Biomedical Engineering Reference
In-Depth Information
precise, complementary roles in the review of gene transfer protocols.
With the benefit of hindsight, one can also ask why the NIH, a funding
agency, was involved in the regulation of research that it funded? Even
more problematically, why was the NIH attempting to regulate clinical
research being conducted by private-sector biotechnology and pharma-
ceutical companies? The short answer to these latter two concerns is
that the NIH had developed a model in the mid-1970s by taking the
initiative in reviewing recombinant DNA research proposals for the
entire nation.
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The NIH and the researchers that the agency funded
preferred this mode of self-regulation to the possibly less flexible regu-
latory proposals that members of Congress were suggesting in 1976 and
1977.
Other questions also confronted RAC and the NIH during these years.
Among them were the following:
•
How high a standard should be set for the scientific merit of human
gene transfer protocols?
•
How much time and effort should be devoted to reviewing the consent
forms for such trials?
•
How could RAC and the NIH avoid having their approval of human
gene transfer studies construed as a Good Housekeeping Seal that com-
panies could then use to attract investors?
•
How could RAC and the NIH counteract the hyperbole that
researchers and companies sometimes employed in publicizing what
seemed to be modest research successes?
•
Could an advisory committee that was comprised primarily of aca-
demics and that met only once each quarter keep pace with a rapidly
evolving field like human gene transfer research?
Despite the ambiguities in its role, RAC performed a creditable job in
keeping pace with an accelerating number of research protocols from
1990 to 1995. Thanks to the insight and creativity of the late Brigid
Leventhal, a pediatric oncologist from Johns Hopkins University, RAC
devised a system that asked researchers to report annually on serious
adverse events that had occurred to subjects in their gene transfer studies.
In June 1995, RAC conducted a comprehensive audit of all U.S. human
gene transfer research to date, noting the numbers of protocols reviewed,
the various applications of gene transfer, and the target diseases in the
studies that aimed to treat patients for a variety of genetic and nongenetic
