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HHS Announces
New Proposed
Rulemaking to the
Common Rule
Protecting Human
Subjects in Research
The U.S. Department of Health
and Human Services (HHS) Office
for Human Research Protections
(OHRP) recently announced new
proposed rulemaking (NPRM)
amending the Federal Policy for the
Protection of Human Subjects (also
known as the Common Rule), the
regulations that govern research on
individuals who participate in clinical research.
The NPRM was issued in
response to the changing social, cultural, and technological environment
and is intended “to better protect
human subjects involved in research
by modernizing, strengthening, and
making more effective” the Common
Rule, which have been in place since
1991, according to a press release
from the agency.
Proposed changes include:
• Strengthened informed consent
provisions to ensure that individuals have a clearer understanding of the study’s scope,
including its risks and benefits,
as well as alternatives to participating in the study
• Requirements for administrative or IRB review that would
align better with the risks of the
proposed research, thus increasing efficiency
• New data security and information
protection standards that would
reduce the potential for violations
of privacy and confidentiality
• Requirements for written
consent for use of an individual’s biological samples, for
example, blood or urine, for
research with the option to
consent to their future use for
unspecified studies
• Requirement, in most cases, to use
a single institutional review board
for multisite research studies
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• The proposed rule would apply
to all clinical trials, regardless of
funding source, if they are conducted in a U.S. institution that
receives funding for research
involving human participants
from a Common Rule agency.
For more details, and to read a full
summary of the proposed changes,
visit www.hhs.gov/ohrp/humansubjects/
regulations/nprm2015summary.html.
“[The Common Rule] was
developed at a time when research
was predominantly conducted at
universities, colleges, and medical institutions, and each study
generally took place at a single
site,” the press release continued.
“The expansion of research into
new scientific disciplines, such as
genomics, along with an increase
in multisite studies and significant advances in technology, has
highlighted the need to update the
regulatory framework.”
On October 20, 2015, OHRP held
a public Town Hall meeting in order
to respond to questions related to the
NPRM. The NPRM is open to comments from the public until December
7, 2015. Go to www.hhs.gov/ohrp/
humansubjects/regulations/nprmhome.
html to voice your opinion.
Jerry Menikoff, MD, JD, director of OHRP, provided some examples of how the NPRM would better
protect human subjects, including making consent forms clearer
for individuals participating in
research, allowing individuals more
autonomy to decide how their DNA
is used by de-identifying biospecimens, and making the IRB system
more flexible and less burdened by
bureaucratic processes.
One of the main topics of interest at the Town Hall meeting was the
issue surrounding consent under the
proposed reforms, particularly the
language of the consent document.
Document examples will eventually
be released to the public for analysis
and feedback. OHRP hopes this will
prompt institutions to pay more
attention to protecting participants
and better informing them if they
are aware that OHRP will be developing examples of consent forms.
There were also many concerns
about the proposed consent rules
for the use of biospecimens. Panel
members explained that two criteria
would need to be met for IRB to
waive consent: the IRB would have
to be presented with a situation in
which there would be a compelling
need for the biospecimen to be used
in the research, and the IRB would
also have to determine that there
would be no other biospecimen
types that might be used in substitute for samples that could receive
consent. Currently, NPRM does
not have any specific regulations or
guidance to help IRBs determine
or identify what biospecimens or
what research would be of absolute
necessity in such a situation, and, as
a result, invited comments from the
public on this matter.
In addition, the panel noted that
biospecimens used in research that is
not geared to collecting information
of individual participants would be
exempt from expansion.
Another point of discussion was
the protection of minorities and
vulnerable populations; currently,
there was no language included in the
proposed refo ɵ́