Policies & Procedures for Researchers Conducting COVID-19 Research
- For FAQs related to the ramp-down of human subjects research due to COVID-19, see COVID-19: Impact on Human Subjects Research.
- For FAQs concerning the ramp-up of human subjects research, see Ramp-up of Human Subjects Research.
- Also see Communicating with Research Subjects Remotely.
NEW - FAQ#5 was added 11/25/2020
Conducting work relating to COVID-19 requires approval from senior leadership of the University and may require multiple offices to review and negotiate the terms of the sponsored award and to assist you in obtaining required institutional approvals (e.g., IRB, IBC, etc.). You should immediately contact your assigned SPA Project Officer, who will then provide you information on next steps.
Researchers interested in conducting research with emerging pathogens such as SARS CoV2, should contact the Biological Safety staff in EH&S at [email protected] for guidance and assistance. For more information, see https://research.columbia.edu/content/biological-safety.
If you are planning to receive and/or send any material (plasma, virus, etc.) containing, constituting, or directly relating to coronavirus research, please contact SPA for assistance. All requests should be directed to Mr. Whitney Meeks at [email protected], indicating 'COVID-19 for coronavirus' in the subject line. If receiving material, please include a copy of the Material Transfer Agreement (MTA) provided by your collaborator, if available.
SPA may need to consult with Columbia Technology Ventures {CTV), the Office of Research Compliance and Training (ORCT) and/or Environmental Health & Safety (EH&S) as necessary, depending on the type of material and nature of the research. SPA will advise you if anything else is needed before the MTA may be signed (e.g.,IRB or other institutional approval).
SARS-CoV-2 virus and its genetic elements are subject to U.S. Commerce Department Export Administration Regulations (“EAR”). A license may be required to export SARS-CoV-2 virus or its genetics elements to certain countries and “restricted parties” (including “restricted universities”). If you plan to send SARS-CoV-2 virus or genetic elements outside the U.S., please contact ORCT at [email protected] as early as possible to determine whether an export license is required. This will help prevent unexpected delays in your research.
Based on recent FDA guidance concerning research in the COVID-19 context, the IRB is prepared to consider remote electronic consent using a secure portal for trials related to COVID-19.
No. Because of safety concerns and restrictions to direct access to patients, consent and data collection will be obtained remotely by telephone or teleconference or through an electronic form in a secure manner.
Yes.
- When convened review is required, the goal is to conduct the review within 1-2 days. Reviews that do not require a convened meeting will be processed immediately.
- To facilitate this timeline:
- Notify the HRPO as early in the process as possible that you will be submitting a protocol so current guidance re consent and contact can be provided.
- When available and during preparation of the Rascal application, send draft documents so preliminary review can begin.
- Include a Word version of the consent form when submitting the protocol, so the IRB can make suggested changes directly, and provide back for Pl approval.
CUIMC, in partnership with NewYork-Presbyterian Hospital (NYP), has established a COVID-19 Biobank (COB) to create a centralized resource to collect, process, store, and disseminate biological specimens, biomarkers, and clinical and related data for Columbia University investigators and beyond. Patients and researchers can obtain more information at the Columbia University Biobank (CUB) website.