Considerations for Human Participant Protections Related to COVID-19

This webpage will be updated with further guidance as requirements change. 

**UPDATED** March 22, 2020

Frequently Asked Questions

  1. Which human participant research studies have to be paused?
    Given the current COVID-19 coronavirus outbreak, and the real or perceived risk of exposure, the risk/benefit ratio for research participation must be reassessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio.Any biomedical or social, behavioral and educational study that involves in-person, face-to-face interactions with participants including faculty, staff, students and community participants must be paused until further notice in recognition of the COVID-19 pandemic. This directive is being made to decrease exposure for our staff, faculty and learners as well as research participants. Research studies that limit participant interactions to online or remote communication, telephone contact, remote monitoring, remote data collection or secondary data analysis may continue.
  1. What if research involving face-to-face interaction with participants provides a direct health benefit?
    If a research activity involving face-to-face interaction with participants provides a direct health benefit and is considered an essential research activity [Coronavirus (COVID-19 Guidance for Researchers], the activity may continue. However, such studies must be approved for continuation by the Department Chair and Associate Dean for Research through the disclosure of essential research activities form. The Office of Research has provided the following online portal for the disclosure and approval of essential research activities: Syracuse University Disclosure of Essential Research Activities.
  1. What will the Syracuse University IRB require for my study?
    The following information is ONLY applicable for studies regulated by the Syracuse University IRB. If your study is regulated by a non-SU IRB, you should consult directly with that IRB for their requirements.The federal research regulations require that the IRB review modifications to a study before they are implemented; there is one important exception, “where necessary to eliminate apparent immediate hazards to the human subjects.” 45 CFR 46.108(3)(iii).Should you determine that such changes in your procedures are required, you may implement them immediately, without prior notice to or approval from the IRB. Implementing protocol changes without prior IRB approval must be limited to changes directly related to eliminating an immediate hazard.
  1. What changes can be implemented without prior notice or approval?
  • Replacing in-person interventions/interviews/focus groups with telephone calls
  • Replacing in-person interventions/interview/focus groups with video-conferencing
  • Replacing in-person interventions/interviews/focus groups with other remote options
  1. Rather than having participants come to Syracuse University, can I conduct home visits to collect data for my study?
    No. Traveling to a participant’s home still carries the COVID-19 related risks.
  1. Do I need to submit a protocol deviation or amendment for all these changes?
    Syracuse University IRB policies require that changes to IRB-approved research may not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject (45 CFR §46.108(a)(3)(iii)). Syracuse University also has a responsibility to ensure the safety of its employees. Therefore, while Syracuse University’s plan for COVID-19 is in effect, these interim measures to reduce immediate hazards to research participants and staff are warranted and may involve deviating from IRB-approved study procedures prior to obtaining IRB approval.
  • For studies that provide no direct health benefit to the participant (studies approved under 45 CFR 46.404 and 406): Protocols and parts of protocols may be paused without formal notification to the IRB to eliminate apparent immediate hazards to the subject. Conducting follow-up procedures with participants by telephone or video-conference while in-person data collection is paused also does not require prompt submission to the IRB. However, any deviations will need to be tracked by the investigator (see the FAQ regarding tracking protocol deviations below);
  • For studies with a prospect for direct health benefit (studies approved under 45 CFR 405): If the risk outweighs the benefits, the study should be paused (as outlined above). If benefits are significant see FAQ #2.
  • If investigators anticipate making the changes to their research plan permanent (e.g. substitute telephone surveys or video-conference for in-person visits), IRB approval of a protocol amendment must be sought.
  1. Do I need to track the protocol deviations?
    Yes. If investigators deviate from their approved protocol to eliminate apparent immediate hazards, please keep track of these deviations and report them to the IRB with the next continuing review (if one is required).
  1. How do I document the justification for these deviations in my study records?
    Investigators can use the following language: Due to the potential risks of COVID-19, Syracuse University has determined that all research studies that provide no direct health benefit to the participant should be paused, unless they can be effectively completed remotely.
  1. I am conducting a study that is currently only approved to obtain written consent? Can I continue enrolling by just getting verbal consent over the phone?
    No. If the IRB did not waive the documentation of consent, written consent must be obtained.  Study teams may discuss the study with a potential subject and answer their questions over the phone, but must have a consent form signed by the participant and the person obtaining consent before any study procedures may begin.  One option is to have the discussion by phone, email the consent form to the subject, who can sign it and send it back to the study team (e.g. scan and email or send via USPS).  Another option is to submit a modification to the IRB to obtain verbal or electronic consent.
  1. I have a continuing review due soon. Do I still need to submit it and should I include information regarding the pause in research activity in the submission?
    Yes. You still need to submit your continuing review on time. Please keep track of the deviations and pause in study activity and report this to the IRB with the next continuing review.
  1. What is the effect of the pause on pending studies?
    The IRB will continue to review and approve submissions. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but explicitly note that enrollment cannot start until the pause in face-to-face human participant research has lifted.
  1. Do I need to let the NIH or other sponsors (e.g. industry) know that some protocol activities or in-person visits for a funded study will be paused?Investigators will need to work with their funders and regulatory sponsors to develop appropriate plans in light of the current circumstances. Contact the Office of Sponsored Programs (OSP) for questions regarding NIH and all other sponsored research.
  1. How do I contact the Office of Research Integrity and Protections/Institutional Review Board Office?
    The office staff is working remotely, therefore, the office is only accepting electronic submissions until further notice. Please submit all IRB new applications, continuing renewals, amendment requests along with appropriate documentation to orip@syr.edu.Due to staff working remotely without physical protocol files, voicemail and email inquiries regarding existing or pending protocols will be answered as soon as possible, please be patient.

Share this information with research staff listed on your protocol as appropriate.