Guidance

FAQ: Repository application (REP)

IRBMED
Feb 15, 2019 4:15 pm
  • Updates regarding Revised Common Rule

    Major changes to the Common Rule (45 CFR 46 subpart A) became effective January 21, 2019. U-M Human Research Protections Program (HRPP) webpage Common Rule & Other Changes has ongoing updates. Guidance page Transition to 2018 Regulations provides details on IRBMED's implementation.

    Some of the updates made to the HUM application and workflow are not available through REP applications. For instance, the eResearch system still requires that REP applications be approved with an expiration date (rather than approval with "no continuing review required").

    U-M is not implementing the new regulatory exemptions 7 and 8, which relate to repositories.

  • “Repository” (REP) applications

    What is the purpose of an REP application?

    “Repository” (REP) applications are a project type in eResearch Regulatory Management (eRRM) (see also the Repository Web Guidance pages).

    REPs are designed to facilitate compliance with University policies and regulatory guidance surrounding the collection and future use of human specimens and data.

    REP applications were introduced through a “phased roll-out” in 2014–2015. See also U-MIC IRB Board Tip: IRB Oversight for Data and/or Biospecimen Repositories

    What information does an REP application collect?

    Similar to other eResearch applications, REPs gather information through smartform logic and uploaded document(s). The application is then routed for review and approval by the IRB and other applicable review committees.

    The REP application focuses on repository procedures for storage, maintenance, and distribution of data/biospecimens.

    Collection activities for data/biospecimens to be deposited into a repository will still be approved through an HUM application. “Secondary uses” of information/biospecimens distributed to researchers from repositories must still be submitted for IRB assessment through an HUM application if they qualify as human subjects research.

    How do I submit my new project as a repository?

    “Repository” (REP) applications are created in eResearch Regulatory Management. The eResearch training page has step-by-step guides (Procedure Documents & Tips → Repository Application heading) on filling out a REP application or related submission. Like other eResearch applications, the REPs involve completing a “smartform” pathway and uploading applicable supporting documents. In particular, a REP application must include an Application Supplement Form.

    What about repositories previously approved through HUM applications?

    Until release of the REP application, IRBs processed repository reviews and approvals in the eResearch system only through the “human subject study” (HUM) application. As such, many existing repositories have HUM approvals.

    HUM applications continue to provide valid approval for all activities described in the approved application. This includes HUM applications for repository activities, or for research studies with repository components. HUM approval satisfies the registration requirement for repositories subject to the “Medical School Governing UMMS Research Biorepositories Policy” (available through PolicyStat).

    Over time, many ongoing repositories should expect to submit an REP application, for instance, at the time of Continuing Review for the HUM. Consult with your IRB staff as to when/whether this is appropriate for your repository.

    In some cases, an REP may entirely supplant an HUM and the HUM can then be terminated. This is particularly likely if ongoing and future repository activities are limited to storage, maintenance, and distribution for “secondary uses” of data/biospecimens.

    In other cases, when data/biospecimen collection continues, or when the repository is an additional aim in a specific research study, the HUM application will continue to remain active, but should be Amended to minimize duplication of information with the REP. Amendment also provides an opportunity to begin using the Specialty Biorepository Informed Consent Template + informational sheet, if appropriate.

    How do HUM and REP applications work together?

    The REP application is designed to address specific types of information associated with repositories that are not optimally captured in the HUM application. It also facilitates connections between repositories and studies that contribute or withdraw materials from them, in order to clarify application processes for those projects.

    IRB staff create two-way hyperlinks between an REP and associated HUM(s). Study teams must notify IRB staff of the relationship so the links can be created (see Studies depositing data/biospecimens into a repository and Studies obtaining data/biospecimens from a repository headings at Elements and Uses of a Repository guidance webpage). The links display in an REP and HUM spaces under “Related Projects” tab. Links are “live” (can be used to navigate from HUM to or from REP) for study team members listed on both applications, as well as for IRB staff and reviewers.

  • Repositories not covered by UMMS policy

    The following are not subject to the “Medical School Governing UMMS Research Biorepositories Policy” (available through PolicyStat):

    • Data repositories that do not store biospecimens
    • Repositories that collect and store biospecimens solely as part of routine clinical care or hospital procedures, such as those stored in blood banks or pathology specimens used in clinical care
    • Research biorepositories that are neither maintained by Michigan Medicine faculty or staff, nor at Michigan Medicine facilities.

    See also UMMS Biorepository decision tree

  • UMMS policy on biorepositories and tissue ownership

    Why has UMMS adopted this policy?

    This policy promotes the effective use of UMMS resources to gather, store, and disseminate human biological specimens intended for research use in accordance with federal and state laws and regulations and sound scientific and ethical principles. It specifies the governance of biospecimen collection, usage, and disposition within all UMMS research biorepositories. Its intent is to facilitate establishment and expansion of biorepositories to support research and to promote sharing of biospecimen resources to the greatest extent practicable while remaining in compliance with governmental and University requirements.

    Do I need to register my project as a biorepository?

    Ref. Policy II.A and III.A

    Refer to Repositories not covered by UMMS policy (above) and to UMMS Biorepository Decision Tree.

    Your project does not have to be registered as a biorepository if you are immediately using and disposing of the biospecimens you collect, or if you are storing biospecimens for a single specified research use.

    If you are cataloging and storing biospecimens for possible future additional uses, your project must be registered by completing an REP application. While your project might not currently include biospecimens for distribution, you are encouraged to think ahead to the possibility that this may one day be the case and consider registering your project as a repository, through the REP application, as soon as you can foresee it becoming one. “Distribution of biospecimens” is meant to include using biospecimens yourself for new research purposes – repurposing existing specimens is considered “distribution to oneself.”

    It is expected that hundreds of U-M projects will need to register as biorepositories.

    See also Elements and Uses of a Repository guidance page.

    What is the purpose of the oversight committee required by the UMMS policy?

    Ref. Policy II.D and III.C

    The purpose of the oversight committees required by the UMMS policy is to facilitate the appropriate use and distribution of bio-resources. These committees will minimize the need for higher level administration to become involved in dispute resolution about the use of biospecimens.

    An oversight committee is required if you plan to share biospecimens outside your department or beyond your original collaborators. Oversight committees are important procedural mechanisms for managing repository resources and requests to use those resources, especially if the repository contains rare or difficult-to-obtain materials.

    Oversight committees consist of at least three individuals, at least two of whom are scientists, to fulfill the functions described in Sections II.D and III.C of the policy. The composition and function of the oversight committee are described as part of the process in registering the repository via the REP.

    Will the oversight committee be an ancillary committee that needs to approve a proposed biospecimen use before an application for secondary use goes to the IRB?

    Oversight committees are not formal ancillary committees in the eResearch review process. Each oversight committee is formed once the REP is approved, and operates within the construct of the individual repository. One function of the oversight committee is todecide upon proposed secondary uses of biospecimens within the review parameters delineated in the approved REP application.

  • Consent/HIPAA Authorization

    How can repositories manage informed consent?

    Research studies involving interaction/intervention with subjects usually include an informed consent process, and often employ a comprehensive written informed consent document. (These may include HIPAA authorization – see below.) When data/biospecimens from these studies are deposited in a repository, the repository takes on responsibility for awareness of and compliance with the terms of the consent.

    Repositories may also receive data/biospecimens generated without prior research consent (such as data from medical records, or residual or to-be-discarded tissue from surgeries). Some repositories should request a waiver of informed consent as part of the REP application: for details, see Informed Consent/HIPAA authorization section at Responsibility for REP Oversight and Compliance webpage.

    How can repositories manage HIPAA authorization?

    Like other human subjects research at UMHS, many data/biospecimen repositories involve accessing, storing, and/or distributing Protected Health Information (PHI) subject to HIPAA Privacy Rule protections.

    Medical research studies with a comprehensive written informed consent process usually include signed HIPAA authorization as part of the informed consent document. When data/biospecimens from these studies are deposited in a repository, the repository takes on responsibility for awareness of and compliance with the terms of the consent/authorization.

    Clinically generated data/biospecimens might be deposited in a repository without prior research HIPAA authorization (UMHS Notice of Privacy Practices does not qualify as a research HIPAA authorization). Some repositories should request a waiver of HIPAA authorization as part of the REP application: for details, see Informed Consent/HIPAA authorization section at Responsibility for REP Oversight and Compliance webpage.

    The REP application section 3 and Application Supplement Form sections I and II include questions about a repository’s plans regarding PHI.

    What kinds of studies use the specialized Biorepository consent with informational pamphlet?

    IRBMED makes available a comprehensive Specialty Biorepository Informed Consent Template intended to be used with an illustrated informational sheet (trifold pamphlet format). The consent forms based on this template in most cases are 2 pages long. U-M studies intending to collect biospecimens for unspecified future research should consider whether the biorepository template + informational sheet will be effective for their consent processes (instead of or in addition to a study-specific consent form, depending on the nature of the study).

    The biorepository template + informational sheet was originally developed in conjunction with UMMS Central Biorepository (CBR). CBR requires studies depositing with them to use the biorepository template + informational sheet however, no relationship with CBR is implied by the use of these documents in and of themselves.

    NOTEDo not use the IRBMED Specialty Informed Consent Template for “One-time blood or tissue sample” if the study deposits into a repository.

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: February 15, 2019 4:15 PM