On January 17, 2018 (just two days before the previously revised rule was scheduled to go into effect),
an interim rule to delay the implementation
and effective dates of the revisions to the
Federal Policy for the Protection of Human
Subjects (the revised Common Rule) was
posted in the Federal Register.1 This interim
rule delayed both the effective and general
compliance dates of the requirements of the
revised Common Rule until July 19, 2018. In
addition to allowing institutions that conduct
human research (regulated entities) additional
time to prepare for the requirements of the
revised Common Rule, the interim rule is
intended to provide “additional time for the
departments and agencies to seek input from
interested stakeholders through a notice and
comment rulemaking process that allows for
public engagement on the proposal for a fur-
ther implementation delay.”2 The interim rule
was published in response to requests from
key stakeholders, including the Association
of American Medical Colleges, the
Association of American Universities,
the Council on Governmental
Relations, and the Secretary’s
Advisory Committee on Human
Research Protections (SACHRP),
which all cited the revised Common
Rule’s complexity, the lack of guid-
ance from the Office for Human
Research Protections (OHRP), and the require-
ment to revise and update institutional-based
electronic systems as the key drivers for the
The gift of an additional six months
presents a golden opportunity to re-evaluate
institutional preparedness to comply with the
requirements of the revised Common Rule.
Organizational and strategic decisions
Noteworthy changes to the revised Common
Rule include modifications to the informed
consent requirements, the addition of new
exempt research categories, new requirements to rely on a single Institutional Review
Board (IRB) of record for federally sponsored
cooperative research, use of a broad consent,
by Scott J. Lipkin, DPM, CIP
Revised Common Rule delay:
» The effective date for the revised Common Rule is delayed.
» The delay provides additional time to establish new organizational policies.
» A robust implementation plan will ease the transition to the new requirements.
» The implementation should include provisions for post-implementation monitoring.
» A compliance risk assessment plan should also be developed.
Scott J. Lipkin ( Scott.firstname.lastname@example.org) is Managing Director at Ankura
Consulting in Orlando, FL.