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COVID-19 IRB FAQ

COVID-19 IRB FAQs:

Last Modified: Tuesday, May 24, 2022 11:18 am

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.

Do I need to modify my consent form if my study is in person and on campus?

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.
• abide by university health and safety rules, including wearing a face covering and social distancing.

[Choose 1 of the following 2 sentences depending on your participant’s research experience]
As a participant in this study, you will spend [time frame] minutes/hours indoors close to (less than six feet) one-two researchers.
As a participant in this study, you will spend [time frame] minutes/hours indoors while keeping social distance (more than six feet) of one-two researchers.

This poses an additional risk to becoming infected with COVID-19. We are taking the following steps to protect you:
• frequent hand washing
• wearing a face covering
• keeping social distance [if your study does not maintain social distance at all times please modify this statement]
• disinfecting the lab and equipment

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.

What should I consider in conducting current research activities?
  • 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.
What safety precautions do I need to put into place to conduct in person research in an MSU clinical setting?
  • Maintain face coverings in accordance with mask requirements set by MSU
  • Human subjects must be screened 6 to 14 hours prior to arriving on campus and again upon arrival. The initial screening will need to be conducted through Hawk Check.
  • 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.
  • 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 for research teams to sanitize the research area and equipment between visits. For additional information on sanitization please review EH&S COVID FAQs.
  • Research personnel and human subjects must frequently sanitize or wash hands at appropriate times during the visit.

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.

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. 

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

What if my research is conducted at a school or off-campus at another site?
  • 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.

Do I need to submit an IRB modification for asking participants to complete Hawk Check contact tracing or COVID-19 screening?
  • 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.

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

For more detailed guidance from Montclair State University, click here.