AMIA Statement on Delayed Human Subjects Rule

Thursday, April 19, 2018

The following statement was released today by Jeff Smith, MPP, Vice President of Public Policy, AMIA, in regards to the delayed Human Subjects Rule by HHS:

AMIA does not support this NPRM as written. The decision to set an effective date of July 2018 for only the “three burden-reducing 2018 Requirements” leaves in place numerous barriers to data-driven discovery and stronger protections for research participants. Specifically, these provisions do not include provisions meant to enable a learning health system through the supplemental use of EHR data.

While we understand that this NPRM proposes January 2019 as the new compliance date, as AMIA advised earlier this year, this Administration’s history of delay hangs over this NPRM like an ominous cloud. We reiterate our preferred recommendation that OHRP proceed with an effective date of July 19, 2018, for all provisions of the 2018 Requirements, and a compliance date of January 21, 2019. An effective date of July 19, 2018, for all provisions would give those more prepared researchers and Institutional Review Boards an opportunity to proceed with the 2018 Requirements, while giving others additional time to comply.

AMIA strongly opposes the NPRM’s alternative proposals to delay both the general effective and compliance date to January 2019 and we reject any notion that further delay beyond January 2019 is necessary. As we noted in a June 2018 letter to HHS and OMB, any further delay beyond January 2019 to the 2018 Requirements leaves in place a legacy rule that neither serves research participants, nor the research community.