IRB Advisor – September 1, 2004
September 1, 2004
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Committee review, public review part of gene therapy oversight process
Genetic therapies are rapidly moving from the laboratory into the clinical setting, with more investigators testing experimental gene delivery systems and therapies designed to fundamentally alter our bodies to prevent or treat disease. -
The unknowns of gene therapy pose challenge
Gene transfer research offers new hope for people suffering from some rare or deadly diseases, but the research also has suffered major setbacks due to serious adverse events, including subjects illnesses and deaths, and this creates a greater burden for IRBs reviewing such protocols, experts say. -
Students learn to work with deaf subjects
Efforts to improve clinical trial participation among medically underserved populations often overlook one group in particular, say some cancer researchers in California. -
Adolescent research needs extra attention
The very idea of deciding when to waive parental permission or allow investigators to inquire into a teenagers sexual history and drug use may make some IRBs a little nervous. But experts in socio-behavioral research involving adolescents say such situations are common and typically involve less than normal risk. -
OHRP seeks feedback on registration form change
OHRP is seeking comments from IRB members and others about proposed changes to the agencys registration requirements, which apply to all IRBs that review human subjects research conducted or supported by HHS. -
News Brief
Several leading medical and science journals fail to enforce their own policies for disclosing financial conflicts of interest among contributing authors, according to a study released July 12 by the nonprofit Center for Science in the Public Interest (CSPI).