reviewing IRB will be selected by the institutions. Will additional resources be necessary to meet Found under federal department/agency supporting this requirement in the short term? Should savings be Section: the research, or if no funding agency, anticipated in the long run? (Page 103) Cooperative by the lead institution conducting the 75. What areas of guidance would be needed for Research and research. institutions to comply with this requirement? Is there Proposal to Cover something that OHRP could do to address concerns about Unaffiliated IRBS IRBs not affiliated with an assured institutional liability, such as the development of model Not Operated by an institution that review research written agreements? (Page 103) Institution Holding covered by the Common Rule would 76. Would it be useful for this requirement to include a Federal-wide be subject to direct compliance Assurance criteria that Federal departments or agencies would need oversight regarding IRB regulatory to apply in determining whether to make exceptions to the requirements. use of a single IRB requirement? If so, what should these criteria be? (Page 103) 77. Are the exceptions proposed appropriate and sufficient, or should there be additional exceptions to this mandate for single IRB review than those proposed in the NPRM? If additional exceptions should be included, please provide a justification for each additional exception recommended. (Page 103) 78. Is three years appropriate timing to establish compliance with this provision? (Page 103) IRB Operations Continuing review would be 79. How often should the Secretary's list of minimal risk eliminated for all studies that undergo activities be updated? Should advice be solicited from Found under expedited review, unless the reviewer outside parties when updating the list? (Page 108) explicitly justifies why continuing Section: review would enhance protection of II.F. Changes to research subjects. Promote Effectiveness and Expedited review can occur for Efficiency in IRB studies on the Secretary's list unless Operations 80. Is this Secretarial list of minimal research activities a the reviewer(s) determine(s) that the useful tool for the research community, or does it study involves more than minimal represent a loss of IRB flexibility in risk determination? risk. IRBs will be required to (Page 108) document rationale when they override that studies on the Secretary's expedited review list involve greater than minimal risk.
Found under Section: Cooperative Research and Proposal to Cover Unaffiliated IRBS Not Operated by an Institution Holding a Federal-wide Assurance reviewing IRB will be selected by the federal department/agency supporting the research, or if no funding agency, by the lead institution conducting the research. IRBs not affiliated with an assured institution that review research covered by the Common Rule would be subject to direct compliance oversight regarding IRB regulatory requirements. institutions. Will additional resources be necessary to meet this requirement in the short term? Should savings be anticipated in the long run? (Page 103) 75. What areas of guidance would be needed for institutions to comply with this requirement? Is there something that OHRP could do to address concerns about institutional liability, such as the development of model written agreements? (Page 103) 76. Would it be useful for this requirement to include criteria that Federal departments or agencies would need to apply in determining whether to make exceptions to the use of a single IRB requirement? If so, what should these criteria be? (Page 103) 77. Are the exceptions proposed appropriate and sufficient, or should there be additional exceptions to this mandate for single IRB review than those proposed in the NPRM? If additional exceptions should be included, please provide a justification for each additional exception recommended. (Page 103) 78. Is three years appropriate timing to establish compliance with this provision? (Page 103) IRB Operations Found under Section: II.F. Changes to Promote Effectiveness and Efficiency in IRB Operations Continuing review would be eliminated for all studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects. Expedited review can occur for studies on the Secretary's list unless the reviewer(s) determine(s) that the study involves more than minimal risk. IRBs will be required to document rationale when they override that studies on the Secretary's expedited review list involve greater than minimal risk. 79. How often should the Secretary's list of minimal risk activities be updated? Should advice be solicited from outside parties when updating the list? (Page 108) 80. Is this Secretarial list of minimal research activities a useful tool for the research community, or does it represent a loss of IRB flexibility in risk determination? (Page 108)
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