Does your research require IRB Review?

Not Required

One of four specified external repositories: ATTC, NDRI, Coriell, Cambrex

Non-identifiable or coded tissue from IRB-approved Research Tissue Banks within Partners

Required

Research on samples obtained prospectively, explicitly, and solely for research

Research on excess clinical samples from clinical departments/services within Partners

Research on autopsy specimens and donated cadavers

Tissue or specimens obtained from collaborators outside of partners

Secondary use of previously collected samples

Special Tissues: hESC and Fetal

Does your research involve identifiable tissue?

[Special Notice] The PHRC recognizes that identifiable, existing, and sometimes very old and valuable tissue may have been collected prior to recent federal guidance on requirements in this area. New informed consent/authorization may not be required for existing tissue collected prior to January 1, 2006. The PHRC will consider requests for a waiver of informed consent/ authorization for existing, archival research specimen collections, i.e. “grandfathering” of existing samples collected in the distant past.

Do you plan on sharing tissue samples?

If the answer to ANY of these 4 questions is YES, then your transfer requires either a:

• Materials Transfer Agreement (Formally negotiated by Partners Innovation)
• Data Transfer Agreement (Formally negotiated by Partners Innovation or Partners Clinical Trials Office)

1. Will you be receiving compensation of any kind that has a value in excess of what it will cost to prepare, collect and ship the Specimens/Patient Data?
2. Was the Specimen/Patient Data collected during a research protocol or clinical study that was funded by a company, or that was part of a collaboration or any other agreement with a company? Note: If this transfer of specimens/data is covered under a Clinical Trials Agreement negotiated by the CTO, an MTA is not required.
3. Is the recipient scientist planning to use the Specimens/Patient Data in connection with research supported by a for-profit company?
4. Have these Specimens/Patient Data previously been transfered to a for-profit company?

Submit Innovation Proposal

for further information on Partners IRB Policy, see here.