The Research Compliance & Safety Committee (RCSC) has provided guidance to the Institutional Review Board (IRB) Safety and Hygiene Standards for Research during COVID-19. The RCSC recently launched research-related information on TC’s preparedness website including a four-phase process for returning to in-person research activities. Information on the policies and procedures regarding in-person research is available in the Research Compliance and Safety section of the TC preparedness site. Teachers College (TC) has been in Phases 1 and 2 for the initial parts of the year while reopening procedures were established. 

 As of May 2021, Teachers College moved to Phase 3.

poster

To prepare for Phase 3, TC IRB has begun reviewing proposals for in-person engagement on a case-by-case basis. The IRB is currently reviewing protocols that meet one or more of these parameters: 

  • The study has direct benefits to participants.
  • The in-person engagement is part of typical practice (e.g., a class already meeting in-person).
  • The study cannot be carried out unless it is in-person (e.g., a neurological assessment study). 

If part or all of the study can be conducted online (remote), then the researcher should move forward with online procedures and forgo in-person engagement. 

As Teachers College gradually moves to in-person research, it is important that all staff on the research team are trained to handle a situation in which a participant is unwell or reports COVID-19 symptoms. In most cases, the below items should be prepared prior to submitting a proposed in-person protocol to the IRB for review.

  • Have all staff on the protocol complete the Return to Campus training modules and the Ethics Amid Uncertainty training on TC's Preparedness website. Each staff member should upload their completion certificates to Mentor IRB's PI Documentation under their individual logins.
  • Update the protocol consent forms to include COVID-19 language (this language is now in our Consent Form templates, found under Mentor IRB>Documentation).
  • If the study is off-campus and site-dependent, complete the form entitled Off-Campus Access Requirements, to compare the hygiene and safety requirements of the off-campus site against TC's.
  • Additionally, upload an unsigned site permission form including COVID-19 language. Signatures can be collected after the IRB protocol is approved.

The IRB, in conjunction with the Office of Public Safety and the Office of Environmental Health and Safety, has created guidance for situations in which participants are unwell or report COVID-19 symptoms. Printable flyers are available for download:

On-Campus, In-Person Research: What to Do if a Research Participant is Unwell

If an individual participated in on-campus, in-person research and then experiences flu-like symptoms, the researcher should: 

  • Immediately cease all in-person activities 
  • Collect or confirm the participant’s contact information 
  • Initiate pre-determined lab-specific steps to keep researchers and participants safe
  • Advise the participant on the nearest location to get a COVID-19 test 
  • Ask to contact the participant in a few days
  • Contact the Office of Public Safety 24/7 at 212-678-3333
  • Explain to the participant that they must leave campus using the same route they followed on entry. Escort the participant if necessary
  • Self-isolate, monitor health, and follow safety precautions
  • Submit an adverse event report to the Institutional Review Board (IRB)
  • Follow any procedures set by the Office of Environmental Health and Safety (EHS) 

On-Campus, In-Person Research: What to Do if a Research Participant Reports a Positive COVID-19 Test

A research participant can report a positive COVID-19 test by: 

  • Answering “yes” to having a positive COVID-19 case through the Daily Health Screening Questionnaire
  • Sharing COVID-19 test results with the researcher
  • Directly reporting their positive COVID-19 result to the researcher or other campus official

If a participant in on-campus, in-person research reports a positive COVID test result, the researcher should: 

  • Immediately cease all in-person activities
  • Collect or confirm the participant’s contact information
  • Inform the participant that public health issues have (limited) mandated reporting obligations
    • When required by law, information (including individually identifiable information) related to a research participant’s COVID-19 test results may be reported to a public health authority.
  • Self-isolate, monitor health, and follow safety precautions 
  • Initiate pre-determined lab-specific steps to keep researchers and participants safe
  • Submit an adverse event report to the Institutional Review Board (IRB)
  • Follow procedures set by the Office of Environmental Health and Safety (EHS)
  • Contact the Office of Public Safety 24/7 at 212-678-3333 for immediate support if needed, or if you have concerns or questions

Off-Campus, In-Person Research: What to Do if a Research Participant is Unwell or Reports a Positive COVID-19 Test

If a participant in off-campus, in-person research study is unwell or reports positive for COVID-19, the researcher should: 

  • Immediately cease all in-person activities
  • Collect or confirm the participant’s contact information
  • Inform the participant that public health issues have (limited) mandated reporting obligations
    • When required by law, information (including individually identifiable information) related to a research participant’s COVID-19 test results may be reported to a public health authority.
  • Follow external site safety guidelines, self- isolate, and monitor health 
  • Initiate pre-determined lab-specific steps to keep researchers and participants safe
  • Submit an adverse event to the Institutional Review Board (IRB)
  • Follow procedures set by the Office of Environmental Health and Safety (EHS)
  • Contact the Office of Public Safety 24/7 at 212-678-3333 for immediate support if needed, or if you have concerns or questions

We ask everyone to continue to work remotely (online) for as long as possible. Minimizing the density of personnel at study sites is crucial for everyone’s safety. Please do not engage in return to in-person research activities unless this is crucial for your work. We will gladly discuss if you wish to assess the risk of in-person research. All in-person research on campus must follow the Teachers College Fall 2021 Visitor Guidelines. Please feel free to reach out by email with any comments, questions, or concerns.

Visit these other links for additional information:

— Karen Froud, Ph.D., Myra Luna Lucero, Ed.D., & Kailee Kodama Muscente, M.A.

Published Tuesday, Jun 8, 2021