January 22, 2018
The federal departments are now proposing a further delay of the rule until January 2019. The Notice of Proposed Rulemaking was published April 20, 2018 and can be accessed at: https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions. The IFR is available at https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/html/2018-00997.htm
Until then, the current regulations remain in place.
In January 2017, final revisions to the Federal Policy for the Protection of Human Subjects were issued by the U.S. Department of Health and Human Services and 15 other federal agencies.
Major changes include:
The revised regulation is available at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htmAs implementation proceeds, more information will be provided.