Operating Paper

Effective Date: April 22, 2011

Revision Date: February 8, 2012; August 14, 2013; June 11, 2014

 OBJECTIVE

To define policies and procedures for appointing Institutional Review Board (IRB) members and for maintaining the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) roster.

GENERAL DESCRIPTION

The Springfield Committee for Research Involving Human Subjects (SCRIHS) is the Institutional Review Board (IRB) for Southern Illinois University School of Medicine (SIU-SOM).  The purpose of the IRB is to protect the rights and welfare of human research subjects.  This responsibility includes the review of all research involving human subjects, ensuring equitable selection of research subjects, and overseeing institutional compliance with all federal guidelines and regulations related to research with human subjects. All research involving collection of data from or about human subjects must be submitted to the IRB for review.  The jurisdiction of the IRB is defined by agreements with the Federal Government described in the Federal-Wide Assurance (FWA) and regulations formulated by the institutions with which it is affiliated.  Affiliated institutions include Memorial Medical Center and St. John’s Hospital.  SIU-SOM has additional IRB Authorization Agreements with other community organizations that rely on SIU-SOM’s FWA to review and approve human subjects research.  The IRB has the authority to:

  • make determinations about what is research;

  • approve, require modifications, or establish conditions to secure approval of, defer action on, or disapprove research protocols involving human subjects;

  • require progress reports from investigators;

  • oversee the conduct of research;

  • suspend or terminate approval of a study;

  • place restrictions on a study;

  • review and/or audit research activities to obtain information necessary for the fulfillment of responsibilities under their Institutional Assurances.

The IRB communicates directly with the Institutional Official (IO) listed on the FWA.  The IO is the SIU-SOM Dean and Provost.

IRB membership must comply with federal requirements  defined in 45 CFR 46.107 and 21 CFR 56.107, and to ensure appropriate diversity of the members through consideration of multiple professions and disciplines, ethnicities and cultural backgrounds, gender, and sensitivities to local community concerns and/or attitudes.  In addition, the IRB includes members who can determine the acceptability of proposed research in terms of institutional commitments, regulations, applicable law, and standards of professional conduct and practice. IRB membership also includes individuals who are knowledgeable and/or have experience working with vulnerable subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons.

The IRB includes members with each of the following primary affiliations:

  1. Scientific members, which will include physicians and non-physician scientists qualified to review FDA-regulated clinical investigations;

  2. At least one non-scientific member;

  3. Community-based (i.e., representatives appointed by SIU affiliated hospitals: Memorial Medical Center, St. John’s Hospital and at least one community member at large);

  4. Prisoner’s representation, who will be invited to participate on an as needed basis;

  5. In addition, the IRB invites individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the committee; and

  6. Administrative representatives who do not vote and serve as administrators to ensure coordination among other SIU-SOM affiliated research units

PROCEDURES

Appointment Procedures/Terms of Membership (See Membership of IRB SOP)

  1. Approximately once a year, the IRB Chair or designee is responsible for soliciting IRB membership recommendations from sources that include SIU-SOM Faculty Council, SIU-SOM affiliated hospitals and other community members.Other SIU-SOM administrative units may also submit nominations for membership, such as the Department of Medical Education and Graduate Medical Education.

  2. IRB members are appointed by the Dean based on the recommendations of the SCRIHS Advisory Panel to the SIU-SOM Committee on Committees.The IRB Chair will ensure that the Federal requirements for IRB membership are met before final recommendations are made to the Dean and Provost.The Dean and Provost will make all final IRB membership appointments, including the IRB Chair and Vice-Chairs appointments.

  3. Appointments for IRB members (including alternates) are for three-year terms beginning with each fiscal year. SIU-SOM has no limit on the number of terms that members and alternates may serve on the IRB.

  4. Alternate IRB members replace regular IRB members who are unable to attend convened meetings. Alternate members have qualifications comparable to the applicable regular member and may be alternates for more than one IRB member. IRB staff maintains the list of alternate members on the official membership list approved by OHRP. The OHRP list specifies which members the alternate is qualified to replace. Terms of appointment, length of service, and duties are identical to those for regular IRB members.

  5. Alternates attending a meeting or conducting a protocol review have all the authority of regular IRB members and receive the same training and protocol review application materials as the regular members. If the regular member and his/her alternate attend the same convened meeting, only one individual may vote.

  6. representatives do not vote. They serve as administrators to ensure coordination among other SIU-SOM affiliated research units.  Examples may include but are not limited to:  Director, Clinical Research Development; Compliance Officer; Associate Dean for Research and Faculty Affairs; Legal Counsel.  The Dean and Provost, or designee, can annually reappoint Administrative representatives when there is no change in the individual’s status regarding conflict of interest.

  7. The IRB Chair or IRB staff may recruit ad hoc consultants with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These ad hoc consultants do not vote with the IRB and do not count toward a quorum at a convened meeting. Ad hoc consultants may provide comments or recommendations in writing to the IRB prior to the meeting or attend the convened meeting to participate in the review.

  8. When reviews of research that involve prisoners are conducted, a majority of the IRB members (exclusive of the prisoner representative) must have no association with the prison involved, apart from their relationship on the IRB.

  9. For IRB review of research on prisoners, at least one voting member at the meeting must be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity.

  10. Individuals under consideration for appointment as IRB Chair must meet the following requirements: completion of human research protections training; recent experience as a voting IRB member (or comparable experience) for at least one year prior to nomination as IRB Chair; display of adequate knowledge of ethical principles, professional standards, federal regulations, and other applicable laws, through IRB meeting attendance and participation; and demonstration of professional competence necessary to review specific research activities.  (IRB Chair Responsibilities are outlined in more detail in the IRB Chair Position Description). The IRB Chair shall have voting privileges and other authorities and responsibilities of members including the responsibility to review, make motions, participate in discussions and vote on approval/disapproval of studies.

  11. Individuals under consideration for appointment as the IRB Vice-Chair must meet the following requirements: completion of human research protections training; recent experience as a voting IRB member (or comparable experience) for at least one year prior to nomination as IRB Vice-Chair; display of adequate knowledge of ethical principles, professional standards, federal regulations, and other applicable law, through IRB meeting attendance and participation; and demonstration of professional competence necessary to review specific research activities.

  12. The IRB Chair, Vice Chairs, members, and alternates are responsible for providing IRB staff with curriculum vitae to document each member’s expertise, degrees, and/or license number. IRB staff maintains vitae in the files for each member throughout his/her term on the IRB and periodically requests updates, as appropriate.

  13. The IRB Chair, Vice-Chairs, Members and Alternates must complete human research protection training requirements before serving on the committee.Refresher training is required every two years. The Institution provides additional research and ethics training to members through a variety of sources throughout the year.

Filling Appointments Due to Resignations During the Year

The IRB Chair or designee solicits recommendations from a variety of sources depending on the committee’s specific needs and/or federal requirements, recruits potential members, ensures appropriateness of and makes recommendations for replacement of members who resign during the year.  If the replacement is an SIU-SOM faculty member, then these members are appointed by the Dean based on the recommendation of the Committee on Committees.  Recommendations are forwarded to the Dean and Provost.  The Dean and Provost makes all final appointments. 

OHRP/FDA IRB Registration/IRB Membership Roster

  1. IRB staff or designee completes the OHRP/FDA IRB registration forms in accordance with OHRP and FDA registration requirements and updates the registration in a timely manner when the IRB membership changes. The OHRP registration form serves as the IRB roster and denotes in which scientific capacity each member serves.

  2. IRB staff or designee maintains membership records. IRB staff use the OHRP/FDA membership list as the official membership list to determine who may attend IRB meetings and count toward quorum. It includes a list of regular members and their designated alternates and indicates the scientific status of all members. IRB staff ensure this list is kept updated and maintained on the SCRIHS website.

  3. To meet OHRP/FDA registration requirements and in order to hold convened meetings, the scientist and nonscientist member designations are as follows:

  • Nonscientific: members who have had little or no scientific or medical training or who do not currently hold positions which involve scientific research or clinical practice (e.g., administrative positions). 

  • Scientific: members who hold M.D., Ph.D., Pharm.D., D.O., or other advanced degrees who are actively engaged in research in the physical, educational, social, behavioral, or biological sciences and disciplines and/or hold regular faculty appointments.

REFERENCES

21 CFR 56.107

21 CFR 56.115(a)(5) & 56.106

45 CFR 46.103(b)(3) & 115(a)(5)

45 CFR 46.107

45 CFR 46 Subpart E