Research Data Agreements
The University processes data agreements for funded and unfunded research conducted under the auspices of WVU and for other projects that may not meet the federal definition of research.
Notes about Data Agreements:
- PIs and Department Chairs are not authorized to sign any data agreement regardless of type and risk on behalf of the University except for publicly available data.
- Research or projects such as Quality Improvement sponsored by the WVU Health System that require data agreements should contact the WVU Health System General Counsel Office.
- Understand the risk related to the data to avoid delays
Is a Data Agreement needed?
Review this guidance to determine the risk and if a data agreement is needed for the transfer and sharing of data when conducting research.How to request a Data Agreement:
Clinical Data Agreements - Contact WV CTSINon Clinical and Non Human Data Agreements - Contact the Research Office - OSP
- * Clinical Data Agreements with a Clinical Trail Agreement or other Agreement
- Clinical Data Agreements without a contract/agreement - Complete the Data Protection Form
- All Non Clinical Human Data Agreements - Complete the Data Protection Form
- All Non Human Data Agreements - Contact OSP Award Negotiation Office
*Clinical Trials and Industry-Sponsored Research Agreements
The agreements and contracts typically cover the requirements related to data, the review and approval processes for the agreement may include additional data agreement requirements. A separate data agreement may not be required.
Incoming Data
Copies of research data that will be transferred into WVU from an external data source may require a data agreement. Please consider the following to avoid delays:
- Documentation may be requested from the data source stating than an agreement is not required, please obtain this information before requesting a data agreement.
- If external collaborators will be added to WVU systems to share the data, an agreement may be needed depending on the risk category of the data.
- Identifiable clinical data from any external source will be treated as high-risk (sensitive data by WVU) regardless of the data agreement requirements unless the data is de-identified by the source (this does not include coded or limited data sets at WVU).
- Data from the WVU Health System medical record systems used by University staff for research, does not require a data agreement. A master agreement exists with WVU to use the data for research. Other clinical data from other systems may require permission from the Health System before it can be used for research.
Outgoing Data
Copies of research data that will be transferred to an external entity may require a data agreement.
Please consider the following to avoid delays:
- Refer to this guidance to determine if a Data Agreement is needed or if a review is needed to make the determination.
- Federally funded data deposited into a third-party repository at the end of an award or contract will require a WVU data agreement or an agreement by the repository.
- If WVU staff will be added as collaborators to external systems to share data, the external entity may require any agreement, if an agreement is not required, WVU may request supporting documentation.