What is an IRB?

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What is an IRB?

  1. 1. What isIRB?anEnsure the rights,safety and well-being of potential study participantsPerform thorough reviews of research design and materialsContinually review updates on safety information,consent formamendments,protocol deviations,and the number of participantsenrolled in a study (as well as the number of participants whowithdraw)Required to follow written,standard operating procedures (SOP’s)Convened meetings which requires a majority of IRB members presentvoting to approve the research studyIn order for the research study to be approved,Board members mustfind that the risks to study participants will be minimized in relationto the study’s potential benefit (if any).They must also find that thestudy recruitment will select participants in an equitable fashion andthat Informed Consent will be sought (if applicable) in accordance with21 CFR 50Who?A committee of at least 5 membersrepresenting different professions and gendersWhatdo they do?Howdo they do it?Protect participants, review studies, and monitor safetyConvene meetings and analysis of risks vs. benefitsAt least 5 membersAt least one member whose primary concerns are in the scientific areaAn“IRB”(Institutional Review Board or Indepedent ReviewBoard) is a committee designed to review clinical studies.The Code of Federal Regulations 21 CFR 56 says that an IRBmust be composed of the following membership:At least one member whose primary concerns are in a non-scientific areaAt least one member who is not otherwise affiliated with the institutionor an immediate family member of anyone affiliated with the institutionDoctorEXAMPLES: Ethicist ClergyFor more information about how an IRB functions,please visit www.QuorumReview.comor call us at (206) 448-4082 or 1-888-776-9115 (toll free)

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