Six Elements of a Data Management and Sharing Plan 

• Data type 

• Related tools, software, and/or code 

• Data standards 

• Data preservation, access, associated timelines 

• Access, distribution, or reuse consideration 

• Oversight of data management & sharing

NIH has developed an optional DMS Plan format page that aligns with the recommended elements. Access the Word document here.

For additional perspective on language to be included regarding "Informed Consent" see the following resource:
Informed Consent for Secondary research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing.

A particular challenge related to Human/Biospecimen Subject Research is how to handle retrospective research protocols. For questions regarding sharing of data related to Retrospective Research Protocols, please contact IRB/PB Submissions.