Updated: February 2, 2022
- New Procedures to Comply with the People's Republic of China (PRC) Personal Information Protection Law
- New Review Procedures for Research Taking Place at the CABI
- COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
- COVID-19: FDA's Guidance for Clinical Trials
New Procedures to Comply with the People's Republic of China (PRC) Personal Information Protection Law
The People's Republic of China (PRC) Personal Information Protection Law (PIPL) is a new and more stringent regulation governing the use of personal data. It imposes new obligations on entities that control or process personal data about people who are located in the China. This regulation applies both inside China and outside of China, and applies to data about anyone in China, regardless of whether they are a citizen or permanent resident of China.
To comply with this new law when conducting human subjects research in China, the following consent form listed below must be completed by the participants who are in China in addition to your own consent form. Additionally, your study submission must provide details about recruiting individuals in China, what will be done with their data, and how you will direct these individuals to complete this additional consent form.
- Please refer to the following links for further details:
The Joint GSU-GT CABI IRB is no longer the reviewing IRB for all research taking place at the Center for Advanced Brain Imaging (CABI). Effective as of June 1, 2021, research taking place at the CABI will be reviewed by the Principal Investigator’s (PI) home institution. Therefore, Georgia Tech researchers will submit for IRB review and approval to the Georgia Tech IRB. All non-Georgia Tech researchers will need to reach out to their own IRB to determine who should review their research taking place at the CABI. Please see our Research Taking Place at the CABI page for more information in regards to this new process.
COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
The Georgia Tech response to COVID-19 has been revised as of May 10th, 2021. The GT IRB Guidelines for Resuming Non-Essential In-Person Human Subjects Research is no longer in effect. Additionally, the screeing questionnaire and the use of the information sheet are now only recommended and are no longer required for non-essential in-person research. Please see the Addtional Guidance section below for the current campus safety precautions that are still in place (e.g., mask wearing, social distancing, etc.).
For non-essential in-person research taking place at the Center for Advanced Brain Imaging (CABI), all of the previous guidelines and requirements are still in place and the safety policies are still in effect. Therefore, ALL researchers and human subject participants involved in non-essential in-person research at the CABI are to use the screening documents prior to performing research activities. The information sheet listed below is also to be given to ALL in-person human subject participants during the informed consent procedure at the CABI.
Please contact the Office of Research Integrity Assurance if you have any questions.
- As of 05/10/2021, face coverings are only required for unvaccinated individuals and additional revisions to social distancing and campus cleaning procedures have been made. Please see the guidance below.
- 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.
Additional Guidance Regarding Georgia Tech's COVID-19 Response:
- Georgia Tech Research - Research Ramp Up
- Georgia Tech Research - Covid-19 Institute Operations Updates
Documents for Resarch Taking Place at Georgia Tech
- GT IRB Guidelines: Resuming Non-Essential In-Person Humans Subjects Research (Archived - no longer in effect)
- GT IRB COVID-19 Pre-Screen Questionnaire/Script (Recommended for use)
- GT IRB COVID-19 Information Sheet for Human Subject Participants (Recommended for use)
Documents for Research Taking Place at the Center for Advanced Brain Imaging (CABI)
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.