COVID-19 Guidance for Human Subject Research
UPDATE: Researchers are no longer required to submit mitigation plans for conducting in-person human subject research. In addition, ORED is no longer providing PPE or reimbursing for PPE for COVID-19 mitigation purposes.
Conducting Research with Human Subjects
Researchers should continue developing protocols that have flexibility for conducting activities remotely whenever possible. Activities that can be conducted remotely include, but are not limited to:
- Screening of Participants
- Verbal Consent or Online Consent
- Online Surveys and Questionnaires
- Interviews and Focus Groups via Teleconferencing
- Online Storage of Data and Documents
As a reminder, all modifications to existing projects need to be submitted to the IRB for review and approval prior to implementing the proposed modifications.
Please note that placing a research project on hold does not require an IRB amendment (and will not be considered as a protocol deviation). However, IRB protocols that have been placed on hold will still need to be renewed by the IRB prior to the protocol’s expiration date.
The IRB currently allows for the following encrypted platforms to be used for video conference calls with research participants: Zoom, Skype, WhatsApp, and FaceTime.
Security Tips for Using Zoom:
- When scheduling your meeting
- During your meeting:
- Remove and or manage participants.
- Lock your meeting once all your participants have joined to avoid uninvited guests.
- Keep control of your screen. Currently this is a default setting for your FIU Zoom account, but if you need to allow someone to share their screen, you can do so by making them a co-host.
- If recording videos, avoid using the Zoom Cloud Recording Storage. Instead use the Local Storage option, which stores the recordings on your own device (i.e., laptop or computer).
- More tips here:
Maintaining Anonymity with Zoom:
- For the Host
- Go to Zoom Settings section. Under the Telephone subtab: Enable Mask phone number in the participant list.
- When scheduling a meeting, turn off “video” for participants.
- For the Participant
- When the participant joins a Zoom meeting, they will see a screen “Join a Meeting.” and a box with their name in it. They can change their name in the box before joining a meeting to maintain anonymity.
Payments to Participants
The FIU Office of the Controller and ORED have developed new procedures for allowing the use of Zelle, Venmo or e-gift cards for research participant compensation. Please note that you will need to amend your IRB approval if you wish to use this new method for compensating subjects.
When amending your IRB submission, you will need to consider the following confidentiality issues in both your protocol and Consent Form:
- If Zelle is used as a payment method, then you will need for the participant to provide you with their email address or phone number.
- If Venmo is used as a payment method, then you will need the participant’s Venmo username.
- Researchers will be required to keep a log of the transaction numbers that are generated by the respective payment systems and match those up with a document that contains the participant ID number for record keeping.
If you have any questions about this new payment mechanism, please contact your Post-Award Administrator.
Other COVID-19 Resources
- ORED COVID-19 Resource Page
- NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency