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BIOPHYSICAL SOCIETY NEWSLETTER
4
OCTOBER
2015
Public Affairs
BPS Weighs in on NIH
Strategic Plan
In response to a request from Congress, the Na-
tional Institutes of Health (NIH) is developing a
five-year NIH-wide strategic plan to advance its
mission to support research in pursuit of funda-
mental knowledge about the nature and behavior
of living systems, and the application of that
knowledge to extend healthy life and reduce illness
and disability. The goal of this larger NIH-wide
strategic plan is not to outline the myriad of im-
portant research opportunities for specific disease
applications as that is covered in the strategic plans
from each of the NIH’s Institutes, Centers, and
Offices (ICOs), which will be referenced appropri-
ately, but to highlight major trans-NIH themes.
The strategic plan is due to the Congress in late
December 2015.
As part of the process, the NIH released a frame-
work for the plan in late July and asked stakehold-
ers throughout the community for input. The
Society’s Public Affairs Committee submitted
a response on behalf of the biophysical research
community. In whole, the Committee is very
supportive of the framework as it was presented.
Specifically, the Committee liked that the frame-
work highlighted the importance of basic research,
the need to focus on discovery rather than spe-
cific disease, the need to work across disciplinary
and ICO boundaries, and the limits faced by the
biomedical research enterprise because of financial
constraints. The Committee also commended
the NIH for recognizing the need to promote a
diverse workforce and asked that the NIH be cog-
nizant of the community’s need for infrastructure
support.
The NIH is now reviewing the comments submit-
ted about the framework, meeting with the ICO
councils, and preparing a full plan. The final plan
is due to Congress at the end of December.
The Society’s comments on the strategic frame-
work can be found on the Society’s website under
“press room.”
Revisions to the Common
Rule Proposed
The US Department of Health and Human
Services (HHS) has proposed revisions to the
regulations that govern research on individuals
who participate in research. While the rule applies
most directly to those who conduct clinical trials,
it may be of interest to individuals in the biophys-
ics community doing basic research as well.
The current regulations that protect individu-
als who participate in research, which have been
in place since 1991, are followed by 18 federal
agencies and are often referred to as the Com-
mon Rule. They were developed at a time when
research was predominantly conducted at universi-
ties, colleges, and medical institutions, and each
study generally took place at a single site. The
expansion of research into new scientific disci-
plines, such as genomics, along with an increase
in multisite studies and significant advances in
technology, has highlighted the need to update the
regulatory framework. Notably, a more participa-
tory model of research has also emerged, with
individuals looking for more active engagement
with the research enterprise.
The Notice of Proposed Rulemaking (NPRM)
was issued by HHS in September; comments are
being accepted until December 7.
This NPRM proposes to modernize the current
regulations by enhancing the ability of individuals
to make informed decisions about participating in
research, while reducing unnecessary burdens by
streamlining the regulatory requirements for low-
risk research.
Changes proposed in the NPRM issued Septem-
ber 8 include:
• Strengthened informed consent provisions to
ensure that individuals have a clearer under-
standing of the study’s scope, including its
risks and benefits, as well as alternatives to
participating in the study.