COVID-19 Guidance for Investigators and Research Staff
Lifting Study Halt on New Approvals
January 14, 2021
As case numbers continue their downward trend, and hospital capacity is adequate, the IRB and the Research Office have, effective Friday 1/15, released the halt on approval of new human subject research projects that involve no prospect of direct subject benefit.
If research has been approved by the IRB AND all other institutional requirements have been met, PIs will shortly be receiving notification thru the RSS portal that they may proceed. YOU MUST WAIT FOR THIS NOTIFICATION BEFORE PROCEEDING
Investigators are reminded to continue to utilize appropriate mechanisms to reduce face to face contact with research subjects. In addition, research personnel and all research subjects undergoing face to face contact must be masked for all research encounters.
The Research Office and the IRB will continue to actively monitor COVID data, and investigators are advised that additional halts or other actions may be needed in the future.
The Pediatric Research Office (PRO) provides infrastructure support to research activities of Pediatric faculty at the University of Nebraska Medical Center (UNMC) and Children's Hospital & Medical Center (CHMC), giving pediatric patients the opportunity to participate and receive the latest in treatment options while adhering to the highest ethical standards in research.
The Pediatric Research Office provides a variety of clinical research support services, ranging from single consultations to full participation at every step of the research process.
Research support may include:
- Study planning consultation
- Regulatory consultation
- Regulatory documentation
- Initial IRB application
- All IRB submissions
- Study coordination
- Subject recruitment
- Subject visits & assessments
- Database development
- Data & source management
- Data entry
- Matrix development
- Matrix maintenance