AAHRPP Reaccreditation Site Visit Completed
IU Human Research Protection Program (HRPP) has successfully completed its AAHRPP reaccreditation site visit on January 21-22, 2026. The virtual site visit included interviews with a representative group of principal investigators, research staff, IRB members and Chairs, HRPP staff, senior leadership, and representatives from other research-supporting units across the institution.
The site visit provided an opportunity for AAHRPP site visitors to better understand how IU’s HRPP operates in practice and how human subjects protections are implemented across a diverse research enterprise. We appreciate the time and engagement of everyone who participated and supported the site visit process. A final reaccreditation decision is expected later this year.
Leadership Update
We are pleased to announce that, following our standard hiring process, Kelly Hersberger has been selected as the Assistant Director for the Greater Than Minimal Risk (GTMR) team within the IU Human Research Protection Program (HRPP), effective November 10, 2025.
Kelly has been a valued member of the IU HRPP since 2015, bringing nearly a decade of experience in research compliance, education, and IRB administration. She has served on both the Biomedical Minimal Risk team and the GTMR team and has contributed to multiple process-improvement initiatives and working groups, enhancing IRB forms and workflows.
Kelly holds a B.S. in Mathematics from Purdue University and a B.A. in Philosophy from Indiana University. She is a Certified IRB Professional (CIP) and is currently pursuing a Master of Public Affairs (Policy Analysis) at IU Bloomington. Please join us in congratulating Kelly on this important next step in her HRPP career. Kelly can be reached at khersber@iu.edu.
Updated IRS Reporting Threshold for Research Participant Payments
The tax reporting threshold for research participant payments has increased from $600 to $2000 per calendar year, effective January 1, 2026. Beginning in 2027, this amount will be adjusted annually for inflation. (Source)
The IU HRPP will be updating its informed consent templates to reflect this change. However, because we are currently working on several broader consent template improvements, this update may take some time. In the interim, study teams should use the language below, which was developed in consultation with the IU Tax & Payroll Department.
[For research involving payment of $2,000 or more in one calendar year, insert the following:] In order to pay you, we will need your Social Security number (SSN) or tax identification number (TIN). If the total amount you are paid meets or exceeds the lesser of $2,000 or the IRS applicable Form 1099 reporting threshold for the calendar year, you will receive a 1099 tax form in January, and you will need to report this payment as income when you file your tax return. If you have questions about how this impacts your taxes, please talk with a tax expert before deciding whether to participate.
For new study IRB applications, include the above-updated consent language as applicable.
For ongoing studies with previously approved consent forms (i.e., those that still reference the $600 reporting threshold) in which participants may be paid in 2026, the following options are available:
- Inform the participants using this IU HRPP-developed Informed Consent Addendum (available on the HRPP website under Forms & Templates under Informed Consent Templates). This HRPP-provided addendum does not require IRB review or approval on a study-by-study basis, provided the only customization is the insertion of the protocol-specific information (i.e., title, number and sponsor).
2. Verbally inform participants of the updated IRS reporting threshold.
3. Include the updated language in the consent document if you are already submitting an Amendment for other consent-related changes. You are not required to submit an Amendment solely to update the IRS reporting threshold language.
Re-consent is not required if the only change to the consent document is updating the IRS reporting threshold. Additionally, regardless of how participants are informed, the participant’s study record should be updated to reflect receipt of the tax reporting requirements change. This can be documented through a note to file, as part of a study visit/study contact note, or through an updated consent/reconsent process documentation, if applicable.
FDA Guidance on Safety Reporting for Drug and Device Studies
In December 2025, the FDA issued a new final guidance titled “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices,” which clarifies investigator obligations for reviewing and reporting safety information in FDA-regulated research.
Notably, section VI of the guidance states that safety information meeting IND safety reporting criteria under 21 CFR 312.32(c) is considered by the FDA to be an unanticipated problem and therefore must be “promptly” reported to the IRB. It also addresses reporting expectations for IND-exempt BA/BE studies, where any SAE is considered an unanticipated problem and must be “promptly” reported to the IRB. As written, this appears to apply broadly to all IND safety reports, including events that occur at the investigator’s own site as well as the sponsor-issued IND safety reports (which include non-local events).
IU HRPP is currently evaluating the impact of this guidance on the Reportable Events Policy and related workflows and will communicate any updates once this review is complete. In the meantime, investigators who believe their study may be impacted by this guidance are encouraged to contact IU HRPP for assistance.
Other Relevant FDA Guidance Documents:
Below are some of the recently issued FDA guidance documents that are relevant to IRB applications and FDA-regulated research (link):
- Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry
- Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff
- General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff
NIH Updates:
• Basic Experimental Studies in Humans (BESH): Effective for applications submitted on or after May 25, 2026, BESH will no longer be considered clinical trials by the NIH (Notice: NOT-OD-26-032). As a result, BESH studies will not be subject to NIH clinical trial requirements, including registration and reporting in ClinicalTrials.gov.
• Request for Information – NIH Data Policies: NIH is seeking public input on the Draft NIH Controlled-Access Data Policy and proposed revisions to the NIH Genomic Data Sharing Policy (Notice: NOT-OD-26-023). Written comments must be submitted by March 18, 2026, using NIH’s online comment form.
Quarterly Outreach Meetings
IU HRPP hosts quarterly outreach meetings to keep study personnel informed about policies, guidance, recent trends, and current HRPP initiatives. These meetings include a review of key reporting metrics and provide time for questions, discussion, and shared learning. Meetings are held on the second Thursday of each quarter at 11:00 a.m. If you are not already receiving meeting invitations, please subscribe to the listserv at iuhrppoutreach-l-subscribe@iu.edu
