[Letter to John D. Dingell from Bernadine P. Healy]

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
~AA 2 2 1991__
The Honorable John D. Dingell
Chairman
Subcommittee on Oversight and Investigations -
Committee on Energy and Commerce
United StateseHouse of Representatives
Washington, D.C. 20515__
Dear Mr. Dingell:__
This is in response to your letter of April 16 regarding our
ongoing assessment of allegations that certain scientists at the
National Institutes of Health (NIH) and their foreign
collaborators failed to comply with Health and Human Services
(HHS) Regulations for the Protection of Human Research Subjects.
The allegations were presented to NIH in letter form by
Mr. John Crewdson on July 13, 1990, and taken up by the Division
of Human Subject Protections in the NIH Office for Protection
from Research Risks (OPRR). As described in detail below, the
actions of OPRR have been prompt, decisive, and responsive to the
specific allegations. As opposed to fostering secrecy, the OPRR
has launched an intense reexamination of all NIH policies and
procedures for the protection of human subjects in collaborative
research. This reexamination, which goes well beyond the
specific allegations, represents a strong initiative to ensure
fail-safe mechanisms for the protection of human subjects in all
NIH research activities. In every instance, OPRR's actions have
been designed with the protection of human subjects as the
priority of utmost importance but also with an unswerving
commitment to achieve fairness to all parties.,Your letter implies that OPRR has relied heavily on press
accounts of the facts. That is not the case. The OPRR's
fact-gathering has been internally generated and directed and has
focused on a wide variety of sources. Although members of the
press are among those queried, none has been responsive.
The course of OPRR's investigation to date can be summarized as
follows:
* Upon learning of the allegations on July 16, 1990, OPRR
immediately made a preliminary assessment, and judging them
to be potentially serious, acted promptly to protect human

subjects. Effective July 23, OPRR, in conjunction with the
Acting Director of the NIH Clinical Center (the signatory