Elements and Uses of a Repository

A human subjects research activity (approved through HUM) may collect data/biospecimens for future research use as a sub-study, or as its primary purpose. Studies depositing into an REP for long-term storage and/or other purposes should include "pointers" to the REP.  Initially, these should include:

• HUM page 01, question 1.1.2 for "related projects": enter REP# and the Repository Title.
• HUM page 11, question 11.6: check "Retain for future research use" (and others as applicable)
• HUM page 11-4, question 11-4.2: check "Only at the University of Michigan" OR "UM and Other Institutions" (as applicable)
• HUM page 11-4, question 11-4.3: Refer to the REP. The REP application comprehensively addresses these questions. 
• Informed Consent Documents (ICDs) uploaded in HUM page 10-1, question 10-1.1: Consent document should address explicitly plans for data/biospecimen use for future undefined research. U-M studies intending to collect biospecimens for unspecified future research use should consider using the Specialty Biorepository Informed Consent Template + informational sheet (in addition to or instead of another study-specific consent form, depending on the nature of the study). Note: UMMS Central Biorepository (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.

IRB staff create two-way hyperlinks between an REP and associated HUM(s). The links display in an REP space under “Related Projects” tab, and in an HUM space under “Document/Related Records” 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. (See also HUM-REP connections question at FAQ: Repository application.)

HUM study teams and REP repository teams are responsible for presenting consistently their intended plans for working together in applications to the IRB.

Secondary use analysis of data and/or biospecimens (including distributions from data repositories and biorepositories) require IRB oversight if the analysis meets the regulatory definition for "human subjects research." See IRBMED FAQ questions "What kind of research and other activities require IRB review?" and "Do I need to submit an IRB application?" Secondary use analysis "involves human subjects" when the investigator conducting the research "obtains identifiable private data."

eResearch HUM application "Secondary research uses of private information and/or biospecimens" application type is designed to route through the correct IRB review and determination path (i.e., not regulated, exempt, or comprehensive IRB approval) all secondary use studies where U-M study team performs data analysis.

Not Regulated may apply if the researchers doing the analysis do not at any point have access to "re-identify" the data.

• U–M faculty, staff and/or students/trainees receive data/specimens without identifiable data through an 'honest broker', either internal (e.g. DataDirect, Central Biorepository, Tissue Procurement Service) or external (e.g. dbGaP, BioLINCC or CMS-ResDAC). In this case, choose either "Secondary research uses..." or  "Activities not regulated..." in application type 01-1.
• U-M faculty, staffa and/or students/trainees PREPARE "coded" or "de-identified" dataset/specimens for analysis by EXTERNAL investigators (U-M role is limited to data PROVIDER). In this case, choose "Activities not regulated..." in application type 01-1.

Exemption 4 is available for retrospective and/or prospective data/biospecimens and applies to most IRBMED secondary use research without biospecimens

• public data sources such as phone book;
• non-public data/biospecimens sources if study team may view but will not record any direct or indirect identifiers.
• "HIPAA exemption" - no biospecimens and all data are covered by HIPAA
  • data sources are regulated as PHI;
  • ALL study team members are members of a HIPAA "covered entity (CE)";
  • ALL institutions involved with the study are "covered entities";
  • The data either NEVER leaves a CE, or is covered by HIPAA-specific data use agreements throughout any and every transfer.

Comprehensive (non-exempt) IRB review and approval is required when "not regulated" and "exempt" are not available. For instance,

• Research dataset for analysis comprises/includes identifiable private information not covered under HIPAA
• Biospecimen analysis where associated identifiable data are kept
• Requirement from data/biospecimen provider for full or expedited IRB review (e.g. some dbGaP datasets, based on Data Use Certification)
• Data are intended for IDE (Investigational Device Exemption) or In Vitro Diagnostic (IVD) device application to FDA
• Secondary use is paired with interaction/intervention. In this case, choose "Human Subjects research involving interaction or intervention..." in application type 01-1.

NOTE: Exemption 4 eligibility is expanded under Revised Common Rule, active as of January 2019. U-M applied the expanded Exemption 4 as a Flexibility Initiative June 2018 - January 2019. Pre-2018 Exemption 4 covered only analyses where both (1) all data already existed at time of IRB application and (2) one of the following applied:

• public data/biospecimen sources such as phone book;
• non-public data/biospecimens sources such as medical records only if study team may view but will not record any direct or indirect identifiers.

An application for "secondary use" research may ask about consent and/or HIPAA authorization for the data/biospecimens received. Consent process or waiver and HIPAA authorization process or waiver MUST be compatible with each other.

Informed Consent

The IRB regulations regarding informed consent apply only to secondary use research requiring comprehensive (non-exempt) IRB review and approval. It is common for these to operate under a waiver of consent and waiver of HIPAA authorization. Waivers are not necessary for "secondary use" research if the initial consent collecting data/biospecimens already addresses broad permission for future use: this constitutes "pre-existing consent." In some cases, a "secondary use" researcher may need to recontact original subject-donors of data/biospecimens to request a new consent.

HIPAA Authorization