SUBJECT: IRB
Administration
PURPOSE: To establish the
guidelines for administrative support of the Marshall University Human Research
Protection Program (HRPP) and Institutional Review Board
(IRB).
POLICY: In accordance with 38 CFR 16.103(b)(2)
and the Common Rule, this facility provides the Office of Research Integrity
(ORI) and the Institutional Review Board (IRB) with sufficient meeting space,
equipment, and staff to support the HRPP’s and IRB’s review and record keeping responsibilities.
RESPONSIBILITIES:
Institutional Official - As the Assurance
Signatory Official (Institutional Official), the Vice President for Research is
responsible for ensuring the IRB has sufficient administrative and clerical
support to assist the IRB in fulfilling obligations as well as allocating space,
and equipment.
The Vice President for Research is also responsible to annually (or
more frequently) evaluate whether the number of IRB's is appropriate to the
volume and types of human research reviewed, so that reviews are accomplished in
a thorough and timely manner. He/she is also responsible to adjust the
number of IRBs as needed.
Vice President for Research - is responsible to
annually review and adjust the membership and composition of the IRB to meet
regulatory and organizational requirements.
Chairman – The IRB Chairman
is responsible for keeping the Director, ORI and the Institutional Official
abreast of administrative and resource needs and make requests based on the
assessed needs of his/her IRB.
Director, Office of Research Integrity
- The
Director, ORI is responsible for (1) directing and overseeing all HRPP and IRB
support functions and operations; (2) training, supervising, and evaluating IRB
staff; (3) developing and implementing procedures to effect efficient document
flow and maintenance of all IRB records; (4) promptly reporting changes in IRB
membership to the Office for Human Research Protections
(OHRP).
IRB Coordinator - The IRB Coordinator is responsible for maintaining the official roster of IRB members, scheduling meetings, distributing pre-meeting materials, compiling the minutes of IRB meetings in compliance with regulatory requirements, maintaining all IRB documentation and records in accordance with regulatory requirements in ProIRB software and provides additional support to the IRB as outlined in his/her position description.
RESOURCES ALLOCATION
Personnel, space, and equipment are allocated based on the needs of the IRB.
Research Program Management Specialist 1.0 FTEE
IRB Coordinator
1.0 FTEE
Meeting Space As needed
Computers, copier, fax, printers, and phones As needed
PROCEDURE:
1. The IRB Chairman determines, at least annually, the assessed need for personnel, space and equipment. The resource needs are requested through the Director, ORI to the Institutional Official.
2. The IRB Chairman determines the dates/times of IRB meetings that are outside the norm of every second Wednesday of the month for IRB #1, and every third Wednesday of the month for IRB #2.
3. The IRB Coordinator maintains the official roster of IRB members, schedules meetings, distributes pre-meeting materials one week prior to the meeting, and compiles the minutes of IRB meetings in compliance with regulatory requirements. He/She maintains all IRB documentation and records in accordance with regulatory requirements and ensures that all IRB records are secured and properly archived. The ProIRB, a computerized database, is utilized to track the progress of each research protocol submitted. He/She serves as a resource for investigators on general regulatory information, provides guidance about forms and submission procedures and facilitates communication between investigators and the IRB. He/She assists new IRB members in completing orientation procedures and meeting required education standards, trains research investigators and staff while maintaining training documentation and reference materials related to human subject protection requirements. He/She drafts reports and correspondence to research investigators on behalf of the IRB or IRB Chairperson regarding the status of the research, including conditions for approval of research and cases of adverse events or unanticipated problems. In addition, he/she maintains and updates the IRB investigators’ manual and IRB forms.
Follow Up Responsibility: Director, Office of Research Integrity
References: 38 CFR 16.103(b)(2)