December 2023 Research Bulletin

We are pleased to announce that we have received over 170 nominations for this year’s Campus Research Awards. Award winners will be announced at a ceremony to be held in February 2024. We hope you will join us for the celebration. A reception will follow immediately after the event. 

We are especially excited to present the new annual Chancellor’s Distinguished Research Lectureship Award that will recognize extraordinary research accomplishments by a CU Anschutz faculty. This award will showcase a CU Anschutz faculty member who has made impactful and innovative research. The award recipient will be announced at the ceremony and invited to present a lecture later in 2024.

The Clinical Research Support Team (CReST) offers a-la carte fee-for-service support for clinical research conducted by CU Anschutz faculty. Their customizable suite of services includes study coordination, subject recruitment, clinical monitoring, eCRF development, administrative support, finance management, and regulatory support.

Since its inception in 2017, CReST has supported over 330 protocols with more than 150 principal investigators across 37 departments. Their team of onboarded and CITI-trained CU Anschutz employees is available to support your research needs. Whether you require an additional study coordinator for a few hours of extra bandwidth, help with IRB submissions, invoicing, or a variety of other clinical research support, CReST is ready to support you. Visit their website to complete the CReST Help Request Form, and they will reach out to setup a meeting

In addition, the IND/IDE program is officially launched in July of 2023 and all FDA communications and submissions for new investigator-initiated studies must be managed through either the IND/IDE Office or the Cancer Center’s OCRST team. Please contact the IND/IDE program by completing their Triage Intake Form. You may also use the form to request a meeting for consultation on a project.

You may have heard that the CCTSI has been re-funded by NCATS/NIH for the fourth time! We received four grants (UM1, Pre-Doc T32, Post-Doc T32 and K12), totaling $63 million, and the UM1 grant will extend, for the first time, for seven years. Longtime CCTSI Operations Director Janine Higgins, PhD, is joining me in leading the CCTSI UM1 as a Multiple PI. Lisa Cicutto PhD, RN, and Ellen Burnham, MD, are the PIs for the T32 and K12 grants, respectively. For more information on what’s ahead in the next seven years, read Five Questions for Ron Sokol and Janine Higgins in CU Connections. 

The CCTSI will host its first Town Hall in this new grant period on January 17 from 11:30 am to 12:30 pm. Join us in person or online to learn about the many CCTSI resources and ways we support clinical research, early-career faculty and train the next generation of researchers. Click here to RSVP for this hybrid meeting. 

Our Clinical Translational Research Centers (CTRCs) are important outpatient and inpatient resources for the unique needs of clinical investigators who conduct clinical research, including clinical trials. Our mission is disease agnostic, and we conduct many mechanistic studies with healthy controls as well. Learn more about how we can support your clinical research and watch our brief video.

Contract Services would like the CU Anschutz Campus to be aware of the process updates related to contracting with the State of Colorado. The team has been working with each of our Colorado state agencies to streamline the state contracting process for all parties. We are proud to announce a couple changes resulting from these strategic partnerships and we will keep you posted as more agencies adopt these streamlined practices.  For more information, please visit the summary here.

In addition, Pre-Award has a Data Management and Sharing (DMS) Update. The NIH has recently released guidance on how to update a revision to a Data Management and Sharing (DMS) plan. In NOT-OD-23-185, the NIH has communicated that a DMS can be updated via the Prior Approval Module. They have added this feature to the “Other Request” section. This function may only be used to revise a DMS and must come from a Signing Official.

If you have a DMS that needs to be revised, please email the changed DMS to xenia@ucdenver.edu and we will update it as requested by the NIH.

Lastly, the Training and Compliance team has an update on Cost Transfers.  Campus Administrative Policy #2018 Cost Transfers on Sponsored Projects, 4-12 became effective January 1, 2021. Cost Transfers are “the transfer of a cost incurred initially on one University program/project and subsequently transferred to a sponsored project”. This includes both Journal Entries (JEs) and Payroll Expense Transfers (PETs).

Compliance has highlighted some key reminders and best practices below, along with an upcoming training opportunity.

• JE Checklist must be attached for all journal entries booking an expense onto a Fund 30/31 sponsored project as of 6/1/2022.
• PET Checklist must be attached for Payroll Expense Transfers (PETs).
• Entries should clearly explain why the charge is being moved, how it benefits the project receiving the charge, corrections made to prevent future errors.
• Entries should be created so that an outside reviewer can understand the background and details of the movement.
• Questions, reach out to Compliance at fs-compliance@ucdenver.edu

I would like to ask everyone to thank the OLAR staff that worked over the Thanksgiving Holiday and those scheduled to work over the upcoming Winter Holidays during the campus closure to make sure that the animals, facilities, and all OLAR operations continue to run smoothly. 

OLAR offices will also continue to operate with limited staffing over the holiday period to ensure support to the animal care, operations, veterinary staff and researchers with the exception that our offices will be officially closed on Monday December 25 and Monday January 1. If a member of the research staff does need assistance during this time, please refer to signage in the vivarium offices on how to contact someone, as staff may be covering more than one building. We also would like to remind all research staff that during the holiday weeks animal orders, animal transfers, and imports/exports will not occur. Please refer to the animal program communications for specific closure dates and deadlines. 

We also would like to remind research staff that in spring 2024, the institution will have its triennial AAALAC site visit. AAALAC is a voluntary accrediting body for animal research programs. CU Anschutz has a proud history of continued full accreditation, indicating our commitment to high quality animal care and research programs. Over the next several months OLAR and the IACUC will be holding a Town Hall meeting (January 31) and will provide information and tips for the site visit during laboratory visits and through email communications. Please reach out to the IACUC office (IACUC@CUAnschutz.edu) or OLAR ( OLAR.Admin@CUAnschutz.edu) if you have any questions or would like more information. 

Thank you to everyone who has already completed the CU: HIPAA Regulations CU Anschutz and CU Denver Skillsoft course for this fiscal year! If you have not yet completed the course, and work in a department designated in APS 5055, you may complete the course at any point before June 30, 2024 to satisfy the requirement. Billable providers may complete an alternative through CU Medicine. For any questions, please email the Privacy Team at hipaa@cuanschutz.edu

The Conflict of Interest (COI) disclosure period ended October 31. The COI office has received more than 7,600 disclosures. Thank you to everyone who took the time to complete and submit their annual COI disclosure. Anyone with an outstanding disclosure is encouraged to submit as soon as possible. For more information about COI visit the website or email COI@cuanschutz.edu.

During the holiday closure, the following units will be impacted as follows:

Biological Safety Program will not be doing any waste pick-ups. The last day for biological waste pick-ups will be Thursday, December 21, 2023. Extra tubs will be staged by the freight elevators on each floor.

Occupational Health Clinic will be closed December 22 through January 1. Appointments, clearances, and all other operations will resume January 2. 

The following services provided by Radiation Safety will be unavailable during the holiday closure:

• Radioactive materials purchase requests, package receipt, and delivery
• Radioactive waste pickups
• Instrument calibrations
• X-ray irradiator daily warm-up
• Cesium irradiator assistance

The NIH is implementing a simplified review framework for most research project grants with receipt dates of January 25, 2025, and after. The NIH is beginning, and will continue over the next year, to roll out resources – including webinars, FAQs, Guide Notices and more – to guide the extramural community through this change. Applicants should start familiarizing themselves with these materials to understand how application sections may need to be approached or written differently to best address the new review framework. CU Anschutz faculty and staff will also be able to find selected materials on the Announcements page of the Office of Research Development and Strategy website.