LSHC Horizons Brochure 2024 - Flipbook - Page 33
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
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Evolving human subject protection rules for clinical trials
At the end of last year, FDA published a final
rule on “Institutional Review Board Waiver or
Alteration of Informed Consent for Minimal
Risk Clinical Investigations,” which permits
an exception from the requirement to obtain
informed consent when a clinical investigation
poses no more than minimal risk to the human
subject and includes appropriate safeguards to
protect the rights, safety, and welfare of human
subjects. Notably, FDA added a criterion
permitting an additional exception from the
general informed consent requirements for
certain FDA-regulated trials involving the
use of identifiable private information or
identifiable biospecimens. In those situations,
an exception from informed consent may be
warranted if the study could not practicably
be carried out without using such identifiable
private information or biospecimens in
an identifiable format. An IRB waiver of
authorization under the Health Insurance
Portability and Accountability Act (HIPAA)
may also be necessary to the extent
HIPAA applies.
Robert F. Church
Partner
Los Angeles
Also, last year FDA finalized nine-year-old
draft guidance on informed consent for
sponsors, institutions, IRBs, and investigators.
FDA’s changes to the draft guidance reflect
innovations like platforms supporting DCTs,
about which FDA issued milestone draft
guidance in May 2023. The changes in the
final version of the informed consent guidance
also respond to the evolving ability to target
therapies based on genetic variations using
machine learning and artificial intelligence,
coming on the heels of FDA’s March 2023
revised draft guidance on regulation of the use
of electronic systems, records, and signatures
in clinical investigations to account for
advances in digital health technologies.
These moves follow FDA’s proposed rules
to clarify inconsistencies between FDA’s
human subject protection regulations and the
Common Rule, and to promulgate a single
IRB requirement. Taken together, this spate
of agency efforts show increasing regulatory
focus on human subject protection issues, and
greater coordination between HHS and FDA.
Heidi Forster Gertner
Partner
Washington, D.C.
Blake E. Wilson
Partner
Philadelphia
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