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Tips on the REP Application and Supplement Form

IRBMED

| Approval Date:

February 17, 2017 11:45 am

An REP application must include an Application Supplement Form, uploaded in Section 08. The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository’s activities and plans. It is critical that REP answers and Supplement Form answers be consistent with each other.

To fill out a Supplement Form, type free-text answers to the non-editable questions in the IRBMED Application Supplement Form. NOTE: for an application submitted to IRB-HSBS, download the supplement form at IRB Repository Application webpage.

References to consider in filling out each Application Supplement Form section are listed below. Refer also for guidance to other sections of this webspace, as well as the “blue help” text in the “smartform” application.

I. Intake Procedures for Acceptance of Data/Biospecimens for the Repository

Describe conditions under which data/biospecimens are accepted into the repository:

Consistency with REP application

Check REP application Section 5: Intake Plans.
Uploaded document(s) in Section 8 may include DUA/MTA templates for intake of data/biospecimens, and may include documentation about data/biospecimens received from outside institutions (e.g. approved consent form templates)

U-M references

UMMS Data Office for Clinical and Translational Research Data & Biospecimen Sharing webpage

U-M Office of Research and Sponsored Projects (ORSP) Data Sharing webpage

U-M Innovation Partnerships (IP, formerly OTT) Material Transfer Agreements webpages

UMMS Research Biorepositories Policy (available through PolicyStat) particularly section II, B “Primacy of Informed Consent…”

II. Distribution and Dissemination

Describe process for releasing data/biospecimens

Consistency with REP application

Check REP application Section 3: Data Details, Section 6: Distribution Plans, and Section 7: Risks and Protections. Uploaded document(s) in Section 8 may include DUA/MTA templates for distribution of data/biospecimens.

U-M references

UMMS Data Office for Clinical and Translational Research Data & Biospecimen Sharing webpage

U-M Office of Research and Sponsored Projects (ORSP) Data Sharing webpage

U-M Innovation Partnerships (IP, formerly OTT) Material Transfer Agreements webpages

UMMS Research Biorepositories Policy (available through PolicyStat) particularly section II, B “Primacy of Informed Consent…”

III. Data security plan

Consistency with REP application

Check REP application Section 3: Data Details.

U-M references

U-M ITS Safe Computing website includes many useful tools and references

IV. Physical Storage and Maintenance of Data/Biospecimens

Consistency with REP application

Check REP application Section 3: Data Details and Section 4: Biospecimen Details.

V. Governance and oversight

Consistency with REP application

Check REP application Section 3: Data Details, Section 4: Biospecimen Details, and Section 6: Distribution Plans.
Uploaded document(s) in Section 8 may include a Charter for an Oversight Committee.

U-M references

UMMS Research Biorepositories Policy (available through PolicyStat)  particularly sections

  • II, D “Conditions of Use”
  • III, C “When a Biorepository Oversight Committee is established …”
  • III, D “As biospecimens are resources owned by the University…”

A Biorepository Oversight Committee is required for any UMMS research biorepository intended to share biospecimens or samples outside the department or beyond collaboration with its creator/s. See UMMS
Biorepository Registration Decision Tree

A Biorepository Oversight Committee shall

  • consist of at least three individuals, including a minimum of two scientists
  • review requests for access to biospecimens
  • decide whether or not an access request will be granted
  • establish a charter which will
    • specify the priorities for access
    • specify the procedure for settling disputes regarding access to valuable biospecimen resources or samples

Oversight or Governance Committees may also be of use for data repositories and/or biorepositories not subject to the UMMS Research Biorepositories Policy (available through PolicyStat).

UNIT: Institutional Review Boards (IRBMED)

TOPICS: Application Types / Investigator & Study Team Responsibilities / Regulations & Policies (Federal, State & Local) / Repository

Questions?

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A list of IRBMED staff is available at our website.

Edited By: [email protected]
Last Updated: June 17, 2024 12:30 PM