NIH Seeks Input on Draft Policies to Protect Human Participant Research Data

By: Yvette Seger
Thursday, January 22, 2026
In December, the National Institutes of Health (NIH) issued a Request for Information (RFI) seeking public input on its proposal to establish harmonized and transparent policy requirements for protecting human participant research data. The RFI includes two components for consideration:

1. A new Controlled-Access Data policy intended to clarify human participant data types that require controlled access and criteria for determining whether controls are needed for other data types; and
2. Proposed revisions to the NIH Genomic Data Sharing policy to reduce duplicative requirements.

Specific questions for which NIH would like feedback include:

1. Additional resources that may be needed to meet increased demand for managing larger amounts of controlled-access data;
2. Appropriateness of the protected data types designated as controlled-access in the draft policy; and
3. Potential updates to the Genomic Data Sharing policy to maintain the privacy of imputation servers and reference panels.

Comments on both the new Controlled-Access Data policy and revisions to the Genomic Data Sharing policy must be submitted electronically via webform, which does accommodate attachments. Comments must be submitted by March 18, 2026.