Archive: CUNY Guidance Memo #21, September 24, 2020

Research is important to the University mission, our capacity to advance discovery and innovation, and four ability to facilitate economic recovery. To this end, based on the work of key stakeholders across our University, the University is following a 4-stage framework for the phasing in of on-site research in CUNY.

• Stage 1 – Plan and prepare to phase in on-site research, with an eye toward Stage 2 research priorities. Plans include establishing clear research priorities and CUNY approval processes per City and State guidance, working with relevant researchers, to discern space, equipment, and personnel needs for safety, developing health and safety protocols, and establishing communication and health monitoring plans.
• Stage 2 – Expand on-site access to research (up to 50% capacity), priorities including: externally funded and deadline-driven work (regardless of researcher rank or tenure status), research by graduate students who are near degree completion, untenured faculty research, and/or research requiring season-specific sample collections. Plan and prepare for Stage 3 priorities.
• Stage 3 – Expand on-site access to tenured associate and full professors, and graduate students and postdoctoral research associates. Plan and prepare for Stage 4 priorities.
• Stage 4 – Expand on site access to undergraduate students.

Based on recent guidance from the State regarding the interaction between University, City, and State standards and how these should factor in obtaining the required approvals for the implementation of the above plan, we are pleased to announce that effective immediately, the University will adopt the following internal approval process.

1. College submits their higher education research reopening plans to CUNY’s Office of Research. The Office of Research will review and work with the colleges to ensure they are in compliance with the State’s Interim Guidance for Higher Education Research (pdf) and meet the mandatory criteria included in the State’s Higher Education Research Guidelines for Employees and Employers (see attached).
2. Once the Office of Research certifies that the plan meets all relevant State and University criteria, the plan will be routed to the Executive Vice Chancellor and University Provost for review and approval.
3. Once the Executive Vice Chancellor and University Provost approves the plan, he will notify the corresponding College President, Chancellor and the Chief Operating Officer of his decision via a formal letter including copies of the approved campus plan and checklist showing how campus plan meets mandatory state guidance. This letter will underline the University’s expectations regarding the fidelity with which the plan must be implemented and any reporting requirements that may be needed to ensure full compliance.

The University is confident the proposed approval process ensures that all research activity will meet State requirements, implement relevant best practices, and ensure that essential personnel currently on site are thoughtfully attended to, including in receiving education/training plans.

We are eager to restart our University’s research operations — because of what it means for our faculty, the disciplines we advance, and the real costs associated with closed labs — and very much look forward to your approval of the proposed way forward. And we are pleased that the following Colleges/Centers have already received approval to implement their phased-in onsite research work effective immediately: ASRC, City College, Hunter College, Queens College, York College and Brooklyn College.

Research interactions with human subjects should be limited to minimize risk of contracting or spreading COVID-19, and conducted in accordance with State and approved College guidance. Follow your college HRPP guidelines and IRB-approved protocol, but in general direct interaction with human participants should be minimized. Study participants should neither be required nor coerced into participating in person, and no undue influence should be presented to encourage participants to travel to CUNY colleges. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio for in-person contact associated with research. The prospect of direct benefit to the participant is determined by justification provided by the PI. PIs should ensure their justification is in the interest of public health.

Studies Which Offer Direct Therapeutic Benefit

Studies which offer direct therapeutic benefit to participants or studies which may not be stopped without causing harm to participants, may continue, on a case-by-case basis. Any modifications to already-approved IRB study protocols must receive IRB approval prior to their implementation.

Studies Which Do Not Offer Direct Therapeutic Benefit

Studies which do not offer direct therapeutic benefit to participants should be conducted remotely, unless they are in a priority area for ramping up, as determined by the College. Any modifications to already-approved IRB study protocols must receive IRB approval prior to their implementation.

PIs should notify the college HRPP Coordinator and sponsor of any changes in research procedures and submit all HRPP/IRB modifications via Ideate. For PIs submitting new protocols, data collection methods should be for remote data collection, except when campus approval for on-site research is granted. Depending upon the planning and preparation Stage for the college, PIs may seek IRB approval for in-person research if it has not already been approved.

Researchers who collect and store protected health information (PHI) should develop procedures that protect the confidentiality of PHI when it is transferred, received, handled, shared, or stored using remote data collection platforms or solutions per the Acceptable Use of University Data in the Cloud Policy (pdf). Both WebEx and Microsoft Teams can be used for real-time videoconferencing, if sessions are not recorded, and are freely available for CUNY affiliates. WebEx is available CUNY-wide until August 31, 2020. Zoom offers a healthcare HIPAA-compliant plan that is not licensed by CUNY.

For studies of data access and analysis covered by data use agreements (DUA), PIs may need to request modification if a different platform is required beyond that covered by the DUA. Please contact the Agreements Point Person at your college. If the DUA involves human subjects and the protocol requires modification, the IRB modification should be submitted via Ideate.

For animal care, essential personnel who are needed to maintain on-site facilities should be identified and trained to ensure coverage. These plans should remain in place until CUNY is in Stage 4, to ensure that needed resources are available in the event that research has to be scaled back. PIs should continue to work with colleges to identify, train, and have available essential personnel. Extra food and bedding for animals should be ordered, available, and maintained, as well as extra PPE for animal husbandry staff. Orders for additional animals should be minimized, especially during Stage 1, 2, and 3, except on a case-by-case basis. PIs should follow their college animal facility and IACUC policies regarding continuation of animal protocols.

Inspections are allowed to be conducted up to 30 days beyond the 6-month period, but this should not drift forward from year to year. During this interim emergency period, non-USDA inspections can be made by one qualified person. Waiver requests for inspections can be made by IOs, or IACUC Chairs, Coordinators, or Vets. There should be communication amongst these groups about requesting waivers. Waivers may be granted for specific functions of the IACUC (defined in The Guide), and must be accompanied by a justification for waiver of each function.

For equipment/facilities that require human attention and/or supplies for operation, college issued maintenance plans to be executed by trained essential personnel should be in place and evaluated on an ongoing basis throughout Stages 1 to 3. PIs should communicate any related needs via the proper college contacts (including via EHS Officers).

Researchers should follow CUNY travel guidance on the CUNY Coronavirus portal, as well as avoid international travel per the U.S. State Department. For guidance on reimbursement from federally-funded travel – see appropriate links or contact your Program Director. For more information see corresponding domestic and international travel guidance in this memorandum.

For tissue and other non-IACUC materials such as insects, plants, and sea animals, additional orders should be minimal except on a case-by-case basis. PIs should be prepared to scale back research, especially during Stages 1, 2, and 3, and may have to decide which materials to maintain (e.g., freeze) and which to abandon. PIs who work with such materials should contact their college EHS Officer to design a contingency plan appropriate to the materials in question.

CUNY researchers have responded to the COVID-19 pandemic with a wide array of technological solutions. Researchers can continue to pursue potential commercial applications (both COVID and non-COVID inventions) during this time by filing invention disclosures, seeking intellectual property protection, establishing contact with companies, writing SBIR proposals, and other related work that can be conducted remotely. For further assistance, please contact CUNY’s Technology Commercialization Office.