Guidance

Protocol Resources

IRBMED
Sep 13, 2021 11:00 am

The study protocol should comprise all the key information about study conduct, including but not limited to rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study design fulfills applicable regulations and how oversight is provided. It is a key resource for study teams, study sponsors, and research support units including ORSP, the IRB, and ancillary committees.

  • Including a Protocol in the IRB application

    The Research Proposal section of a grant application does not take the place of a study protocol focusing on human subjects protections, and should not be uploaded as part of a HUM application (the IRB can access PAFs and AWDs in eResearch Proposal Management (eRPM) when indicated).

    A separately uploaded detailed protocol is the best practice for all human subjects research studies involving interaction and/or intervention which require comprehensive IRB review and approval. The IRB may require one if not initially provided.

    For externally sponsored studies, the sponsor, lead site, or CRO most usually provides a protocol. Studies initiated by a U-M investigator may use any protocol template that contains all the required information (see heading below). Include a table of contents in the document (.docx or .pdf).

    For non-exempt studies with a single IRB-of-record (sIRB) requirement (ceding or accepting oversight), a protocol is required regardless of study design. Studies limited to secondary use (no interaction/intervention), exempt studies, and not regulated projects usually are not required to include a separate protocol document, because these study designs are typically simpler and generally ‘captured’ adequately in the application. Any application type may upload a separate protocol document.

  • Protocol Resources

    Selected templates that can be filled out or adapted are listed below for researcher convenience. Note that some are intended for specific study designs and may not be appropriate to adapt beyond their intended function: please carefully consult the instructions embedded in each template. It is often appropriate to delete non-applicable sections of a protocol template. Delete instruction text from the template before submitting. Various private companies also provide fee-for-use protocols.

    Please enhance our guidance by contacting IRBMED to suggest additional examples that would be useful to the U-M community.

    For assistance in protocol development, contact your departmental research administrator, MICHR Research Development Consultation, or Clinical Trials Support Office.

    Source Source type Templates available include
    NIH/FDA Federal
    • Phase 2/3 clinical trials involving FDA IND or IDE
    • Behavioral and Social Sciences Research Involving Humans

    Cancer Center PRC 

    (level-1 login required)

    U-M
    • Clinical Trials
    • Sociobehavioral
    MICHR U-M
    • Investigator-Initiated Clinical Drug Trials (Non-Oncology)

     

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800
A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: September 13, 2021 11:00 AM