STANDARD OPERATING PROCEDURE (SOP) IRB-004
TITLE: INSTITUTIONAL REVIEW BOARD (IRB) - MANAGEMENT
ORIGINAL DATE: 11/15/01
EFFECTIVE DATE: 1/30/02
NEXT REVIEW: 2/3/05
REFERENCE: 45 CFR 46; 21 CFR 56; OHRP FWA Guidelines
OBJECTIVE: To establish and maintain the Children’s Research Institute Institutional Review Board
1. The Code of Federal Regulations requires that all research involving human subjects conducted or
supported by a federal department or agency must comply with all sections of 45 CFR Part 46
including the establishment of an IRB.
2. All clinical investigations regulated by the Food and Drug Administration (FDA) must comply with 21
CFR Parts 50, 56, 312, 600, and 812. Part 56, Subpart A sets the standards for the composition,
operation, and responsibilities of an IRB.
3. Children’s Research Institute, by virtue of its “Assurance” with the federal government, applies these
federal regulations to all research involving human subjects conducted under its auspices.
DESCRIPTION OF PROCEDURES:
1. The IRB Chairperson is selected and appointed by the President of the Children's Research
2. The length of term/service is open-ended at the discretion of the CRI President.
3. Duties include, but are not limited to:
Performs oversight of all IRB activities
Oversees compliance with federal regulations, state/local laws, institutional policy, and IRB
Develops, implements, and interprets policies and procedures
Provides interpretation and application of federal guidelines
Responsible for the protection of human subjects involved in research activities conducted at
Responsible for the application and compliance of federal regulations, state/local laws,
institutional policy, and IRB procedures
Supports and facilitates the IRB process
Ensures compliance with the Federal Wide Assurance (FWA)
Ensures training and education of IRB staff, IRB committee members, and research staff
Ensures performance and documentation of audit process to assure compliance
B. Vice Chairperson
1. The IRB Vice Chairperson is selected and appointed by the IRB Chairperson.
2. The length of term/service is open-ended at the discretion of the IRB Chairperson.
3. The Vice Chairperson performs the duties of the Chair as listed above in the Chair’s absence.
4. The Vice Chairperson is a member of the Executive IRB Committee.
5. The Vice Chairperson reviews Adverse Events and determines which are to be reviewed in full
Committee as Serious Adverse Events.
C. IRB Committee Members
1. In the event of a vacancy on the Committee, the Director of Research Services shall recruit
individuals by contacting staff within the Institution or outside community leaders asking for
2. The IRB Executive Committee shall interview the applicants and choose the best candidate based
upon the membership requirements noted in SOP #002 IRB Membership.
3. The CRI Medical Director, with appropriate input and consultation, shall designate the new
member as either a voting member or non-voting member and to serve for the period of one
calendar year. The new member will be notified in writing and will receive a copy of the
“Children’s Research Institute Administrative Charge to the Institutional Review Board”.
4. Since a quorum (majority) is required to conduct business, members are expected to attend every
meeting if possible. If unable to attend, the member must notify the IRB office as soon as
possible. If the member was assigned a review, he/she must submit their response in writing
before the scheduled meeting.
5. Annual re-appointments shall be at the discretion of the CRI Medical Director. Reasons for a
member not to be re-appointed include lack of attendance or lack of substantive contributions
D. Training of IRB Members
1. Orientation - New members shall attend training sessions conducted by the Director of Research
Services and shall attend 4 6 IRB meetings before being assigned as a reviewer. During these 4
meetings, the new member is not allowed to vote.
2. Continuing Education - IRB members shall receive continuing education through the distribution
of reading materials, presentations at the meetings, attendance at related conferences, etc.
3. Reference Materials shall be maintained in the IRB office. (IRB Library)
E. Compensation of IRB Members – IRB Members may be paid an honorarium based upon attendance.
F. Liability Coverage for IRB Members is provided through the hospital's liability plan.
G. Consultants - The IRB may request individuals with special competence to assist in the review of
projects beyond the expertise of the Committee members. These individuals may not vote.
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H. Secretarial/administrative support staff (duties) – The IRB Committee shall be supported by (1) the
Director of Research Services who assists with recruitment, education & training of members, and
regulation compliance, and (2) IRB Technical Coordinators who assist with meeting agendas, minutes,
correspondence, file maintenance, record keeping, and document handling.
I. Resources – The Children’s Research Institute shall provide appropriate personnel support, adequate
meeting space, visual/technical equipment, and storage space for files as needed.
J. Conflict of Interest (See SOP# IRB-014, Conflict of Interest)
IRB Chair Signature Date
CRI Medical Director Signature Date
CHI Medical Director Signature Date
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