Updated: April 30, 2021
Page Contents:
- COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
- COVID-19: Electronic Consent, Online Data Collection, and Sending and Receiving Materials from Participant's Homes
- COVID-19: FDA's Guidance for Clinical Trials
Click here for older news and updates (archives)
COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
The following guidance documents are to be used to for all non-essential in-person human subjects research. ALL researchers and human subject participants involved in non-essential in-person research are to use the screening documents prior to performing research activities. The information sheets listed below are to be given to ALL in-person human subject participants during the informed consent procedure. Please contact the Office of Research Integrity Assurance if you have any questions.
Recent Updates:
- As of 03/29/2021, all in-person research, including minors, may resume on campus and in-person.
- As of 10/30/2020, minors can be enrolled in in-person research at the CABI as long as the following procedures described below in the revised documents are followed.
- As of 10/30/2020, adults who are classified as being vulnerable to COVID-19 according to the CDC may enroll in in-person research as long as the following procedures described below in the revised documents are followed.
Georgia Tech Central IRB Documents
- GT IRB Guidelines: Resuming Non-Essential In-Person Humans Subjects Research (Updated 03/22/2021)
- GT IRB COVID-19 Pre-Screen Questionnaire/Script
- GT IRB COVID-19 Information Sheet for Human Subject Participants (Updated 03/22/2021)
Center for Advanced Brain Imaging IRB Documents
- CABI: COVID-19 Safety Policies
- CABI: COVID-19 Day 1 Recruitment Screener
- CABI: COVID-19 Day 2 (24-36 hr.) Recruitment Screener
- CABI: COVID-19 Recruitment Screener for Minors
- CABI: COVID-19 Screener for Day of Study
- CABI: COVID-19 Information Sheet
COVID-19: Electronic Consent, Online Data Collection, and Sending and Receiving Materials from Participant's Homes
If you need to make any changes to your study due to COVID-19, then please submit an amendment for your study as soon as possible.
Electronic Signatures for Consent and Approved Online Software
- Electronic Signatures may be used in lieu of hand written signatures for consent. If this will be done, then you will need to use DocuSign to officially document the consent process. It is recommended that you use a DocuSign PowerForm, where you can create a standard form signature that you can link to your survey. Additionally, the PI will need to apply to be a DocuSign admin via esignature.gatech.edu. More information can be found on the following websites:
- Online data collection (e.g., surveys, interviews, focus groups) may be conducted while using one of the following Georgia Tech approved platforms: Qualtrics, Web Ex, Blue Jeans or Teams. More information can be found on the following OIT websites:
At-Home Interventions
- If you intend to ship products and/or interventions related to human subjects research during this situation , Georgia Tech recommends the following process/order (approved by EH&S):
- Wipe/spray item with EPA- approved disinfectant and allow items to air dry
- Wash hands
- Pack items to ship
- Ship items
COVID-19: FDA's Guidance for Clinical Trials
The Food and Drug Administration (FDA) has released guidance on how clinical trials shall be conducted during the COVID-19 pandemic. Please CLICK HERE to read the guidance and see how this may impact your clinical trial.
