Final Rule Changes: Delayed until July 19, 2018
Substantial revisions to the federal regulations for the protection of human participants in research (Common Rule) will take place on July 19, 2018. These changes will apply to all new studies submitted for IRB determination or review on or after July 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 UGA researchers?
The regulatory changes were designed to reduce administrative burden and to enhance the protection of human subjects. The UGA Human Research Protection Program is working to implement the revised regulations. The revisions will include changes to the IRB Portal, policies, and some procedures. There are some specific changes that may be of interest to many UGA 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 July 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.
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
Information about the delayed effective and compliance date can be found at https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html and https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00997.pdf
How Do I Report an Adverse Event?
The Principal Investigator (PI) bears direct responsibility for the implementation and conduct of the research and for ensuring the protection of human research participants. The PI must promptly report any unanticipated problems or incidents involving risks to subjects or others to the IRB.
Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious (see below), must be reported to the IRB by submitting a Report of New Information in the e-portal (irb.ovpr.uga.edu) within 72 hours of any member of the investigative team becoming aware of the event. You also should notify the chair of the department.
If you have any questions, please contact the HSO at 542-3199.