OHRP Announces Availability of Three Draft Guidance Documents Related to Revised Common Rule

As you may recall, NIH issued guidance for implementing the burden-reducing provisions of the 2018 Common Rule (NOT-OD-18-211). Subsequently on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions Continue reading

Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules. …. Continue reading