The mission of the Institutional Review Board (IRB) is to perform an ethical review of all proposed research at Henry J. Austin Health Center (HJAHC) to assure, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. The IRB is a Standing Committee of the organization.
Henry J Austin Health Center (HJAHC) IRB is registered with the Department of Health & Human Services, Office for Human Research Protections and our four (4) main sites have Federalwide Assurances (FWA). The IRB is responsible for reviewing all human subject studies and ensuring that all studies are in line with institutional, State and Federal laws. The IRB ensures that potential research subjects’ rights and well-being are always protected.
All research studies reviewed by HJAHC IRB must uphold the following ethical principles: Respect for people, Beneficence and Justice in line with the Belmont Report.
Authority and Responsibilities
- The HJAHC IRB maintains the sole responsibility across the organization for the review and approval of human subject research at HJAHC. No human subject research may be conducted at HJAHC without prior review and approval by the HJAHC IRB Committee.
- The IRB will be responsible for the review of all proposed research studies to be conducted at HJAHC and to determine if they require review and approval by the HJAHC IRB or if the research is exempt from federal regulations.
- In the event that a research study, including research study modification and continuation requests, requires HJAHC IRB Committee review, it is the responsibility of the IRB Committee to determine if the protocol requires a facilitated review, an expedited review, or a Convened Review as set forth in the HJAHC IRB policy.
- The IRB will be responsible to review completely and appropriately submitted research proposals and determining if the proposal will be approved as submitted, approved with conditions, or disapproved.
- The IRB will be responsible for conducting a continuing review, which is substantive and meaningful, of approved ongoing research not less than once per year. The frequency of continuing review will be appropriate to the degree of risk. Continuing review will be based on receipt of appropriate progress reports from the investigator and include study-wide findings where available.
- The IRB will be responsible for reviewing any unanticipated problem or adverse event associated with an approved protocol and address each as per the HJAHC IRB Policy.
- The IRB will be responsible for reviewing any protocol deviation, determining the type of deviation, and addressing each deviation as per the HJAHC IRB Policy.