Update from IRB Chair Re: Human Subjects Research in Light of COVID-19
In light of the ongoing closures related to the coronavirus, the IRB office wants to provide guidance on human subjects research. We ask that you read the following information carefully if you have or are supervising an on-going human subjects project or if you are considering beginning a new human subjects project. Please note that our IRB office is open and reviewing protocols/requests for change through our IRBManager system. Investigators are asked to review this letter and the help documents available on the IRBManager website before emailing our office. While we will certainly respond to your emails, there are literally thousands of you and about four of us.
In making decisions about human subjects studies, the health and well-being of the research subjects must be our primary concern. With the coronavirus outbreak, we must re-evaluate the risk/benefit ratio. Below you will find several research scenarios along with guidance and restrictions on how to proceed.
Please note, if possible, we encourage you to switch your mode of interaction with the research subjects to a NON-face-to-face option (e.g., Qualtrics survey, Skype/Zoom/phone interviews). Per IRB policy, investigators are required to submit any changes to their approved protocol to our office. If you do wish to switch the mode of data collection from face-to-face to non-face-to-face, here are things to consider when submitting a request for change:
Complete the Request for Change form using the instructions provided in the form. Provide a justification for your change; this could be as simple as stating that concern about coronavirus spread led to the change in data collection procedures. We encourage you to make this as brief as possible given the anticipated high volume of modification reviews the IRB will be conducting in the coming weeks.
If your original informed consent document and recruitment materials (e.g., recruitment email, post, signage) indicate that subjects will be asked to participate in a face-to-face study, you must change the language of the informed consent or recruitment document and include updated documents as part of the Request for Change.
Note: If your approved study is grant-funded, you must adhere to the guidelines provided by the granting agency. These guidelines are changing rapidly in some cases. However, the links below provide access to the most up-to-date information available.
National Science Foundation
National Institute of Health
Department of Defense
Department of Education
Bill and Melinda Gates Foundation
If you plan to submit a new protocol with the idea of recruiting subjects in the near future, please read the appropriate section above for guidance. In all cases you should try to minimize contact with human subjects and look for opportunities to conduct your research in a non- face-to-face manner.
Sincerely,Jennifer Roberts, PhDChair, Institutional Review Board for the Protection of Human Subjects