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

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Now it seems to me from the papers that we have
received from McCarthy and Fletcher that it is very obvious
that the history has very much shaped the present approach
to human subjects regulations. In particular, from the
1950's as NIH grew by leaps and bounds the Intramural
Research Program was the major focus.
Disregard spelling errors, please.
And within that program normal volunteers did
receive an informed consent process and a prior review by
disinterested scientists, not by outsiders but at least by
scientists who were not directly involved in the research.
But patient subjects were not federally protected because,
in effect, the studies they were in were regarded as
therapy. Beginning in the mid 1960's extramural research
grew more rapidly and the process of overseeing the
protections was handled by the institutional relations
branch in the Division of Research Grants. That was done
centrally for all the institutes. That was true of all the
negotiations that went on with the institution since
research is institution and not investigator based.
(Slide.)
In 1966 Surgeon General Stewart at the time
that certain revelations were coming out about problems
with human subjects research issued a policy on the