HRPP Manual Section 8-8-C

Two Year Approvals

MSU Institutional Review Boards (IRB) may issue two year approval periods for certain types of studies. To qualify for two-year approval, the research project must pose no more than minimal risk to subjects and cannot include any of the exclusions listed below.

Exclusions
To qualify for two-year approval, the research project must not include any of the following:

  • Federal funding or federal training grants

  • FDA regulated

  • Sponsor or other contractual restrictions

  • Clinical interventions (including clinical behavioral interventions)

  • Prisoners as subjects

  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data

  • Be a project for which MSU serves as the IRB of record

If any of the above criteria become applicable to a project determined exempt under this flexibility initiative, the IRB office must be promptly notified prior to implementation of the criteria and the project must be reviewed and approved in accordance with the appropriate review level (e.g. expedited, full board).

Requirements
Research studies which could be granted a two year approval will be reviewed and approved by an IRB member. See HRPP Manual 8-2 “Expedited Review Procedure” for procedures.

Granting of a two year approval only impacts the continuing review date; it does not change or alter any other IRB requirements for an approved research study. For example, any proposed revision must be reviewed in accordance with HRPP Manual 8-6 “Revisions to an Approved Research Study.”

Process
The investigator must submit an initial application or renewal application to the IRB. Review procedures as defined in the HRPP Manual will be followed for applications under consideration for a two year approval. See HRPP Manual 8-2 “Expedited Review Procedure,” 8-5 “Initial Review,” and 8-7 “Renewed Approval.”

IRB staff will review the application and initially determine if the research may meet the criteria for a two year approval. If the research study appears to meet the criteria for two year approval, IRB staff will notify the IRB member assigned to review the research study and will provide the criteria to the PI to confirm that the research satisfies inclusion and exclusion requirements. If the PI confirms that the project does not include any of the exclusions, the assigned IRB member(s) will make the determination of whether to grant a two year approval period. A worksheet will be used to document the two year approval determination. The completed worksheet will be placed in the file.

IRB staff will process research studies granted a two year approval by IRB members in accordance with HRPP Manual 8-2 “Expedited Review Procedure”.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-11-2015.

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