BIoBanks, BroaD ConsEnTs, anD waIvErs: wHaT THE rEvIsED Common ruLE maY CHangE
Health Care law Section
Chairs: TJ Ferrante – Foley & Lardner LLP & Kevin Rudolph – Shriners Hospitals for Children
Institutions now will have to
confirm that the proper broad
consents were obtained
from all individuals whose
B
iobank. For some, the
term conjures up an
image of a highly
futuristic lab with vaults,
tubes, and cryogenic chambers
billowing dry ice smoke everywhere.
For others, the word is just a fancy
way of describing an old freezer in
the back of a lab containing a bunch
of leftover test tubes haphazardly
organized. Although the reality lies
32
biospecimens may be used
in an identifiable manner in
a secondary research study.
somewhere in between for most
biobanks, the revised Common
Rule issued by the United States
Department of Health and Human
Services (HHS), with its latest
effective implementation date of
January 21, 2019, requires certain
changes to the informed consent
process for obtaining samples from
human subjects. One particular
change is to “broad consents” for
human subject samples to be used
in future research efforts.
Under the earlier version of the
Common Rule, many institutions
used variations of “broad informed
Continued on page 33
JAN - FEB 2019
|
HCBA LAWYER