COVID-19 IRB FAQ

COVID-19 IRB FAQs:

Last Updated: July 16, 2020

In light of the current public health emergency, the IRB has created a list of FAQ’s to guide you in your decisions regarding your IRB studies.

What should I consider in conducting current research activities?

  • MSU has released RedHawk Restart guidance on human subjects research. All researchers must review those HERE.
  • All State and Federal guidelines supersede any approvals made by the IRB. The NJ Office of the Secretary of Higher Education (OSHE) released research related guidelines on 6/18/2020. Please review them (specifically pages 16-17).
  • Recently approved studies have been approved during ever-evolving state regulations due to COVID-19. Please check those state mandates regularly at  https://covid19.nj.gov/
  • If you have any questions  about the impact of COVID-19 with regards to the methods proposed in your study, please do not hesitate to contact us via email or at Open Labs.

What safety precautions do I need to put into place to conduct in person research?

  • MSU has released RedHawk Restart guidance on human subjects research.
  • Human subjects must be screened prior to arriving on campus and again upon arrival. The screening should ensure that subjects:
    • have not received a diagnosis of COVID-19.
    • have not/are not experiencing any COVID-19 related symptoms.
    • have not been in close contact with a person diagnosed with or awaiting test results for COVID-19.
    • have not travelled domestically or internationally by air or cruise ship within the last 14 days.
  • The researcher must either conduct the screening or require the human subject to employ a self-check application and release form (if appropriate) made available by the University. The researcher must maintain a record of the screening. Such screenings do not require IRB approval as long as the information will not be added to the research data set.
  • Subjects in known high-risk groups—e.g., adults older than 65; minors; adults with known high risk medical conditions—may be invited to campus but must be required by researchers to wear a mask at all times and follow University social distancing protocols. Where possible and consistent with the needs of the research project, individuals who identify as high risk should be permitted to participate remotely.
  • Social distancing of at least 6 feet must be maintained during the visit unless alternative procedures have been approved for the specific research protocol.
  • Participants should be scheduled for appointments at times that do not overlap with other participants to avoid individuals waiting in areas within 6 feet of each other. Participant schedules should provide adequate time to sanitize the research area and equipment between visits.
  • Research personnel and human subjects must frequently sanitize or wash hands at appropriate times during the visit.
  • Subjects and research personnel must wear face coverings, which follow the University face covering policy. Research personnel interacting with subjects must wear gloves and remove them properly between subjects. If the research requires participation by persons who have been diagnosed with or exposed to COVID-19, personnel shall also wear goggles or face shields, and gowns.
  • A list of the name, date, location, and screening information for all human subjects participating in research must be recorded for possible contact tracing purposes. Subjects must agree in writing to this limitation to confidentiality as outlined in approved protocols.

How do I modify my study if I want to do interviews online instead of face-to-face?

Your study can be modified to include email/telephone/teleconferencing/video meetings/email.  Consider what changes can work with your study and submit a modification. See How to Submit Modifications for guidance on submission.

My study includes face-to-face interviews and/or focus groups, how can I continue my study remotely?

Your study can be modified to include email/telephone/teleconferencing/video meetings/email.  Consider what changes can work with your study and submit a modification. See How to Submit Modifications for guidance on submission.

Can consent forms be signed electronically?

Yes, in most studies electronic signature of consent is an acceptable method of consent acknowledgement. If you would like your consent forms to be signed electronically, please propose this method in a modification to the IRB. These modifications reviews will be triaged and reviewed expeditiously. 

How can I get a electronic signatures on my Study Consent Form (remote signatures)?

  • PIs are allowed to propose any number of options as part of your current protocol. Please submit those consent changes in Cayuse as a modification and the IRB will evaluate risk to participants. Some available options for you are (the list is not all inclusive):
    • Create a Qualtrics consent form with signature. Qualtrics instructions available here.
    • Mail your consent form to participants and have them send you a picture of the signed consent.
    • Propose a waiver of signature to your consent process. Please submit this change via Cayuse modification submission and describe the verbal documentation process of consent via phone. You should consider how you will document verbal consent in your modification submission.

Is the MSU IRB in operation during this emergency?

  • The IRB is functioning remotely and is available by email, phone and scheduled meetings.  The Open Labs program is ongoing, see schedule.

If I am proposing a COVID-19 study will you provide a faster review?

  • The IRB staff will be prioritizing COVID-19 emerging studies. 

What are my options for securely storing research data while working remotely?

  • MSU filehawk is encrypted and secure. It is a great option for transfer of data from researcher to researcher.
  • MSU fileshare is secure and can be used for research data (except if it involves PHI).
  • Research data is secure if on MSU devices (laptops or desktops).  Practices to maintain research data on non-MSU issued devices should be disclosed in the research study procedures. 

Is the MSU IRB requiring researchers to notify them of research that is postponed or cancelled?

  • If your plans are to postpone research activities and there are no additional risks to participants by delaying the study then you do not need to notify the IRB. Student researchers should notify their faculty sponsors, if they have not already done so.
  • If you will be unable to conduct your study due to the current pandemic, and you do not plan to return to that study, we ask that you close your study via Cayuse closure submission at a time convenient for you. We ask that you note in your submission the reason for project closure so that the University can identify those studies impacted by the pandemic.

My research has experienced an incident, how should I handle this?

  • In the event that you’ve experienced an incident with your research, follow our normal practice of submitting through Cayuse as an incident submission. Please see the FAQs on adverse events here. 

I need some assistance with completing my IRB submission, how can I get help?

  • The IRB is functioning remotely and is available by email, phone and scheduled meetings.  The Open Labs program is ongoing, see schedule. Also the best email address to reach us at is reviewboard@montclair.edu