Updated: December 6th, 2018
- Preparing for the Implementation of the Revised Common Rule Policy for the Protection of Human Subjects
- Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC) and Clinical Trial Definition
- Notice of the EU GDPR - Effective May 25, 2018
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 note: at this time, the revised 2018 Common Rule does NOT apply to FDA-regulated or human subjects research supported by the Department of Justice. 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”:
- Georgia Tech will not implement the Broad Consent option for storage and secondary research of identifiable private information or biospecimens;
- 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,
- 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 email@example.com to request training.
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.
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:
- EU GDPR website
- Institute GDPR Compliance Policy
- GT's Institutional Review Board EU GDPR Privacy Notice
- GT's Institutional Review Board EU GDPR Consent Form for Sensitive Personal Data
- Researcher’s EU GDPR Human Subjects Research Data Protection Regulation Privacy Notice