Rule Would Extend Deadline for 2018 Common Rule Requirements

Apr 20, 2018 - 02:37 PM
compliance-deadline

The Department of Health and Human Services and other federal agencies today proposed delaying the general compliance date for 2018 requirements under the Common Rule to Jan. 21, 2019, which would give covered entities six additional months to implement the requirements. The agencies will accept comment on the proposed rule for 30 days, including whether to continue to permit institutions to implement on July 19 three provisions of the 2018 requirements intended to reduce burdens on regulated entities. The Common Rule establishes specific requirements to protect the safety and privacy of individuals participating in human subjects research, including requirements for institutional review boards, informed consent and assurance of compliance for institutions conducting research.

Related News Articles

Perspective
Keeping Congress Focused on Protecting Access to Care
Congress returns to Washington, D.C., next week following the summer recess, and lawmakers can expect a busy fall as they face a full plate of issues that need…
Perspective
With Congressional Action Limited, Administration Releases Flurry of Health Care Regulations
While Congress passed legislation last month to fund the federal government through September, it’s looking like there will be very few other pieces of…
Headline
CMS proposes changes to requirements for accrediting organizations
The Centers for Medicare & Medicaid Services Feb. 8 released a proposed rule intended to strengthen oversight of organizations that accredit health care…
Headline
OCR issues FAQs on patient visitation rights
The Department of Health and Human Services’ Office for Civil Rights Jan. 25 released guidance reminding hospitals, critical access hospitals and long-term…
Headline
CMS releases rule implementing new Medicaid renewal enforcement authorities
The Centers for Medicare & Medicaid Services Dec. 4 released an interim final rule implementing new enforcement authorities the agency will use if states…
Headline
FDA proposes enforcing requirements for laboratory developed tests
The Food and Drug Administration Sept. 29 released a proposed rule that would phase out over four years its general enforcement discretion approach for most…