32nd Edition - September 22, 2022

ORC and the Institutional Biosafety Committees (IBCs) are pleased to announce that Kuali Protocols launches on October 10, 2022 for all submissions to IU’s IBCs! Beginning Monday, October 10, 2022 Kuali Protocols will be the system of record for IBC protocols. This includes new submissions and amendments to existing protocols, as well as review and approval for the IBCs. Basic information about existing protocols will be transitioned into Kuali Protocols. To allow for the new system transition, all submissions have been paused as of September 26, 2022. More information about steps you’ll need to take when submitting a new protocol or amending an existing protocol can be found on our website.

Kuali Protocols is designed to be user-friendly and will ease the IBC submission process, paving the way for quicker review, turnaround, and approval. The system is already in use for submissions to the IRB and plans are underway to roll out to the IACUCs in 2023.

IU’s IBC office will provide support to investigators who have questions or want training on how to use the system for IBC submissions. Please visit the website often as we share training guides, opportunities for live training, and more information about the launch.

Please contact the IBC with any comments or questions about the transition to Kuali Protocols at IBC@iu.edu.

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 researchers 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
September 29th from 4:00 – 6:00 pm
RCR Seminar Series: Research Misconduct, Conflict of Interest & Conflict of Commitment

Presenters
T. Rowan Candy, PhD, MCOptom, Executive Associate Dean for Academic Affairs, Professor, School of Optometry, Indiana University
Theodore Cummins, PhD, Department Chair and Professor of Biology at IUPUI, School of Science, Indiana University
Shelley Bizila, MS, CIP, CCEP, Director and Research Integrity Officer, Office of Research Compliance, Indiana University
Eric Swank, JD, Executive Director, Office of Research Compliance, Indiana University
Audrey Williams, PhD, Conflict of Interest Officer, Office of Research Compliance, Indiana University
Facilitator: John Baumann, PhD, Associate Vice President for Research Compliance, Office of Research Compliance, Vice President for Research, IU

Next RCR Seminar Session Dates:

• October 27th from 4:00 – 6:00 pm via Zoom
• February 23rd from 4:00 – 6:00 pm via Zoom
• March 30th from 4:00 – 6:00 pm via Zoom

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 or contact rhopson@iu.edu.

The National Institutes of Health (NIH) updated RCR education requirements for recipients of NIH T, F and K awards. NIH requires that all trainees, fellows, participants, and scholars receiving funding through any NIH training, an individual career development award, an institutional career development award, a research education grant, and/or a dissertation research grant, to receive instruction in responsible conduct of research (RCR) education. Summary of the change in the requirements are outlined below.

• Format: updated with the option for video conferencing, however this should not be the sole method of delivery. To satisfy this requirement, RCR education will be delivered through two paths:
  • Office research of Compliance at IU will organize online RCR discussion-based seminars – two in each fall and spring semesters
  • In-person protocol specific education delivered by PI/mentors
• Frequency & Timing: Same recommendations remain to undertake RCR training at least once during each career stage, and at a frequency of no less than once every four years. With a consideration to alter the approach for those who have been exposed to the full range of topics traditionally included in RCR. The PI is responsible for monitoring this requirement; to assist, ORC maintains a database of all webinar attendees.
• Subject Matter: NIH has expanded the areas to be included in the RCR education (see bolded content below); ORC will incorporate these into the webinar series and PI/mentor should, as well, address them in their in-person mentoring, as appropriate.
  • conflict of interest – personal, professional, and financial – and conflict of commitment, in allocating time, effort, or other research resources
  • policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
  • mentor/mentee responsibilities and relationships
  • safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment)
  • collaborative research, including collaborations with industry and investigators and institutions in other countries
  • peer review, including the responsibility for maintaining confidentiality and security in peer review
  • data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or working with digital images); recordkeeping practices, including methods such as electronic laboratory notebooks
  • secure and ethical data use; data confidentiality, management, sharing, and ownership
  • research misconduct and policies for handling misconduct
  • responsible authorship and publication
    the scientist as a responsible member of society, contemporary ethical issues
  • in biomedical research, and the environmental and societal impacts of scientific research

Several pieces of federal legislation have included what may amount to substantive changes to the NSF RCR requirements. While no action is required at this time as NSF has not yet released an effective date or any guidance, ORC wants to alert the NSF research community to these potential expansions of the RCR mandate.

• Section 10337 of the Chips Act: Expands who will be required to complete RCR training and the subject matter. Faculty and other senior personnel are now required to complete the RCR training.
• Section 7009 of the America COMPETES Act. 10313: NSF now also requires individual development plans for graduate students and postdoctoral researchers receiving substantial support from an award.

IU’s Policy for RCR NSF Awards
As a reminder, in an effort to standardize RCR training required for NSF trainees, Indiana University developed an institutional RCR educational program that requires:

• Successful completed of 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.

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

Did you know helpful human subjects research resources are just a click away?! Okay, it may take a couple clicks. A quick link to our IU HRPP Guidance can be found at the bottom of our Policies webpage. We provide Guidance on a wide-range of human subjects research related issues. Guidance represents best practice, recommendations, and/or the IU IRB’s current thinking on a topic, while our Policies represent requirements for IU and IU-affiliated investigators conducting human subjects research.

Additionally, the IU Quality Improvement Office has developed several clinical research management templates that can be customized by you to meet your study’s needs. These templates can be found on our Managing Study Documents After Approval webpage. When visiting our Human Subjects and IRBs webpage, click on Study Review in the left-hand navigation, then Managing Study Documents After Approval will appear just below it in the navigation.