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

Page 2 - The Honorable John D. Dingell

for the NIH Multiple Project Human Subjects Assurance),
stipulated that any activities involving transfers of funds,
information, or chemical/biological materials between the
National Cancer Institute (NCI) Division of Cancer Etiology
(or its scientists) and Dr. Zagury (or the institutions with
which he is affiliated) were prohibited, unless cleared in
advance through the Acting Director, NIH Clinical Center,
and OPRR. No such clearances were requested or granted. In
addition, all affected parties were advised that any use of
HHS support for research involving human subjects could
occur only in accord with an Assurance of Compliance
approved by OPRR.
* Also, on July 23, OPRR requested that the signatory of the
NIH Human Subjects Assurance investigate the allegations and
report findings to OPRR. This report was received by OPRR
on October 8 but found to be deficient in some important
respects, whereupon OPRR made several requests for
additional records from the signatory. On November 21,
OPRR, still dissatisfied, began preparing the requisite
documentation for (a) imposing a formal restriction on the
NIH Multiple Project Assurance, and (b) intensifying the
investigation.
* OPRR notified the Acting Director, NIH, on January 24, 1991,
that effective February 7, the NIH Multiple Project Human
Subjects Assurance was restricted to exclude all activities
involving human subjects in (a) any international
collaborative research involving the NCI Division of Cancer
Etiology or (b) any collaborative research involving the
institutions with which Dr. Zagury is affiliated. Under
this formal restriction, which is broader in scope and
imposes more stringent OPRR oversight than the clearances
required on July 23, such activities may be carried out only
under new OPRR-approved Single Project Human Subject
Assurances that are specific to each activity. No such
Assurances involving institutions affiliated with Dr. Zagury
have been requested or granted, and NCI officials have
indicated that all such collaborative activities with
Dr. Zagury have ceased.
* From February 27 through March 1, OPRR assembled a group of
Special Consultants to assist in evaluating NIH
collaboration in and/or support of the research under
investigation, as well as the adequacy of NIH intramural
procedures for protecting human subjects in international
collaborative research. The consultants interviewed NIH
administrators responsible for human subject protection
policies as well as NIH intramural scientists whose
activities are under investigation. After discussions with
one another and OPRR staff, each consultant prepared an