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IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). Additional requirements apply to IRBs that oversee clinical trials of drugs involved in new drug applications, or to studies that are supported by the United States Department of Defense.
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's primary duty is the implementation of 45 CFR 46, a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection ...
FDA: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA Regulated Clinical Trials. This guidance describes the FDA policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is called a Research Ethics Board (REB).
The IRBs can approve research proposals, make modifications, or disapprove them entirely. Research projects cannot receive federal funding without approval from an IRB. Noncompliance can also induce sanctions from the institution, such as revoked access to facilities and subjects, suspension, and dismissal.
The Common Rule is a 1991 rule of ethics (revised in 2018) [2] regarding biomedical and behavioral research involving human subjects in the United States.The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...