such data should be useful in designing informed consent procedures that are
readily comprehended by prospective participants and impart all critical information. The goal of
the present initiative is to develop and test alternative strategies for obtaining informed consent in
diverse populations and determine optimal ways to obtain informed consent for research
participation.
The three agencies have set aside funds in FY 1997 to support projects in response to this RFA.
More than 80 proposals were submitted by the March 11, 1997, closing date for receipt of
applications. These three agencies are igniting the engine of research in an area that has for too
long been under explored.
Conclusion
In the final analysis, Mr. Chairman and Members of the Subcommittee, research
investigators, institutions, NIH, and DHHS are stewards of a trust agreement with the people
who volunteer to be research subjects. We have a system in place that to the greatest degree
possible 1) minimizes the potential for harm; 2) enables and protects individual, autonomous
choice; and 3) promotes the pursuit of new knowledge. By doing so, we protect the rights and
welfare of our fellow citizens who make a remarkable contribution to the common good by
electing to volunteer for research studies. We owe them our best effort.
Thank you. Mr. Chairman. I will be pleased to answer any questions you may have.

11