Procedure for Qualifications and Composition of IRBs and OIRB - PRO104

Procedure for Qualifications and Composition of IRBs and OIRB - PRO104

Abstract:
This procedure details the requirements for the composition of IRBs and IRB staff members.
Effective Date:
10/26/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO104
Effective Date:   3/30/07
Revision Date:  11/26/08, 10/26/10
Subject:  Procedure for Qualifications and Composition of IRBs and OIRB

PROCEDURE

Under this procedure, each UAB IRB will meet the membership requirements of the federal regulations found at 45 CFR 46.107 and 21 CFR 56.107.

General Committee Requirements

The IRB must have a minimum of five members of varying backgrounds to promote full and adequate review of proposed and ongoing research activities under the IRB’s jurisdiction.

IRB membership will include individuals with expertise, experience and diversity taking into consideration race, gender, cultural backgrounds and sensitivity to such issues as community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

Each IRB:

  • Will possess the professional competence necessary to review specific research activities;
  • Will have the ability to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice;
  • Will have the knowledge and/or experience about vulnerable categories of subjects which are included in proposed research projects that are regularly reviewed by the IRB including children, prisoners, pregnant women, and physically and mentally impaired subjects;
  • Will possess appropriate knowledge of community attitudes and conditions surrounding the conduct of the research;
  • Will, at the time of initial and continuing phases of the research, ensure the rights of participants are protected and the consent process is appropriate for the subject population studied at each study site.

The IRB may form standing or ad hoc subcommittees to enhance the efficiency of its operation. The IRB may invite consultants to assist in the review of complex issues and provide expertise beyond, or in addition to, that available on the IRB. Consultants may not vote with the IRB. (See POL014 policy on, PRO114 procedure for IRB use of consultants.)

The IRB composition is subject to the following conditions:

  • Membership selection may not be made on the basis of gender. Every non-discriminating effort will be made to avoid membership composed entirely of one sex;
  • Membership may not consist entirely of one profession;
  • At least one member will have a primary interest in scientific areas;
  • At least one member will have a primary interest in a non-scientific area; biomedical health professionals (e.g., nurses, pharmacists) are not considered non-scientific members;
  • At least one member will have no affiliation with UAB and have no immediate family member affiliated with UAB.

The IRB may include both regular and alternate members. The IRB roster will list the regular members and specify alternate(s) who are authorized to substitute for each regular member. Alternate members will have qualifications comparable to those of the regular member and will serve in the same representative capacity as the member for whom they substitute. Alternates may attend any IRB meeting, but their vote will only count when serving as the substitute for the regular member.

The IRB minutes will document each alternate’s status, vote, and attendance as they relate to IRB actions and quorum requirements. When an alternate attends a meeting as a substitute for a regular member, the alternate’s participation counts toward the quorum requirements.

When vulnerable populations are involved in the research, additional conditions apply to the membership in attendance when the convened IRB reviews the research:

  • Children—At least one voting member with expertise or experience relating to children;
  • Prisoners—A prisoner representative with voting privileges will review and participate in IRB discussions involving prisoners;
  • Mentally disabled or impaired individuals—At least one voting member with expertise or experience relating to the mentally disabled or impaired (or a consultant with the same qualifications) will review and participate in IRB discussions involving mentally disabled or impaired individuals;
  • Physically handicapped individuals—At least one voting member with expertise or experience relating to handicapped individuals (or a consultant with the same qualifications) will review and participate in IRB discussions involving physically handicapped individuals;
  • Pregnant Women—At least one voting member with expertise or experience relating to pregnant women will participate in IRB discussions involving pregnant women.

Members

The UAB Institutional Official appoints all IRB members (including alternate members), including Chair(s) and Vice-Chair(s), who serve at the discretion of the Institutional Official. The Institutional Official will receive nominations from senior administrative officials, deans, department chairs, and division directors, and from the IRB Chairs, Vice-Chairs, members, and OIRB personnel. Self-nominations will be considered. Appointments to the UAB IRB will be made in writing. Appointments and changes of status will occur as needed.

An IRB member will assume the following duties:

  • Examine all review materials forwarded to him/her in preparation for the convened meetings to which they are assigned;
  • Perform the assigned roles within the Primary Review Team at the meetings or notify OIRB staff or the IRB Chair of his/her inability to do so;
  • Promote human research protections within the university culture;
  • Acquire and maintain a working knowledge of federal human subjects regulations through education and training requirements for IRB members.

Members will be appointed based on their willingness to serve on the IRB, commitment to fulfill the duties of an IRB member, and eligibility under the general requirements for IRB composition. Furthermore, members will be appointed on the basis of their representative capacity as follows:

  • Scientific member—Individual who possesses the clinical and/or scientific knowledge and ability to effectively evaluate the research and clinical investigation;
  • Non-Scientific member—Individual who possesses expertise and/or experience outside scientific areas and serves to represent either vulnerable populations or local cultural and community attitudes relative to the rights and welfare of human research participants;
  • Non-affiliated member—Individual who is a scientific or non-scientific member, is knowledgeable about local cultural and community attitudes, and has no affiliation with UAB.

An IRB member may be compensated for his/her duties.

An IRB regular member or alternate who has completed initial human subjects protection training, attend at least 8 meetings, and demonstrated active participation during IRB meetings will qualify as an "experienced IRB reviewer."

The Institutional Official may remove an IRB member for any reason, with or without cause. Failure to perform IRB duties, such as not attending assigned meetings, is a cause for removal.

Chair(s) and Vice-Chair(s)

The UAB Institutional Official is solely authorized to appoint UAB IRB Chair(s) and Vice-Chair(s). The Institutional Official shall make such appointments with the advice and consent of the President and Provost. Nominations for these positions may be received from UAB deans, department chairs, and other senior academic/administration officials. When appointing an IRB Chair or Vice-Chair, the Institutional Official will consider the following factors:

  • Academic appointment and position of leadership;
  • Experience with IRB and human subjects research protection issues;
  • Clinical expertise;
  • Willingness to commit the time required;
  • Administrative abilities;
  • Organizational skills involved in conducting committee affairs, including the ability to serve as a fair and impartial moderator.

Besides presiding over convened IRB review, the duties of the IRB Chair may comprise without limitation:

  • Reviewing protocols submitted for exempt or expedited review;
  • Assigning studies to IRB reviewers;
  • Adding to or altering the IRB committee agenda;
  • Summarizing IRB review recommendations for dissemination to investigators;
  • Reviewing and signing letters generated from committee actions;
  • Reviewing and evaluating investigator responses to committee requests that are minor;
  • Approving minor amendments and determining which amendments go to the convened IRB;
  • Reviewing correspondence from investigators and preparing responses, as necessary;
  • Reviewing reported problems and determining whether they are unanticipated problems involving risks to subjects or others; and
  • Designating a Vice-Chair or experienced IRB members to perform expedited review procedures either by permanent assignment or on an ad hoc basis.

The IRB Chair may delegate the duties listed above to the Vice-Chair, experienced IRB reviewers, or OIRB staff in accordance with federal regulations and UAB policy. The Chair will prepare a memorandum to the IRB staff with a list of IRB members who can conduct review using the expedited procedure. Vice-Chair(s) will assume the duties of the Chair in his/her absence or if a conflicting interest arises. The IRB Chair or Vice-Chair(s) may be removed by the Institutional Official for any reason, with or without cause. Failure to perform assigned duties constitutes a cause for removal.

An IRB Chair or Vice-Chair may be compensated for his/her duties.

OIRB Staff

The Office of the Institutional Review Board (OIRB) is an administrative unit established for efficient and effective administration of day-to-day IRB operations and implementation of UAB’s institutional responsibilities for human research protections. The OIRB staff includes senior staff, administrative staff, and clerical staff. Senior staff includes the Director, Associate Director, Assistant Directors, and Regulatory Compliance Manager. Administrative staff includes the administrative associate, protocol analyst, program administrator II, editor, information systems specialist, technical writers, and program director. Clerical staff includes office services specialists and program coordinator.

The OIRB will assume the following functions:

  • Manage all administrative aspects relating to IRB submissions and approvals;
  • Maintain IRB records and documentation;
  • Communicate to UAB academic and administrative units regarding human subjects regulations and IRB actions;
  • Arrange, provide, and account for human subjects research training for investigators and IRB members;
  • Monitor human subjects research and related activities as determined by the IRB or UAB;
  • Review all research proposals submitted to extramural funding agencies for compliance with federal and UAB policies.

OIRB personnel will apply for positions in accordance with standard UAB employment procedures. The OIRB will select individuals on the basis of their ability to perform the described job duties and their commitment to education and training in human research regulations and IRB procedures.

Evaluations

The Institutional Official will evaluate annually the performance of the IRB members and IRB Chair(s) and Vice-Chair(s) through IRB member self-evaluations and written reports provided to the IO at the time of the bi-annual payment to IRB members. Evaluations for members will include measures of activity such as meeting attendance, level of participation, satisfactory completion of training requirements, and knowledge of the Human Research Protection Program policies and procedures. Evaluations of the Chair(s) and Vice-Chair(s) performance will be based on personal interactions and evaluations by IRB members and OIRB staff. Chair and Vice-Chair self-evaluation forms will be forwarded to the IO or Associate VP for Research for review and feedback. A letter will be sent to IRB members yearly providing them with feedback based on the evaluations and reports.

OIRB personnel will be evaluated annually through the employee performance appraisal mechanism according to UAB policy and the Office of Human Resource Management.

Approved on October 19, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director