Archived IRB News and Updates

Updated: January 19, 2024

Page Contents:

  1. FDA Final Guidance on Informed Consent
  2. New Single Sign-On (SSO) Requirement for CITI Training
  3. New Procedures to Comply with the People's Republic of China (PRC) Personal Information Protection Law
  4. New Review Procedures for Research Taking Place at the CABI
  5. COVID-19: Georgia Tech Human Subjects Research IRB Guidance for Non-Essential In-Person Restart of Research
  6. COVID-19: Electronic Consent, Online Data Collection, and Sending and Receiving Materials from Participant's Homes
  7. FERPA Protected Data Research Requirements
  8. Exempt IRB Review Procedures
  9. Single IRB Requirement
  10. New ORIA Office Location
  11. Preparing for the Implementation of the Revised Common Rule Policy for the Protection of Human Subjects
  12. Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC) and Clinical Trial Definition
  13. Notice of the EU GDPR - Effective May 25, 2018

Click here for current news and updates

FDA Final Guidance on Informed Consent

The FDA has released Final Guidance on Informed Consent for the consent process during clinical investigations involving FDA regulated products. This document details requirements and responsibilities for investigators, sponsors, and IRBs. Additionally, this document provides guidance, examples, and FAQs regarding multiple topics that are relevant to Georgia Tech clinical investigations. It is highly recommended to review this document when preparing your informed consent prior to submitting to the IRB for review and approval if your study is investigating an FDA regulated product.

 

New Single Sign-On (SSO) Requirement for CITI Training

Effective May 8th, 2023: To access the CITI training website, all users (both GT and non-GT) will need to use the GT Single Sign-On (SSO) process. GT users will need to use this link to access CITI. Non-GT users will have to use an existing GT affiliation in CITI or will have to request a GT guest account so they can obtain CITI access and affiliate with GT. To request a guest account, please go to the Responsible Conduct of Research website and click "Submit Request for Georgia Tech CITI Access."

 

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.

 

New Review Procedures for Research Taking Place at the CABI

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. 

Recent Updates: ​

  • 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:

Documents for Research Taking Place at Georgia Tech

Documents for Research Taking Place at the Center for Advanced Brain Imaging (CABI)

 

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

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

 

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

 

Preparing for the Implementation of the Revised Common Rule Policy for the Protection of Human Subjects

These changes are federally mandated by the U.S. Department of Health & Human Services (DHHS) and are the first complete overhaul of the human subjects protection regulations in 25 years.

*Implementation Date: January 21, 2019

Read the April 2018 NPRM in the Federal Register.

Please see this list of Federal Agencies who have agreed to comply with 2018 Common Rule. Any human subjects research conducted involving these agencies must comply with the regulations outlined in the 2018 Common Rule.

Please note: at this time, the revised 2018 Common Rule does NOT apply to FDA-regulated human subjects research. The FDA intends to harmonize its policy with the DHHS policy in the future.

What does this mean for GT researchers?

The regulatory changes were designed to reduce administrative burden and to enhance the protection of human subjects. The GT Human Research Protection Program is working hard to implement the revised regulations in time to comply with the implementation requirement date of January 21, 2019.  The revisions include changes to the IRB Portal (IRBWise), policies, procedures and forms.  There are specific changes that will impact the GT research community. 

The following have been adopted as Georgia Tech Institutional Policy and Procedure regarding the revised 2018 Common Rule “options”:

  1. Georgia Tech will not implement the Broad Consent option for storage and secondary research of identifiable private information or biospecimens;
  2. Georgia Tech will continue to apply the Common Rule regulations (45 CFR 46) to ALL human subjects research, even if the research is not federally funded; and,
  3. Georgia Tech will continue to verify grant congruency of human subjects research protocols. This shall be carried out by the ORIA IRB office.

Additional changes affecting the GT research community are described below.

New Exempt Categories

The Pre-2018 Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The revised 2018 Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 21, 2019, benign behavioral interventions conducted with adults may be determined to be exempt. Also, the collection of identifiable, sensitive information from adults may be determined to be exempt; however, this new category requires a limited IRB review by an IRB member to determine that appropriate privacy and confidentiality protections are in place.  Submission to the IRB office to obtain the exempt determination is still required.

Continuing Review Changes

Most minimal risk research will no longer require annual continuing review (renewal). A general progress report will be requested every three years after initial approval but research activities can continue as approved without waiting for the IRB to acknowledge the report.  Such projects will not be assigned an expiration date unless a justification for continuing renewal exists. This will be determined by the IRB. Examples of justifications for continued annual review would include such research as (but not limited to): research with specific vulnerable populations, research that is greater than minimal risk, and FDA regulated research.

Consent Form Changes

Consent forms must begin with a concise and focused presentation summary of the key information that is most likely to assist in understanding why one might or might not want to participate in the research. Consent forms must now include information regarding the potential for future use of de-identified data and biospecimens. A new consent template containing the key information summary information has been posted under the Forms button on ORIA’s IRB website.  This consent form can alos be found here.

New Policies and Procedures

We have written new Policies and Procedures to reflect the changes made in the 2018 New Common Rule and how they apply to human subjects research at Georgia Tech. These Policies and Procedures went into effect on 01/21/2019.  Please use the following link to access this document: Policies and Procedures for Revised 2018 Common Rule.

Transition to the Revised Federal Policy for the Protection of Human Subjects (aka New Common Rule)

All current and ongoing human subjects research will continue under the Old Common Rule (pre-2018 Rule) and the old GT Policies and Procedures until the study has officially concluded or has hit the GT maximum four year limit on continuing annual renewals. There will be no conversion of ongoing research to the New Common Rule.

All new IRB protocol submissions submitted on January 21, 2019 and after will be subject to the new Revised Common Rule changes and a new IRBWise application.

IMPORTANT! PLEASE NOTE:  ANY IRB PROTOCOL APPLICATION THAT WAS SUBMITTED PRIOR TO JANUARY 21, 2019 AND HAS NOT RECEIVED IRB APPROVAL PRIOR TO THAT DATE WILL BE NULL AND VOID AND A NEW IRB APPLICATION SUBMISSION WILL BE NEEDED to remain in compliance with the new Federal Policy. In order to manage this transition given the volume of initial IRB protocol submissions, ORIA and the IRB are requesting a temporary freeze on all initial minimal risk IRB protocol submissions at 12am on January 7th, 2019 until 8am January 21, 2019. Please keep in mind that any minimal risk initial IRB protocol submissions submitted on or after this date of January 7th that do not receive approval by the implementation date of January 21, 2019, will need to have a new IRB protocol application submission as the old IRBWise application will no longer be viable. ORIA and the IRB will be diligently working to complete all reviews on protocols that are submitted prior to the freeze period in order to get them completed and approved prior to the January 21, 2019 implementation date. These protocols will be grandfathered in under the old Common Rule Policies.

We ask in advance for the GT research community to work with us during this complex transition period. We will be working hard to get your research projects approved by the implementation date for those that would like to remain under the old Common Rule Policy. All amendments, protocol deviations, AE’s, etc. will be accepted and reviewed as normal. The transition only applies to new IRB protocol submissions. We will work individually with researchers on a case-by-case basis to manage submissions with special circumstances (ie. Funding/Sponsor deadlines).

Training links are available to the research community below and are accessible from the ORIA IRB website. ORIA’s IRB office is available to provide training to the research community on the new Revised Common Rule Policy. Please contact irb@gatech.edu to request training.

Learn More

The revised 2018 Common Rule can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

Revised 2018 Common Rule OHRP Training Videos:  https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-videos/index.html

Additional resources can be found on the CITI site at https://about.citiprogram.org/en/final-rule-resources/#irbimpact and https://about.citiprogram.org/en/final-rule-resources/#overview

 

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC) and Clinical Trial Definition

Under the new policy, as of October 1, 2017, NIH-funded researchers will no longer have to request a CoC, nor will they receive an actual certificate. The CoC will be issued automatically to NIH-funded grants, cooperative agreements, contracts and intramural research projects funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy.

More information on Certificates of Confidentiality 

Investigators who will be seeking NIH support of clinical trial should review the new and pending NIH policies including: the NIH Definition of a Clinical Trial the Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov requirements for Good Clinical Practice Training, and the Single IRB Policy for Multi-site Research.

 

Notice of the EU GDPR - Effective May 25, 2018

What is the EU GDPR and when does it take effect?

The European Union General Data Protection Regulation (“EU GDPR”) 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 European Union.  This regulation applies both inside the European Union (“EU”) and outside of the EU, and applies to data about anyone in the EU, regardless of whether they are a citizen or permanent resident of an EU country.

The regulation took effect on May 25, 2018.

What information is subject to the EU GDPR?

The EU GDPR applies to the control or processing of ‘personal data,’ which is defined as:

Any information relating to an identified or identifiable natural person (the data subject); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, psychological, genetic, mental, economic, cultural or social identity of that natural person.

Examples of identifiers include but are not limited to: name, photo, email address, identification number such as GT ID#, GT Account (User ID), physical address or other location data; IP address or other online identifier.

What does this mean to YOU as a GT researcher?

If you obtain personal data about any human subject or research collaborator located in the European Union, this policy applies to your research.

Please refer to the following links for further details: