1. Human Research Protection Program
  2. COVID-19 and Human Subjects Research

COVID-19 and Human Subjects Research

Please review the following information regarding human subjects research in the time of COVID-19:

Above all else, safety and maintaining social distancing are the priorities right now.

Please note that there is no planned disruption to review pending submissions and availability to you to assist with questions or study discussions. As always, email Rebecca Banchik to set up a meeting.

    You can find the latest CUNY information regarding COVID-19 at:

    New Applications and Current Studies

    If you have a new application to submit that is federally funded, please alert your Sponsored Program Officer and director of Human Research Protection Program Rebecca Banchik as soon as possible so we may prioritize review of this study.

    Consider the studies you have in draft mode at this time. Now is a time to delineate how you will plan to collect data in the near term versus the future once restrictions are lifted.

    For initial applications, organize your project plans in phases that can be conducted remotely and without in-person interaction. The exact time/month that will be reasonable to resume normal in-person visits is unknown. You’ll need to be flexible right now.

    Remember that if you need to revise your currently approved research design for existing projects to include online/phone/remote study visits and activities submit amendments via IRB Manager.

    Graduate Center (GC) In-Person Human Research Resumption Plan

    December 2020

    The Graduate Center acknowledges the importance of the continuance and resumption of human subjects research studies involving in-person activities. Due to the ongoing COVID-19 pandemic, most in-person human subject research has been halted. While many researchers have altered their study designs to allow for remote and online communications, for some there is an essential need for face-to-face interactions and contact to continue successful testing and evaluation. As a result, requests to resume in-person research will be evaluated on a case-by-case basis through the process outlined below. Please note that based on City/Region/State/Country and University guidelines, this process could be postponed at any time.

    The Graduate Center Human Research Protection Program (HRPP) has organized a Reopening In-Person Research Committee (RIPRC) charged with reviewing case-by-case requests. The committee will evaluate Covid-19 risk exposure to GC researchers and research subjects. The committee will consider what safety measures are in place to protect the researchers, participants, and institution. This committee is responsible for considering approval to conduct research activities in-person, at a specified site(s), with safety protocol implemented. This committee is not responsible for overseeing travel, funding, changes to local rules and safety measures, nor local ethics committee approval that may be necessary to begin the study.
     
    This committee does not supplant the need to obtain CUNY IRB approval for all Human Subjects Research (initial applications or amendments).
     
    Applicants will complete the Human Subjects Research Resumption Form and make a determination of COVID-19 exposure risk. This form along with any other requested materials will be used evaluate risk to determine if in-person human subjects research activities may begin (initial application) or resume (existing, currently paused study).
     
    All students/researchers will be required to complete the NYS Blackboard training on Covid-19 and the CITI Online training on Covid-19. Certificates of completion must be submitted with the application.
     
    Individuals (researchers and subjects) entering the Graduate Center (GC) will have to complete the Everbridge App. Any other procedures required for entry including confirmation of viewing safety video and screening questionnaire completion are the prerogative of the site location and are not monitored by the committee or IRB.
     
    Upon review the committee will issue an approval letter to commence in-person research activities. Note that this review process is done outside of the IRB Manager system.

    Send the following to Rebecca Banchik, HRPP Director at: rbanchik@gc.cuny.edu :

    1. Human Subjects Research Resumption Form
    2. IRB approval letter (initial approval or amendment approval)
    3. Consent form(s)
    4. CITI Program Online Covid-19 training completion
    5. If offsite activities, supplemental safety information and procedures in place.
    6. If offsite/international, evidence of local ethics committee approval to conduct the research.

    FAQs in the Age of Research During the COVID-19 Pandemic

    Yes. You can design your project to have phases.
    Phase 1 can be online activities. Phase 2 can be the in-person activities.
     
    In the procedures you will outline each Phase as a separate process. Describe the timeline of Phase 2 as beginning once restrictions are lifted due to the COVID-19 pandemic. It is understood that we do not know the exact month/date that this will happen.

    Submit an amendment to your existing project. Do not start a new study for this change.
     
    In the amendment summary you will outline the changes being made to accommodate this climate and should include the justification that in-person study procedures are on hold indefinitely. You must decide if you will continue these remote procedures after the restriction is lifted or if you’ll resume your original study design and in-person activities.

    • Standard data management and confidentiality procedures still apply for recording of data collection and storing research data.
    • Consenting requirements are also still in effect. Participants must agree to allow for their information and responses during online sessions to be recorded – whether that’s manually-written, audio, video, or electronic.
    • The consent form and the research application under Privacy and Confidentiality must describe the procedures in place to minimize the risks to loss of confidentiality and privacy considerations of participants.

    (Cited from New York State Intelligence Center Cyber Analysis Unit)

    • DO use the service’s waiting room to vet who is allowed to access the meeting.
    • DO limit the number of attendees allowed to join a meeting.
    • DO manage screen sharing through the host account to prevent an attendee from taking over what is shown on the screen.
    • DO password protect meeting access.
    • DO ensure that meeting attendees are using the latest version of the service’s software.
    • DON’T share meeting invitations in public forums found on social media or published on websites.

    You can generate an electronic certificate by logging into the CITI program website and retrieving a copy as evidence of completion. Please upload to the Attachments tab of your IRB Manager application. This document must be uploaded to each study you’re associated with and will be requested if you did not include it in the submission.
    https://about.citiprogram.org/en/homepage/

    Yes. Any modifications to study design or process must be submitted and approved by both IRBs prior to implementation. Please refer to the DOE guidance for any specific DOE requirements. 

    Yes. The HRPP can schedule video conference trainings and sessions upon request. Presentations on submission tips and basic requirements are available. Contact Rebecca Banchik at rbanchik@gc.cuny.edu to discuss.