Georgia Institute of Technology

Updated: February 2, 2021

Page Contents:

1. COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
2. COVID-19: Electronic Consent, Online Data Collection, and Sending and Receiving Materials from Participant's Homes
3. COVID-19: FDA's Guidance for Clinical Trials
4. FERPA Protected Data Research Requirements
5. Exempt IRB Review Procedures
6. Single IRB Requirement
7. New ORIA Office Location

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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 determine how and when non-essential in-person human subjects research can restart. 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 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 11/02/2020)
• GT IRB COVID-19 Pre-Screen Questionnaire/Script (Updated 01/29/2021)
• GT IRB COVID-19 Information Sheet for Human Subject Participants (Updated 01/29/2021)

Center for Advanced Brain Imaging IRB Documents 

• CABI: COVID-19 Safety Policies (Updated 02/01/2021)
• CABI: COVID-19 Day 1 Recruitment Screener (Updated 02/01/2021)
• CABI: COVID-19 Day 2 (24-36 hr.) Recruitment Screener (Updated 02/01/2021)
• CABI: COVID-19 Recruitment Screener for Minors (Updated 02/01/2021)
• CABI: COVID-19 Screener for Day of Study (Updated 02/01/2021)
• CABI: COVID-19 Information Sheet (Updated 02/01/2021)

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:
  • https://esignature.gatech.edu/cfeis/docusign/
  • https://powerforms.docusign.net/3896b491-3144-4c51-a3c2-8f78198e0f2c?env=na3-eu1&acct=7554587e-5afc-4247-8977-071ef5c80e3b
• 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: 
  • https://security.gatech.edu/covid-19-guidance-working-remotely#ApprovedEndpointSoftware
  • https://gatech.service-now.com/continuity?id=kb_article_view&sysparm_article=KB0023604

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.

FERPA Protected Data Research Requirements

A new process has been put in place for requesting the use of Georgia Tech FERPA protected data for research purposes.  Please CLICK HERE to review the document and to see what is now required when requesting the use of FERPA protected data for research purposes.

Exempt IRB Review Procedures

The process for applying for Exempt IRB Review has changed.(Georgia Tech IRB review is still required for all Exempt Research Determinations). When applying for Exempt Review, you are only required to provide specific information, in which the entire submission does not need to be completed (details provided on the Exempt Review page).  To see if your study qualifies for Exempt Review, please use our Submission Decision Tree tool .  An Example of this type of submission can be found on our Example Submission Page.

Please note that what is required is subject to change depending on the specifics of your study.  Additionally, all other requirements that may apply to your study (e.g., required training, certified translation of documents, PI eligibility, etc.) still apply to your Exempt research.

Single IRB Requirement

Effective 1/20/2020: Single IRB (sIRB) policy requirement of 45 CFR 46.114(b) of the 2018 Requirements goes into effect for ALL Federally Funded Human Subjects Research January 20, 2020.

The revised Common Rule (i.e., the 2018 Requirements) requires at 45 CFR 46.114(b) that all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States. Reliance on a single IRB of record in cooperative research is optional before January 20, 2020, even for research subject to the 2018 Requirements. Reliance on a single IRB of record in cooperative research is required beginning January 20, 2020, unless the study meets the criteria for an exception described in §46.114(b)(2) of the 2018 Requirements.

You may read more on this requirement here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html

New ORIA Office Location

The administrative offices for both IRB Commitees has moved from the Research Administration Building to the Dalney Street Building.  Our new address is listed below:

Office of Research Integrity Assurance

Institutional Review Boards

Georgia Institute of Technology

Dalney Street Building

926 Dalney St, NW Atlanta, GA 30318