A data/specimen transfer agreement allows a researcher to share data and/or specimens with a collaborator (a person or entity not associated with the study or the researcher’s institution).
The Tufts Health Sciences IRB must be notified if a researcher or institution plans to share data and/or specimens with a recipient (person or entity). An agreement is required between the institution providing the data and/or specimens and the entity receiving them such as a Material Transfer Agreement (MTA), Data Use Agreement (DUA), Collaboration Agreement, etc. An agreement is not required if the recipient is part of a clinical trial that has an existing contract and the use is included in the IRB authorization (or waiver of authorization) approval for the clinical trial.
An agreement is established between a provider institution and recipient institution. This is to document the data and/or specimens being transferred and terms and conditions with respect to ownership, permitted uses of the data and/or specimens, publication of results, development of inventions, disposal of the data and/or specimens, and liability.
The following elements should be included in the agreement:
HIPAA defines a Limited Data Set as protected health information that excludes 16 categories of direct identifiers which may be used or disclosed for research, public health or health care operations purposes without authorization, with a Data Use Agreement (DUA).
The following identifiers must be removed from health Information if the data are to qualify as a limited data set:
The health information that may remain in the information disclosed includes:
Please note that Tufts researchers are not authorized to sign Agreements on behalf of Tufts – the agreement must be submitted to Tufts Medical Center Research Administration or Tufts University OVPR to obtain the proper review and signature.
For questions or to establish an agreement, please contact:
|Tufts Medical Center
Grants and Contracts
Tufts Tech Transfer
Office for Technology Transfer and Industry Collaboration (TTIC)