38th Edition - July 03, 2024

After a long career with ORC, Eric Swank has resigned as Executive Director to assume teaching position at the IU McKinney School of Law. In his absence, we are breaking RICE into different units. We are creating a Conflict of Interest Office to be led by Stephanie Jones and a Research Safety Office, including bio- and radiation safety, to be led by Holly Moore. Export control has moved under Research Security. Please join me in wishing Eric success in his new position and welcoming Stephanie and Holly to their new positions and responsibilities.

As many of you already know, Purna Garimella began as Director of the HRPP on 1 May. Please continue to welcome him to IU from University of Michigan where he served as Associate Director.

IU Indianapolis’ triennial AAALAC International site visit is confirmed for July
29- August 1, 2024. Thank you for filling out the AAALAC Lab Readiness
Survey! The ARPO team will be in touch regarding checking lab spaces and
records prior to the site visit.

Informational drop-in sessions, to answer questions, were held on:

• Tuesday 6/25 11a - 2p: https://iu.zoom.us/j/89767264510

• Thursday 6/27 10a - 1pm: Daly Student Center, Room 182

On June 14, UA-17 Conflict of Interest and Commitment Policy was
updated. As part of the policy revisions the definition of family member for
research related significant financial interests was updated. The new
definition extends the coverage of family member to include individual’s
spouse or domestic partner, dependent children, AND any other family or
household member whom the covered individual reasonably knows may
benefit personally from actions taken by the covered individual on behalf of
the University. The Kuali COI-C Disclosure form will be updated to include
this new definition and require all researchers to re-answer the research
form questions based on the updated definition. If you have any questions
about this policy change or what should be included on your disclosure form
please contact coi@iu.edu.

As previously announced, beginning January 1, 2024, the IRB fee schedule
was updated to account for increased costs – last revised 6 years ago in
2018. These fees apply to all industry or other for-profit-sponsored human
subjects research. There are no fees for research which is supported by
federal, foundation, or department funds or is otherwise unfunded. Please
be sure these fees are included in contract negotiations with sponsors. The
fee schedule can be found here.

If you have ever struggled to determine the appropriate risk group for your
biological agents while completing the IBC protocol form, the Research
Safety would like to make you aware of this useful resource to help in
determining risk groups called the ABSA International Risk Group
Database. The database is web-based and can be accessed here:
https://my.absa.org/Riskgroups. There is also a free app available on both
Apple and Android phones that will work even when there is no internet
connection. To download this app search for “Risk Group Database” in the
app store.

Starting in April, all IBC required training should be completed in CITI. This
includes IUEHS Biological Safety, IUEHS Bloodborne Pathogens, NIH
Recombinant DNA Guidelines, and IUEHS Filtering Facepiece Respirator
(N95/P100) trainings. For more information on which trainings apply to your
work and how to access CITI to complete the trainings, please visit our
website: https://research.iu.edu/training/required/biosafety.html. If you still
have questions after reviewing the website, please feel free to contact our
office at ibc@iu.edu.

The Research Safety Office will soon publish updates to the IBC protocol
form in Kuali Protocols IBC. The next time you submit an amendment, Kuali
may prompt you to complete some additional questions in the Other
Compliance Approvals, Viral Vectors, Biological Materials, Animals, and/or
Lab Practices sections, depending on the work described on your protocol.
Many of the form updates are intended to improve usability and help ensure
congruency between the IACUC and IBC protocols.

In 2021, the NIH established the Gene Drives in Biomedical Research
working group of the Novel and Exceptional Technology and Research
Advisory Committee (NExTRAC) to consider whether existing biosafety
guidance is adequate for contained laboratory research utilizing gene drive
technology and to outline any conditions under which the NIH could
consider supporting field release of gene drive modified organisms. Based
on the working group’s determination, the NIH published revisions to the
NIH Guidelines in April 2024: https://osp.od.nih.gov/nih-publishes-revisionsto-
the-nih-guidelines-for-research-involving-recombinant-or-syntheticnucleic-
acid-molecules-nih-guidelines/. Indiana University does not currently
have research that will be affected by these changes. The updated NIH
Guidelines can be reviewed here: https://osp.od.nih.gov/wpcontent/
uploads/NIH_Guidelines.htm.