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- Research Continuity - Archive: March 21, 2020
Research Continuity - Archive: March 21, 2020
Page Updated: March 21, 2020, 2:30 p.m.
To the extent possible, Principal Investigators (PIs) should continue their research, particularly aspects of research that can be conducted without visiting a campus or site, such as manuscript writing, data analysis, report writing, administrative tasks. PIs should consider suspending projects or not starting new projects, but if study activities can be conducted remotely, research should proceed in this way (see below). The research enterprise must continue to follow appropriate regulatory guidance. Federal sponsors are allowing for maximal flexibility with regard to administrative, cost, and reporting requirements (see NSF, NIH). If a study needs to be paused, use the standard process to notify the sponsor in accordance with sponsor issued timelines. Unless otherwise notified by the sponsor, all reports due to sponsors must continue to be submitted.
PIs should follow guidance provided by their campus administration, many of which are asking PIs to ramp down to only essential functions. PIs should consider whether maintenance of research resources (e.g., equipment, animals) require emergency personnel (trained people to work on site), in case the University were to close, or mass transit is impacted. It may take time to develop sufficient plans to ramp down research activities. Planning now will help us to be proactive and responsive if the University were to close. Note for students engaged in any research (from undergraduates to graduate students, for courses, theses, dissertations, etc.), they should be guided by their faculty, who should be guided by their campus and the information below. All research engagement, whether funded or not, requires compliance with federal guidelines.
For research involving interactions with people, interactions should be limited to minimize risk of contracting or spreading COVID-19, in accordance with CUNY Coronavirus Guidance, CDC Guidance, and campus guidance. Follow your campus HRPP guidelines, but in general human subject research involving direct interaction with study participants should be paused and no study participants should travel to CUNY colleges (except studies with therapeutic benefit, see below). 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. This guidance is being provided in order to promote public health. When PIs do not follow guidance that is in the interest of public health, they are not engaging in responsible conduct of research. Unethical or irresponsible conduct may result in disciplinary action taken by campus administration.
Direct Therapeutic Benefit
Studies which offer direct therapeutic benefit to participants or where stopping procedures would cause harm to study participants may continue, on a case-by-case basis. For health and safety, changes to protect study participants can be instituted immediately. Please submit a modification to the IRB to indicate temporary modifications within 5 business days.
No Direct Therapeutic Benefit
Studies which do not offer direct therapeutic benefit to participants or where stopping procedures will not cause harm to participants and PIs would like to continue the study, PIs must submit a modification to change study procedures requiring no face-to-face interactions. Studies which do not involve face-to-face interactions (i.e., conducted electronically or via telephone) may continue.
PIs should notify the campus 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 protocols should be for remote data collection, depending upon therapeutic benefit on a case-by- case basis. Protocols may also include in-person data collection for some future time, when guidance for remote collection is removed CUNY-wide.
For studies of data access and analysis covered by data use agreements (DUA), PIs may need to request modification if you require a different platform than what is covered by the DUA. Please contact the Agreements Point Person at your campus. If the DUA involves human subjects and the protocol requires modifications, an IRB modification should be submitted via Ideate.
For animal care, essential personnel should be identified and trained. PIs should work with campus leadership to determine which personnel are needed on campus to provide such essential campus services. This is consistent with Governor Cuomo’s Executive Order, which defines essential personnel as “anyone whose job function is essential to the effective operation of their agency or authority, or who must be physically present to perform their job, or who is involved in the COVID-19 emergency response.” In the case of University closure, identification of emergency essential personnel may depend on ease of access to the animal facility and public transit availability. Extra food and bedding for animals should be ordered, as well as extra Personal Protective Equipment for animal husbandry staff. Orders for additional animals should be suspended, except on a case-by-case basis. If a campus shuts down, PIs should follow their campus and IACUC policies when determining whether a holding protocol is appropriate.
For tissue and other non-IACUC materials such as insects, plants, and sea animals, additional orders should be suspended, except on a case-by-case basis. PIs should decide which to maintain (e.g., freeze) and which to abandon. PIs who work with such materials should contact their campus EHS Officer to design a contingency plan appropriate to the materials in question.
For equipment/facilities that require human attention and/or supplies for operation, preparations should be made for extra supplies and training of essential personnel, who would be able to maintain equipment if necessary, in case of University shut down. PIs should communicate this via the proper campus contacts (including campus safety). PIs should follow their campus policies regarding ramping down equipment/facilities.
For researcher travel, including conferences and field research, researchers should follow CUNY travel guidance on the CUNY Coronavirus portal. For guidance about NSF or NIH reimbursement, see the CUNY Research links. Additional guidelines for PIs from federal funders can be found on the CUNY Office of Research, which also links to the CUNY Research Foundation.