COVID-19 Guidance for Resuming Face-to-Face Human Subjects Research Activities
As Illinois moves into the Recovery Phase (Phase 3) of the COVID-19 response, NIU has developed some guidance to assist researchers who conduct human subjects research activities. The Office of Research Compliance, Integrity, and Safety (ORCIS) is following President Freeman's general guidance on return to campus activities. The gradual shift in operations is based on scientific evidence and the desire to protect the safety of NIU faculty, staff, students, and the larger research community.
Below, ORCIS lays out guidance for researchers who are considering returning to face-to-face data collection with human research participants. Those who would like to resume in-person data collection are asked to create a “Request to Resume F2F” submission within the existing InfoEd protocol record in order to submit a very brief application. Please use these instructions for assistance with creating the submission.
- Face-to-face data collection is permissible although discouraged
- Face-to-face data collection must follow state, local, and university guidelines for human interaction
- If on campus
- No more than two people may be in a room (e.g., waiting room, lab) with social distancing at a given time
- Proper PPE (e.g., masks, gloves) is required if contact is necessary as part of data collection
- If off campus
- Follow local guidelines at established settings (e.g., clinics, schools, prisons)
- Data collection in the general community (not established settings) is still on pause
- If on campus
- All researchers who can continue with remote data collection are asked to do so.
- Be aware of the impact of conducting face-to-face research.
- Is it possible to conduct the study remotely?
- Will an external site (if relevant) allow the research to take place?
- How will the study be impacted if participants become quarantined after the initial meeting?
- If some participants contract the virus, how would the study be impacted?
- This is a fluid situation; therefore, it is important to check the RIPS website regularly for possible changes to this guidance.
Verbal or written pre-screening is required prior to face-to-face contact with participants on campus. Adding a screening to a protocol does not require IRB approval.
Researchers will need to ensure that participants:
- have not received a diagnosis of COVID-19 in the past 14 days.
- have not had close contact with someone with a lab confirmed COVID-19 diagnosis in the past 14 days.
- do not exhibit any of the following COVID-19 symptoms:
- shortness of breath or difficulty breathing.
- repeated shaking with chills.
- muscle pain.
- sore throat.
- loss of taste or smell.
- fever (temperature of 100 or greater).
Research with participants who fall into one of the following high-risk categories should only occur remotely:
- adults over the age of 65.
- research involving any of the following as inclusion criteria:
- chronic kidney disease treated with dialysis.
- chronic lung disease.
- hemoglobin disorders.
- liver disease.
- people in nursing homes or long-term care facilities.
- serious heart conditions.
- severe obesity.
Required Precautions When Conducting Face-to-Face Data Collection
- Self-screening: researchers should be aware of their own symptoms and exposure.
- Wear masks – labs must provide masks and gloves to participants if requested.
- Social distancing – maintain a distance of 6 feet (unless the research requires brief contact).
- Gloves are required if there is direct contact with participants.
- Schedule sessions so that participants do not overlap.
- Sanitize research area and equipment after each participant.
- Wash and sanitize hands frequently.
Researchers must keep a list of all participants who came to their lab and who interacted with them.
Research Conducted in External Settings (not on NIU campus)
Researchers collecting data from human participants at established institutions (e.g., clinics, schools, prisons) must follow the external institution's policies for interactions with others.
Research in non-institutional or community settings is not permissible at this time.
Requesting IRB Persmission to Resume Face-to-Face Data Collection
The request form can be accessed with the InfoEd system using the following steps:
- Go to the InfoEd Submission Portal.
- Select "Click Here" to login with your NIU credentials (on the left-hand side of the screen).
- Enter your NIU username and password, if prompted.
- Click on "Locate My Records" in the top navigation bar.
- Find the protocol regord associated with the proejct that you would like to resume. Hover over the record number, slide over to "Edit" and select "Master Record."
- You should land on the "Submission Summary" page. Use the dropdown menu next to the "Add" button to select the "Request to Resume F2F" from the list. Then click "Add."
- Select the "Request to Resume Face-to-Face Data Collection" document under the "Document/Form" heading.
- Complete the document with sufficient detail.
- When you are ready to submit the document, click "Complete" and then "Close."
- Select "Submit" (on the right side of the screen).
The document will be sent to the ORCIS office for review. You will hear back from the IRB via email. Refrain from beginning face-to-face data collection until you receive confirmation from the IRB that the project may resume.
Please contact Patty Wallace (firstname.lastname@example.org) in ORCIS with any questions.