Decentralized IRB model for automonous specimen banks
Overview
The supplementary materials are provided here to allow network organizers to setup a specimen sharing network, to aid individual specimen banks in joining the network, and to illustrate investigator responsibility and research benefit along the specimen access pipeline.These are the official materials used in the preparation and continual operation of the PSL network, provided here with summary annotations.
For Network Organizers
The Network guidelines
- Certify that the network is not a centralized specimen bank or data warehouse
- Certify that institutions wishing to join PSL need to:
- Agree to share specimens that are judged valuable
- Obtain IRB approval and follow local(IRB) and federal(HIPAA) regulations
- Publish business rules for tissue access
- Deploy and test the certified SPIN software
- Contribute to the continual oversight of the PSL Network
For Individual Specimen Banks
The Business Rules [BWH]- Describe how the SPIN software tools are deployed and tested at the institution
- Define the use of De-Identified and Limited Datasets
- Define participation in the PSL Oversight Committee
- Include Tissue Access Rules
The Tissue Access Rules [MGH] [BIDMC][CHB]
- Define the direct relationship between the investigator and bank owner, the network does not own the specimens or have central authority to access tissue
- Include a Material Transfer Agreement (MTA) between investigators and tissue bank owners
- Define the required IRB applications from the investigator home institution and the institution holding specimens.
- Specify bank specific changes for specimen retrieval and services.
For Investigators
The Terms Of Access Agreement certifies the investigator:
- Has a faculty appointment at one of the participating institutions
- Has completed human subject training in accordance with HIPAA regulations
- Will not attempt to use the network to identify any individual patient
- Acknowledges the full autonomy of the individual tissue banks
