Editor’s Corner
Take My Leftover Tissue, Please!
I
To weigh in on the changes proposed
in the NPRM, visit www.hhs.gov/
ohrp/humansubjects/regulations/
nprmhome.html or scan the QR code.
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ASHClinicalNews.org
CAN UNDERSTAND IF MAYBE you missed the big announcement on
September 8.
Perhaps you were out apple-picking with your kids, or were
getting ready for a hot date that night. Or maybe you failed to scroll
through your entire Twitter feed that day.
If that’s the case, brace yourself. This is a big one. Years from now,
this will be akin to the day that president Kennedy was shot, or the
day the Space Shuttle exploded. People will ask you “Where were
you when …?”
On September 8, 2015, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services
published in the Federal Register its Notice of Proposed Rulemaking
on Federal Policy for the Protection of Human Research Subjects!
Have you totally fainted to the floor? Shall I administer some
smelling salts?
Or better yet, perhaps I should explain what the heck this means,
and why we should care.
This notice suggests revising the Common Rule, the federal
policy protecting human subjects who engage in basic, translational,
and clinical research. It has been codified in separate regulations by
18 federal departments and agencies. Our institutional review boards
(IRBs) follow the Common Rule, as do our compliance committees.
Some of the suggested changes make a lot of sense. For example,
improving informed consent documentation to facilitate the ability
to understand these documents.
That’s one of my favorites. Have you ever read through the 10
or 12 pages of an informed consent document? Have you ever read
through those pages placing yourself in the position of a potential
trial participant? Imagine you’re 80 years old, you forgot your glasses
at home because you didn’t know you’d need them at the doctor’s
office, you’re fasting because you thought the bloodwork the doctor
was getting that day might require 12 hours of fasting, and you’re
also trying to absorb information about your cancer and treatment
options while reading through these forms.
Have you ever wondered whether our patients truly understand
the informed consent documents they sign, and thus are truly i