Strings Attached to Burden-Reducing Parts of Research Rule?

Research institutions want to make sure new options to cut paperwork don’t inadvertently cause more headaches once new regulatory requirements kick in next January.

The Health and Human Services Office for Human Research Protections plans to release the first-ever draft guidance document on revisions to the human subject protection regulations known as the Common Rule (45 C.F.R. 46). This draft guidance will address three “burden-reducing provisions” research institutions can adopt as of July 19, about six months ahead of the effective and compliance dates of the revised rule itself.

But adopting any of those burden-reducing provisions within ...