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consents” to obtain samples, or biospecimens, from
individuals that they then “banked” for future unspecified
research purposes. (Hence, the term biobank.) The
revised Common Rule, however, puts in place a specific
regulatory framework for the “broad consent” process,
contained at 45 C.F.R. § 46.116(d), which may impact
biobanks. The new “broad consent” process essentially
allows an alternative to the typical informed consent
process (defined in 45 C.F.R. § 46.116(b)-(c)) for these
biospecimens to be used in future research, or secondary
research, as HHS has labelled it.
Without delving into the technical elements of the
new “broad consent” process, one change is that when
individuals opt-out of consent for secondary research,
the relevant institutional review board (IRB) overseeing
such secondary research cannot later issue a waiver of
consent to permit these individuals’ identifiable banked
biospecimens to be used in a future research study. This
creates a mechanism whereby those who have opted out
via the broad consent process must have their refusals
continually tracked to ensure their samples are not used
in an identifiable manner in any secondary research.
Although many institutions likely already implemented
these safeguards, the reality is that they no longer can
rely on a waiver of consent from the IRB for all of
the samples to be used in a secondary research study.
Institutions now, according to the regulation, will have to
confirm that the proper “broad consents,” or “opt-ins,”
were obtained from all individuals whose biospecimens
may be used in an identifiable manner in a secondary
research study.
HHS has released questions and answers surrounding
the “broad consent” process, but has yet to issue compre-
hensive guidance on “broad consents” and how they tie
into the existing, and future, framework for biobanks.
With this new “broad consent” process, institutions will
have to ensure that opt-ins and opt-outs are documented
for all future secondary research involving banked
biospecimens. Although HHS has stated that the use of
individuals’ biospecimens in a nonidentifiable manner
still is permissible, the advent of genome sequencing raises
significant questions about what is nonidentifiable. For
institutions, the challenge will be ensuring that the correct
pathways are followed for all secondary research involving
biospecimens, so that their highly futuristic lab (or old
freezer) operates properly as a biobank.
Author: Kevin Rudolph – Shriners Hospital for Children
JAN - FEB 2019
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HCBA LAWYER
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