Tips of the Week
Did you know...
...that IRB meetings are not convened if a nonscientist is not present? [IRB Policy III.D]
Did you know...
...that no official actions take place at a meeting where a majority of the voting member are not present? [IRB Policy III.D]
Did you know...
...that should the Committee meeting lose quorum (e.g., those with conflicts being excused, early departures, loss of all non-scientists), the meeting is terminated from further votes until the quorum is restored? [IRB Policy III.D]
Did you know...
...that Wherever possible, IRB Committee meetings take place with all participating IRB members physically present. However, circumstances sometimes warrant conducting IRB meetings via telephone conference call. OHRP will recognize as "convened" those IRB meetings conducted via telephone conference call, provided that each participating IRB member
Did you know...
...that no IRB Committee member may participate in the IRB Committee's initial or continuing review of a project in which the member has conflict of interest? If a conflict exists, the Committee member can provide information requested by the IRB Committee but cannot be present for th ediscussion and the vote. [IRB POlicy III.D]
Did you know...
...that applications undergoing review are individually presented and discussed at a convened meeting of the IRB Committee? [IRB Policy III.D]
Did you know...
...that in conducting the full IRB Committee review, the majority of the Committee must agree that materials are in sufficient detail to determine the study meets criteria under 45 CFR 46.111 and if applicable, 21 CFR 56.111 or 38 CFR 16.111 for approval? [IRB Policy III.D]
Did you know...
...that during IRB review...it must be determined that risks to subjects are minimized by (a) using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (b) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes? [IRB Policy III.D]
Did you know...
...that during IRB review..it must be determined that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonable be expected to result? In evaluating risks and benefits, the IRB Committee should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB Committee should not consider possible long-range effects of applying knowledge gained in the research
Did you know...
...that selection of subjects must be equitable considering the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations and the potential need for additional protections, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons? [IRB Policy III.D]
Did you know...
...that informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by Federal and State regulations and Institutional policies and procedures including the IRB? [IRB Policy III.D]
Did you know...
...that informed consent must be appropriately documented, in accordance with, and to the extent required by the Federal and State regulations and Institutional policies and procedures including the IRB? [IRB Policy III.D]