Human Subjects Research Protection Program (HRPP)

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

December 2020

Purpose
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.
 
Procedure
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 Ideate system.
 
Application
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. NYS Blackboard Covid-19 training completion
  5. CITI Program Online Covid-19 training completion
  6. If offsite activities, supplemental safety information and procedures in place.
  7. If offsite/international, evidence of local ethics committee approval to conduct the research.

FAQ in the Age of Research during the COVID-19 Pandemic

Can my study be designed to have two data collection protocols: One in-person, one online?
How do I make this clear in the application?
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.
 
I need to change my study design to conducting study procedures remotely/online. Do I need to submit a new application OR an amendment to my existing project?
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.
 
Are there guidelines regarding recording online sessions and saving those conversations and 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.
 
What are some best practices for secure online meetings and interactions/study visits?
(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.
 
The copy of my CITI certificate of completion is printed in my office. How can I provide you this certificate while I’m at home?
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 Ideate 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/
 
My study is also approved by the NYC DOE IRB. Do I need to submit the change to remote activities to the DOE IRB as well as to the CUNY IRB?
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.  
 
Is the HRPP available to assist in training or group meetings to teach about the IRB process while we are all remote?
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.




The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research projects conducted at CUNY or by CUNY faculty, staff and students and RF CUNY staff. The program provides oversight, administrative support and educational training to ensure that CUNY research complies with federal and State regulations, university policy and the highest ethical standards. The CUNY HRPP comprises of 3 University Integrated Institutional Review Boards (IRBs); 2 convened and 1 expedited panel; and 21 on-site HRPP offices. For more information about the CUNY Human Research Protection Program, please click here. 
 

CUNY IRB review is required when ALL of the following criteria are met:

1. The investigator is conducting research or a clinical investigation;
2. The proposed research or clinical investigation involves human subjects; AND
3. CUNY is engaged in the research or clinical investigation involving human subjects.

Rebecca Banchik

Director of the Human Research Protection Program
The Graduate Center
Room 3300.28


Phone 212-817-7525