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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 8 / 23

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A1.0050

the Lexington VAMC, a teaching facility affiliated with the UK Colleges of Medicine and Dentistry for the training of residents in accredited specialty/subspecialty programs. In selected circumstances, the IRB serves as the IRB of record for other agencies, institutions, or facilities. Policies and procedures include provisions for adjustment of the number of IRB or reliance on a non-UK IRB to ensure that reviews are accomplished in a thorough and timely manner.

Chairs, vice chairs, and members are responsible for conducting ethical review of human research activities—initial, continuation, modification, and unanticipated problems/adverse experience—to ensure compliance with all applicable federal and state laws and regulations and with the ethical principles endorsed by the University. The IRB is further responsible for scientific and scholarly review within the context of the risk/benefit assessment and for conducting continuation review of approved research at intervals appropriate to the degree of risk, but not less than once per year.

Each IRB member and alternate bears the following responsibilities: (1) conducting protocol review; (2) applying disciplinary and regulatory knowledge when conducting reviews; (3) attending full review meetings; (4) avoiding conflict of interest in conducting reviews; (5) proposing and developing IRB policy; (6) completing the mandatory education requirements; (7) handling allegations or reports of noncompliance; (8) maintaining confidentiality; and (9) determining whether federal reports are required.

The IRB conducts review and approval operations in strict accordance with the complete set of policies and procedures governing research review at the University. The ORI publishes membership rosters and meeting dates prominently on the ORI website and makes these documents available in paper copy. Meeting dates occur at regular intervals, and ORI administrators disseminate agendas in a timely fashion to allow members sufficient time to review protocols under consideration. The ORI maintains the full set of documents detailing the development, requirements, implementation, review, and revision of policies and procedures for the conduct of research review. In addition, the ORI maintains all records of IRB review in a secure manner and in accordance with the provisions of all applicable regulations and accreditation guidelines, limiting access to authorized personnel as specified in IRB/ORI operating procedures.

A1.0950 Institutional Review Board Chair/Vice Chair

The designated Medical and Nonmedical IRB chairs are responsible for (1) ensuring that the respective IRB committees carry out their responsibility to review each protocol for compliance with the requirements of 45 CFR 46 and, if applicable, 21 CFR 50 and 56, 38 CFR Part 16, as well as all other applicable federal, state, and institutional regulations and policies; (2) conducting exempt/expedited review or delegating this authority through the ORI to qualified IRB member(s); (3) maintaining communication with the investigators and ORI; (4) providing oversight and leadership in conducting review of alleged cases of noncompliance; and (5) chairing the Full Review Committee meetings.

For each IRB, a designated vice chair assists the chair in fulfilling the responsibilities listed above. In addition, as appropriate, the vice chairs serve as primary reviewers in conducting expedited and full continuation review and are responsible for reviewing the full continuation review application and making recommendations to the full boards. The vice chairs also may

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