Entire Transcript in Adobe Acrobat Format - National Reference ...

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for NIH was extended to the whole of the Public Health
Service and this begins part of the history of the
discomfort in this area because the moving force remained
the NIH and the IRB/DRG.
(Slide.)
In 1972 Robert Marston, who was Director of the
National Institutes of Health, faced with the emerging
scandal of the Tuskegee study, which had been a PHS study
and not an NIH study but was focusing on the government's
involvement in research and with Senate hearings going into
a wide range of other questionable research, changed the
Institutional Relations Branch into the -- that aspect of
their work into the Office for Protection of Research
Risks, which he lodged in the Office of the Director.
(Slide.)
At this time there were some in Congress who
favored enacting legislation with sanctions for violations
of human subjects rights but this was steadfastly opposed
by the National Institutes of Health and eventually an
agreement was worked out and the DHEW relented on the
notion that it should not have any regulations as such.
There previously had been a policy, not regulations. They
should not have regulations. They agreed they would have
regulations and the Senate backed off of the notion of