37th Edition - January 11, 2024

On October 5, 2023, the DHHS Office of Research Integrity (ORI) released a Notice of Proposed Rulemaking (NPRM), which announces new or revised federal regulations and invites public comment. ORI’s NPRM revises the Public Health Services 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 NPRM proposes a number of changes that will impact how institutions like IU conduct inquiries and investigations into potential allegations of research misconduct. Proposed changes include:

• Addition of a number of definitions of important terms relevant to the research misconduct process
• Clarification of confidentiality provisions, specifically when institutions may need to share information about potential research misconduct or findings of research misconduct
• Formalization of the process for assessing potential new allegations
• Additional requirements for inquiry and investigation proceedings
• Potential for publication of institutional findings of research misconduct by ORI

Indiana University submitted a comment responding to the specific questions posed by ORI in the NPRM, commenting on the proposed revisions, and proposing additional edits to the revised language. Submitted comments are available for public review at https://www.regulations.gov/document/HHS-OASH-2023-0014-0001/comment.

If you’re interested in learning more about the NPRM, there are a number of publicly available resources:

• Full text of the NPRM
• Epstein Becker Green’s overview of proposed changes
• Hogan Lovells’ analysis of proposed changes

If you have questions or concerns about the NPRM or the research misconduct process, please contact the IU Research Integrity Office at rio@iu.edu.

Obtaining valid informed consent is essential in human subjects research, safeguarding participants' rights. A well-meaning informed consent process empowers participants to make informed choices. The Human Research Protection Program supports the use of electronic consent, as a modern and efficient approach that enhances accessibility and comprehension. If research participants will be signing the informed consent using an electronic system, this should be indicated in your IRB application.

REDCap is a self-managed, secure, web-based platform that is designed to support data collection and data management for research. This easy-to-use, intuitive tool provides functionality and features to allow individuals to develop databases and surveys for collecting and managing data. But there’s more!

Currently, REDCap’s e-Consent Framework can be used to obtain informed consent and authorization signatures electronically for non-FDA regulated studies. To learn more about using REDCap for your research, including e-Consent, contact IU REDCap Support at redcap@iu.edu.

For FDA regulated studies, an eConsent module will soon be added to the Advarra eRegulatory system (estimated Q3 in 2024). Once validated as Part 11 compliant by IU, the Advarra eConsent module can be used to obtain informed consent and authorization signatures electronically for FDA regulated studies. Stay tuned for updates from the Office of Clinical Research about the Advarra eConsent module implementation.

Under the National Security Presidential Memorandum (NSPM-33), new guidance has been issued by the Office of Science and Technology Policy for federal research agencies, with an emphasis on developing standardized policies and practices for disclosing information to assess conflicts of interest and commitment among researchers and research organizations applying for federal awards.

Given IU’s reputation as a world-renowned research institution, it is important that we understand these new standards and requirements for disclosure under NSPM-33 as they are intended to enhance transparency, strengthen protections around research and data, and discourage research misappropriation all while aimed at preserving international engagement and academic freedom.

At this webinar you will hear from Office for Research Administration, Office for Research Compliance, and the Research Security Office to help you better understand NSPM-33 and these new standards with an opportunity to ask related questions. So come and join us on February 29th @ 1200 EST and let us better serve you and your research! Register for this free webinar.

In recent years, the U.S. academic research community has become increasingly aware of the threats posed by malign actors—particularly malign state actors. Following federal regulations and requirements to address these concerns, the IU Research Security Office (RSO) exists to:

• mitigate threats to the IU research environment;
• assist researchers in complying with related regulations and requirements; and
• work with IU researchers to safeguard national and/or economic security against:
  • misappropriation of research and development;
  • violations of research integrity; and
  • foreign government interference.

RSO is committed to implementing its research security program consistent with IU's longstanding commitment to global engagement and academic freedom, as well as its IU 2030 pledge to make IU a welcoming environment of mutual respect where students, faculty, and staff from every corner of the world are embraced as Hoosiers.

Collin Rich named Chief Research Security Officer

On December 13, Collin Rich joined RSO as Chief Research Security Officer. Rich joins IU from The University of Alabama, where he most recently served as Executive Director of the Office for Research Security and Export Control. “I look forward to working with faculty to provide guidance and assistance to help protect and drive the innovation and excellence of IU’s researchers. We will strive to promote a secure research environment, all while maintaining an emphasis on open scientific and scholarly collaboration with a global perspective,” Rich said.

Contacting RSO

RSO stands ready to assist you with questions or concerns related to research security, including perceived threats and/or regulatory compliance issues. For assistance, please contact rsohelp@iu.edu.

The Responsible Conduct of Research (RCR) Seminar Series will hosting 2 live seminars this semester. The Office for Research Compliance in collaboration with the 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 trainees as a resource affiliated with NIH T, K, or F awards, it is open to all members of IU research.

• This series is led by faculty researchers and representatives of the Office for Research Compliance, including faculty members of compliance committees and key administrators.
• 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 trainees complete an RCR education that includes interactive program of RCR education of at least 8 hours.

Join us for the next sessions:

The Practice of Research, February 29 4:00 – 6:00 pm

Reporting and Reviewing Research, March 28 4:00 – 6:00 pm

Registration for this session will hold your ‘seat’ in all sessions. Topics and presenters will be sent to registered participants via 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.