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Ignorance and confusion about the ethical rules for research on people
are widespread among scientists at the US National Institutes of Health.
This is the conclusion of an internal report by the NIH which criticises
the institution’s failure to protect people taking part in research carried
out by its staff.

‘The investigation has revealed a disjointed, compartmentalised system
of protection (for human subjects) within the NIH . . . ‘, says the report.
It attacks the institution for having ‘uncertainty at all levels’ and ‘ill-defined
lines of authority’. And although the NIH is responsible for protecting
people who are involved in research by its staff, it has no policies or
procedures to monitor such work, the investigation found.

The interim version of the report, released last week, follows an investigation
into joint projects between NIH scientists and the controversial French
AIDS researcher Daniel Zagury. Officials at the NIH stopped all collaboration
between Zagury, the institutes in France and Zaire where he works, and NIH
staff after allegations that some projects had violated the NIH’s ethical
guidelines (This Week, 16 March 1991).

Å®ÉúСÊÓƵs at the NIH who do any research on human subjects – including,
for example, the analysis of blood samples – must gain approval for their
work within rules spelt out by the NIH’s Office of Protection from Research
Risks. The rules apply to joint projects with foreign researchers as well
as projects in the US. Among those who worked with Zagury are Robert Gallo
at the NIH’s National Cancer Institute, Bernard Moss, the head of the Laboratory
of Viral Diseases, and Takis Papas, head of the Laboratory of Molecular
Oncology.

Gallo, who has joint authorship of no fewer than 14 papers with Zagury,
is singled out for criticism by the report. He and Zagury ‘have demonstrated
a continuing lack of understanding about (the rules for research on human
subjects)’, it says. In future, any projects involving these two researchers
will have to be specially cleared by the NIH.

The report looks at eight projects, including one in which 18 HIV-negative
Zairean children received an experimental AIDS vaccine. Some of the children
were only two years old. Another project concerned an immune therapy for
AIDS patients in Paris. In both these projects, NIH researchers supplied
materials such as HIV and vaccinia virus used in the research, and in others
they analysed blood samples for Zagury. The American scientists say they
provided the materials for animal research only.

Three patients in the Parisian trial died (This Week, 27 April). Zagury
has told the investigators at the NIH that all 18 Zairean children remain
well, but the investigators say they must determine this for them selves,
‘independently and objectively’. They are trying to review Zagury’s records
in France.

This move has provoked heated reactions. Zagury and his principal collaborator,
Odile Picard, have written an angry reply to the interim report. Questions
about the work ‘are entirely without foundation’, say the French researchers.

Jean-Paul Levy, head of the French Nat ional Research Agency, who recently
completed a report on Zagury, says an American inquiry would be ‘perfectly
useless’. ‘There has already been a thorough investigation and I was quite
harsh on Zagury,’ says Levy. ‘Anything further would be an inquisition.
It’s McCarthyism, a witch-hunt which is completely masking the real scientific
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The report finds fault with the NIH on six separate grounds for failing
to protect people. It also says there is widespread ignorance among its
scientists about their responsibilities under government regulations for
work on human subjects. ‘ŮÉúСÊÓƵs were unaware of the regulatory definition
of human subjects and assumed they had no responsibilities in this area
as long as they did not directly inject human beings with experimental materials,’
says the report. ‘Some seemed to believe that compliance with foreign standards
was all that was required. Others seemed to be unaware of the applicability
of either US or foreign standards for the protection of human research subjects.’

So far, Gallo has not responded to the report. Moss and Papas have both
contested some of its findings in written replies.

The investigators are waiting for all involved to respond before publishing
a final version. In future, says the report, there must be a single authority
within the NIH to authorise all research projects on humans. The rules will
also be overhauled. The responsibilities of scientists and administrators
will be clearly spelt out, and scientists will receive ‘mandatory’ education
to make sure they understand the rules.