The Office of Human Research Protections (OHRP) has announced major changes to the federal regulations that protect the rights and welfare of human research participants, known as the Common Rule. Major changes to the Common Rule (45 CFR 46 subpart A) were issued by the Department of Health and Human Services (DHHS) on January 18, 2017. The majority of changes will go into effect on January 19, 2018
*WHAT YOU CAN EXPECT*
No longer required for some minimal risk research, including studies where the only remaining activity is analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
Please note: Investigators are responsible for submitting the 2018 Continuing review for each study. If the continuing review is not submitted by the due date, the study will lapse and will not be eligible for the new regulation. Please do not submit an amendment to obtain a determination from the IRB before the continuing review due date.You can expect to see the following changes over the next month:
*WHAT YOU CAN DO*
*DECISIONS MADE TO DATE*
Exemptions – AU has decided to adopt the “limited IRB Review” under exemption #2 only.
sIRB - AU IRBs will continue to assess its criteria for whether AU will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.
Broad Consent - AU is determining if use of broad consent will e adopted under exemptions 7 & 8.
Any changes made to IRBNet documents will still be housed in the IRBNet system under Forms and Templates.