7.2 Collection, Storage and Use of Human Biological Material in Research

Last Revised: 1/25/20189/24/2025

1.0 Purpose

The purpose of this policy and procedure is to describe the Organizations requirements for the use and/or banking of human biological material (HBM) infor research.

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2.0 Policy

It is the policy of the Organization that

• 2.1. Use of identifiable (including coded where investigator has access to the key) HBM be used in research inis accordancesubject to HHS regulations at 45 CFR 46; FDA regulations at 21 CFR 50, 56; HIPAA Privacy Rule, applicable HRPP policies, and Organizational requirements.

• 2.2. Collection of identifiable (including coded where investigator has access to the key) HBM into a bank constitutes human subject research subject to HHS regulations at 45 CFR 46, HIPAA Privacy Rule, other applicable HRPP policies and Organizational requirements.
• 2.3. Collection of HBM to be stored for future undefined use cannot be a requirement for participation in another study for which there is the potential of direct benefit.
• 2.4. Collection of extra (additional) HBM for exploratory objectives may not be a requirement for participating in a study for which there is the potential of direct benefit unless the collection of that extra HBM is associated with a low risk of complications (for example, collection of blood by venipuncture, or biopsies of bone marrow, skin, and superficial masses). This is in accordance with recommendations from the American Society of Clinical Oncology (ASCO) (see below).
• 2.5. Excess HBM obtained from persons who refuse to consent to HBM banking may not be de-identified and banked.
• 2.6. Collection of HBM without identifiers, or collected as part of an exempt protocol, requires consent of the donor when the donor of the HBM is known to the person obtaining the material, and is reasonably accessible.

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3.0 Definitions

• 3.1. Human Biological Materials: HBM includesMaterial (butHBM) is any material derived from a human (including but not limited to) sub-cellular structures (e.g., DNA); cells; tissues (e.g.,to blood, bone,urine, muscle,DNA/RNA, connectivetissues, tissue,organs, teeth, and skin); organs (e.g., liver, bladder, heart, kidney, and placenta); gametes (e.g., sperm and ova); and waste (e.g.,saliva, hair, nail clippings, urine,or feces,any saliva,other cells or fluids).

  • 3.1.1. Except as noted specifically below, HBM in this policy refers to both samples obtained directly from a person and sweat).
    then used for research, and to samples which have been collected and stored in an HBM bank for future use.

• 3.2. IdentifiableExcess HBM refers to HBM that is leftover after research or clinically indicated tests are conducted and would not be needed for purpose of their care.

• 3.3. Extra (additional) HBM refers to HBM that is collected for the purposes of the research and would not otherwise have been collected had the subject not been participating, including HBM that is collected solely for banking.
  • 3.3.1. Extra (additional) HBM may be obtained as part of a clinically indicated procedure (for example, biopsy or phlebotomy), or may require an additional procedure that is not clinically indicated in order to obtain the material. In the latter case, the risks associated with the procedure are risks of the research.
• 3.4. Identifiable HBM refers to HBM to which identifiers (including codes linked to any identifier) are attached, or for which the identity of the subject is or may readily be ascertained by the investigator or is associated with the HBM.
  biospecimen.
  • 3.4.1.

    3.2.1.In accordance with the 2018 revision of the Common Rule, what constitutes “identifiable” will be defined by the Secretary of HHS and re-examined on regular occasions. At a minimum, HBM is identifiable when it is associated with any of the 18 HIPAA identifiers.

    Note: Following the effective date for the Revised Rule, what constitutes “identifiable” will be re-examined on regular occasions; therefore, HBM currently considered not identifiable may become identifiable in the future as technologies and techniques change.

• 3.5.

  3.3. Coded HBM refers HBM for which identifying information has been replaced with a code, and a key to decipher the code exists, enabling linkage of the identifying information to the biospecimens.

• 3.6. De-identified HBM refers to HBM for which either (1) all identifiers have been removed from the HBM (and any associated data) or (2) the key that links the code number to the identifiers has been destroyed.
• 3.7. HBM Bank (also referred to as biobank or biorepository) is a collection of HBM that is intended for use in future unspecified research. HBM banks may consist of:
  • 3.7.1. Samples (either extra or excess) obtained from specific IRB-approved research (involving only that group of subjects participating in the associated withresearch) aand code which canto be used tofor indirectlyanother identifyunspecified theresearch donorproject; or
  • 3.7.2. Samples collected as part of thean HBM.
    IRB
    approved
    • banking 3.3.1.protocol Codedto HBMbe is considered identifiableused for theanother purposesunspecified ofresearch thisproject, andwhether otherthose HRPPsamples policiesare unless:used
      immediately
      • or 3.3.1.1. Specimens were not collected specificallystored for thefuture researchuse; AND
      • 3.3.1.2. The investigators cannot readily ascertain the identity of the individualsor
  • 3.8. Banking refers to collection of HBM into a bank as defined above.

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  4.00. IRB Review and Consent Requirements

  • 4.1. Collection of HBM
    • 4.2.1. The collection of identifiable (including coded where the investigator has access to the key) HBM for immediate or future use (specified or unspecified at the time of collection), constitutes human subject research and will be reviewed in accordance with all applicable federal regulations and HRPP policies.
    • 4.2.2. The collection of identifiable (including coded where the investigator has access to the key) HBM for immediate or future use (specified or unspecified at the time of collection) may qualify for expedited review, as per HRPP policy 2.3 (Expedited Review).
    • 4.2.3. The collection of identifiable (including coded where the investigator has access to the key) HBM for immediate or future use (specified or unspecified at the time of collection) may be exempt under 45 CFR 46.104(d)(4) (secondary research of identifiable private information or identifiable biospecimens).
    • 4.2.4. The collection of de-identified (not identifiable) HBM for immediate or future use (specified or unspecified at the time of collection), does not constitute human subject research subject to 45 CFR 46.
      • 4.2.4.1. If (1) the material was obtained specifically for banking, or (2) the person obtaining the material is involved in the bank, the material is considered “identifiable”, and therefore constitutes human subject research.
    • 4.2.5. The collection of de-identified HBM for use in a clinical investigation conducted in support of premarket submissions to FDA is considered a clinical investigation involving human subjects, and therefore subject to the IRB review under 21 CFR 56, and to the informed consent requirements of 21 CFR 50.20.
  • 4.3. Use of HBM
    • 4.3.1. The use of identifiable (including coded) HBM previouslyobtained stored infrom an HBM bank or pathology archive constitutes human subject research, and will be reviewed in accordance with all applicable federal regulations and HRPP policies.
    • 4.3.2. The use of identifiablecoded HBM previouslyobtained stored infrom an HBM bank constitutes human subject research, unless the investigator cannot readily ascertain the identity of the individuals to whom the coded private information or pathologycoded archivebiospecimens pertain. Examples include but are not limited to:
      • 4.3.2.1. The investigator and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased; or
      • 4.3.2.2. There are IRB-approved written policies and operating procedures for an HBM bank that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
      • 4.3.2.3. There are other legal requirements prohibiting the release of the key to the investigators until the individuals are deceased.
    • 4.3.3. The use of de-identified (not identifiable) HBM obtained from an HBM bank does not constitute human subject research subject to 45 CFR 46.
      • 4.3.3.1. As noted above, if (1) the material was obtained specifically for banking, or (2) the person obtaining the material is involved in the bank, the material is considered “identifiable”
    • 4.3.4. Excess HBM obtained from persons who refuse to consent to HBM banking may not be de-identified and used or banked.

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  5.0. Informed Consent

  • 5.1. Collection of HBM
    • 5.1.1. The collection of identifiable (including coded where the investigator has access to the key) HBM for immediate or future use (specified or unspecified at the time of collection), requires informed consent of the donor,person from whom the tissue is obtained, unless consent can be waived under 46 CFR 46.116(f) or 21 CFR 50.22.
    • 5.1.2. The collection of de-identified (not identifiable) HBM for immediate or future use (specified or unspecified at the time of collection), does not require informed consent unless the donor of the HBM is known to the person obtaining the material, and is reasonably accessible. In that case, consent of the donor is required.
  • 5.2. Use of HBM
    • 5.2.1. The use of identifiable (including coded) HBM obtained from an HBM bank requires informed consent of the subject, unless:
      • 4.5.2.1.1. Consent can be waived under 45 CFR 46.116(d)f) (or rev 4521 CFR 46.116(f)).50.22; OR
      • 4.5.2.1.2. Consent obtained at the time the HBM was obtained and banked was sufficiently detailed with regard to the future use of the HBM that a reasonable person would expect that the consent would permit the types of research conducted.
    • 4.3. The use of non-identifiable HBM previously stored in an HBM bank does not constitute human subject research subject to 45 CFR 46; therefore, no IRB review is required and no informed consent is needed.
      • 4.3.1. Under FDA regulations, clinical investigations using human specimens (even those that are non-identifiable) conducted in support of premarket submissions to FDA are considered human subject investigations, and therefore subject to the informed consent requirements of 21 CFR 50.20. However, FDA intends to exercise enforcement discretion as to the informed consent requirements for clinical investigators, sponsors, and IRBs if an in vitro diagnostic device investigation is performed and the requirements in section 4 of FDA Guidance “Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” (April 25, 2006) are met.
    • 4.4. The use of coded HBM previously stored in an HBM bank or pathology archive constitutes human subject research, and requires IRB review, unless (1) the HBM was not collected specifically for the proposed research AND (2) the investigator cannot readily ascertain the identity of the donors of the HBM. If both these conditions are met, the HBM is considered non-identifiable, and no IRB review is required.
    • 4.5. If the coded HBM is identifiable (as above), informed consent is required unless:
      • 4.5.1. Consent can be waived under 45 CFR 46.116(d) (or rev 45 CFR 46.116(f)).
      • 4.5.2. Consent obtained at the time the HBM was obtained and banked was sufficiently detailed with regard to the future use of the HBMsuch that a reasonable person would expect that the consent would permit the types of research conducted.
    • 4.6.5.2.2. The use of de-identified (not identifiable) HBM previouslyobtained stored infrom an HBM bank may qualifynot require informed consent.
      • 5.2.2.1. As noted above, if (1) the material was obtained specifically for expeditedbanking, reviewor (under2) categorythe 5),person obtaining the material is involved in the bank, the material is considered “identifiable”
      • 5.2.2.2. If the use of de-identified HBM obtained from the HBM bank goes the potential uses described in the consent document when the subject enrolled in the bank, additional consent may be required at the discretion of the ORA.
    • 5.2.3. If informed consent is required as above, the informed consent process must include basic and additional elements of consent related to biospecimens as per HRPP45 policyCFR 2.346.116.
    (Expedited
    Review).

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  6.0. Mandatory Participation in HBM Collection and Banking

  • 6.1. HBM may be collected for immediate or future use as a component of another research protocol with or without the prospect of direct subject benefit.
  • 6.2. Collection of HBM for future undefined use cannot be a requirement for participation in another study for which there is the potential of direct benefit.
  • 6.3. Collection of extra (additional) HBM for exploratory objectives cannot be a requirement for participation in another study for which there is the potential for direct benefit, unless the collection of HBM is associated with a low risk of complications.
    • 6.3.1. Low risk in this context is defined as procedures with an expected rate of major complications of <0.5% (for example, collection of blood by venipuncture, or biopsies of bone marrow, skin, and superficial masses) (J Clin Oncol 37:2368-2377, 2019)
  • 6.4.7. TheCollection of HBM for immediate or future use, may be included as a requirement for participation in a research protocol for which there is no prospect of direct benefit, since potential subjects may opt-out of the use of HBM previouslyby storeddeclining to participate without loss of any direct benefit.
    • 6.4.1. The IRB will consider the risks associated with mandatory collection and/or storage of HBM in andetermining HBMwhether bank(1) the risks to subjects are minimized, and (2) the risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be exemptexpected underto result (in accordance with 45 CFR 46.101(b)(4)111 (priorand to21 CFR 56.111).
  • 6.5. For studies conducted within the effectiveorganization datewhere the UNMC IRB is the IRB of record, consent for participation in HBM collection and banking associated with a study with the prospect of direct benefit must be documented in a separate consent form.
    • 6.5.1. Studies conducted within the Organization where another IRB is the IRB of record will document consent is accordance with the requirements of the Revisedreviewing Rule),IRB.
    or
    rev
  45
  • 6.6. CFRDocumentation 46.104(d)(4)of (followingconsent for mandatory participation in HBM collection and banking associated with a study without the effective dateprospect of thedirect Revisedbenefit Rule).may Thebe Organizationincluded does not utilizein the exemptionconsent underform revfor 45the CFRassociated 46.104(d)(8).study without the prospect of direct benefit

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  DOCUMENT HISTORY:

   Written: 1/14/2016 (Approved: 1/14/2016) - original author not recorded

   Revised: 1/25/2018 - revision not documented

   Revised: 3/14/2023 – revision not documented

   Revised 5/15/2025 - Merged policies 7.1 (Banking Human Biological Material) and 7.2 (Use of Human Biological Material in Research) without substantive changes (except as below); extensive revision to focus on responsibilities rather than procedures more appropriate for SOPs; added policy that collection of extra (additional) HBM for exploratory objectives may not be a requirement for participating in a study for which there is the potential of direct benefit unless the collection of that extra HBM is associated with a low risk of complications (section 2.4); correction of typographic errors.

   Revised 9/24/2025 – minor clarification to section 4.2.4.1