Biomedical Engineering Reference
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and his family, signs of toxicity its researchers had seen with lower
doses of the vector. Additionally, the trial's principal investigator
had treated Gelsinger with the vector despite lab test results that
should have disqualified Gelsinger for the trial. These findings led
to changes in how applications to perform gene therapy clinical
trials are reviewed, how local and federal agencies monitor trials,
and how adverse events among subjects in trials are reported. The
study protocols for all proposed clinical trials, including those
involving gene therapy, are reviewed for soundness of the science as
well as risks and benefits to the subjects, the study staff, and society
as a whole. Clinical study protocols must include background
justification for the trial and criteria for enrolling or excluding
subjects, as well as information about exactly what the subjects will
be given, what tests will be done, and how the safety of the subjects
will be monitored and protected. Subjects in clinical trials must give
informed written consent after they have received all the available
information about the treatment plan, communicated in a language
they can understand.
Since Jesse Gelsinger's death and the ensuing investigations,
human gene therapy trials have been watched much more closely.
Groups reviewing proposals for gene therapy clinical trials include
the Recombinant Advisory Committee of the NIH; the Center
for Biologics Evaluation and Research of the FDA; the hospital's
Institutional Review Board, which is responsible for assuring that
human subjects will be protected; and the Institutional Biosafety
Committee, which assesses the safety of the patient, the research
staff, and the public. During the clinical trial, an independent safety
board of experts, established by the hospital, monitors patient data
for evidence of serious adverse events and for evidence that the
agreed-upon study protocol is being followed. Currently, the FDA
requires several months of follow-up for each subject before a new
subject may begin treatment in a gene therapy trial, a situation that
will slow the rate at which the field advances.
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