Research-specific COVID-19 Update: August, 2021
In order to better align with overall Yale public health protocols, we will be retiring our previous ‘Stage 1, Stage 2 and Stage 3’ COVID research reactivation stages in favor of the ‘red, orange, yellow, green’ alert levels that the rest of the university currently employs. Registration through EHS Integrator, implemented to monitor and track on-campus personnel and COVID-specific safety plans during the pandemic, will also be eliminated. The research community will still be required to adhere to any on-going University safety measures such as the current mask mandate and any other mitigation measures indicated by the Public Health and Safety committee.
The only COVID-specific research guidance that persists applies to research involving Human Subjects and/or Off-Campus Research and Fieldwork. That information is summarized below:
Beginning in May of 2020, Yale required all researchers conducting human subjects research and/or research at off-campus locations to take extra steps before resuming or initiating their research activities. Those steps were designed to mitigate COVID-19 transmission risks to researchers, subjects, and the communities in which Yale researchers work around the world, and they were overseen by two specially appointed committees of faculty, trainees, staff, and administrators: the Human Subjects Research Review Committee and the Off-Campus and Fieldwork Review Committee. Although current circumstances continue to demand enhanced attention to research safety, we are streamlining our review and education processes.”
The following changes will go into effect on August 18, 2021:
Researchers engaged in human subjects research will be required to complete a supplement to their existing or new human subjects protocol(s), and review of these supplements will be undertaken by members of the Yale Human Research Protection Program.
Researchers planning to conduct research at any off-campus locations should complete a newly developed educational Travel Self-Assessment before traveling or initiating off-campus research–whether that research will be undertaken directly by Yale affiliates or those (e.g. local contractors) acting on their behalf. Some campus units may require submission of a copy of this self-assessment in order to disburse research funds.
Researchers planning off-campus research that is covered by a human subjects protocol should take both of the above steps.
Researchers whose plans have already been approved through the EHS Integrator process or who have been exempted from review via an earlier self-assessment tool do not need to re-submit their plans.
Human Subject Research
Effective August 18th, safety protocol review related to conducting human subjects research during a pandemic will transfer from the Human Subjects Research Review Committee to the Human Research Protection Program (HRPP) which administers Yale’s Institutional Review Boards (IRBs). This change supports Yale’s research and public health and safety goals while the community continues to navigate the challenges of COVID-19.
All human subject research will be reviewed by the HRPP prior to review by the IRB. In certain circumstances, the HRPP will additionally consult with representatives from the Office of Environmental Health and Safety, Off Campus Research and Fieldwork Committee, and Human Subjects Research Review Committee who previously conducted such reviews during prior research reactivation phases.
Who needs to complete ‘Supplement to IRB Submission and Requests to Use External IRB – Safety During Pandemic’ form:
All Principal Investigators conducting human subjects research must complete and submit the supplement form unless:
The research consists of secondary data analysis only, or
It is a request for an emergency use of a test article or a device.
When to complete the ‘Supplement to IRB Submission and Requests to Use External IRB – Safety During Pandemic’ form:
The supplement must be submitted at the time as the according protocol for initial review. Research that has previously been approved for reactivation through EHS Integrator does not require the supplement and may proceed as approved unless a change in research protocols is planned. If you wish to reactivate your existing research but you have not submitted a request through the EHS Integrator before this transition, you should complete the supplement and submit it as a modification in IRES IRB.
How to submit a safety protocol
Complete ‘Supplement to IRB Submission and Requests to Use External IRB – Safety During Pandemic’ form available in Other Forms tab in IRES IRB Library (https://ires-irb.yale.edu).
Upload it as a supporting document along with the research documentation and submitted in IRES IRB at the time of initial request for IRB review/authorization to use external IRB.
The HRPP will contact you and the primary contact for the study within 2 business days should there be any questions about the proposed safety plan.
Once the safety plan is accepted, the study will proceed to the IRB for review or will receive authorization to use external IRB.
Researchers planning to conduct research at off campus locations should also complete the Travel Self-Assessment.
Please, contact the HRPP Office at firstname.lastname@example.org with any questions about this notification.
Off-Campus Research and Fieldwork
Effective August 18th, the Off-Campus Research and Fieldwork Committee will no longer review safety protocols. The committee’s self-assessment tool for determining what research requires review will also be retired.
Instead, all faculty, students, and staff initiating research off campus–including that conducted by others on behalf of Yale researchers–must complete a newly designed Travel Self-Assessment. All travelers must be prepared to follow all government regulations and guidelines for their destination(s). Although this self-assessment will not be formally reviewed, we are counting on members of the Yale community to make use of the resources it provides for navigating travel and other dimensions of off-campus research during the pandemic.
Researchers may request a copy of their survey results to be emailed upon completion of the Travel Self-Assessment survey. Everyone who completes the Travel Self-Assessment survey is encouraged to retain a copy of the completed survey should a record of your results be required for travel approval or reimbursement.
Research that has already been approved through the EHS Integrator process or exempt through the Committee’s self-exemption process may proceed as approved unless a change in the research protocol(s) is planned. Additionally, research that involves human subjects will need to go through the process described above as well as the Travel Self-Assessment.
Please, contact the Office of International Affairs at email@example.com with any questions about this notification.
Safety Guidelines for Review
Yale established guidelines for safety on the campus and in research. You should familiarize yourself with the guidelines before completing the safety protocol for human subject studies or finalizing plans for off-campus research or travel:
Work on campus: https://your.yale.edu/work-yale/workplace-guidance
Visitor Policy: https://covid19.yale.edu/visitors-policy