Background:
Scientific Justification: Explain the need for establishing this biobank and why existing established banks are insufficient.
Relevant References or Supporting Documents: Reference or attach any pertinent documents.
Objectives:
Purpose of the Biobank: Provide a clear statement of the biobank's purpose.
Study Design:
Indicate if this protocol is solely designed to collect, store, and share material and/or information for future secondary research.
Bank Personnel Use: Indicate if any bank personnel will use specimens for research.
Research Procedures:
Potential Research: Indicate if secondary research will be broad and unspecified or specific based on condition or another attribute.
Genetic or Genomic Research: Indicate if genetic or genomic studies are planned.
Creation of Cell Lines or Animal Models: Specify if applicable.
Commercial Use and Sale of Biospecimens: Clarify if specimens will be sold and under what conditions.
Data Collection & Research Materials:
Types of Biospecimens to be Collected: Specify the types of specimens (e.g., blood, tissue, saliva, etc.)
Source of Biospecimens: Indicate whether specimens are left over from clinical procedures, research-specific collections, or both.
Associated Data: List any accompanying information or protected health information (PHI) to be stored with the specimens.
Storage Facilities and Security Measures: Describe where and how specimens and data will be stored and secured.
Duration of Storage: Specify how long specimens will be stored (e.g., indefinitely, until depleted).
Resources:
Describe adequacy of personnel, infrastructure, and facilities to manage bank.
Legacy Plan - potential plan for transfer of custodianship or ultimate dispensation of specimens should the bank close.
Potential Risks & Benefits:
Risk Assessment of Confidentiality Breach: Assess potential risks associated with breaches, including impacts on privacy, insurability, and stigmatization.
Whether or not donors would share in financial or commercial profit from discoveries or intellectual property.
Records, Privacy, & Confidentiality:
Access Controls: Explain who will have access and how access will be managed.
Measures to Protect Privacy: Describe measures to protect participant privacy and data confidentiality, such as coding or encrypting.
Re-contact Plans: Describe procedures for re-contacting participants, if necessary, for re-consent or incidental findings.
Withdrawal Procedures: Describe how participants can withdraw and how their specimens/data will be handled.
Future Use & Sharing of Material:
Sharing of Biospecimens: Identify potential recipients (e.g., internal researchers, external collaborators, commercial entities).
De-identification and Coding Procedures: Describe methods for de-identifying specimens prior to sharing.
Honest Broker System: Identify individuals or systems managing de-identification. Indicate honest broker training completed.
Verification of need for IRB review: Indicate if bank will require either a Not Human Research determination or IRB approval.
Use Agreements: Provide details of any agreements in place such as agreement for secondary user to use responsibly and not attempt to re-identify donors.
