Question

Identify and explain the primary priorities and responsibilities of the IRB.

Answer 1

• The IRB is responsible for providing guidance and oversight for the human participant protection program and for helping to maintain compliance with applicable laws, regulations, and policies. The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority.To meet this goal, the IRB have specific responsibilities in the following areas:
• A. Expertise- In performance of its review activities each IRB will have the professional competence necessary to review the specific research activities presented for approval.
• Should have effective knowledge of subject populations and other factors that can foreseeably contribute to a determination of a risk-benefit ratio to subjects and subjects’ informed consent.
• Should be able to judge the adequacy and accuracy of information on the informed consent document, advertising, and other materials distributed to the subjects.
• B. Communication-The IRB will provide the investigator and the institution with written notification of decisions to approve or disapprove research and of modifications required to secure IRB approval of the research activity; the written notification must include reasons for the decision and give the investigator an opportunity to respond in person or writing.
• C. Criteria for Approval-Each IRB will determine that elements are satisfied prior to approval of research activities.
• D. Expedited Review-Each on-campus IRB must conduct expedited review in accordance with DHHS and/or FDA regulations and guidance.
• E. Convened Meetings-Each IRB must review research in convened meetings at which a majority of the IRB members are present including at least one member whose primary concerns are non-scientific areas (i.e., quorum).
• F. IRB Minutes- The IRB must maintain minutes that include:Names of Attendees;Attendees Affiliation;Attendees representative capacity;Actions taken;The vote on each action including number of yes, nays, and abstentions etc.
• G. Continuing Review-Each IRB will conduct continuing review, which is substantive and meaningful, of approved ongoing research not less than once per year.
• The IRB is responsible for the following oversight functions:-
• Determine what activities constitute human participant research.
• Review, approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy prior to the commencement of the research.
• Require that information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and international standards. The IRB may require that additional information be given to the participants when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
• Require documentation of informed consent or waive documentation in accordance with federal and New York State laws and regulations.
• Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
• Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, (unless the research has been classified as "Exempt") and have authority to observe or have a third party observe the consent process and the research.
• Suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants.