Updated: December 6, 2017
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.
Federal Policy for the Protection of Human Subjects (New Common Rule)
Final Rule Changes coming January 19, 2018
Substantial revisions to the federal regulations for the protection of human participants in research (Common Rule) will take place on January 19, 2018*. These changes will apply to all new studies submitted for IRB determination or review on or after January 19, 2018. Please note: the revised Common Rule does NOT apply to FDA-regulated or human subjects research supported by the Department of Justice.
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 to implement the revised regulations. The revisions will include changes to the IRB Portal (IRBWise), policies, and some procedures. There are some specific changes that may be of interest to many GT researchers. These changes are described below.
New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 19, 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 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
Some minimal risk research will no longer require continuing review (renewal). A general progress report will be requested at a period determined by the IRB during initial review 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.
Consent Form Changes
Consent forms must begin with a concise and focused presentation 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.
The revised Common Rule can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
Additional resources can be found on the CITI site at https://about.citiprogram.org/en/final-rule-resources/#irbimpact
*A one-year delay for the general implementation of the Common Rule was proposed on October 7. This delay is currently being reviewed by the U.S. Office of Management and Budget. We will provide any updates about the implementation date and further details as soon as they are known.