39th Edition - November 11, 2024

The DHHS Office of Research Integrity (ORI) recently released a Final Rule announcing revisions to the Public Health Service Policies on Research Misconduct (42 CFR Part 93), the federal regulations that define the process for receiving and addressing allegations of potential falsification, fabrication, and plagiarism in PHS-funded research. The PHS Policies create a national standard for the conduct of research misconduct proceedings (much like the Common Rule (45 CFR 42) creates the standard for human research protections) and were last revised in 2005. The IU Policy on Research Misconduct is largely based on these policies.

The Final Rule includes a number of changes that will impact how institutions like IU conduct inquiries and investigations into potential allegations of research misconduct, including:

• Addition of a number of definitions of important terms relevant to the research misconduct process
• Clarification of confidentiality provisions
• Formalization of the process for assessing potential new allegations
• Additional requirements for inquiry and investigation proceedings

The revised regulations are effective January 1, 2026. The IU Research Integrity Office has convened a working group to help analyze the changes and their impact, and to propose revisions to the IU Policy in preparation for the implementation date. If you are interested in learning more about the Final Rule, or have questions or comments, please contact the IU Research Integrity Office at rio@iu.edu.

• New Short Form Informed Consent documents: The IU HRPP has added Haitian Creole and French short form consents, now available on the IU HRPP website: Short Forms. Please refer to the Informed Consent policy for guidelines on using these forms. 

• IUPUI and IUI Reference Update: If your study documents under IU HRPP oversight refer to IUPUI, you do not need to submit an amendment solely to update this to IUI. Please feel free to make this change at your next convenient amendment. 

• eConsent: As mentioned in the January 2024 ORC newsletter, the Advarra eConsent module is now available through IU’s Office for Clinical Research (OCR). This FDA 21 CFR Part 11 compliant system enables electronic routing and signing of consent documents for clinical research. While recommended for FDA-regulated studies, the module is available for any study needing electronic consent. Please note there may be associated costs. For more information, contact the OCR team at oncore@iu.edu. If you are not sure whether your study is FDA regulated (in order to use Advarra eConsent), contact the IU IRB at irb@iu.edu with your IRB application number. 

• Holidays: Consistent with the University holidays, the IU HRPP office will be closed from December 25 through January 1, reopening on January 2, 2025. Here are three quick tips/reminders for research teams: (1) Account for the office closure when planning IRB submissions, especially for studies with IRB approvals expiring or grants due during this period. (2) Note that convened IRB meetings will not be held during the closure; the IRB meeting schedule has been adjusted accordingly. (3) For any emergencies with human participant research (including the expanded access protocols involving investigational medical products) during the holiday period, contact the HRPP Director, Purna Garimella, at pgarime@iu.edu. 

• PEAR Consultations: The Pre-Enrollment Auditor Review (PEAR) program, introduced in October 2023, has completed its first year. The eight completed PEARs have identified source documentation deficiencies and protocol discrepancies and provided strategic recommendations for regulatory compliance and study documentation clarity. PEAR consults should be requested after initial IRB approval has been granted and prior to the first subject’s enrollment. Requests for PEAR consults can be sent to the QIO Associate Director, Neala Lane, at lanen@iu.edu. 

• ClinicalTrials.gov (CT.gov) Website Transition: Access to create and edit records in CT.gov is managed through the Protocol Registration and Results Reporting platform, also known as PRS. This platform is managed by NIH’s National Library of Medicine (NLM) and is currently undergoing a “modernization” effort to update the platform’s features and improve the user experience.  Recently, NLM set the Modernized PRS Site to be the default display site upon user log-in.  Not all features on the Modernized site are ready to use, however, and users frequently encounter a number of false errors and/or submission blockers.   Until the modernization effort is further along, please continue to use the Classic PRS site to manage your CT.gov records.  Just prior to, or just after log-in to the PRS, you can opt to change your display back to the “Classic PRS” version. Until further notice, Classic PRS should continue to be your primary platform to create, edit and submit record registrations, as well as to create, edit and submit record results.   For more information about the modernization effort, please visit the CT.gov website.  For questions about selecting and/or navigating the Classic PRS site, please reach out to the IU CT.gov compliance office at ctgov@iu.edu.

We are pleased to announce that the Indiana University – Indianapolis campus has received continued Full Accreditation from AAALAC International. We greatly appreciate the diligence and attention that each and every one of you gave to preparing for this most important re-accreditation visit. Achieving continued full accreditation from AAALAC International is a significant accomplishment, reflecting an institution's unwavering commitment to the highest standards of animal care and use in research.

This accreditation is awarded to organizations that meet or exceed AAALAC's rigorous standards, demonstrating dedication to humane and ethical practices in scientific research. Maintaining this accreditation requires ongoing evaluations and adherence to evolving standards, ensuring that research practices remain ethical and scientifically valid. This commitment not only upholds the integrity of the research but also assures the public of the institution's dedication to responsible animal care.

In addition, we are pleased to announce that Indiana University - Bloomington will soon undergo a site visit by representatives from AAALAC International as part of our continued commitment to excellence in animal care and use. This visit will be an opportunity to showcase our dedication to high standards in animal welfare and ethical research practices. In preparation for the visit, we encourage PIs and personnel to review their animal protocols and documentation. Ensuring that all areas reflect AAALAC’s high standards will not only facilitate a smooth review process but also affirm our shared dedication to humane and ethical practices. Please stay tuned for additional updates and reminders as the visit approaches.

Thank you for your partnership and support of our Animal Care and Use Program. You play an integral role in fostering a culture of shared responsibility for safe, compliant, and ethical research here at Indiana University.