COVID-19 IRB FAQ

Yes, please add the following language to the risks section of your consent, if your research is being conducted at an MSU on-campus clinic:

Additional Risks due to COVID

This study will take place on campus in [location]. All researchers will meet university health and safety rules. These were put in place to prevent exposure to COVID-19. However, we cannot guarantee that you would not be infected due to this visit. To reduce risks, you are required to complete a HawkCheck before coming to campus. This is MSU’s online health and safety screening. The screening will include questions about your current health status, travel, and exposure to COVID-19.

The research team and Montclair State University are exempt from any medical liability due to participation in this study. Any medical expenses that occur are the responsibility of the participant.

• 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.

• The researcher must verify that the participant has completed Hawk Check. (Participant will receive an end of survey prompt indicating if they can come to campus.) The researcher may also conduct an additional screening if applicable and appropriate. Such screenings do not require IRB approval as long as the information will not be added to the research data set.
• Research personnel and human subjects must frequently sanitize or wash hands at appropriate times during the visit.

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. 

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. 

• 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.

• 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. 

• 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. If you are reporting a COVID diagnosis or potential exposure please use the University reporting guidelines.

• Researchers must comply with any additional requirements of the host site. The researcher must obtain written notice from an authorized person at the research site certifying that approval has been granted for research activities to resume at the off-campus location and a list of the COVID-19 related precautions and measures that must be taken at the site.

• No. Your contact tracing protocol and COVID screening process applies to an MSU policy for safety and health of the campus community. Contact tracing and screening documentation should be kept separate from all study related data collection and storage.

• The IRB is functioning hybrid schedule, both remote and on-campus and are 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