[Memorandum to Director, Office of Protection from Research Risks, Office of Extramural Research, NIH from F. William Dommel]

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
5571095.0346.056
Room 5B-59
301-496-8101
FAX [phone]
July 2, 1991
To: Director, Office for Protection from Research Risks,
Office of Extramural Research, NIH
From: Director, Division of Human Subject Protections,
Office for Protection from Research Risks,
Office of Extramural Research, NIH
Subject: Findings and Required Actions Regarding Investigation
of Noncompliance with HHS Regulations for the Protection
of Human Research Subjects Involving the National
Institutes of Health Intramural Research Program
Attached is the interim report of the Division of Human Subject
Protections (DHSP) concerning its investigation of noncompliance
with Health and Human Services (HHS) Regulations for the
Protection of Human Research Subjects (45 CFR 46) involving the
National Institutes of Health (NIH) Intramural Research Program.
The report was provided to NIH for review on May 31, and NIH
submitted a written response to OPRR on June 21. This response
is included as Attachment F of the report. The report was also
forwarded to Dr. Zagury and Dr. Picard of the Universite Pierre
et Marie Curie for review. An English translation of the
preliminary response from Dr. Zagury and Dr. Picard was reviewed
by DHSP on July 1 and is included as Attachment G of the report.
The findings and required actions contained in the report
represent interim actions considered necessary by DHSP to ensure
the protection of human research subjects under the NIH Multiple
Project Human Subjects Assurance (MPA 4 M-l000). I recommend
that final OPRR action in this matter be taken only after (a)
review by DHSP of evidence (which may include examinations of
patients and records) that may establish the nature and degree of
any harm experienced by human subjects, and (b) review and
approval by DHSP of an appropriate revision of the NIH Multiple

Project Human Subjects Assurance (see pages 19 and 20 of the
report). Relative to item (a), DHSP is attempting through
diplomatic channels to provide for independent review of relevant
medical and research records, as well as access to findings of
relevant investigations conducted by French and Zairian
authorities. DHSP also expects to receive a more extensive
response to the report from Dr. Zagury and Dr. Picard on or about
July 15.