Secondary research for which consent is not required and the researcher uses:  

  • identifiable biospecimens that are publicly available; or  

  • identifiable biospecimens but the researcher does not record or retain identifiers, contact subjects, or try to re-identify subjects.  

See our Exempt FAQs and Exempt Review SOPs for more information on exempt review.  

Examples of exempt research involving biospecimens:  

  • An investigator requests to perform a medical record review to identify subjects for whom they would like to request their biospecimens, then:  

    • an approved biorepository or third party provides the biospecimens in a de-identified manner so the information is not linked to a subject identity.  

    • A HIPAA waiver must be approved by the IRB to perform the medical record review portion of the study.  

  • An investigator uses identifiable biospecimens that were originally obtained:   

    1. for non-research purposes and allows for reuse for research purposes under applicable guidelines, and the investigator does not record identifiable information in the research record, contact subjects, or attempt to re-identify subjects.  

    2. for research purposes, and the reuse is allowed based on the information included in a signed consent document, and the investigator does not record identifiable information in the research record, contact subjects, or attempt to re-identify subjects.  

Research on de-identified biospecimens typically does not meet the definition of human subject; therefore, no IRB approval is required. This means the researcher would not have identifiable biospecimens at any time before, during, or after the conduct of the study. The researcher also cannot hold a code that would connect the identity of the subject with the biospecimens.    

However, if you are using an investigational (not yet FDA approved) in vitro diagnostic device, even when all biospecimens are de-identified/anonymous, expedited IRB review is required per the FDA regulations on medical devices. Consent can likely be waived with an IDE exemption for diagnostic devices. See FDA guidance   

Examples of studies not needing IRB approval (please see below for submission requirements for Human Subjects Research Determination form):  

  • An investigator requests biospecimens from an approved biorepository in a de-identified manner. In this case, the biorepository would be acting as a third party to ensure the biospecimen is not identifiable.  
  • An investigator requests biospecimens and associated medical record information from an approved biorepository in a de-identified manner. In this case, the biorepository would be acting as a third party to ensure the biospecimens and associated medical record information are not identifiable.  
  • An investigator requests biospecimens and/or identifiable information of deceased individuals but will not use or disclose identifiers of the decedent’s relatives, employers, or household members. The investigator should complete the Research on Decedents Form in eCompliance for confirmation of no IRB approval needed.  

Submission Requirements: Instead of submitting an IRB application, investigators should submit the Human Subject Research Determination (HSRD) Form for IRB documentation of not human subjects research (with the exception above regarding decedents). If using a biorepository to obtain the biospecimens, upload a letter or email from the biorepository confirming the de-identification process. There will not be a HIPAA or consent waiver approved by the IRB with this submission since the study is not subject to IRB review and oversight.  

If NO informed consent is planned:  

  • An investigator requests access to identifiable biospecimens through a biorepository or other entity. The biospecimens are identifiable in the research record either for a period of time or indefinitely to allow for future collection of medical record information and/or biospecimens. Appropriate protections must be in place to allow for expedited review with a consent waiver and likely a HIPAA waiver.  
  • An investigator requests to perform a medical record review to identify subjects for whom they would like to request their biospecimens. An approved biorepository provides the biospecimens with identifiers, and the information is linked to the subject identity. The investigator maintains the link either in a (1) coded manner (maintains a code sheet linking the identity to the biospecimen and information) or (2) identifiable manner. Appropriate protections must be in place to allow for expedited review with a consent waiver and likely a HIPAA waiver.  
  • An investigator using an investigational (not yet FDA approved) in vitro diagnostic device, even when all biospecimens are de-identified/anonymous, expedited IRB review is required at minimum per the FDA regulations on medical devices. Consent would be waived with an IDE exemption for diagnostic devices. See question #2 for more information.    

If informed consent is planned:    

  • The researcher can include identifiable biospecimen collection or analysis of secondary biospecimens according to what is allowed in the consent language.  
  • Depending on the details of the study, the IRB will determine on a case-by-case basis whether expedited or full board review is required. Studies that must be reviewed full board include:  
    • Invasive collection method of biospecimens (i.e. surgery, placement of IV)  
    • Studies involving greater than minimal risk.  
    • Studies not meeting exempt or expedited categories.  

The IRB reserves the right to send any study full board.  

To determine the level of risk to subjects, the IRB needs to know exactly how biospecimens (solid tissue, blood, saliva, urine, etc.) are collected. On the Biospecimens Subform, you will be asked to indicate one of the three methods of collection below.

  1. Biospecimen is collected during a routine/standard of care procedure, and the remaining/extra biospecimen that was removed during the procedure, and not needed for diagnosis, will be used in the study. May be reviewed expedited if overall study is not greater than minimal risk.
  2. Biospecimen will NOT be collected/removed during a routine/standard of care procedure and will only be collected/removed because subject agrees to be in the study. May be reviewed expedited if collected by non-invasive means and rest of the study meets expedited criteria.
  3. Some biospecimens will be collected during a routine/standard of care procedure, and additional/extra tissue/blood/urine/other biospecimen will also be collected/removed for research. May be reviewed expedited if collected by non-invasive means and rest of the study meets expedited criteria.

To determine the level of review, the IRB needs to know which method below will be used.

  • Peripheral and/or Central Line (IV) - If placement of IV is for research-only (protocol driven), project must be reviewed at the convened board meeting.
  • Finger stick, Heel stick, Ear stick, or Venipuncture (Needle stick) – If this method will be used for research purposes, you will need to indicate if it will require an additional stick/venipuncture beyond routine/standard of care collection. May be reviewed expedited if overall study is not greater than minimal risk and the volume/timing of blood collection meets the expedited category requirements described below.

The following is the Expedited Category for research involving blood collection:

  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
  • from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.

Any collection outside of these parameters will likely require full board review.

Please refer to the Required Elements of Consent in the “Written Consent – Biomedical” template on the Researcher Resources page. Also, see the Additional Elements of Consent if you will receive a commercial profit from biospecimens and/or if your research involves whole genome sequencing.   

See the Informed Consent FAQs for additional information as well.  

Biorepositories are established to centralize and standardize services for procuring, obtaining, processing, and storing human biospecimens for IRB-approved biomedical research projects.   

Submission Requirements: If a proposed study includes establishment of a research biorepository, an IRB application for non-exempt review must be completed in the eCompliance system. If a proposed study includes solid tissue, blood, urine, saliva, or specimen data for tissue/specimens collected as part of a MU Health encounter, investigators are expected to follow applicable MU Health policies. Any researcher utilizing tissues/specimens obtained from an internal or external tissue or blood bank, biorepository, or external laboratory will need to provide proof to the IRB that appropriate consent and collection processes were utilized to obtain samples and provide support regarding the identifiable nature of the tissue/specimen.    

Review the Informed Consent FAQs and templates so all necessary elements of consent are included. Please review the Additional Elements when Creating Biorepositories and Databases in our Informed Consent SOPs.  

It is important to familiarize yourself with the policy outlining exempt specimens from routine/standard of care pathologic examination. You will want to check on the availability of specimens for research before proceeding with IRB approval: MU Health Care Policy.