EMU Research

In-Person Human Subject Research During COVID-19

When the number local and regional COVID-19 cases allow, in-person human subject research may occur. The phase of in-person human subject research will be announced by the Provost and posted on the research compliance website.

Studies will be approved on a case-by-case basis based on resource availability and research risks to human subjects and investigators.

Process for approval:

Step 1: Complete application for in-person human subject research

Principal investigators must develop study-specific procedures to protect human subjects and themselves from COVID-19. These procedures should be based on the Human Subject Research Plan, and include the following:
- Additional PPE required
- Use of face coverings
- Physical distancing measures
- Hygiene protocols
- Enhanced cleaning and disinfecting procedures
- Health checks for symptoms of COVID-19
- Obtaining information for contact tracing
- A mechanism for informing research subjects of both the risks of COVID-19 and the additional study-specific precautions.
All research staff must complete the online in-person human subject research training in Canvas. Principal investigators must email [email protected] with a list of the names and email addresses for all research staff, including the principal investigator, to be added to the course.
Principal investigators must complete the application form for in-person human subject research . Once PIs submit this form, they will receive an email with the responses.
- One form will be completed per study, not per individual researcher.
- Faculty advisers must submit the form on behalf of their students who are principal investigators.

Step 2: Submit application responses to Department Head/School Director

Principal Investigators will email their application responses to their Department Head or School Director.
The Department Head/School Director will review the responses to determine if the department/school has sufficient resources for the in-person research procedures.
- Resources can include PPE requirements, face coverings for subjects who do not have them, and cleaning and disinfecting supplies.

Step 3: Submit application responses to Dean

After the Department Head/School Director approves the application, the Department Head/School Director will forward the application responses to the Dean's office.
The Dean's office will review the responses to determine whether or not the study can be conducted with the given space restrictions due to COVID-19.
- Space considerations include sufficient space for physical distancing and traffic flow markings within the buildings.
The Dean's office will email the principal investigator with their response and copy the Department Head/School Director.

Step 4: Submit application to the IRB

Once they receive their email approval from the Dean's office, principal investigators will submit an IRB application for final approval for in-person human subject research.
For existing studies: The PI will submit a modification request in Cayuse IRB to add the following to their previously approved IRB application:
- Enhanced safety procedures due to COVID-19 as outlined in their in-person human subject research application (the google form)
- Information about how they will inform research subjects about the risks of COVID-19, the enhanced safety procedures, and subject requirements to comply with such procedures (e.g., wearing a face covering, health screenings, etc.). This must include information provided to the subject prior to the in-person session and in the consent form.
- Revised study documents, including recruitment information, consent forms, phone scripts, and any additional information provided to the subject
- A pdf copy of the in-person human subject research application responses and the approval email from the Dean's office
For new studies: The PI will submit a new study application in Cayuse IRB. The application must incorporate the following:
- Enhanced safety procedures due to COVID-19 as outlined in their in-person human subject research application (the google form)
- Information about how they will inform research subjects about the risks of COVID-19, the enhanced safety procedures, and subject requirements to comply with such procedures (e.g., wearing a face covering, health screenings, etc.). This must include information provided to the subject prior to the in-person session and in the consent form.
- Pdf copies of the grade reports from the in-person human subject research training for all research staff members.
- A pdf copy of the in-person human subject research application responses and the approval email from the Dean's office
The IRB will review the Cayuse application (modification or new study) for human subject protections
You cannot conduct in-person human subject research without IRB approval

Phases of Research:

The phases for resuming in-person human subject research map onto the phases for reopening on-campus research. During all research phases, COVID-19 safety protocols must be implemented.

EMU is currently in Phase 2 of in-person human subject research.

Investigator Responsibilities:

All research staff must adhere to the following requirements:

Daily self-screening for potential cases of COVID-19
Screening in-person subjects prior to their study visit/appointment for symptoms of COVID-19
Marking research spaces for traffic flow and to ensure physical distancing
Using face coverings as required in the approved application for in-person human subject research
Making sure that research subjects use face coverings to the greatest extent possible. If the human subjects do not have a face covering, the investigator must provide a face covering or reschedule the study visit/appointment
Maintaining physical distancing of at least 6 feet between people at all times unless study procedures require closer contact with subjects. Interactions with subjects that take place at fewer than 6 feet (including direct physical contact) may not last longer than 15 minutes, cumulative, in duration
Using PPE whenever necessary and whenever there is physical contact with the subject
Cleaning and disinfecting all supplies and spaces before and after each study visit/appointment and at the end of the day
Obtaining information from each subject for contact tracing in the event that a subject tests positive for COVID-19 within 72 hours of the study visit/appointment