Archive: CUNY Guidance Memo #12, May 19, 2020

Some researchers collect and store protected health information (PHI). Researchers 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. 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 availability ends August 31, 2020. Zoom offers a heallthcare HIPAA-compliant plan, but it is not licensed by CUNY centrally. Here is the link to the Acceptable Use of University Data in the Cloud policy:

https://www.kbcc.cuny.edu/its/documents/CUNY-Acceptable-Use-of-University-Data-in-the-Cloud-Policy-08192019.pdf

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 grants, and other related work that does not require the use of their labs. For further assistance, please contact CUNY’s Technology Commercialization Office (https://www.cuny.edu/research/innovation-entrepreneurship/TCO/).

For animal care, essential personnel who are needed to maintain on-site facilities should be identified and trained to ensure coverage. PIs should work with campus leadership to designate essential personnel in such cases. Identification of such essential personnel may depend on ease of access to the facility and the availability of mass transit. Extra food and bedding for animals should have been ordered and should continue to be maintained, 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. PIs should follow their campus 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 https://www.ncbi.nlm.nih.gov/books/NBK54050/), and must be accompanied by a justification for waiver of each function. Also see USDA Coronavirus guidance page: https://www.usda.gov/coronavirus.

Effective Monday, March 23, all research projects must ramp down/suspend unless they can be conducted remotely and all colleges shall activate their corresponding emergency protocols related to animal care, equipment etc. Is 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.

Principal Investigators (PIs) should continue aspects of their research that can be conducted remotely (without a campus or site visit) such as manuscript writing, data analysis, report writing, administrative tasks, and should continue to support those who are grant or contract funded who can assist in this work. Contact your program director and/or grants officer and document these decisions. PIs should have suspended projects and not start new projects requiring on-site activities, but continue or modify their research to engage in remote activities (see below for more detail). 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 (e.g., NSF, NIH). For example, NSF allows payment of salary and stipend costs, as long as those costs align with CUNY and RF CUNY policy. Documentation of charges for research, operational changes required to be flexible and remote, and their rationale/justification will be very important for funders and auditors. If a study needs to be paused (because all activities require on-site work) then PIs should 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 also ensure that their Program Directors/Grants Officers are aware of any changes being implemented to sponsored projects.

PIs should follow guidance provided by their campus administration, many of which have asked PIs to cease on- site activities excepting essential functions (e.g., animal care, facility care). These essential functions require essential personnel (trained people to work on site), who can be designated as such at any time, though adequate training and coordination with campus leadership is required. In designating such personnel, please consider access to campus (e.g., in case the University were to close or mass transit is impacted). Those students who are engaged in any research (from undergraduates to graduate students, for courses, theses, dissertations, etc.), should continue to be guided by their faculty mentors, who in turn should be guided by their campus leadership and the information below. All research engagement, whether funded or not, requires compliance with federal regulations and guidelines and University policies.

Lastly, as we are all facing these difficult and uncertain times, we want you to know that we are with you. Many of us are dealing with myriad issues, anxieties, and frustrations, let us take a moment to be grateful for what we are able to do, to reorganize our activities to focus on pressing priorities, and to work together to find solutions to new issues as they arise. Please be as flexible, patient, and compassionate as possible with yourself and your research teams.

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). PI judgment is most critical and we rely on PIs for determining necessary changes to protocols. 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. This guidance is being provided in order to promote public health. PIs should follow guidance that is in the interest of public health, and thus engage in the responsible conduct of research. Unethical or irresponsible conduct may result in disciplinary action from campus administration.

Studies Which Offer 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.

Studies Which Do Not Offer 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 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, campus issued maintenance plans to be executed by trained essential personnel should be in place and evaluated on an ongoing basis. PIs should communicate any related needs via the proper campus contacts (including campus safety).