Which of the following irb members in attendance at the irb meeting would not be allowed to vote?
Updated July 26, 2021 Show
Responsibilities of IRB MembersPrimary members attend IRB meetings as voting members. Alternative members attend IRB meetings as voting members only when replacing a specified Primary member; when the specified Primary member is present at the meeting, Alternative members attend as non-voting members. In carrying out their duties, IRB chairs and members:
In evaluating the risks and benefits of the study, IRB members have the additional responsibilities to:
IRB members are expected to:
Additional IRB Member Responsibilities for Research Involving Sharing Data or SpecimensWhen University or Affiliate investigators plan to conduct non-exempt research that involves providing data/specimens to or obtaining data/specimens from an external entity, AND the dataset includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), the Primary or expedited reviewer must confirm the following before approving the research:
The research agreement confirms that the Data Provider complied with Department of Health and Human Services (DHHS) requirements for informed consent as it relates to the use of the data/specimens as specified in the agreement. IRB Member TrainingIn-House OrientationAll prospective IRB Committee members are required to complete an initial two hour orientation session prior to serving on the IRB. This training includes how to review electronic applications, post reviewer notes, and access checklists and other supporting documentation. All new members are provided the following information:
Observation of IRB MeetingAll new IRB Committee members are required to observe at least one IRB committee meeting prior to functioning as a voting member. Continuing EducationIRB members will receive, on an ongoing basis, continuing education related to human research protection issues and requirements.
Evaluation of Committee MembersEach member will be given an annual letter that describes performance as satisfactory or requiring attention. The letter will include metrics on attendance and volume of IRB assignments for the member. Self evaluations will be distributed annually to members and members will have the opportunity to meet informally with the IRB Chair. Attendance of the members will be monitored by the Director or designee. Any issues that arise related to non-attendance will be discussed with the IRB Chair to determine whether action is necessary. Committee member performance is discussed quarterly with respect to awareness and understanding of relevant ethical issues, regulations, and institutional policies. The performance of the members will also be assessed by evaluating quality of performed reviews to ensure they are timely, comprehensive, and well-informed. If concerns are identified, the IRB Chair will address these with the individual committee member and then provide necessary guidance materials or educational sessions. IRB Membership status may be terminated by the IRB Chair due to failure to attend and/or otherwise actively participate in IRB functions. Additional Responsibilities of the IRB Chair and Co-ChairThe Chair and Co-Chair are voting members of the IRB and assumes the aforementioned responsibilities of IRB Members. In addition to their responsibilities as a voting IRB member, the IRB Chair and Co-Chair oversee IRB meetings to ensure reviews and approvals consider with regulatory requirements, the Belmont Report, state laws, and University policy. The IRB Chair and Co-Chair are authorized to sign all documents relevant to the review and approval of human research projects (e.g., waivers of HIPAA authorization) and documents submitted for post-approval monitoring (e.g., safety reports that are not unanticipated problems; acknowledgement of and notifications from external IRBs), except IRB Institutional Agreements, which are signed by the Institutional Official or designee). The IRB Chair and Co-Chair may designate signature authority to qualified IRB members, the Research Integrity Director, and IRB staff who are voting members of the IRB as appropriate. In all cases individuals sign their own name. NOTE: Electronic signatures procured via IRBNet require access through secure login procedures and are therefore considered valid by Research Integrity and the IRB. IRB Chair, through annual “Designation of Authority” letters (or more frequently as required by rapid turnover of IRB members or other circumstances) identify members who are qualified to complete reviews using expedited procedures and members who may serve in the absence of the Chair/Co-Chair. The IRB Chair and Co-Chair oversee IRB meetings to ensure reviews and approvals comply with regulatory requirements, the Belmont Report, state laws, and University policy. During IRB meetings, The Chair and Co-Chair:
For reportable events, the IRB Chair and Co-Chair:
With respect to their relationships with other members, the IRB Chair and Co-Chair:
The IRB Chair and Co-Chair work with the Research Integrity Director to:
Which of the following IRB members must be present during the IRB?Which of the following IRB members must be present during the IRB's discussion and vote on a proposal? The non-scientist member. A non-scientist must be in attendance at a convened IRB meeting in order for the committee to conduct the review and vote.
Who is typically not a member of an IRB?The IRB is not comprised of either all male or all female members. The IRB is not comprised of members who represent only a single profession. At least one member has primary concerns in scientific areas. At least one member has primary concerns in nonscientific area.
Who of the following is a required member of the IRB that will review the research?An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific. Additionally, there must be one member who is not otherwise affiliated with the institution (a community representative).
What is the role of an IRB member?The primary responsibility of IRB members is the protection of the rights, safety, and welfare of the individual human beings who are serving as the subjects of research.
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