COVID-19 and Human Subjects Research

COVID-19 and Human Subjects Research

This page is intended to provide basic information about conducting research with human subjects at John Jay as we respond to and anticipate changes related to COVID-19. Researchers are advised to stay current on institutional, local, state and national requirements and guidance.

 

FAQ related to Human Subjects Research and COVID-19

The following information is current as of May 18, 2020.  Updates to the content will be identified with the date of the update.  Any questions can be directed to Lynda Mules at lmules@jjay.edu

Can I continue in-person interactions in my current approved research?

Researchers at John Jay should follow CUNY guidance.  On or around March 20, 2020, CUNY issued guidance stating that research involving in-person interactions should be put on pause unless the research can be amended to include remote procedures.  This includes recruitment procedures, consent procedures, and data collection.   Procedures that do not require in-person interactions can continue.

Some research that presents the prospect of direct therapeutic benefit to participants may be able to continue in-person interactions.  While this does not apply to most research conducted at John Jay, if you would like to discuss whether your in-person research can continue under the current guidance, please contact Lynda Mules at lmules@jjay.cuny.edu

If you want to transition to remote procedures, you can do so by submitting an Amendment to your IRB application in IDEATE. (see below for additional guidance)

Can I submit a new IRB application if my research involves in-person interactions?

Yes, you are not discouraged from submitting a new research application to the IRB.  However, if feasible, you may want to consider including a remote procedures phase, to avoid a delay in starting your research.  Otherwise, you are advised to include a statement confirming that in-person interactions will not proceed until the release of new guidance allowing such interactions to resume.

When will I be able to resume in-person interactions in my research?

The COVID-10 pandemic is an evolving situation.  As locations in the United States and internationally begin to relax restrictions and guidance related to stay-at-home orders, guidance related to resuming in-person research activities will be provided.  We will continue to follow CUNY guidance, as well as CDC, national, and state updates related to social distancing, and will continue to assess the situation to evaluate when in-person interactions in research can resume.  It is possible that in-person interactions will be able to resume in some scenarios prior to others.

What do I need to consider when in-person research interactions resume?

As locations in the United States and internationally begin to relax restrictions and guidance related to stay-at-home orders, researchers may be able to consider resuming in-person research activities.  It is likely that such interactions will require modification to how or where the interaction occurs, including considerstaions related to social distancing, safety screening, contactless interactions, and PPD, for the safety of reserach participants and personnel. 

Do I need to submit an Amendment to my IRB application to start remote procedures in an existing project?  What information do I need to include?

Yes, if you wish to modify your research procedures to add remote procedures – including recruitment, consent and data collection – submit an Amendment in IDEATE.

You should review all fields in the application and revise as needed, and should attach documents to be used during the remote data collection phase. You should ADD these details rather than removing/replacing existing descriptions of in–person interactions, unless you have no intention of conducting the in-person procedures at any point in the future.  You can describe these scenarios as ‘phases’, such as “Remote data collection phase” and “In-person phase”.

Two main considerations with remote recruitment and data collection are 1) the consent process, and 2) if/how the remote procedures affect privacy and confidentiality, in terms of the technology used as well as the fact that the researcher cannot control the setting. 

Overall, you may want to give yourself flexibility by describing a variety of methods for recruitment and data collection, while also considering if these various methods affect confidentiality, privacy, and other risks in different ways.  You may need to add information about remote data collection to the following sections of the application. 

  • Summary tab, Lay Summary
  • Research Design tab, Research Design and Methodology
  • Research Design tab, Procedures and Risks:
    • Describe/name the “location” – for example, the survey or meeting platform. 
    • Also consider here if collecting data in a setting where you cannot control privacy might introduce different/more risks related to confidentiality
  • Participants tab:
    • Recruitment:  Add info about remote recruitment if not already described
    • Consent:  If you have indicated that you will obtain signed consent, also check 'oral/internet based consent' and complete the subsequent fields (if any) to explain the situations in which you'd obtain consent without a signature. 
  • Participants tab, Privacy and Confidentiality: 
    • Explain the technology to be used and if/how privacy will be protected
    • Explain the process for obtaining oral consent if you were not prompted to provide this info in the Consent section
    • Describe any changes to data collection/storage specific to the technologies used as well as location (if you are not able to store data in your office, for example)
  • Consent form:
    • If your consent process currently involves obtaining signed consent, you will need to submit a new consent form without signature lines, OR you can revise the current consent form to include language in the signature section to clarify that signed consent will be obtained if the interview is conducted in person, but that otherwise the participant will be asked to provide verbal consent.
    • Describe the new remote procedures including any technology to be used
    • Describe any changes to or new risks
    • Explain how confidentiality will be protected during remote procedures, including any specifics related to the technologies used, as well as how data will be collected and stored
  • Recruitment materials:
    • You may need to submit new or revised recruitment materials, depending on what you’ve described in your current materials, and if your recruitment process has changed.
       

What should I consider in terms of confidentiality and privacy when conducting research remotely?

USE OF ONLINE MEETING PLATFORMS:


Some researchers are turning to online meeting platforms to review consent forms, conduct interviews, or carry out complex study procedures.  These platforms may introduce risks to privacy and confidentiality.  The following suggestions for the use of online meeting platforms should be considered and described in your IRB application. 
(These suggestions are borrowed from the CUNY Graduate Center HRPP website, and 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.
  • limit the number of attendees allowed to join a meeting.
  • manage screen sharing through the host account to prevent an attendee from taking over what is shown on the screen.
  • password protect meeting access.
  • 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.

 

COLLECTION OF SENSTIVE DATA OR INTERACTIONS WITH VULNERABLE PARTICIPANTS:

If your research involves the collection of sensitive information from participants via an online survey or an oral interview, you should consider if collecting such information from participants in an environment that you do not control, particularly when participants may be required to stay at home due to local restrictions, introduces new risks related to privacy and confidentiality.  You should provide the IRB with your assessment of such risks and how they will be mitigated, and should provide the participant with adequate information to make an informed and autonomous decision.

Some things to consider:

  • Implement screening procedures to reduce risks related to privacy.
  • Require or recommend personal devices with password-protection for survey completion
  • During informed consent and/or prior to the survey or interview, remind the participant to complete the survey on a private device in a private location, or confirm that the participant is in a private location where responses will not be overheard.
  • Ask only the questions that are necessary to satisfy the research aims, and make sensitive questions optional.
  • Provide participants with instructions for limiting access to a completed online survey (close the browser, clear the cache, etc.).

 

What about obtaining consent remotely?  What are my options?

Most minimal risk research is eligible for approval of a waiver of the requirement to obtain documented (signed) informed consent – which means approval of a consent process where the participant is provided with full details about the research via a consent document, but no signature is required.  This type of consent process must be requested on the IDEATE application and approved prior to implementation.

To request a waiver of documentation of informed consent, include the following changes/information in the IDEATE application and consent form:

  • Participants tab, Consent section: If you have indicated that you will obtain signed consent, also check 'oral/internet based consent' and complete the subsequent fields (if any) to explain the situations in which you'd obtain consent without a signature, and select the criteria applicable to your study to justify the waiver (usually this be that the research is minimal risk and involves no procedures for which written consent is required outside of the research context).
  • Participants tab, Privacy and Confidentiality section: Explain the process for obtaining oral consent if you were not prompted to provide this info in the Consent section.
  • Consent form:
    • If your consent process currently involves obtaining signed consent, you will need to submit a new consent form without signature lines, OR you can revise the current consent form to include language in the signature section to clarify that signed consent will be obtained if the interview is conducted in person, but that otherwise the participant will be asked to provide verbal consent.
    • Be sure to describe the new remote procedures including any technology to be used
    • Describe any changes to risks and/or new risks
    • Explain how confidentiality will be protected during remote procedures, including any specifics related to the technologies used, as well as how data will be collected and stored
    • Include a check box at the end of the document for participants to indicate their agreement to participate before proceeding, for example, to an online survey.

 

Are HRPP staff available to provide assistance or training?

 

HRPP staff at John Jay and at CUNY are working remotely and available for questions and consultations.  Your first point of contact is Lynda Mules, Director of Research Compliance and Integrity at John Jay.  Lynda is available for phone or video consultations and can provide training to you and your team on issues related to the HRPP and other aspects of research compliance. 

How can I get updates?

This page will be updated as needed and new guidance will be identified by date.  You can also request to receive email updates by contacting Lynda at lmules@jjay.cuny.edu.