IRB Considerations for Researchers
Review your IRB-approved application, informed consent, and recruitment materials to determine whether they will be impacted by the pause of in-person gift card pick-up. If the inability to utilize these in-person gift cards affects participant expectations for receiving their incentive, an IRB amendment may be required.
Submit any necessary IRB Amendment before implementing changes to your incentive method. Include in the Amendment title “HSIP-required” for efficient processing.
When Is an IRB Amendment Required?
Submit an Amendment if any of these circumstances apply:
- Changing the type of incentive to one not listed in your approved IRB application (e.g., Section 13: Subject Payments or Other Incentives, including Section 13.1)
- Updating incentive details in consent forms, recruitment materials, or participant communications
- Collecting new personal information from participants for incentive delivery (e.g., email address or phone number for electronic gift cards) is necessary
- Altering the timing or method of incentive distribution in a way that affects participant expectations, privacy, or risk (e.g., switching from in-person distribution to electronic delivery)
NO Amendment is required if all of the following apply:
- The incentive type remains unchanged from what was approved in your IRB application
- No updates are needed to participant-facing materials (consent, recruitment, communication)
- Study materials use only generic terms (e.g., “gift card” or “token of appreciation”), and participant expectations do not change
- No new personal information (e.g., email address) is collected and there is no impact on participant expectations
- Changes are limited to internal operational processes and have no impact on participants
PI Checklist: Reviewing and Updating Incentives for IRB Compliance
- Review Your IRB Application
- Check your approved IRB application, especially Section 13 (“Subject Payments or Other Incentives”)
- Determine if any updates are needed to reflect new incentive types or distribution methods
- Review Consent and Recruitment Materials
- Look for specific references to incentive type, timing, or delivery method in any participant-facing documents
- Assess Personal Data Collection
- Ensure study documents and privacy language accurately describe any new data you will collect (e.g., email addresses)
- Submit Amendments as Needed
- File an IRB amendment if changes will affect approved consent documents, recruitment materials, participant communications, data collection, or the incentive distribution method
- Include in the Amendment title “HSIP-required” for efficient processing
- Plan Ahead
- Obtain IRB approval for any required amendments before implementing new incentive procedures or collecting new participant data
Questions?
For IRB amendment questions: Contact the IRB office overseeing your study
For operational/payment processing: Contact HSIP at [email protected]