Frequently Asked Questions (FAQ)

Regulatory Roadmap: Creating a Biospecimen Collection using the Central Biorepository (CBR)

Do I need IRB approval for collecting and storing biospecimens with the CBR?

Almost certainly. The only situation where you may not need IRB approval is if you were amassing a collection consisting only of biospecimens collected anyway for a clinical purpose, and no links to identifying information will exist. This would require special approval by the CBR Governance Committee.

In order to obtain IRB approval, you will need to complete a HUM application within eResearch and possibly a REP application.

  • HUM applications - for biospecimen collecting activities (e.g. recruitment, informed consent, interaction/interventions with specimen donors).
  • REP applications - for collection and future use of human specimens and data (e.g. physical storage, data security, administrative infrastructure).

Do I need to complete a REP application?

If you are depositing into the CBR, you usually do not need your own REP application. You can reference the CBR’s REP (REP00000002) within your HUM application through Question 1.1.2 .

It may make sense to complete your own REP if:

  • You will be storing collected biospecimens in your own lab space, rather than sending all to the CBR for storage.
  • Your collection will include its own special administrative and/or regulatory elements.
  • ​IRBMED staff can help you make this decision during review of the HUM application.

How should I reference the CBR in my HUM application?

Note: This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section depending on the specifics of your study. Click here to learn more.

Is there a checklist that I can use for Creating a Biospecimen Collection using the Central Biorepository (CBR)?

  1. Yes.
  2. Contact the CBR to get advice and support for your grant, IRB, and other applications before you submit them for review. The CBR may have biospecimens that can support your grant application or make it unnecessary for you to collect new biospecimens. A full inventory of samples stored in the CBR can be found here.
  3. Complete and submit the Request for Prospective Collection Services form.
  4. IRB approval must be obtained for all human subjects research.
    • More information about IRB requirements can be found on the IRB website and the Research A-Z website.
    • The only scenario where it may possible to set up a CBR collection without IRB approval is if your collection consists of biospecimens collected for a clinical purpose and has no linkage to subject-identifying information. This would require special approval by the CBR Governance Committee.
  5. Establish an Oversight Committee or choose to utilize the CBR Oversight Committee.
  6. Complete the Submittal Agreement which can be found on the CBR Website.

 

Regulatory Roadmap: Proposing New Studies Using Central Biorepository (CBR) Resources

What biospecimens and corresponding data are available through the CBR?

Biospecimens donated by CBR participants are available for a broad spectrum of research uses. A full inventory of samples stored in the CBR can be found here.

Annotations from the medical record are accessible via DataDirect. This self-serve tool allows users to get counts of CBR participants who meet desired inclusion/exclusion criteria without any regulatory review required.

Additional data (e.g., genetic, survey, epidemiological data, etc.) can be made available from other U-M study teams.

How do I request access to CBR biospecimens for my research?

Before you can receive CBR biospecimens, you will need to complete the Use Proposal Form and receive approval from a CBR Oversight Committee.

  • If approved, you will be asked to sign a Memorandum of Understanding (MOU) that outlines your use of the materials. 
  • You will have the option to appeal to the CBR Governance Committee if you believe your proposal is unreasonably denied.

If you wish to directly access the medical records or identifiable information of participants, you will also need IRB review and approval after Oversight Committee approval.

  • Once you have IRB approval you will be able to log back into DataDirect and re-run your query in “PHI mode.” This will allow you to select and download clinical data of interest for the cohort and identify specific biospecimens for distribution.  

In addition to accessing existing CBR biospecimens, I also want to collect additional samples and/or recontact subjects who have their biospecimens stored in the CBR. What should I know?

If you are conducting a study where you will collect additional biospecimens to contribute to the CBR, please refer to the CBR’s “Creating a Biospecimen Collection using the Central Biorepository (CBR).” listed in the FAQ block above. 

If you are both accessing existing samples and contributing new samples, you may want to fill out two IRB applications: one HUM for the new collection and a second HUM indicating which collections will undergo analysis. IRBMED regulatory staff can help you make this decision.

If you plan to recontact subjects who have their biospecimens stored in the CBR (i.e. in the case of using biospecimens for screening for a new study), you will need to coordinate with the primary study that originally collected samples and obtain proof of previous informed consent.

How should I write my HUM application for use of samples that are stored in the CBR where I will only perform secondary analysis on samples with no patient interaction or intervention?

This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section depending on the specifics of your study. Please reference your CBR MOU and/or Use Proposal Form to assist with this application. Click here to learn more.

How should I write my HUM application for use of samples that are stored in the CBR where I plan to recontact subjects whose samples are stored in the CBR for either additional sample collection or new study enrollment?

This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section depending on the specifics of your study. Please reference your CBR MOU and/or Use Proposal Form to assist with this application. Click here to learn more.

Note: If you plan on storing additional biospecimens within the CBR, refer to the CBR’s “Creating a Biospecimen Collection using the Central Biorepository (CBR)” FAQ block above for more detailed instructions on that activity.

Is there a checklist I can use for Proposing New Studies Using Central Biorepository (CBR) Resources?

  1. Yes.
  2. Use DataDirect to determine how many CBR participants meet your inclusion/exclusion criteria.
  3. Complete the CBR Use Proposal Form.
    • This will undergo review by a CBR Oversight Committee.
    •  You will have the option to appeal to the CBR Governance Committee if you believe your proposal is unreasonably denied.
  4.  If approved by the Oversight Committee, you will be asked to sign a Memorandum of Understanding that outlines your use of the materials (an example of the MOU can be found on the CBR website).
  5. If you wish to directly access the medical records or identifiable information of participants, you will need to complete a HUM application for IRB review.
  6. Once approved by the Oversight Committee and the IRB (if needed):
    • Submit the list of biospecimens you’d like pulled to the CBR.
    • Contact the Data Office for coordinating data delivery.