Guidance

UMMS Biorepository Registration Decision Tree

IRBMED
May 22, 2018 9:45 am

This decision tree represents UMMS policy for registration of biorepositories

  • funded by a UMMS Department, and/or
  • operating in UMMS space, and/or
  • directed by faculty with an appointment in the Medical School.

For more information, see University of Michigan Medical School (UMMS) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition.

Others may use this decision tree to help evaluate whether an REP and oversight committee may be useful for a biorepository or data repository.

  • Decision Tree - Flow Chart Image

  • Decision Tree - Flow Chart Text

    Question 1

    Will biospecimens be cataloged and stored for possible future additional use by anyone, including the study team?

    • If no, then repository registration is not required. HUM application suffices for the use of biospecimens for a specified research aim.
    • If yes, then repository registration is required in eResearch through the REP application. Now, continue to next question.

    Question 2

    May biospecimens be used by others outside the department or beyond the original collaborators?

    • If no, then oversight committee is not required.
    • If yes, then oversight committee must be established in accordance with requirements at Regulatory Affairs "Tissue Sample Policy" Section II, C and Section III, C.
Questions?

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A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: mhayward@umich.edu
Last Updated: August 17, 2018 10:00 AM