Steps for Clinical Research Restart:
1. Develop clinical research restart plan (see sample clinical research plan).
Principal investigators (PIs) with approved human subjects research studies must adhere to the restart requirements of the university and other relevant requirements of the location where the research is taking place (IU Health, Eskenazi Health, or VA Medical Center).
- Clinics are operating at reduced capacity and may not be able to accommodate clinical research visits yet. In addition, team rooms may not be big enough to accommodate an influx of research staff. There must be a discussion with the unit/clinic manager (inpatient and/or outpatient) to ensure adherence to the unit/clinic requirements.
- The unit/clinic requirements must be addressed in the restart plan. For example, if research is being conducted at the Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Centers (CRCs), the CRCs re-opening guidelines can be referenced in the restart plan. If using IU Health Enterprise Clinical Research Operations (ECRO) to conduct your research, the ECRO restart plan can be referenced.
- If approved by the Department Chair, one group restart plan can be submitted for multiple PIs conducting research in the same therapeutic area/group. For example, all studies managed by the Cancer Center’s clinical trials office will resume their research under one approved plan.
- PIs can request PPE at: research.iu.edu/coronavirus/ppe-request-form.html. A 30-day supply of PPE must be accessible. Currently, IU Health is providing a disposable isolation mask at each facility entrance. Eskenazi Health has asked that research staff bring their own PPE. PPE is available from the VA Medical Center and can be requested from the VA Research and Development Office.
2. Submit the clinical research restart plan for approval to your Department Chair.
- In addition to the clinical research restart plan, if you are conducting clinical research studies at the VA, completion of the Investigator COVID-19 Risk Assessment Form is required and the completed form must be submitted to the VA Research and Development Office. The VA Research and Development Office will then contact you directly via email regarding the VA restart process.
3. Once the Department Chair has approved the restart plan, the Chair must notify the Dean’s office. Additionally, the Department Chair is responsible for maintaining the approved plans for their unit.
4. Ask your research staff to complete the Community Responsibility Acknowledgement also available at one.iu.edu.
5. Once plans are approved by the Department Chair, the PI/Clinical Research Manager can complete the university's on-campus research form: research.iu.edu/coronavirus/return-to-on-campus-research-form.html.
6. Once the university's on-campus research form is received, school-level approval will be issued via email to Department Chairs and research can begin.
7. Clinical research PIs who also have bench research labs still need to submit restart plans and request approval, to cover each activity.