Author: bartj

The White House announced the release of a revised policy on the oversight of dual-use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPPs). Some of the new elements include: defined roles, clear levels of oversight, and new list of pathogens covered. The new policy can be found here: https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and-PEPP.pdf

This spring ORC engaged external consultants to review the IRB and IACUC office operations. Since then, we have been busy implementing their recommendations. In the fall, we look forward to unveiling updated eForms in InfoEd, new positions, new staff, updated guidance and “how to’s” and a new communications strategy. If you would like an update on our progress at a staff or department meeting, please contact us at orc@clemson.edu. Stay tuned!

The Division of Research keeps a list of Regulatory Alerts that impact Sponsored Programs, Research Security, Post-Award and Compliance. We provide timely updates regarding regulatory and policy changes that can impact your proposals and conduct of research. Be sure to check out the Regulatory Alerts page periodically for new updates.

The InfoEd upgrade applied on May 29th was successful. All compliance modules are online and functional. You may use the system normally. Thank you for your patience.

The production InfoEd server hosting the Compliance modules will be unavailable on May the 29th, 2024 as the system is being upgraded.

The Mentoring Plan requirement has been expanded to include graduate students. Research.gov and Grants.gov will enforce that a Mentoring Plan not to exceed one page is uploaded for proposals when there is funding for graduate students and/or postdoctoral scholars. Refer to PAPPG Chapter II.D.2.i(i). Clemson has resources for Mentoring Plans.

The NIH has published revisions to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). These revisions are specific for research involving gene drive modified organisms (GDMOs) in research settings. These revisions include:

• Research with GDMOs requires IBC review and approval PRIOR to initiation.
• The minimum containment level for research involving GDMOs will be BSL-2.
• When a researcher at an institution conducts research involving GDMOs, the institution must ensure that the IBC has adequate expertise on the committee as well as a BSO (biosafety officer).

Clemson’s Office or Research Compliance will be updating the e-form in InfoEd to reflect the category for this research (III-D-8).

The InfoEd Compliance modules supporting our IRB, IACUC, and IBC processes will be offline on Monday, April 18 from noon to 2PM and on Friday, March 22 from noon to 2PM for disaster recovery testing. During this time users will not be able to log into the system nor will they receive system notifications. Please contact the Office of Research Compliance if you have any problems or questions.

https://www.clemson.edu/research/division-of-research/offices/orc/

The ORC has unveiled its schedule for the Fall series of RCR Brown Bags.  These Brown Bags offer 1 hour of Advanced RCR credit.

Please see our offerings here:

https://www.clemson.edu/research/division-of-research/offices/orc/rcr/index.html

Please register for those you are interested in here:

https://cucourse.app.clemson.edu/orc/student-index.php

Do you need help figuring out if you need a permit to ship and/or receive transgenic or biological samples? Please see our Permits webpage as a resource.