August 1, 2018

Click Unavailable Friday, August 3 at 5:00 P.M. until Saturday, August 4 at 8:00 P.M.

The Click™ Research Compliance System will be unavailable on Friday, August 3 at 5:00 P.M. until Saturday, August 4 at approximately 8:00 P.M. for planned maintenance. During this time, you will not be able to log into Click.  When Click becomes unavailable on Friday, August 3 at 5:00 P.M., all individuals working in the system will lose access and will be automatically kicked out of Click. If you are working in Click on Friday afternoon before 5:00 P.M., please be sure to save your work prior to 5:00 P.M.

Revised Human Research Protection Rule Delayed until 2019

What?

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 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).  Please note this does not apply to research regulated by the U.S. Food and Drug Administration or the Department of Justice.

When?

The Final Rule delays the general compliance date of the revised requirements for an additional 6-month period until January 21, 2019.  Institutions cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019. As a result of this delay to the general compliance date, institutions will be required, with an exception, to continue to comply with the current requirements of the Common Rule until January 21, 2019.

Exception?

The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the revised requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:

(1) The revised definition of “research,” which deems certain activities not to be research;

(2) The allowance for no annual continuing review of certain categories of research; and

(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the revised requirements beginning on January 21, 2019.

MSU’s Implementation Plan?

MSU is working on implementation plans and at this time, the three burden reducing provisions have not yet been implemented. This means that MSU continues to comply with the current requirements. More information will be provided on MSU’s implementation plans.

The Final Rule to delay the compliance date can be accessed at: https://www.federalregister.gov/documents/2018/06/19/2018-13187/protection-of-human-subjects-delay-of-general-compliance-date.