Assoc. Dean For Practice/Research Job Descp

AAHRPP DOCUMENT # 77

THE UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTION PROGRAM

FORM: JOB DESCRIPTION FOR IRB CHAIR AND VICE CHAIR

Position Description

IRB chairs are appointed by the Vice President for Research to facilitate the research mission of the University of Alabama by ensuring that full board review of human subjects research adheres to the ethical standards outlined by federal and state regulations, AAHRPP standards, and the policies of the University of Alabama. The chairs review proposals before and outside of meetings, conduct IRB meetings, and communicates IRB feedback to investigators. Chairs work collaboratively with board members and research administrators to maintain and improve the Human Research Protection Program (HRPP) and promote an ethical research climate at the University. The usual term of appointment is for three years. Vice-chairs have essentially the same responsibilities and qualifications but serve on an occasional basis when the chair is absent or has a conflict of interest with a project.

Responsibilities:

A. Training

1. Completes initial and ongoing IRB training in a timely fashion as specified by the Director of Research Compliance.

2. Participates in ongoing continuing education offered during IRB meetings.

3. Contributes to improvement of IRB member training and continuing education through service on monitoring committees, evaluation of programs and suggestion of new ideas or avenues for each.

B. Proposal Review

1. Meets with Director of Research Compliance in advance of IRB meetings to  identify protocols appropriate for full-board review  determine that protocols submitted are ready for review  ensure that attendance at the prospective meeting will provide adequate review of all protocols  identify need for external consultation  identify conflicts of interest for self, IRB members, or the institution  assign primary reviewers  prepare the agenda 2. Arranges for vice-chair to conduct meeting if s/he will be absent or must leave the room because of conflict of interest on particular applications.

3. Reads proposals thoroughly and evaluates them within the context of the federal regulations, and the ethical standards of both the AHRPP, and of the University of Alabama.

4. Responsibilities in conducting full board Meetings  Determines that a quorum is present  Convenes meeting  Executes the agenda  Promotes discussion of research protocols as regards protection for human research participants  Endeavors to complete the agenda in a timely manner  Conducts balloting in regard to protocol disposition

5. Assists as asked with review of proposals for exempt or expedited review.

6. Serves on committees for routine monitoring of approved protocols or monitoring for cause.

C. Reporting

1. Reports to the Director of Research Compliance.

2. Signs reports of IRB decisions to principal investigators.

3. Provides evaluative comments about IRB members to Director of Research Compliance as needed to maintain an effective /adequate IRB membership.

D. Maintenance and Improvement of AHRPP accreditation

1. Solicits and volunteers ideas for improving efficiency and effectiveness of the Human Research Protections Program. Includes evaluation of IRB members and functioning.

2. Appoints or serves on subcommittees or task forces as needed to improve the HRPP.

3. Attends IRB/HRPP-related conferences as needed.

E. Assistance to Faculty and Investigators

1. Provides information to investigators about the need for IRB review and IRB perspectives. 2. Relays information about faculty and investigator concerns or needs for IRB guidance to the IRB or the Director of Research Compliance.

F. Assurance of IRB Independence

1. Reports and responds to notice of any attempts to exert undue influence on self, investigators, or IRB members to the Research Compliance Officer, or the Associate Vice President for Research.

G. Qualifications

1. Member of the faculty or professional research staff of the University of Alabama or a representative of the community

2. For faculty members and professional research staff, a record of teaching, research or other scholarship, or ethical expertise needed to achieve representativeness of the IRB membership.

3. Thorough knowledge of OHRP, DHHS, and FDA regulations or willingness to acquire as needed.

4. Commitment to the advancement of research through the ethical treatment of human research participants

5. Ability to work collaboratively with other board members and research office personnel.

H. Evaluation

1. Completes annual self-evaluation, including performance and needs and accomplishments in IRB-related self-development.

2. Files updated copy of CV with Research Compliance Office annually.