© 2023 Vial. All rights reserved
- Investigational New Drug Application
- Investigational New Drug Application (IND)
- IRT (Interactive Response technology)
- JAK inhibitor
- Lactose Intolerance
- Liver cirrhosis
- Lysosomal Storage Disorders
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
Institutional review boards (IRB), also known as independent ethics committees (IEC) in the European Union, are formally designated independent bodies that safeguard the rights, safety, and well-being of all human subjects involved in a trial.
These bodies review and monitor clinical trial documents (protocol, informed consent documents, investigator brochures, and advertising material) in advance and by periodic review in accordance with written operating procedures. The IRB has the authority to approve, require modifications prior to giving a favorable opinion, disapprove, or terminate/suspend any prior approval of the research. Records must be kept for three years after the completion of the trial.
IRBs are composed of medical and nonmedical members that have no conflicting interest with the clinical trial. Regulations require IRBs to have a diverse membership, which can be in terms of race, gender, cultural background, and community members. The recommended composition of an IRB includes at least five members, with at least one whose primary area of interest is in a nonscientific area, and at least one member who is independent of the institution or trial site. Nonmembers with expertise in special areas may be invited. The investigator may attend an IRB meeting to provide information, but should not participate in the meeting discussion or vote.
What if the institution does not have an IRB?
Institutions without their own IRB are permitted by the FDA to arrange for an external IRB to be responsible for the initial and continued review of studies conducted at that institution.
Source: Food and Drug Administration (FDA). (2020, May). E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). US Department of Health & Human Services. https://www.hhs.gov/guidance/document/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1