News

Protecting research participants is the responsibility of everyone within an organization and is not limited to the Institutional Review Board (IRB). The Human Research Protection Program (HRPP) committee has a mission to collaborate in the development, coordination, and evaluation of the University’s HRPP.

Based on feedback from the research community and recent regulatory changes, we have updated and enhanced several HRPP Toolkit documents.

On January 19, 2018, changes to regulations for protecting human research participants (also known as the revised “Common Rule”) were scheduled to take effect. We learned on January 17 that the revised Common Rule will be delayed for six months. The new compliance date is now July 19, 2018.

A significant revision to the Common Rule, also known as the Federal Policy for the Protection of Human Subjects, will go into effect on January 19, 2018.

The NIH sIRB policy is effective for NIH grant applications with due dates on or after January 25, 2018. For contracts, the policy applies to all solicitations issued on or after January 25, 2018. At this time, the University of Minnesota is not agreeing to serve as the sIRB, though this may change in the future.

We have noticed an uptick in the number of approval lapses due to a failure to submit continuing review materials in advance of study expiration. We recognize this is a period of tremendous change and want to ensure that research teams are aware of and have the information and resources needed to ensure compliance with continuing review requirements.

Effective October 1, 2017, written reports of study monitors will require central filing with the Post Approval Review (PAR) program of the HRPP and no longer require mandatory submission to the IRB.

This month we will begin the process of migrating over 2,400 existing, active biomedical studies to ETHOS. Over the past few weeks, the IRB has received several questions about the process. 

Basic information about a study, including the study title, approval and expiration dates, and study team information will be converted from the old system to ETHOS. 

The IRB receives frequent requests for guidance on who should be identified as research personnel for IRB submissions. In preparation for the launch of the smart-form in ETHOS, the IRB has developed guidance on who should be listed in IRB submissions.