On the new Protection of Human Subjects site, you can find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, resources, and updated information on the revised human subject regulation (Common Rule).
For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.
NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)
NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050. The effective date for the amended regulation is January 21, 2019. It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019).
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on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions
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. ….