Institutional Review Board
DATA AND/OR SPECIMEN REPOSITORIES ADDENDUM
Please use this form when requesting approval for a data and/or specimen repository.
Repository InformationTitle of Data/Specimen Bank:
PI Name:
IRB Approval Number, if applicable:
Is this a new bank? Y N
Is this a request to move a bank? Y N
Collection
Describe the purpose for collecting and storing data/specimens:
Describe the types of data/specimens to be collected and stored:
Describethe source(s) and circumstances of data/specimen collection (i.e. obtained directly from participants or from a secondary source). If applicable, describe how information/tissue is being transferred from/to another bank and if a Material Transfer Agreement or other agreements are being negotiated.
Are you requiring (or have required) that all participants consent before entering them into the repository? Y N
If participants are not consented, please describe why you feel that you meet the requirements for waiver of consent? (please complete a waiver of consent request)
Were participants consented elsewhere? Y N
Describe how you will certify the conditions under which the data/specimen was obtained. (i.e. consent, obtain for clinical purposes only, waiver from local IRB).
Maintenance
Security and confidentiality: Describe how and where data/specimens will be stored, and how the privacy of subjects and the confidentiality of data will be protected, including if a Certificate of Confidentiality will be obtained.
Describe the physical location/equipment and security provisions for data/specimen storage including your coding process.
Describe the length of time data/specimens will be stored. Please describe the process for destruction or de-identification or coded data/specimens at the end of the retention period, if applicable.
Describe any limits on the data/specimens’ intended future use (e.g. for cancer research only).
Describe who will have access to the data/specimens, what the requirements for access are, and who is designated as the person who has Oversight of the data/specimens. Please describe any auditing practices that are in place.
Release
Explain how data/specimens will be released (i.e. identified, coded, or de-identified).
Example: A statement should be made in the repository protocol that separate IRB approval/determination will be required for each specific human subject research activity that uses identifiable data/specimens from the repository. Each study is considered a research activity that is separate from the repository.
Describe who will have access to the data/specimens, what the requirements for access are, and who is designated as the person who has Oversight of the data/specimens.
Describe procedures for participant’s to withdraw data/specimens from future research. Describe your tracking process for this.
Honest Broker
Are you using Honest Brokers? Y N
If yes, then which Honest Broker Systemare you using? (examples: Tissue Bank, OIS, Medical Records, etc)
Are the Honest Brokers Certified? Y N
If no, then have them complete the Honest Broker Certification.
Other Information
Please provide any other information that you feel is relevant regarding your protection of human subjects in the context of this repository.
Page 1 of 2 / SOP # FO 301-A Repository Addendum Effective Date: 05/29/2012 Supersedes: New