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Institutional Review Board
The mission of the Institutional Review Board (IRB) and the Office for the Protection of Human Subjects (OPHS) is to protect the rights and welfare of research participants. The IRB is a committee consisting of scientists, non-scientists, and other people with sufficient expertise, not affiliated with Children's National Medical Center, who review and evaluate all research protocols, or studies, involving research with human participants.
Research protocols cannot be implemented without IRB review and approval. In addition, each study must be reviewed at least once per year to ensure that there have been no changes to the risks and benefits to participants. All research protocol alterations (e.g., change of Investigator, modification of procedures, or outcome measures) must also be reviewed and approved by the IRB.
Children's currently has four IRB committees. IRB 01 and IRB 04 are standard committees that are responsible for reviewing most protocol submissions. IRB 02 is convened when clinically urgent situations, unanticipated funding issues, or unusual scientific circumstances require a rapid IRB response. IRB 03 reviews high-risk protocols (typically clinical trials) in the domains of Hematology, Oncology, and HIV/AIDS.
The OPHS is the administrative arm of the IRB. It serves as the gatekeeper of all issues related to the protection of human research participants. OPHS acts as the liaison between the IRB committees and the research investigators, documents compliance with federal research regulations, and educates the Children's research community about the proper and ethical conduct of research involving human participants. Investigators, project coordinators, and others engaged in human subjects research are encouraged to work with the OPHS prior to submitting protocols to the IRB to smooth out the application process.
IRB Chair:
Naynesh R. Kamani, MD
IRB 01 (Standard)
Vice Chair: Nalini Singh, MD, MBBS
Vice Chair: Jay Salpekar, MD
Alternate Vice Chair: K. Rais Bahrami, MD
IRB 02 (Rapid Response)
Vice Chair: Tamara Rakusan, MD, PhD
Alternate Vice Chair: Joan Conry, MD
IRB 04 (Standard)
Vice Chair: Edward Wong, MD
OPHS Manager
Birdena Samuel, CIP
(301) 565-8488
bsamuel@cnmc.org
AAHRPP
Maryann Rossi, PhD
(301) 565-8485
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