IRB Help Sheet
Repository Protocol Checklist
A.
Purpose Statement
B.
Collection Information
 Describe the data/specimens to be included.
 Indicate the sources of data/specimens.
 Describe the process of acquiring data/specimens, including methods of collecting
specimens, if applicable.
 Submittal requirements – Describe conditions under which data/specimens may be
accepted, including the requirement for a signed Submittal Agreement, if applicable.
 Describe the plan for certifying documentation of local IRB approval to the OHSU IRB for
each site contributing data/specimens to the OHSU database/repository. Indicate that a
copy of the approval letter from the contributor should be included in the submission to the
repository.
 Consent and authorization (C/A)
 Describe how C/A has been or will be obtained from subjects, or why a waiver of C/A
is justified.
 Describe the process for documenting whether the person from whom the
data/specimens were obtained signed a legally effective consent and authorization
(C/A).
 If applicable, state that any IRB approved consent forms for the collection of the
material being submitted to the repository should be included with data/specimen
submissions.
 Data transfer security – Describe methods to ensure security and confidentiality during the
collection of data and specimens.
C.
Maintenance Information
 Security and Confidentiality – Describe how and where data/specimens will be stored.
Include:
 Location and housing of data/specimens.
 Coding – A method to code the data/specimens, including a process to
protect/maintain the key to the code and limit access to the key. The coding system
must be adequate to reduce the possibility of unauthorized re-identification.
 Control of access to the data/specimens – access to the un-coded data/specimens
must be restricted to a limited number of repository staff. Accountability for
controlling and monitoring access must be provided.
 Describe who will have access to the data/specimens.
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 Describe the requirements for access.
 Security procedures – a method to prevent unauthorized access to the coded
data/specimens (including computer security and specimen storage security
measures) must be provided.
 Description of how the privacy of subjects and the confidentiality of data will be
protected, including if a Certificate of Confidentiality (CoC) will be obtained. A CoC is
required for sensitive information.
 Repository Guardian
 Indicate who is designated as the Guardian.
 Describe details of the Guardian’s responsibilities, including:
 Ensuring that data/specimens are received and released according to OHSU
policy and the IRB approved repository protocol.
 Executing a repository sharing agreement each time data or specimens are
released for research purposes.
 Ensuring the security and confidentiality of stored data and specimens.
 Ensuring the security and confidentiality of data and specimens during
transfer.
 Tracking acquisitions and releases of data and specimens.
 Maintaining methods for identifying data/samples for which consent has
been withdrawn and ensuring no future use.
 Identifying data/samples that have limitations on future uses and ensuring
that future uses are not contrary to those limits.
 Certifying genetic opt out status with OHSU officials, if applicable.
D.
Methods for Tissue and Sample Storage & Handling (If applicable)
E.
Release Information

Describe the mechanisms for release of data/specimens. Include a complete description
of the process and requirements for requesting and releasing data/specimens.

State that separate IRB approval/determination will be required for each specific human
subject research activity that uses identifiable data/specimens from the repository.

Describe methods for securing and tracking signed Repository Sharing Agreements from
recipient investigators, if applicable.

Describe methods for verifying that releases of data/specimens are not contrary to any
previously imposed limits, via law, previous consent, genetic opt-out, or other applicable
limits.

Verify that material transfer agreements will be used when necessary for the transfer of
biological materials.

Data transfer security – Describe methods to ensure security and confidentiality during
the release of data and specimens.
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