MSU HRPP Manual Section 11-1-B

11-1-B, Education: IRB Members

Institutional Review Board (IRB) members, including chairs, will be trained through an initial orientation process and continuing education to ensure that all IRB members are appropriately educated about the regulatory requirements and ethical considerations for the protection of human subjects involved in research.

Orientation
New IRB members are required to complete an orientation process prior to reviewing any human research studies.

New member orientation includes meetings with the IRB chair and IRB administrator III. The focus of the meetings will include:

  • Human subject protection at MSU

  • Other regulations that pertain to human subject research

  • Key issues in the protection of human subjects

  • Day-to-day operations of the IRB

  • MSU IRB online system

Copies of appropriate documents will be provided to the IRB members. These include:

  • Belmont Report

  • 45 CFR 46

  • 21 CFR 50, 21 CFR 56 for BIRB

  • MSU HRPP Manual 4-5, 5-3, and 5-5

  • Pertinent reviewer documents and checklists

  • Other documents as appropriate

In addition to the orientation process, new IRB members are required to complete the “Overview of Human Research Protection at MSU” and the “Ethical and Regulatory Considerations” online modules through the Saba Learning Management System, if not already completed, and the OHRP “Institutional Review Board (IRB) Membership” module. IRB members will be asked to complete these online modules prior to the initial orientation session. IRB members will also be encouraged to complete other Office for Human Research Protections (OHRP) training modules and relevant Collaborative Institutional Training Initiative (CITI) courses in the Protection of Human Research Subjects.

As part of the training process, new IRB members perform a minimum of six “shadow reviews” of new initial applications. “Shadow review” means that the IRB member is able to observe (via the MSU IRB online system) the initial application review process between the researchers and the IRB members assigned to review the application. The new IRB member is able to access and review all materials and comments that the assigned reviewers’ view. The new IRB member is not a reviewer on the research study, but may submit comments or questions if there is an issue they believe has not been addressed. IRB members also will attend a minimum of six convened IRB meeting as a voting member prior to being determined an experienced reviewer. See HRPP Manual 5-3 “IRB Membership” for requirements.

The orientation procedure for the IRB chair will vary by level of IRB experience and familiarity with the MSU IRB review process.

Ongoing education
The HRPP will provide and support continuing educational opportunities including opportunities for IRB members to attend training at the local, state, or national levels, updates on new federal and state laws and university guidelines and policies, as needed, and refresher presentations and tutorials.

Continuing education encompasses many additional activities, such as education at convened IRB meetings, strategic planning meetings, subscriptions, and other resources. The HRPP works on the development and implementation of additional continuing education activities as needed.

Convened IRB Meetings
At convened IRB meetings, IRB staff may disseminate updates, guidance, and other materials containing ethical and regulatory guidance for the review of protocols, including in specialized areas (e.g. tissue banking) or selected vulnerable subject populations (e.g. prisoners).

Continuing education presentations or discussions will typically be provided monthly at the convened IRB meetings. The presentations will typically last 10-15 minutes. Presentations may be provided by HRPP staff, IRB chairs, members, or others. Presentations may focus on topics specific to items on the agenda. IRB members are encouraged to contact the HRPP director with topic suggestions.

Records of the training will be documented in the IRB minutes. The IRB administrator will make available any continuing education materials distributed at the IRB meeting so that non-attendees of the IRB meeting may access the materials.

Human Research Protection Program Strategic Planning Meeting
The HRPP plans and conducts an HRPP strategic planning meeting for members of the MSU IRBs and HRPP staff. Updates and education on human research protection are provided throughout the meeting, in addition to other pertinent programmatic discussions.

Subscriptions
The HRPP maintains subscriptions to journals and news services related to human research protection, as appropriate. Copies of the IRB Ethics and Human Research Ethics journal are made available to IRB members. The HRPP also maintains subscriptions to the Journal of Empirical Research on Human Research.

Resource Library
The Office of Regulatory Affairs (ORA) maintains a resource library which includes books on human research protection. IRB members and HRPP staff may access and check out such books.

Other Activities
IRB members are also encouraged to participate in the IRB conferences and the workshops described in HRPP Manual 11-1-A “Investigators and Research Staff.” They also receive electronic communications with updates.

Fulfillment of Requirements
Education requirements are evaluated by the IRB chair, with assistance from the IRB administrator III. The IRB chair and/or the IRB administrator will work with IRB members who may need additional IRB training within allotted time frames to assure that continuing education requirements are met. The IRB chair will initiate corrective actions which may include not being involved in reviewing research studies until the requirement is satisfied.

If the IRB chair/member does not fulfill his/her initial and/or continuing education requirements, the Institutional Official may require removal.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-22-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 11-24-2015.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 11-1-B, Education: IRB Members.