As part of the push to implement the NIH Data Management and Sharing Policy on January 25, 2023, the NIH has released Informed Consent for Secondary Research with Data and Biospecimens. This document reviews points to consider and offers sample language that investigators and IRBs can utilize when developing consent forms for secondary use of data/biospecimens.
The NIH is also seeking public input on draft supplemental information to the NIH Policy for Data Management and Sharing to address creating a strong privacy framework. The protection of human research participant privacy through responsible scientific data sharing practices is crucial and the draft supplemental information offers the following to assist stakeholders in achieving that goal:
- DRAFT Operational Principles for Protecting Participant Privacy When Sharing Scientific Data
- DRAFT Best Practices for Protecting Participant Privacy When Sharing Scientific Data
- DRAFT Points to Consider for Designating Scientific Data for Controlled Access
See the official request for public comments for more details and on how to submit a formal comment. The comment period is open through June 27, 2022.