IRB: Tissue Banking and Data Registries
Policy number:
406
References:
45CFR46.101(b), 45CFR46.111(a)(7), 21CFR56.111(a)(7),
45CFR46.116(d)OHRP - Guidance on Research Involving Coded Private
Information or Biological Specimens
http://www.hhs.gov/ohrp/policy/cdebiol.html
Date: 3/22/14
Policy Owner:
Executive Director, HRPP
Cross References:
401 Exemptions
702 Waiver or Alteration of Consent
Definitions:
None
1.0 Reason for Policy
Describe University of Minnesota requirements for registries (data banks) and repositories (tissue
banks).
2.0 Scope of Policy
This policy applies to the University research community and its healthcare components.
3.0 Policy Statement
The research use or disclosure of individually identifiable private information or individually
identifiable human specimens requires the review, approval and oversight of the IRB. A data registry is
a collection of information. A tissue bank is a collection of biological specimens. Organizers of data
registries or tissue banks receive information from multiple sources; maintain the information over time,
control access to and use of the information by multiple individuals and/or for multiple purposes which
may evolve over time.
Data registries and tissue banks often contain codes that link information or specimens to the donor’s
identity. Tissue banks often include demographic and/or medical information about the individuals from
whom the specimens were obtained.
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IRB oversight is required for research use of identifiable private information or identifiable human
specimens from non-research databases or repositories. Each research use must receive prospective IRB
review and approval and continuing IRB oversight, unless the research satisfies the criteria for
exemption in HHS regulations.
Informed Consent and Confidentiality
Obtaining informed consent for the research use of data or specimens from non-research databases and
repositories can be problematic. Because research use may not have been anticipated at the time of
collection, research consent may not have been obtained from the individuals who provided the data or
specimens. Standard treatment and surgical consents rarely meet the regulatory requirements for
research informed consent.
Where it is possible to do so, the IRB may require investigators to obtain the informed consent of
subjects for research involving use of existing data or specimens contained in non-research databases or
repositories.
However, the IRB can, and where justified does, waive or alter the requirements for informed consent if
it finds and documents per HHS regulations that:
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The research involves no more than minimal risk to the subjects
The waiver or alteration will not adversely affect subjects’ rights and welfare
The research could not practicably be carried out without the waiver and
Where appropriate, subjects will be provided with additional pertinent information after
participation.
If data or specimens are to be collected prospectively for research use in a registry or tissue bank, then
prospective informed consent of subjects is required. Investigators should make clear the intended
research use of the data or tissue, to the extent that use is known. Possible options for future use of data
or tissue should also be delineated as much as possible.
Subsequent research use of banked data or samples must be in agreement with consent given by the
subject who provided the data or samples. The IRB may waive the informed consent requirements if it
determines the regulatory criteria for waiver have been met.
When proposing to bank tissue, investigators should take into consideration potential cultural
sensitivities of the subject which may affect a subject’s decision to provide consent.
Investigators wishing to use data or samples for research that differs in any way from that described in
the IRB-approved protocol must submit a new or amended protocol for IRB review before initiating the
project.
4.0 Required approvals for this document
Title
Executive Director HRPP
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5.0 Revision History
Revision
03/22/14
10/14/09
07/10/09
05/11/09
09/29/06
Reason for change
Administrative review
Update AAHRPP references
Revision
Reformat
Policy Development
Date of release
09/02/14
10/14/09
07/10/09
05/11/09
09/29/06
To obtain a copy of a historical policy, e-mail the IRB at irb@umn.edu or call 612-626-5654.
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