35th Edition - June 29, 2023

On 30 June, Fred Cate officially steps down as Vice President for Research and hands the baton to Russ Mumper. Speaking for the entire ORC staff, it has been an absolute delight to work with Fred over these past 8 years. As I have told him before, I was more than a bit worried about a lawyer assuming the VPR role but, time and time again, his judgment, trust, vision, and leadership proved those worries to be entirely misplaced. We collectively, individually, and personally thank him from the bottom of our hearts and he will be missed. But, as the old saying goes, the King (so to speak) is dead, long live the King. We welcome Russ Mumper as our new leader and are so excited to get to know him, his style, his leadership and his collegiality. I, fortunately it turned out, know several people at the University of Alabama and what they have told me about their working relationship with him more than confirms our confidence and excitement in the opportunity to work with him here at IU. May he find us to be trusted, professional colleagues as well.

John R. Baumann, Ph.D.
Associate Vice President for Research Compliance

Holly Moore, Research Compliance Consultant in the Institutional Biosafety (IBC) Office, received her Certified Professional Biosafety Compliance Administrator (CPBCA) credential on May 15th. The CPBCA is a new certification offered for the first time this spring through the Biosafety Administrators Association (BSAA). The certification tests knowledge of a wide-range of rules impacting Institutional Biosafety Committees, including regulations and policies of the National Institutes of Health, Occupational Health and Safety Administration, and Centers for Disease Control. Holly was one of twenty-three individuals to pass the test and received one of the first CPBCA credentials awarded in the country. Congratulations to Holly on this prestigious accomplishment!
Contact the IBC office at IBC@iu.edu.

The Human Research Protection Program (HRPP) Policies are being updated with two substantive changes that will be effective July 1, 2023. Changes include:

• Reportable Events Policy:
  • The following will no longer be considered a promptly reportable event: For research subject to IU Office of Clinical Research policies on research billing compliance, failure to record subject consent in OnCore within the required timeframe
  • This is being replaced by a new promptly reportable event: Research billing compliance error which results in a subject being incorrectly billed for research procedures
• Use of PHI in Research Policy:
  • IU IRB will no longer rely on IU research staff being designated as members of the IU Health workforce for purposes of utilizing the preparatory to research provisions of HIPAA
  • Instead, studies using information from medical records to recruit subjects will require a waiver of authorization for recruitment

Additionally, updates are being made to the Kuali Protocols IRB form. Changes will be reflected in the protocol submission form for all new studies submitted to the IRB/HRPP on or after July 1, 2023. Existing studies will not be impacted by these changes. Kuali Protocols updates include:

• The collection of information regarding the Principal Investigator’s IU appointment/role
• Whether any research personnel have an affiliation with an IU research partner, such as Eskenazi Health, IU Health, Roudebush VAMC, Regenstrief Institute, or Purdue Pharmacy Practice
• Waiver of authorization for recruitment will be required for all studies recruiting from medical records. The waiver justification will be automatically populated in the system for research studies indicating they are using medical record information for recruitment. However, researchers will be required to provide a brief description of the PHI to be accessed and/or used for recruitment purposes.

If you have any questions or concerns regarding any changes to the HRPP Policies or the Kuali Protocols IRB application, please contact the HRPP office at irb@iu.edu.

The Office of Research Compliance in Indianapolis has moved. When filling out feasibility surveys for sponsors and other documents that request the mailing address of the IU Institutional Review Board (IRB), please be sure to use our new address:

Indiana University IRB
986 Indiana Avenue, 5th floor
Indianapolis, IN 46202

Contact the IRB office with any questions at irb@iu.edu.

The National Science Foundation (NSF) has issued new guidance that requires all principal investigators, co-principal investigators, faculty, and senior personnel who are or will be supported by NSF funds to complete the Responsible and ethical Conduct of Research (RCR) education requirement. This requirement will be effective for all proposals and awards beginning July 31, 2023.

To prepare for this new requirement, you can complete this training at any time, beginning immediately. It is accessible via the Collaborative Institutional Training Initiative (CITI) at IU program.

The CITI RCR training modules are tailored to specific areas of research, such as humanities, engineering, physical science, social science, and behavioral science or specific roles within research such as administrator and for faculty and senior personnel. If choosing the module for faculty and senior personnel this is a RCR refresher education module that meets the NSF RCR requirement. Timing to complete each module varies per person but on average take 25-35 minutes per module. For information about setting up a CITI account or adding RCR training to your profile, please visit the Indiana University Research Compliance webpage.

IU’s Policy for RCR NSF Awards

Effective July 31st, IU’s Policy for RCR NSF Awards will be for students, postdocs, principal investigators, co-principal investigators, faculty, and senior personnel supported by an NSF that requires a multi-layer approach:

• Successful completion of selected modules of the online responsible conduct of research program hosted by Collaborative Institutional Training Initiative (CITI); and
• Project/Discipline-specific mentoring by the principal investigator and lead investigators during the course of the grant, and understanding of the university policies for research security, export controls and disclosure reporting requirements.

To learn more information, visit the ORC RCR website or contact rhopson@iu.edu with any questions.

The U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA) awards program directors, faculty, undergraduate and graduate students, postdoctoral researchers, and any staff participating in the research project must receive Responsible and ethical conduct of research education. In effort to standardize RCR education required for USDA-NIFA awards, Indiana University developed an institutional RCR educational program:

• Successful completion of selected modules of the online responsible conduct of research program hosted by Collaborative Institutional Training Initiative (CITI); and
• Project/Discipline-specific mentoring by the principal investigator and lead investigators during the course of the grant, and understanding of the university policies for research security, export controls and disclosure reporting requirements.

To learn more information, visit the ORC RCR website or contact rhopson@iu.edu with any questions.

The Office of Research Compliance within the Office of the Vice President for Research, in collaboration with Vice Provost for Research and Vice Provost for Graduate Education and Health Sciences, is pleased to continue offering the Responsible Conduct of Research (RCR) Seminar Series. While specifically designed for RCR requirements with NIH T, K, or F awards, it is open to all members of the IU research team.

• This series is led by faculty researchers and representatives of Office of Research Compliance, including faculty members of compliance committees.
• The series offers two, 2-hour workshops per semester held during the academic year
• The format includes discussion-led, face-to-face video conference workshops and managed through IU Canvas
• Designed to partially satisfy the NIH RCR requirement. If your research is supported by National Institutes of Health (NIH) F, K, T, or Dissertation Awards, NIH requires that all eligible researchers complete an RCR education that includes interactive program of RCR education of at least 8 hours

Join us for the following sessions:

• September 28, 2023 from 4-6pm  Responsible Conduct of Research Topics on Conflict of Interest, Conflict of Commitment, Research Misconduct, & Responsible Scientist
• October 26th, 2023 from 4-6pm  Responsible Conduct of Research Topics on Human Subjects Research, Research with Animals, & Responsible Scientist
• February 29, 2024 from 4-6pm  Responsible Conduct of Research Topics on Mentor/Mentee Relationships, Collaborative Research, & Data Management
• March 28, 2024 from 4-6pm  Responsible Conduct of Research on Authorship, Peer Review, & Publication

Registration is free and required for this session will hold your ‘seat’ in all sessions. Topics and presenters will be sent to registered participants via IU Canvas Announcements.

These sessions will not be recorded and only offered during the live online meeting time. Provided instructions on how to obtain RCR certificates of completion via Canvas (registration is still required).

To register or learn more information visit the IU RCR Seminar Series website or contact rhopson@iu.edu.