Human Research Protections

Informed Consent Templates

12/23/25: IMPORTANT NOTICE 

Tax Reporting Threshold Change

The annual Federal tax reporting compensation threshold is changing from $600 to $2,000, effective January 1, 2026.

What does this mean for researchers?

  • All human research studies that include paid compensation will require notification to enrolled participants.  A consent addendum has been drafted by the IRB to be used to notify participants.  A link to the form can be found below.
  • For new participants to be enrolled in existing studies that include paid compensation moving forward, please update the compensation section and signature page of your ICF to include the following language:

Will I be paid? 

You will be paid  [amount]  by  [method]  for each visit, for a total of  [amount] . You will be paid  [indicate when payment will be received] . If you do not complete the entire project, you will be paid  [amount]  for each visit you complete. Payment totals across all study participation at WCM of $2,000 or more in a calendar year will be reported by WCM to the Internal Revenue Service (IRS). You will be asked to complete a W9 form. At the end of the tax year, Weill Cornell Medicine will use this information to provide you with Federal Form 1099-MISC. This payment is considered taxable income and you will need to provide your name, address, and social security number to receive payment.  If you do not complete the W9 form, you may join this study, but you will not get any payments. [If applicable, include any alternatives to the payment schedule or information regarding reimbursements.]

[Include this option in the signature section if participants will be paid:]

[  ] I opt out of receiving payment for my participation in this study.

  • Updated informed consent templates are available below.

Given the consent addendum is already approved by the IRB for this specific change, you do not need to submit an amendment prior to using this consent addendum, but you will need to include the consent addendum used for enrolled participants and update and include your previously approved consent form with the new compensation language for new participants to be enrolled at the time of your next amendment or continuing review submission, whichever comes first.  

Investigators are only required to complete the following fields on the template:

  • Principal Investigator’s name
  • Contact Information
  • Study Title
  • Participant Name and MRN (when required) 

You may download the IRB-approved consent addendum here

Frequently Asked Questions (FAQs)

Will I have to start using these new consents today?

Yes.

Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do I have to transition my existing study consent(s) to these new templates?

No.

Any existing study using the previous consent templates can continue to use their IRB-approved consent. Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do these new ICF templates need to be used under a ceded/sIRB study with an external IRB as the IRB of record?

No.

Studies with an external IRB are expected to use consent forms provided by the lead IRB. Once the externally reviewed ICF is provided to the WCM IRB, we will conduct a local context review to confirm any required language (i.e. research-related injury, NYS Genetic testing requirements, etc.). The new WCM ICF templates are available as a resource if needed, but not required for externally reviewed studies.

If I am updating my protocol and the change requires an update to the ICF, will I need to use the new ICF templates?

No.

You can continue to use the same ICF.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200