The use of data and/or biospecimens that were collected for future research activities may include:
- Sending data and/or biospecimens to other institutions/entities/investigators (including sponsors) from the University of Utah Covered Entity
- Receipt of data and/or biospecimens by the University of Utah Covered Entity from
Identifying information and/or samples can only be shared between institutions if the participant has given authorization to do so. The consent and authorization document must specify which outside institutions/entities/investigators the identifying information will be shared with. If the receiving institutions/entities/investigators are not listed in the authorization, the identifying information and/or samples cannot be shared.
If use of the data and/or biospecimens is approved under a method other than full consent and authorization, the data or biospecimens must be de-identified before they are shared. The samples may or may not have accompanying medical information. If a code exists to link the samples and the identity of the participants, it should remain with the home institution or entity and not be made available to the other institutions/entities/investigators.
Policy and procedures defining the handling, storage, and disposal of samples should be developed by the investigators and the process for the return of the sample to the original requestor or the process of destruction of the sample(s) should be clearly defined. See Management Plan on the Building Data or Biospecimen Repositories for Future Use page.
IRB review must be conducted for both institutions before the data and samples are shared. The IRB requires all external IRB approvals to be submitted as part of the IRB application. One of the following agreements outlining tissue use and transfer must also be signed by officials representing each institution or entity before the transfer of data and samples may occur:
- A sponsor contract: All contracts must be signed and approved through the Office of Sponsored Projects (OSP).
- A Materials Transfer Agreement (MTA): All MTA’s must be signed and approved by the University’s innovation office before the IRB will issue final approval for a study.
For more information about what elements a data/biospecimen use and transfer agreement should entail, please review the IRB guidance on Human Tissue Transfer.
Is IRB Approval Necessary to Use Collected Data or Biospecimens from a Repository?
The use of data and/or samples from a repository typically requires the submission of a new study application to the IRB, disclosing the proposed use of the data/biospecimens. Data/Samples may not be released until final IRB approval has been issued.
- Describe the data or sample source(s) and its purpose in the IRB application.
- Request a waiver of consent or describe a consent process as appropriate.
The acceptable use and disclosure of information and biospecimens from a repository are determined by the (a) IRB responsible for oversight of the repository, and (b) the IRB responsible for research at the site where the information and biospecimens are used.
Information and biospecimens from repositories may be accessed, used, shared, or disclosed in accordance with the IRB-approved repository protocol, informed consent and authorization document, and any additional conditions stipulated by the IRB overseeing the repository. Use and disclosure of the information and biospecimens must also comply with any additional requirements of the recipient institution and it’s IRB.
Additional Guidance for Use of Collected Data & Biospecimens
Secondary analysis of publicly available data is a common method of research. Publicly available is defined as data that that is accessible to the general public, not restricted to researchers. Public use datasets are prepared with the intent of making them available for public use. The data available to the public are not individually identifiable. In some cases, data may have both publicly available de-identified data and restricted use data. Restricted use data is not considered publicly available.
The University of Utah IRB has already determined that research projects involving analysis of secondary data from certain datasets will not require prior IRB approval. Find the list of datasets/repositories in the Investigator Guidance Series: Secondary Analysis of Public Use Datasets.
For projects using de-identified datasets that are not listed in the Investigator Guidance Series: Secondary Analysis of Public Use Datasets, investigators are invited to submit an application for a determination of non-human subjects in ERICA, the University of Utah’s electronic submission system. Investigators may select “Create a New Study Application” in ERICA and then select “Request for Non-Human Subject Research Review”. The short application will be reviewed by the IRB staff and may request additional information or will make a determination that the project does not meet the definition of human subjects research.
FDA regulation does not make provision for a full waiver of consent. This means an IRB should not approve the use of samples for the testing of in vitro diagnostic devices without informed consent. However, the FDA has released a guidance document on this topic, indicating that they will exercise enforcement discretion in certain cases to allow for the use of samples without informed consent.
To qualify for a waiver of consent in this case, the following criteria must be met:
- The study uses an in vitro diagnostic device that meets the IDE exemption criteria described in 21 CFR 812.2(c)(3),
which means the testing
- is non-invasive
- does not require an invasive sampling procedure that presents significant risk
- does not by design or intention introduce energy into a subject
- is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
- The study uses leftover specimens collected for either (a) routine clinical care or analysis that would have been discarded, or (b) future use as part of a tissue bank.
- The specimens are de-identified to the investigator(s) who will be conducting the study. This must be according to HIPAA standards. Clinical information may be included with the samples, so long as it is de-identified.
- The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation.
Investigators must attach a copy of the FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable to the IRB application when requesting such use.
Research with nonidentified newborn dried blood spots, similar to other research with nonidentified biospecimens, is not considered research with human subjects under both the 2018 and pre-2018 Requirements, and thus, is not subject to 45 CFR part 46.
Although Section 12 of the Newborn Screening Saves Lives Reauthorization Act (NSSLRA) of 2014 stated that certain federally funded research on newborn dried blood spots would be considered human subjects research (regardless of the identifiability of the blood spots), and prohibited IRBs from waiving consent for such research, Section 12 applied only until changes to the Common Rule were promulgated. Thus, as of the effective date of the revised Common Rule (July 19, 2018), the requirements in Section 12 of the NSSLRA of 2014 are no longer in effect.