Research oversight

When the Department of Energy (DOE) was established in 1977, along with its many missions, it was granted authority over a coveted prize oversight of all the laboratories and research facilities from the predecessor agencies. These included the Bureau... 

The Center for Biologies Evaluation and Research (CBER) is responsible for the oversight of what might be considered more traditional biological products, such as... 

NAS/NRC. 1989. Report of the oversight committee. In Biologic markers in reproductive toxicology. Washington, DC National Academy of Sciences, National Research Council, National Academy Press. 

Sponsor Monitoring. Another important oversight process to ensure quality, compliance, and subject safety, monitors may be employees of the sponsor s medical staff or a contract research organization, or may be independent contractors. In each... 

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution s potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

What Research Requires Institutional Review Board Approval and Oversight... 

As gene therapy and stem cell research progress, we can expect more regulatory requirements to be developed to ensure proper safeguards are implemented. Similarly, xenotransplantation and control of biopharmaceutical products will experience specihe regulatory controls as new advances are made. Exhibit 11.13 presents the FDA s current oversight on gene therapy and its cautious approach to cancer vaccine. 

Toxic Substances, Environmental Oversight, Research and Development of the Senate Committee on Environment and Public Works. Washington D. C. US General Accounting Office. 

The IND filing step, and the oversight of proof-of-concept clinical research, would be safely implemented by cutting back the detail customarily required from pharma sponsors and others (i.e. CROs, Institutions, IRBs and perhaps other entities) that have been formally qualified as responsible in this context. All such sponsors would have been previously screened by the agency, and accepted for the accelerated programme if qualified, based on the applicant s historical record with the agency. 

Friedman T, Noguchi P, and Mickelson C. The evolution of public review and oversight mechanisms in human gene transfer research Joint roles of the FDA and NIH. Curr Opin Biotechnol 2001 12 304-307. 

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