Please see below for important information relating to human subjects research and the impact of the COVID-19 pandemic.

• Review the Ramping Research Plan for resuming in-person research involving human subjects. MU is currently in Stage 3 of the plan.
• IRB protocols must follow the Guidelines for Standard Operating Procedures for Human Subject Research in Response to COVID-19.
• Research subjects involved with in-person interactions with MU personnel should receive a copy of the COVID-19 Research Participant Risk Information Sheet.

The expectation of the IRB is that research interventions will be conducted in a manner that reduces risk to human subjects while thinking about the health and safety of research participants and study team. Please consider the following protocol modifications:

1. Maximizing social distancing by changing to online/remote data collection procedures whenever possible.
2. Allowing for flexibility in the scheduling of data collection sessions to account for disruptions to schedules and travel of subjects.
3. Consider delaying in-person subject recruitment and in-person data collection.

IRB Office Operations: The IRB office is currently open and operational. Staff may be working remotely so please contact us via e-mail or phone. IRB staff are happy to meet with investigators over the phone or remotely through a Teams meeting. Monthly convened IRB meetings will still occur as needed but may be conducted remotely.

Screening: It is recommended that researchers screen subjects for exposure to the novel corona virus (COVID-19) and for symptoms of illness before any study-related visits and in-person interactions. This screening does not have to be reported as an amendment to currently approved studies unless COVID-19 screening data will be incorporated into the research data. A recommended tool is available from the Office of Research and Innovation, Appendix E (/innovation/research-ramp-up.php).

Amendments to currently approved studies: Changes to remote options for recruitment, screening, interviews, questionnaires, surveys and check-ins that were approved for in-person methods need to be approved in advance by the IRB unless needed to immediately reduce the risk of human subject exposure to COVID-19.

Temporary changes to protocols due to COVID-19 that have been implemented without prior MU IRB approval (i.e., amendment was not submitted and approved) may need to be reported as a Protocol Deviation. Protocol Deviations may be reported:

1. Submitting a Reportable Event Form to the IRB; or
2. Waiting until the renewal/check-in is requested by the IRB and answering the appropriate questions.

Amendments that are requested to reduce risks to human subjects related to COVID-19 will be given priority processing by the IRB office. Please note this in your submission.

If requesting amendments to add remote procedures please make sure to consider and address the following:

• If using online data collection procedures such as Qualtrics or Google docs- what steps are you taking to maintain confidentiality of the data being collected?
• If using Skype to interact with subjects how are you maintaining the privacy of subjects in this environment?
• How will you obtain consent from the subjects for requested changes in procedures? If your study is non-exempt please make sure to also request a waiver of documentation of consent.

Please also consider if you need to submit an amendment for changes in data collection schedules:

• If you plan to pause data collection we recommend looking at your protocol to determine if you were approved for X number of visits (no amendment needed for a pause), or if you were approved for X number of visits within a specific time frame (an amendment would be needed to add flexibility).

Use of Personal Protective Equipment in Research Studies

• For previously approved studies that are implementing PPE use in order to remain compliant with local and university guidance, no amendment is needed.
• For new studies, please add a comment to the risk section of the protocol form that the use of personal protective equipment will follow local and university guidelines

New Study Submissions: There may be a delay in processing new study submissions due to a potential increase in the volume of submissions and reduced IRB member availability for reviews. IRB staff will maintain communication with PIs about the status of their submissions.