Barbara Davis Center Research Approval 

All studies with an inclusion criterion of any type of diabetes and who will recruit patients who receive care at the Barbara Davis Center must receive approval from the clinic from which you are hoping to recruit. This is to protect the privacy of our patients; please do not prescreen or contact any patient who receives care at the BDC without an existing treatment relationship. Please see the following instructions for how to receive approval and steps you must follow when recruiting from the BDC.  

Pediatric Research Approval

If you have a study that wishes to recruit patients at the BDC Pediatric Clinic, please take a moment to complete this survey: https://redcap.link/BDCPediatricResearchWelcome

The BDC Pediatric Research Collaborative Committee (PRC) reviews all protocols which hope to recruit participants from the BDC Pediatric Clinic. This includes all patients seen at the BDC Pediatric clinic regardless of age, as we have many patients who remain with the pediatric clinic throughout college (and some beyond). All protocols must have PRC approval prior to starting recruitment.

Please note that the PRC recommends a member of the BDC pediatric staff be included as a part of the research team to help with navigating the specifics of BDC research and recruitment.

For questions, please reach out to [email protected]

Thank you for your time and help to ensure that research and recruitment among the BDC pediatric clinic is collaborative and fruitful for all!

Adult Research Approval (ages 18+)

The BDC Adult Clinic Research Collaborative Committee requires submissions for protocols to recruit participants from the BDC Adult Clinic. The committee must approve all protocols seeking to recruit patients from the BDC Adult Clinic prior to the start of recruitment. Study teams must use the following link to complete a submission for all protocols: https://redcap.link/bdc-adult-research-form. Please submit a separate application for each protocol.

Additionally, pre-approval is required for projects where the principal investigator (PI) or site-PI is not a staff member of the BDC Adult Clinic. Pre-approval may be requested by PIs from within the BDC Adult Clinic who have additional needs (e.g., letter of approval for a grant application or FDA submission). Study teams must mark the submission as a pre-approval or regular submission in the research form.

Once a submission is completed, you will receive an email confirming that the committee has received your submission. This email will contain a survey link for the study that study teams can use to update the committee with changes to the project. Please save this link so updates can be submitted for the study, including but not limited to anticipated updates to recruitment completion and duration.

All approved and actively recruiting studies are listed on the BDC Intranet in the “Enrolling Protocols” section. The BDC Intranet is updated monthly with two lists: one list can be printed and given to patient who are interested in learning about actively recruiting studies and one list is for internal BDC staff who want more detailed information about each protocol.

The committee strongly encourages a BDC Adult Clinic staff member be part of all research protocols. After committee review, a protocol which does not have a BDC Adult Clinic staff member as part of the research team may be required to add such a person prior to obtaining approval to enroll. There are no set criteria for a protocol to meet in order for this requirement to be necessary. However, some general guidance is that a staff member from the Adult Clinic may be required to be part of the research protocol if:

• The protocol limits co-enrollment in other studies for an extended period of time
• The protocol targets a potentially limited patient population from the BDC Adult Clinic, i.e.
• Patients on multiple daily injections
• Patients not taking a GLP-1 agonist or GLP-1/GIP agonist
• Patients with a specific comorbidity
• Patients who are pregnant
• The protocol requires an intervention that has the potential for significant harmful side effects
• The study team may need assistance identifying patients who may be eligible for the study given its inclusion/exclusion criteria

The Adult Clinic employs MDs, PAs, NPs, RDs, RNs, and CDEs who have been members of research study teams in the past. If you need assistance finding a potential research collaborator, please visit the BDC Adult Clinic staff website for contact information for potential partners.

If you have any questions, please reach out to [email protected] or [email protected].

Thank you!