Guide on Restarting Face-to-Face Human Subject Research
This guide has been developed to assist researchers needing to resume or start in-person human subject research at Florida Tech beginning August 10, 2020. IRB approval is contingent upon there being no remote alternative and with appropriate safety precautions in place. If there is a possibility for the study to be conducted remotely, IRB strongly urges these studies not be opened up for face-to-face interactions. The primary concern of IRB is to ensure safety of research participants and investigators. Maintaining the scientific integrity of research protocols is a secondary concern.
Those studies that were already issued an IRB approval prior to the pause of research due to COVID-19 i.e. prior to April 3rd 2020 and are now wanting to resume the same study, will first need to submit a Revision Request Form to IRB. In this form, researchers will need to describe amendments to their existing protocol (both research design and data collection procedures) to facilitate social distancing, health screening, regular disinfection of commonly shared surfaces, and use of personal protection equipment. For instance, if the research design was approved for a group setting but now needs to move to an individual setting, these changes need to be described in the revision request form. In general, investigators will need to establish that they have sufficient measures in place to reduce contamination or spread of Coronavirus and that the study cannot be performed remotely.
IRB applications needing to initiate new in-person research beginning August 10th can continue to use the exempt/expedited/full forms depending on the nature of their study. Researchers will need to describe clearly all measures in place to mitigate risks due to COVID-19. In the IRB application form, researchers will need to establish that they have sufficient measures in place to reduce contamination or spread of Coronavirus (social distancing, health screening, regular disinfection of commonly shared surfaces, and use of personal protection equipment) and that the study cannot be performed remotely.
The following considerations should be taken into account when (re)designing research to enhance the safety of research participants and investigators.
- If research can be conducted at a site where six feet of social distance can be maintained among research participants and investigators, such a change is strongly encouraged. Researchers can either take their in-room study outside in a field or can minimize the number of total number of people present in a room at any given point to maintain the 6 feet distance. In cases where 6 feet social distancing is not feasible, a mask, gloves and eye protection should be used.
- Researchers must screen participants on a daily basis (via phone) using a COVID-19 exposure questionnaire before any in-person interactions are made. Please reference this Screening Questionnaire Template.
- Only schedule in-person procedures with participants that pass the screening questionnaire or are presumed to be COVID-19 negative.
- Entry to research site should be limited to only those directly involved in the research.
- Sign in logs can be used to keep a track of all researchers, research assistants, and participants interacting among each other. The log can include details on date and time of interaction, and whether the individual’s temperature was in the normal range. This log can be useful in performing contact tracing, if needed.
- Enforce masks (bilayer cloth or standard surgical mask) and gloves if individuals are required to be present in proximity. This enforcement should be clearly stated in the informed consent. Investigators are responsible for supplying masks and gloves to any research subject without a mask. Please note that while researchers can mandate wearing a mask, the decision to participate shall be voluntary and not coerced.
- Researchers and research participants should wash hands or use a hand sanitizer at regular intervals. For this, it is the researcher’s responsibility to ensure hand sanitizer and/or hand washing facilities are readily available.
- Researchers should establish clear protocols on regularly disinfecting and sterilizing equipment, study materials, and any other commonly used areas (e.g., door handles after each use) with EPA approved disinfectants. More information about recommended disinfectants is available on EPA.gov.
- All informed consent forms will need to be revised to include a section describing what COVID-19 precautions researchers are taking and what participants can expect relative to those precautions. Researchers can also opt to use the Florida Tech Safe - Return to Learn Plan safety guidelines to inform the participants about policies and procedures in place to enhance everyone’s safety.
- Direct traffic in labs or research sites that have two entry doors using an “enter only” and “exit only” sign on the doors. When there is only one door, a “knock-knock” policy can be used to ensure social distancing through the doorway.
- Where possible, post educational, pathways, social distancing, and/or hygiene signs, which may be readily downloaded from the Florida Tech website.
- Data collection can be held in person. However, debriefings or any other type of meetings should be held online via Zoom, phone or Skype wherever possible.
- Researchers must ask participants to sign a Declaration of Compliance to ensure all human subjects will comply with the study’s COVID-19 protective measures. Researchers can edit this template as needed.
- All researchers needing to start new studies or resume previously paused face-to-face research are strongly encouraged to complete a CITI Program course called COVID 19-Back to Campus (Fall 2020). This course is optional, not mandatory. Upon completion of the course, a completion certificate will be generated and emailed to you for your records. Read detailed instructions on accessing the CITI course and printing out the completion certificate.
For any questions or concerns, please contact the IRB chair, Dr. Jignya Patel.