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An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical.
Approval by an Institutional Review Board (IRB), or Independent Ethics Committee (IEC), is necessary before all but the most informal research can begin. In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial.
The master protocol is submitted to the IRB and once approved, only arm-specific appendices need to be submitted for Institutional Review Board (IRB) approval in the event of changes to the trial arms. Establishing a stable master protocol with adaptive therapy arms allows for faster, more efficient trial execution.
All research involving human subjects must be approved by an Institutional Review Board (IRB). Each IRB has protocol submission requirements, which typically involve an IRB application and informed consent document. A study cannot begin without IRB approval.
The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some (but not all) of the responsibilities include: Contract
The Certified IRB Professional (CIP) program is a certification initiative in the United States for individuals administering and overseeing the daily activities of institutional review boards (IRBs). IRBs are committees that are charged with determining if a research project conforms to ethical principles and federal regulations that protect ...
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Other commitments are commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug ...