CPHS Policy for the Revised Federal Policy for the Protection of Human Subjects

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies have issued a Final Rule to delay for an additional six months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule – 45CFR46) making the general compliance date of the 2018 Requirements now effective on January 21, 2019.

Background

This policy was originally promulgated as a Common Rule in 1991, and was revised on January 19, 2017 (82 Fed. Reg. 7149) (the revised Common Rule is also known as the “2018 Requirements”). The effective and general compliance date for the 2018 Requirements was delayed to July 19, 2018 by an interim final rule that was published on January 22, 2018 (83 Fed. Reg. 2885). Subsequently, a Notice of Proposed Rulemaking (NPRM) was published on April 20, 2018 (83 FR 17595), which proposed an additional six-month delay for the general compliance date for the 2018 Requirements making the general compliance date of the 2018 Requirements final and now effective on January 21,2019.

The University of California, Berkeley, consistent with other campuses in the University of California System, has developed an implementation plan to accommodate the changes and provisions of the revised Common Rule that will go into effect on January 21, 2019. The Committee for Protection of Human Subjects (CPHS) and the Office for Human Subjects Protection (OPHS) will be disseminating these plans shortly. Investigators who conduct human subjects research should be attentive to email notices from OPHS and postings on the CPHS website regarding the upcoming changes.

Upcoming NIH Mandate: T32, TL1, T90/R90, and T15

The National Institutes of Health has announced that they will be mandating data tables in training grants and progress reports for the following activity codes: T32, TL1, T90/R90, and T15.

These data tables are to be created using the xTRACT system.

NIH principal investigators and their assistants are encouraged to become familiar with this system, which is accessed via the eRA Commons, before it becomes a proposal/report requirement.

xTRACT is designed to make it simpler for applicants and grantees to create training tables required for training grant applications and progress reports to NIH, as this system is designed to replace the current laborious method of creating the tables in free form in Word format. Automation should significantly reduce workload.

For more information, see Advance Notice of Transition to the xTRACT System for Preparing Research Training Data Tables (NOT-OD-18-133).