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Saginaw Valley State University

Institutional Review Board

Responsibilities/Actions of IRB

Composition of the IRB and Appointment of Members:

Federal regulations require that the IRB must be composed of at least five members (45 CFR 46.107). The University IRB shall be composed of at least eight (8) members.  Representation will include members whose primary concerns are in scientific areas, such that social and behavioral sciences, education, business, and biomedical sciences are represented.  The IRB should have at least one member whose primary concerns are in non-scientific areas, and a community representative who is not otherwise affiliated with the University nor a member of the immediate family of a University employee.  At least one member (or alternate) must be able to act as an advocate for “vulnerable populations”, by virtue of experience and education.  At least one member shall have expertise in both qualitative and quantitative research methods.  In addition, the membership shall include men and women, as well as representation of racial and ethnic minority groups reflective of the composition of the University, when at all possible.  All IRB members and alternates shall serve three-year terms, which are staggered, and they may be reappointed for consecutive terms. 

If a member goes on sabbatical or other leave for a semester, then an alternate will take his or her place from the college they represent. If a member or alternate leaves the University or goes on leave for one year or more, then the Provost and the Institutional Official, in concert with the IRB Chair, will appoint a replacement for the period of leave or for the remainder of the member or alternate’s term, whichever is applicable.

The IRB Chairperson will be appointed by the Institutional Official.  He or she will serve a three-year term with each year being a renewable contract between the individual and the Institutional Official, and he or she may be reappointed for consecutive terms.  If either the IRB Chair takes a sabbatical, other leave of absence, or leaves the University, the Institutional Official shall recommend a replacement to the remainder of the IRB.  The IRB members will then vote for or against this nominee, with a simple majority being needed for ratification.  Once ratified, the new Chair will serve during the previous Chair’s absence.

 IRB Chair

In conjunction with the Office of the Provost, Director of Sponsored Programs and IRB Research Compliance Officer and others, the IRB Chair promotes a culture consistent with the objectives of SVSU Institutional Review Board for the Protection of Human Research Subjects (IRB), with special emphasis on the respect for and protection of individuals participating in research at the University.  In promoting such a culture, the Chair is directly responsible for overseeing the protection of research participants by ensuring the proper review, approval, disapproval or determination of exemption from further review of research protocol submissions to the IRB.

Responsibilities of the Institutional Review Board Chair

  • Preside over meetings of the fully convened IRB and ensure that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws and University policy.
  • Review and approve protocol submissions that qualify for expedited review pursuant to federal regulations, ethical principles, state laws and University policies, or delegate such authority to a qualified and experienced IRB member to conduct such review and approval.
  • Ensure that membership of the IRB is recruited, appointed and oriented such that the IRB is duly qualified to fulfill its obligations to review, require modifications to, approve (or disapprove) research protocols that represent the breadth of research submitted to the IRB by SVSU researchers.
  • Serve as a liaison between the SVSU IRB and the University research community to promote communication and understanding of the concerns of the IRB and the SVSU research community.
  • Ensure that reports related to safety, noncompliance, unanticipated problems in research and adverse events are reviewed, attended to and reported pursuant to federal regulations, state laws and University policy.
  • Respond to local and federal investigations relating to protocols and actions, as required.
  • In conjunction with the Office of the Provost, Director of Sponsored Programs and IRB Research Compliance Officer, and others as appropriate, develop and revise Research and IRB policies, procedures and guidelines to stay current with societal thinking, regulatory changes and national best practice standards.
  • Annual Report – Liaison to Provost


IRB Members

Each IRB member is appointed by the Provost and typically serves a three-year term of service. IRB member responsibilities include all of the following:

  • Attending IRB meetings and actively participating in the review of research, unless arrangements have been made for the alternate’s attendance
  • Completing initial training in human subjects protection for IRB members prior to voting on any research, with continuing education every three years and as provided
  • Understanding and applying the principles of the Belmont Report and the federal regulations related to the protection of human subjects
  • Providing timely written comments on research undergoing IRB review, when required
  • Annually completing and providing a copy of the SVSU Financial Conflict of Interest Screening/Disclosure Form and disclosing any potential conflicts prior to IRB review of the research for which a conflict may exist
  • Maintaining confidentiality of IRB-related information in accordance with the terms and conditions of the SVSU’s IRB Member Confidentiality Agreement
  • Maintaining a current knowledge of and assuring compliance with relevant regulations, laws, and policies related to the protection of human subjects
  • Working with investigators to resolve matters relating to research approval and participating in educational efforts for investigators, research staff, and new IRB members
  • Participating in the discussion of issues affecting the human research protection program and contributing to policy development, as appropriate
  • Reviewing and approving research by expedited procedures, when designated by the IRB Chair to perform this review.

IRB Alternates

Federal regulations allow organizations to appoint an alternate(s) to substitute for an IRB member(s) who is/are unable to attend so that IRB business may move forward in a timely manner. Alternates are appointed by the same process and for the same length of time as IRB members.

  • IRB alternates function as regular board members when they are in attendance. An alternate may substitute for the primary IRB member for an entire meeting or at any time during a meeting. Alternates and IRB members have equal responsibilities in terms of required education, service and time commitments, and participation.
  • Each alternate member is paired with one or more regular members with comparable experience and expertise, as possible. The IRB roster identifies the primary member(s) for whom each alternate may substitute. Minimally, alternates and members are paired by scientific “class,” as physician scientists (when applicable), other scientists, and non-scientists. The IRB roster will identify the member(s) for whom each alternate can substitute.
  • When an alternate substitutes for a regular IRB member, the alternate receives and reviews the same materials that the regular member received (or would have received), and IRB minutes document that an alternate replaced a primary member.

Consultants

For research that requires expertise beyond or in addition to that available on the IRBs, or involves a vulnerable population where no IRB member knowledgeable about or experienced in working with these participants will be present at the meeting, one of the following will occur:

IRB Chair/Staff/Member may identify the need for review by a consultant during the screening of a protocol submission. The IRB Protocol Reviewer will work with the IRB Administrative Staff and IRB Chair to invite an individual with the necessary expertise to serve as a consultant and assist the IRB in its review.

  • The primary reviewers or IRB membership may identify the need for a consultant during their review. The primary reviewer(s) will work with the IRB Chair and the IRB Administrative Staff to invite an individual with the necessary expertise to serve as a consultant and assist the IRB in its review.
  • Consultants with potential conflicts of interest may not provide information to the IRB. Conflicts will be identified as described by SVSU policy.
  • The use of a consultant and the result of the consultant’s review will be shared with the IRB by either having the consultant attend and present to the convened IRB or by having the consultant provide a written report to the IRB.
  • If the consultant presents at a convened meeting, the IRB minutes will document key information provided by the consultant. The consultant will not vote with the IRB.
  • If the consultant provides a written report, the report will be included in the protocol records.

Review/Approval of Research

Review of Research:

In conducting the review of research, the IRB shall follow the regulations as stated in 45 CFR 46.109 and the University policy as described herein.

Approval of Research:

  • Risks to participants are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
  • Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research benefits that fall within the purview of its responsibility.
  • Selection of participants is equitable. In making this assessment the IRB takes into account the purposes of the research and the setting in which the research will be conducted and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
  • Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with 45 CFR 46.116.
  • Informed consent will be appropriately documented, in accordance with 45 CFR 46.117.
  • The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
  • There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
  • Further, when some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.

IRB Actions/Authority

Action on any of the options listed below requires a majority vote of the quorum.  Action to require revision of an application may be initiated by any reviewing IRB member upon initial review of an application if the Board member determines that such revisions are (a) needed to determine the level of risk to participants and/or (b) needed to complete an application.

Actions Regarding Approval of Applications:

  • Approve application as submitted.
  • Approve pending changes. The IRB determines the changes that are required for approval and these are communicated in writing to the PI. The PI submits the changes to the IRB Chairperson. The Chairperson (or designated IRB member) may approve the application on behalf of the IRB if the changes meet the requirements described in the written communication with the PI.
  • Require modifications and resubmission to the IRB.
  • Request consultant review.  At any point, the IRB Chairperson or the IRB may determine that someone not on the IRB with relevant expertise needs to be consulted to address research issues, as they relate to the protection of human research participants.  The consultant shall not be involved in the proposed project.  In some cases, the identity of the consultant may need to remain confidential if there is any question that there could be problems should the PI know the identity of the consultant.
  • Disapprove the application as submitted: When a project is disapproved, the PI may revise the proposal in accordance with IRB recommendations; discuss the project with the IRB Chairperson or respond in writing; or withdraw the proposal application.


Additional Actions and Authority of the IRB:

  • Consult with the OSRP concerning matters of development and implementation of policies and procedures regarding the protection of human participants and the training of University employees and students regarding the conduct of research involving human participants.
  • Monitor projects having received a full Board review for adherence to an approved protocol.

Suspend or terminate approval of research that is not being conducted in accordance with Federal Regulations and University policy or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a written statement of the reasons for the IRB’s action and shall be reported promptly to the OSRP, the PI’s Department Head, and the funding agency (if applicable).

IRB Meetings and Quorums

Responsibilities and Actions of the IRB Chairperson:

The Chair of the IRB is ultimately responsible for the conduct of the Board.  It is the responsibility of the Chair to coordinate all aspects of Board function, or to arrange for them to happen.  This responsibility includes arranging for regular meetings, causing minutes to be kept, distributed, approved, and posted, arranging for appropriate training for Board members, consultations with PI’s about current or prospective applications, and monitoring relevant federal guidelines and regulations.

Meetings and Quorums:

A quorum is required to convene a meeting of the IRB.  A quorum consists of at least a majority of members (or their alternates) present at the meeting, either in person or via a conference call.  When members or alternates are associated with a project being reviewed, they are ineligible to vote on the project.  However, the IRB may ask them to provide information about the project or they may excuse themselves from the meeting during the review.  Potential conflicts of interest should be noted in the IRB meeting minutes.  Should the quorum fail during a meeting (e.g., loss of a majority through recusal of members with conflicting interests), the IRB may not take further actions or votes until the quorum is restored.  Alternate members of the Board may be invited to each meeting and may participate in the discussion of agenda items, including reviews, although if they are not serving in a member’s place, they are not be eligible to vote.

The Chairperson will convene meetings of the board for review of new applications, modification requests, continuation requests, suspension or termination of IRB approval, and Board procedural and educational issues.