Standard Operating Procedures

New NJH HRPP SOPs January 2019

In January of 2017, the US Department of Health and Human Services (HHS) published the Final Rule, which is a revised version of the Common Rule (45 CFR 46) first published in 1991 and last amended in 2005. After some delays, it is anticipated that the new Final Rule will be implemented with a general compliance date of January 21, 2019.

Please note that our revised Standard Operating Procedures, incorporate these changes and are effective on January 21, 2019.

Within the SOP, the 1991 Common Rule will be referred to as the “Pre 2018 Rule.” The new version will be referred to as the “2018 Rule.

Download HRPP SOPs

 

For studies approved on or before January 20, 2019

Download July 2018 HRRP SOP

Download Data Handling & Disposal SOP (updated 24 Oct 2018)