Human Subjects Research and COVID-19

To assist faculty and students navigate human subjects research under current pandemic conditions, the MU IRB has prepared a number of documents providing guidance. To understand the policies we have put in place, please review this flowchart and read the FAQ below. Helpful documents are linked throughout the FAQ and are also linked at the bottom of this page. If you have questions, please feel free to contact Mr. Jeffry Porter.

Finally, Additionally, the MU IRB also suggest that you take the CITI training module, COVID-19: Back to School (Fall 2020). This training consists of a series of videos covering the history and epidemiology of Corona virus as well as general guidelines for avoiding infection. This training is available to any member of the University Community. If you need help logging into CITI, please contact Jeffry.Porter@millersville.edu 

Q: Will I be able to conduct human subjects research in the Fall?

Yes. The IRB Committee has developed guidelines to assist you in completing your research in the fall. These guidelines include information on how to collect information securely while working remotely to keep participant data confidential and/or anonymous, as well as how to protect your own and your subject’s health during face-to-case meetings or interviews.

Q: My research will take place off-campus and requires face-to-face contact. What do I need to do to continue my research if the event of a Covid-related closure?

If not included in your original protocol, the IRB will require that you submit a revised protocol including information on how you will protect your own and subject health, as well as permission from the facility to conduct the research during the outbreak. In addition, the University colleges may also have specific policies you will need to adhere to.

Given the potential for a University shutdown in the Fall, how should I approach my previously approved human subjects research project, especially if it involves face-to-face contact?

If your research required face-to-face contact the MU IRB strongly suggests that you revise your protocol as soon as possible to accommodate for remote data collection in the event of a shutdown. You may do this by submitting a revised protocol that includes a contingency plan in the event that face-to-face meetings are no longer possible. This contingency should include information on how you will protect your own and subject health, information on maintaining data security, as well as permission from the facility (if relevant) to conduct the research during the outbreak. Doing so before any potential closure will ensure that research can proceed with only minor interruptions.

Additional information can be found in the Millersville University Covid-19 Health and Safety Plan.

Q: What will happen in the event of a University or other closures? Will I be able to continue my research?

If your research requires face-to-face meetings you must suspend your research immediately and inform the MU IRB.

If your approved protocol included a contingency plan for continuing in the event of a University or other closure, let us know. We will review the contingency plan to ensure that it meets any University guidelines as well as any System or State guidelines.

If your research requires face-to-face meetings and your protocol did not include a contingency plan (i.e. submitted before August 2020) you must suspend research immediately and submit a revised protocol, if the required changes are significant, or an IRB Extension/Addendum form if the changes are relatively minor (e.g. switching from in-person interviews to Zoom meetings). The contingency plan must include information on how you will l protect your own and subject health, information on maintaining data security, as well as permission from the facility (if relevant) to conduct the research during the outbreak.

The IRB will work as fast as possible to review and approved the revised protocols and forms.

If your research requires no face-to-face meetings, please pause your research and inform the IRB. We respond as quickly as possible and provide permission for you to continue as soon as possible.

Q: Do I need to update my consent form with risks related to COVID-19 exposure?

No, informed consents do not need not be updated to include the risks of exposure to COVID-19.  Researchers can instead hand out the information sheet, "Important Information about COVID-19 and Research Participation"

Q: I would like to conduct research focused on COVID-relate topics. Can this research be given priority review because it is time-sensitive?

Yes. The MU IRB committee understands that this research may be valuable and is time-sensitive. Therefore, protocols that need only expedited review will be reviewed by the committee chairs and returned for revision or with approval as quickly as possible. Protocols requiring full review will be circulated electronically for committee comment without waiting for a scheduled meeting date.

Q: Will the IRB committee continue to review protocols in the Fall?

Yes. Importantly, the IRB committee has modified the protocol form to request more information regarding how you will protect human subject health during face-to-face activities, as well as how you plan to proceed in the event that the University, school, institution, or another facility in which you are conducting your research closes. Facility closure will not necessarily mean the end of your research, it may simply require you to move to remote means of data collection. 

Q: Will the IRB committee meet during the Fall semester?

The MU IRB committee has scheduled meetings for the fall. We will meet in person if University and other conditions permit. Otherwise, we will meet virtually. We expect to be able to review any protocol needing full review at these meetings in the same way as we have in the past

Q: What is the best way to get in touch with the IRB committee?

Email remains the quickest way. If you have a question, please email Jeffry.porter@millersville.edu for general questions, ann.gaudino@millersville.edu for questions regarding educational research, or karena.rush@millersville.edu for questions regarding psychological or other social science research. In addition to email, the Millersville IRB will continue to hold faculty sessions monthly as well as weekly office hours. The times and links for the IRB faculty sessions and IRB Office Hours can be found on the IRB website.

Q: My research is supported by a grant. If my research is interrupted because of university or other closures, what steps should I take?

The precise steps you should take will depend on the agency providing funding. However, in almost all cases the first thing you should do is contact your program officer and inform them that the funded research has been suspended or delayed. In most cases, the agency will make allowances and permit the timeline for your research to be extended as needed. If you need assistance with this, please contact Mr. Jeffry Porter

Q: What do I do if I test positive for Coronavirus or develop symptoms while conducting my research?

 If your research involves face-to-face contact, you must halt your work immediately and inform the IRB. An IRB committee chair will request contact information for everyone you have come into contact with during the course of your research. The chair(s) will work with you to create a communication plan to inform these individuals of possible exposure to Covid-19 as well as work with any University or state group involved in contact tracing efforts.

HELPFUL LINKS 

Protecting your and your subjects health

MU IRB Suggestions for Maintaining Data Security When Working Remotely

MU IRB Guidelines for Modifying Your Protocol for Remote Data Collection

Covid-19 Information Sheet for Study Participants

CDC Guidelines Regarding Social Distancing

CDC Guidelines Regarding the Use of Masks

CDC Guidelines Regarding Handwashing and the use of Hand Sanitizers