FDA Inspection Success
The IU HRPP recently completed a routine FDA inspection of our Institutional Review Board (IRB) operations. The inspection, held August 4-8, 2025, concluded with no Form 483 issued.
This result is a strong validation of our compliance with FDA regulations and the quality of our review processes. It also reflects the dedication of HRPP staff, IRB members, and the broader research community who ensure high standards in protecting research participants. Thank you for your continued partnership in advancing human participant research at IU.
Leadership Update
We are pleased to announce that, following our standard interview process, Ryan Ballard has been selected as the new Assistant Director for the Reliance Team within the IU HRPP, effective October 1, 2025.
Since joining the IU HRPP in 2017, Ryan has specialized in IRB reliance agreements and multi-site research. He has played a critical role in implementing the single IRB policies, facilitating complex multi-site studies, and serving as a trusted subject matter expert on reliance-related matters. Ryan has contributed to policy development, advised colleagues across the HRPP, and supported the education of researchers navigating multi-site study requirements. He holds a Juris Doctor (JD) degree and is a Certified IRB Professional (CIP).
Please join us in congratulating Ryan on this important next step in his HRPP career. Ryan can be reached at rcballar@iu.edu.
New Reliance Email Address
To better streamline communications, the IU HRPP has created a dedicated email address for all reliance-related inquiries: relyirb@iu.edu. Please use this address moving forward for questions or submissions related to IRB reliance agreements and multi-site research.
AAHRPP Re-accreditation Update
As noted in the previous ORC newsletter, IU HRPP has initiated the institutional efforts to prepare for our next AAHRPP reaccreditation. We submitted a Step 1 application in June 2025 and responded to feedback. We are currently preparing the Step 2 application and planning for a site visit in December 2025 or January 2026.
Reminder: Required Documents for IRB Applications
We have noted an increase in incomplete IRB applications. To ensure timely review, investigators are reminded that all required documents must be submitted with new IRB applications. A full list of required documents is available here: Submission to the IRB. Investigators are also advised to use the most recent version of the Informed Consent Document templates for Biomedical and Social/Behavioral/ Education (SBE) research to ensure the consent includes all required elements. Updated templates are available on the Forms & Templates page of the HRPP website.
DOJ Bulk Data Rule
The Department of Justice (DOJ) issued its Final Rule under Executive Order 14117 on preventing access to U.S. sensitive personal data and government-related data by countries of concern. This “bulk data” rule, effective April 8, 2025, establishes restrictions on certain transactions involving large datasets containing health, genomic, biometric, and other sensitive personal information. Importantly, it prohibits or limits transfers that would provide access to such data by entities or individuals associated with six designated “countries of concern”: China (including Hong Kong and Macau), Russia, Iran, North Korea, Venezuela, and Cuba. Even de-identified data may fall within the scope depending on the circumstances. Researchers should be aware of thresholds, restrictions, and compliance obligations when engaging in international collaborations, contracts, or data transfers, or involving international students.
For more information, visit the DOJ’s
Frequently Asked Questions or contact
rsohelp@iu.edu with questions.
NIH Policy on Human Biospecimens NIH has released a new policy, Enhancing Security Measures for Human Biospecimens (NOT-OD-25-160), effective October 24, 2025. NIH policy aligns with broader federal directives, including the DOJ’s bulk data rule. The policy states, “NIH expects the research community to recognize the risks posed by the sharing or distribution of U.S. persons biospecimens that were collected, obtained, stored, used, or distributed with previous NIH funds or support with countries of concern. The entity (e.g., biorepository, institution, investigator) that holds human biospecimens of U.S. persons collected, obtained, stored, used, or distributed using on-going or new NIH funds are prohibited from directly or indirectly distributing the human biospecimens to institutions or parties located in countries of concern.”
For more information, review the
NIH Policy,
IU RSO announcement, or contact
rsohelp@iu.edu with questions.
