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This Copy Was Generated On: June 7, 2026

HUM Application Guidance for Creating a Biospecimen Collection Using the Central Biorepository

Central Biorepository

| Approval Date:

May 26, 2026 10:00 am

This document provides guidance to assist investigators in completing an IRBMED HUM application when creating a new biospecimen collection within the Central Biorepository (CBR).

Please note that the following guidance does not cover the entire HUM application. The examples and recommendations provided are meant to accurately reference and cite CBR activities in your application.

For guidance on other parts of your application, please consult available resources (eResearch Regulatory Management, Regulatory Management PI & Study Team Support, and IRBMED guidance) or seek additional assistance from the IRB office. Note that some resources referenced in this document require Level-2 access.

HUM Application Guidance for Creating a Biospecimen Collection Using the Central Biorepository

01. General Study Information
- Question 1.1.2: Enter “REP00000002 – University of Michigan Medical School Central Biorepository” alongside any other related projects.
- Question 1.8: Indicate proposed use of CBR resources in the project summary.
- Question 1.11: In addition to providing an estimate for the duration of the study, describe plans for long-term storage of samples in the CBR.
  - Note: If samples are intended to be retained without a defined end date, terms such as “indefinite” or “future use” may be appropriate when describing storage duration.
01-1. Application Type
- Question 1-1.1: Select “Human Subjects Research Involving Interaction or
  Intervention” and indicate “Yes” for the research involving the collection of biospecimens from subjects.
03. UM Study Functions
- Question 3.1: Select any services that will be performed by the CBR in addition to those of the study itself and indicate these activities are occurring at the University of Michigan in subsequent questions for “03-1.1 Performance Sites.”
05. Research Design
- Question 5.1.2: When the only purpose of the study is to collect and store samples and gather data for unspecified future use, include the following statement in the Statistical Design section of the question: “Calculations for power and sample size will be performed individually for each research study proposing to utilize the resources of the [NAME] biorepository and/or database.”
  - Note: This question is displayed only if you answer “Yes” to Question 5.1, indicating that there is a stand-alone scientific protocol document or research plan.
07. Special Considerations
- Question 7.1: Select “Yes” for the study involving biological specimens (Requires Section 18).
- Question 7-1.1: Select “Yes”; this triggers a clarifying Question 7.1.1.1 about the type(s) of human genetic analysis expected.
- Question 7.1.1.1: Select the “Biorepository” option and all the other options applicable to your study.
08. Participation
- Question 8.1: For studies without a set enrollment limit (e.g., ongoing recruitment, no specific target number), provide an estimate using standard enrollment numbers (enter “999” if expected enrollment is in the order of hundreds, “9999” if it is expected in the order of thousands). This can be amended later.
10-1 Informed Consent – Adults
- Please note that CBR policy requires that two IRBMED repository consent templates in conjunction with any study-specific informed consent documents. Tailor the templates to your study. For example:
  - Biorepository Informed Consent Template (with instructions) — Required Reading
    1. Indicate the name of the biorepository collection in the top paragraph – e.g., “the Ann Arbor Genomic Biobank, which takes part in the University of Michigan Medical School Central Biorepository.”
    2. Describe the biospecimens that will be collected from subjects and indicate whether these are obtained specifically for research or are additional to any clinical procedures.
    3. Include contact information for both the PI and the CBR.
    4. Include/remove the bullet point regarding health surveys, as appropriate for your study.
  - Biorepository Informed Consent Informational Sheet (Editable PDF)
    1. Page 1, left panel, top: Describe the physical risks of any collection procedures that are performed specifically for research or additional to any clinical procedures.
    2. Page 1, middle panel, bottom: Ensure contact information is present for both the PI and the CBR.
    3. Page 1, right panel, top: Include the repository name or study name.
    4. Page 2, left panel: Detail the procedures for specimen collection. If you are using a separate standard informed consent document, it is appropriate to cross-reference it for specific procedural details.
    5. Page 2, middle panel, top: Provide sponsor name if applicable.
    6. Page 2, middle panel, bottom, in Box numbered 2: Include/remove the bullet point regarding informational surveys, as appropriate for your study.
    7. Keep the language about the Certificate of Confidentiality.
  - Note: You may not need any additional consent documents beyond those referenced above if your research meets the following IRBMED guidelines:
    “Projects that include plans for no more than the following may seek consent under the single signature of the biorepository consent documents:
    (a) interactions and interventions reasonably designed to enhance the research value of the collection being assembled for future research; and
    (b) data generation and management with risks/benefits that fall within those of in vitro human research in general, as described in the documents.”
- Question 10-1.6: Select “Yes” specimens will be retained for future use.
- Question 10-1.7: Select “Yes” the informed consent does specify specimens will be maintained for future research use.
10.2. Informed Consent – Children
- Notes on Research Involving Children and Long-Term Biospecimen Storage
  1. If the research involves biospecimens from children, you will need to take into consideration the child age, maturity and psychological state when determining if/how an assent will be obtained. In this section, you should clearly describe the process for obtaining both child assent and parental permission.
  2. While there is no CBR-specific assent template, you can use the IRBMED Assent Template and tailor it to your study. Consistent with CBR policy, parental permission must be obtained using two IRBMED repository consent templates in addition to any study-specific informed consent documents that may be required.
  3. Even when participant interaction and biospecimen collection are limited to pediatric participants (under the consent of a parent or legal guardian), please recognize that biospecimens and associated data may be stored indefinitely within the CBR. When completing this section, consider applicable IRB regulations regarding research involving children, as well as requirements for the continued use of data and biospecimens after participants reach the age of majority.
  4. Protocols should address plans for re-consent upon participants reaching adulthood and/or provide appropriate justification for a waiver of consent in accordance with regulatory criteria.
- Question 10.2: Select all that apply
  - Select “Waiver of parental consent/permission” if you plan for the continued storage and use of biobanked biospecimens with the CBR after the participant turns 18. This selection will trigger section 10-3, where additional details must be provided.
    - Important Clarification: this selection is NOT a waiver of initial parental consent/permission for participation in the research. Parental permission is still required at enrollment. Instead, this selection reflects a prospective waiver of consent for the continued use of biospecimens once the participant reaches adulthood.
- Question 10.2.4: Select “Child subject reaches the age of majority” if you plan to retain and/or use biospecimens collected from child participants (whether currently active or not), after they become legal adults.
- Question 10.2.4.1: Describe your approach for obtaining (or waiving) consent from participants who were originally enrolled as children, once they turn 18.
  - If the now adult participant will still be actively contributing to the study:
    - Specify the methods you will use to reach participants who have reached the age of majority (e.g., phone calls, mail, email).
    - State your contact plan (e.g., methods, number, and timing of contact attempts) and steps if contact cannot be made.
    - Detail how you will record their legal adult consent.
  - If the now adult participant is no longer actively contributing to the study: Please detail your plans for the future use of data and biospecimens. For example:
    1. Reconsent: Attempt to contact the participant for continued storage and use of biospecimens. You must define a “fail-safe” plan if they cannot be reached (e.g., anonymize, dispose, or request a waiver of parental consent/permission).
    2. Prospective Waiver of Consent: Seek a waiver for “prospectively impractical recontact” based on high scientific benefit and low risk/high logistical burden. (Requires justification in Section 10-3; see also Section 10.2).
    3. De-identify the biospecimens by removing all links to identifiable data
    4. Disposal or utilization of all biospecimens.
  - In any case, state your plan for when the participant withdraws consent (e.g., what happens to samples or data already shared or in use).
    - Example Response: “For participants enrolled in [Study Name] as children, upon reaching age 18, we will:
      1. Attempt Reconsent: We will attempt to obtain adult consent via phone or during a scheduled Michigan Medicine visit. If contact fails after three attempts (minimum 2 days apart), we will continue to use their existing samples and data under the waiver justification detailed in Section 10-3.
      2. Withdraw: If a participant is reached and declines further participation, we will remove their samples from [Study Name]. The participant will be informed that any data or samples already shared with outside researchers cannot be retrieved.
      3. New Samples: If additional samples are required after the age of 18, a full adult informed consent process will be initiated.“
10-1. Informed Consent
- Question 10-1.1: Upload here all documents related to consent, assent, permission, etc.
- Question 10-1.6: Select “Yes” specimens will be retained for future use.
- Question 10-1.7: Select “Yes” the informed consent does specify specimens will be maintained for future research use.
- Question 10-1.8: In most cases involving CBR, select “Yes.”
- Question 10-1.8.1: Triggered by “Yes” to 10-1.8. In most cases, explain that the purpose of your project is the establishment of a long-term resource.
- 10-3. Informed Consent Waiver
  - Question 10-3.1: Select all that apply. If you are seeking a prospective waiver of consent (use of biospecimens after the child turns 18) select: “Waiver – General -PART of the project”.
  - Question 10-3.1.1: Provide a high-level description of the waiver justifications (e.g., continued use of biospecimen and data for child-subjects reaching adulthood).
  - Question 10-3.1.2: Describe the consent omissions (e.g., full adult consent).
  - Question 10-3.2: Check all boxes and provide study-specific justifications to support each of the criteria.
    - In many cases, particularly for biobank-based research, the continued use of stored biospecimens and associated data may be considered no more than minimal risk, and re-contacting participants at the time they turn 18 may be impracticable.
11. Confidentiality/Security/Privacy
- When addressing this section, please note that biospecimens and associated data may be retained long-term/indefinitely in accordance with the CBR consent and CBR Governance. To ensure signed documents can be retrieved for as long as specimens/data remain in the CBR, the signed informed consent and any HIPAA authorization must be stored in an approved UMMS system of record. Acceptable approaches include:
  1. MiChart (requires level-2 login): Scanned and included in the patient’s permanent medical record. Documents stored in MiChart are retained under Michigan Medicine Health Information Management (HIM) retention rules and remain accessible independent of PI/staff turnover.
  2. Secure storage with archiving and access controls. Be sure to utilize only systems listed on the UM Safe Computing list for any documents containing PHI (refer to the Sensitive Data Guide to IT Services / safecomputing.umich.edu).
- Not recommended are personal accounts (e.g., individual-managed Dropbox folders) because access can be lost when personnel depart, and retention or archiving is not guaranteed. If a file-sharing platform is used, it must be UMMS-supported or compliant.
  - References: Michigan Medicine Release of PHI Under an Authorization Policy, 01-04-310, UMHS Medical Record Requirements Policy, 03-09-001, UMHS Medical Record Retention Policy, 03-09-003, Record Keeping Guidelines – Medical School Office of Research.
- Question 11.1: Most often, select “Yes” the study team will access data linked to the subject’s identity [Requires Section 11-1].
- Question 11.2: Indicate that all samples will be coded and stored in secured conditions in the CBR or in labs in which processing is occurring. The CBR Laboratory Information Management System contains a secure link to patient identifiers that only approved personnel are permitted to access. Key codes linking participants with their sample ID numbers are kept in a secure database.
- Question 11.3: Complete this section to indicate the precautions that you will take. CBR precautions are outlined in CBR REP and do not need to be reiterated here.
- Question 11.4: Select “YES”, because both options include collection of identifiable biospecimens.
- Question 11.6: Select “Retain for future research use [Requires Section 11-4]” and others as applicable.
11-1 Identifiable Data
You will be required to fill in this section if you indicated the study team will access any data that is linked to a subject’s identity by name or other identifier or code.
- Question 11-1.1: Select “Coded or indirect identifiers – data record includes a link to direct identifiers (e.g., name, initials, phone number, SSN, or medical record number linked to data record but stored separately)” and others as applicable.
- Question 11-1.2: Include in your response that Electronic Health Record (EHR) may be used in conjunction with future secondary uses of biospecimens.
- Question 11-1.3: Indicate how long the study team will maintain identifiers and that identifiers will be indefinitely maintained within the CBR Laboratory Information Management System.
  - Example language: “Identifiers will be retained by Central Biorepository indefinitely per their policies and procedures. REDCap database coded identifiers will be destroyed at the conclusion of the study.”
  - Note: CBR will not request/maintain data collected by the study team and kept in their records or databases.
  - For information on retention periods, refer to the IRBMED Recordkeeping Guidelines. Records retained for future use may be retained by the researcher or in a research bank or repository.
- Question 11-1.4: Select “Yes” to access, collect, use, maintain, or disclose identifying data.
- Question 11-1.4.1, Question 11-1.4.2, Question 11-1.4.3, and Question 11-1.4.4: For CBR activities, the answer is “No.” However, if these pertain to your study specifically, adjust the answer accordingly.
11-2 Certificate of Confidentiality (CoC)
You will be required to fill in this section if you answered “Yes” to question 11.4.
- Notes about consent forms:
  - The CBR holds a Certificate of Confidentiality, which protects biospecimens and associated data collected for participants consented with the Biorepository Informed Consent template.
  - For parts of the Study that are NOT covered by the Biorepository Informed Consent template (e.g., other branches, priorities, or study areas outside CBR’s scope), you might use another consent form.
    - If using a different informed consent for the non-CBR part(s) of the study, the CoC language can be included or excluded as appropriate, depending on whether those specific parts of your study are protected by a CoC.
- Question 11-2.1:
  - Select “Yes” if any of the following apply:
    - ALL biospecimens and data are collected exclusively with Biorepository Informed Consent template.
    - You have a second study branch that is using a separate consent other than the Biorepository Informed Consent template and:
      1. You are planning to obtain a CoC on your own, OR
      2. Your study is funded by an agency that automatically issues a CoC (e.g., NIH, CDC, FDA).
  - Select “No” when all of the following apply:
    - You have a second study branch that uses a separate informed consent other than the Biorepository Informed Consent template.
    - You are not planning to obtain a CoC on your own.
    - Your study is not funded by an agency that automatically issues a CoC (e.g., NIH, CDC, FDA).
- Question 11-2.1.1: If you said Yes to 11-2.1:
  - When all biospecimens and data are collected exclusively with Biorepository Informed Consent template, select “I have obtained a CoC (uploaded below)”.
  - Otherwise, select the options that apply to the non-CBR branch of your study.
- Question 11-2.1.2: This question will appear only if you indicated “I have obtained a CoC (uploaded below)” to question 11-2.1.1.
  - Upload a signed attestation by the PI stating that the CBR’s CoC (at REP00000002) will govern the study confidentiality protections. Please include:
    - Confirmation that you will be using CBR’s REP00000002 and what components of your study will be covered.
    - Disclosure of plans for or existence of any additional CoC.
- Question 11-2.2: If you said No to 11-2.1:
  - Describe whether your study will rely on CBR’s CoC, and/or describe any additional confidentiality protections.
11-4 Retention of Data and/or Specimens Details
- Question 11-4.1: Indicate specimens will be stored for future research use.
- Question 11-4.2: Check “Only at the University of Michigan” or “UM and Other Institutions” as applicable.
- Question 11-4.3:
  - For all biospecimens held at the CBR, all arrangements will follow CBR REP00000002. Ensure that this application is referenced as a related project in Question 1.1.2.
  - Outline your oversight plans.
    - Note: Please keep the CBR up-to-date on members/contact points, even after termination of your HUM, and provide the CBR with a copy of your oversight committee charter.
18. Biological Specimens
- Question 18.1 subsections: Indicate which type of samples will be stored in the CBR under each sample type.
  - Note: Question 18.1.15 is only for using samples that are already stored in the CBR, not for creating a new collection.
- Question 18.2: Select “Yes” to receiving or recording direct/linked identifiers for biospecimens.
20. Genetic Analysis
This section is triggered if specific genetic analysis options were selected in 7.1.1.1. While information pertaining to standard CBR processes is provided below, you must ensure all applicable questions in this section are completed for your study.
- Question 20.4: Select “Yes” biospecimens may be shared with colleagues outside the study.
  - Question 20.4.1: State that for future studies requesting samples from the CBR:
    - Biospecimens will be coded,
    - Identifiable information will only be released if approved by IRBMED, and
    - A Memorandum of Understanding (MOU) will be supplied and required before transfer can take place.
- Question 20.5: Select “Yes” if the study uses the Biorepository Informed Consent template.
- Question 20.6: Select “No” if the study uses the Biorepository Informed Consent template.
- Please refer to available guidance on the Research Involving Genetic, Genomic, and/or DNA Collection or Analysis – Medical School Office of Research
25. HIPAA Covered Components
Complete this section as it is appropriate for your study.
- Note: if you are requesting a waiver of consent, ensure your responses here align with the details provided for Section 10-3.
- Please refer to available guidance on the Waiver or Alteration of HIPAA Authorization – Medical School Office of Research.

UNIT: Central Biorepository

TOPICS: eResearch Regulatory Management (eRRM) / Repository

Questions?

Contact us at [email protected] or 734-647-8809

2800 Plymouth Road, NCRC Building 60, Room 1661, Ann Arbor, MI 48109-2800

Edited By: [email protected]
Last Updated: March 30, 2021 1:15 PM

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