Update to consent templates

• IRS reporting limit: The IRS reporting threshold for compensation payments has increased from $600 to $2000 per calendar year effective January 1, 2026. Compensation payments to NIH research volunteers totaling $2000 or more will be reported (most likely via Form 1099 - Miscellaneous Income) and will be adjusted for inflation beginning in calendar year 2027. Participants with questions about taxes or their filing status should be directed to consult their tax professional or the IRS for guidance. NIH study staff cannot answer tax questions. Participants with questions about NIH reporting to the IRS should be directed to the Clinical Research Volunteer Program at CC-PRPLRVSSupport@cc.nih.gov or by calling 301-496-4763.
  • For this specific change only: an information sheet has been approved and may be given to participants who receive payment. You do not need to submit a modification (MOD) to the NIH IRB to use this sheet. It is available on our website.
• Privacy Act language: The Privacy Act language has been revised to include citations to the applicable regulations and additional explanatory information.
• Administrative block: The previous administrative block regarding use of an interpreter has been removed and replaced with updated instructional language.
• Other minor updates: Additional suggested text and instructional language have been incorporated into the consent templates to improve clarity and consistency.

Templates

• The updated consent templates are available on our website. The CIRB template will be posted once approved by that IRB.

Requirements for Studies

• New or modified consent forms must:
  • Include the new IRS reporting language (if applicable to your protocol)
  • Include the updated Privacy Act language (applies to all protocols)
  • Remove the prior interpreter administrative block (if applicable to your protocol)
• Ongoing studies with previously approved consent forms for a protocol that provides payment must either:
  • Provide participants who have received/will receive payment in 2026 with the approved information sheet found below or
  • Provide verbal notification using the information sheet as a script and document that conversation in the medical/research record.

Timeline for Updating Consents

• You must update your consent form with this information at the time of your next MOD or before your next Continuing Review (CR), whichever occurs first.
• For studies that do not undergo Continuing Review, you must modify your consent within the next year.

NOTE: OHSRP has obtained a Spanish translation of the updated required payment language, Privacy Act language, and note regarding the witness signature. This content in Spanish is available in the consent library.

If you have questions about these updates, you may contact us at irb@od.nih.gov