[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
ACADEMIC RESEARCH REGULATORY RELIEF:
A REVIEW OF NEW RECOMMENDATIONS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON RESEARCH AND TECHNOLOGY
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
September 29, 2016
__________
Serial No. 114-96
__________
Printed for the use of the Committee on Science, Space, and Technology
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://science.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
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COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. LAMAR S. SMITH, Texas, Chair
FRANK D. LUCAS, Oklahoma EDDIE BERNICE JOHNSON, Texas
F. JAMES SENSENBRENNER, JR., ZOE LOFGREN, California
Wisconsin DANIEL LIPINSKI, Illinois
DANA ROHRABACHER, California DONNA F. EDWARDS, Maryland
RANDY NEUGEBAUER, Texas SUZANNE BONAMICI, Oregon
MICHAEL T. McCAUL, Texas ERIC SWALWELL, California
MO BROOKS, Alabama ALAN GRAYSON, Florida
RANDY HULTGREN, Illinois AMI BERA, California
BILL POSEY, Florida ELIZABETH H. ESTY, Connecticut
THOMAS MASSIE, Kentucky MARC A. VEASEY, Texas
JIM BRIDENSTINE, Oklahoma KATHERINE M. CLARK, Massachusetts
RANDY K. WEBER, Texas DONALD S. BEYER, JR., Virginia
JOHN R. MOOLENAAR, Michigan ED PERLMUTTER, Colorado
STEPHEN KNIGHT, California PAUL TONKO, New York
BRIAN BABIN, Texas MARK TAKANO, California
BRUCE WESTERMAN, Arkansas BILL FOSTER, Illinois
BARBARA COMSTOCK, Virginia
GARY PALMER, Alabama
BARRY LOUDERMILK, Georgia
RALPH LEE ABRAHAM, Louisiana
DRAIN LaHOOD, Illinois
WARREN DAVIDSON, Ohio
------
Subcommittee on Research and Technology
HON. BARBARA COMSTOCK, Virginia, Chair
FRANK D. LUCAS, Oklahoma DANIEL LIPINSKI, Illinois
MICHAEL T. McCAUL, Texas ELIZABETH H. ESTY, Connecticut
RANDY HULTGREN, Illinois KATHERINE M. CLARK, Massachusetts
JOHN R. MOOLENAAR, Michigan PAUL TONKO, New York
BRUCE WESTERMAN, Arkansas SUZANNE BONAMICI, Oregon
GARY PALMER, Alabama ERIC SWALWELL, California
RALPH LEE ABRAHAM, Louisiana EDDIE BERNICE JOHNSON, Texas
DARIN LaHOOD, Illinois
LAMAR S. SMITH, Texas
C O N T E N T S
September 29, 2016
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Barbara Comstock, Chairwoman,
Subcommittee on Research and Technology, Committee on Science,
Space, and Technology, U.S. House of Representatives........... 4
Written Statement............................................ 6
Statement by Representative Daniel Lipinski, Ranking Member,
Subcommittee on Research and Technology, Committee on Science,
Space, and Technology, U.S. House of Representatives........... 8
Written Statement............................................ 10
Statement by Representative Lamar S. Smith, Chairman, Committee
on Science, Space, and Technology, U.S. House of
Representatives................................................ 12
Written Statement............................................ 14
Witnesses:
Dr. Larry R. Faulkner, President Emeritus, The University of
Texas at Austin
Oral Statement............................................... 17
Written Statement............................................ 19
Mr. John Neumann, Director, Natural Resources and Environment
Team, Government Accountability Office
Oral Statement............................................... 27
Written Statement............................................ 29
Mr. Jim Luther, Associate Vice President for Finance & Compliance
Officer, Duke University
Oral Statement............................................... 43
Written Statement............................................ 45
Dr. Angel Cabrera, President, George Mason University
Oral Statement............................................... 52
Written Statement............................................ 54
Discussion....................................................... 63
Appendix I: Answers to Post-Hearing Questions
Dr. Larry R. Faulkner, President Emeritus, The University of
Texas at Austin................................................ 74
Mr. John Neumann, Director, Natural Resources and Environment
Team, Government Accountability Office......................... 81
Mr. Jim Luther, Associate Vice President for Finance & Compliance
Officer, Duke University....................................... 84
Dr. Angel Cabrera, President, George Mason University............ 88
Appendix II: Additional Material for the Record
Statement submitted by Representative Eddie Bernice Johnson,
Ranking Member, Committee on Science, Space, and Technology,
U.S. House of Representatives.................................. 90
ACADEMIC RESEARCH REGULATORY RELIEF:
A REVIEW OF NEW RECOMMENDATIONS
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THURSDAY, SEPTEMBER 29, 2016
House of Representatives,
Subcommittee on Research and Technology,
Committee on Science, Space, and Technology,
Washington, D.C.
The Subcommittee met, pursuant to call, at 10:05 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Barbara
Comstock [Chairwoman of the Subcommittee] presiding.
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Chairwoman Comstock. The Committee on Science, Space, and
Technology will come to order.
Without objection, the Chair is authorized to declare
recesses of the Committee at any time.
Good morning, and welcome to today's hearing titled
''Academic Research Regulatory Relief: A Review of New
Recommendations.'' I now recognize myself for five minutes for
an opening statement.
How can we cut the red tape to optimize our Nation's
investment in scientific research? That is the question we aim
to answer in today's hearing.
Since becoming Chair of the Subcommittee on Research and
Technology, I have heard concern from many scientists and
university leaders that too much time and money is being spent
complying with federal rules, regulations and other
administrative work, thereby taking away from vital research
and education. Surveys have shown that, on average, researchers
spend 42 percent of their time meeting administrative
requirements.
Last year, I introduced the Research and Development
Efficiency Act, a bill to establish a working group under the
National Science and Technology Council to review federal
regulations and make recommendations on how to streamline and
minimize the regulatory burden on research institutions. That
bill overwhelmingly passed this Committee on a bipartisan basis
and in the House in May of last year. I guess we're still
awaiting the Senate as always.
Since that time, work has continued by the National Academy
of Sciences and the Government Accountability Office to study
and report on solutions for fixing the patchwork of rules and
regulations that govern federally funded research. In June, the
National Academy of Sciences issued its final report:
``Optimizing the Nation's Investment in Academic Research: A
New Regulatory Framework for the 21st Century.'' The report
includes four major findings and dozens of recommendations for
updating and reforming regulations. We are grateful to have Dr.
Larry Faulkner here, the chair of the committee that authored
the report, who will testify on those recommendations.
Also in June, the Government Accountability Office released
a report called ``Federal Research Grants: Opportunities Remain
for Agencies to Streamline Administrative Requirements.'' That
report makes three major recommendations, which we'll hear more
about from Dr. Neumann, who led the study team.
We are also fortunate to have two university leaders with
us today to talk about the impacts of regulations on their
institutions and share their expertise. I'm pleased to have Dr.
Cabrera here, President of George Mason University, which
serves northern--well, serves the whole country but I'm very
proud to work with you in our region, and leads not only one of
the fastest growing research institutions in the country, but
one that happens to be partially in my district, and my
daughter's alma mater with her graduate degree also, and
actually I'm leaving after the hearing today. I'm going to a
Women in Virginia Bioscience that also has George Mason folks
there, so thank you for your leadership, Dr. Cabrera.
I look forward to hearing from all of our witnesses about
what actions Congress and agencies can take to provide
regulatory relief to the research community, ensuring that more
of our federal research dollars are spent on scientific
breakthroughs and developing a STEM-trained workforce.
[The prepared statement of Chairwoman Comstock follows:]
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Chairwoman Comstock. I now recognized the Ranking Member,
the gentleman from Illinois, Mr. Lipinski, for his opening
statement.
Mr. Lipinski. Thank you, Chairwoman Comstock, for holding
this hearing, and thank Chairwoman Comstock and Chairman Smith
for being here this morning and all of the witnesses for being
here. As you all know, we finished up our work for a few weeks
last night, so I'm glad that we're able to still hold this
hearing.
Efforts to streamline and reduce the burden of
administrative requirements placed on academic researchers
while maintaining a strong system of accountability and
scientific integrity are not new. The Federal Demonstration
Partnership (FDP) began 30 years ago, and the Council on
Governmental Relations, which represents and supports
universities in complying with federal regulations, dates back
to the post-WW II era.
However, as research budgets have flattened or declined and
our best and brightest young researchers increasingly look
elsewhere, the topic of reducing the administrative burden on
federal research has taken on new urgency. The FDP reported
that academic researchers spend 42 percent of their time on
activities other than academic research, including
administrative burden. That number has since been challenged,
but I think we all agree with the basic premise of this hearing
and all of the related reports: too much valuable time of our
researchers is wasted on excessive compliance with excessive
regulations. Issues like subrecipient monitoring, micropurchase
threshold, biosketches, open access policies, and time and
effort reporting adds up to a lot of time for researchers. I
understand this from my own experiences as a college professor,
through discussions with former colleagues, and from talking to
researchers and research university administrators as I have
served as Chair and then the Ranking Member of this
subcommittee for the past eight years.
The Uniform Guidance issued by the Office of Management and
Budget in December 2013 made several steps in the right
direction. For example, it provided flexibility for
universities to examine alternatives to traditional time and
effort reporting on grants including using payroll systems to
verify work performed. Inspectors General, who opposed this
change, still have full authority to conduct audits of those
systems to ensure accountability for federal funds.
Unfortunately, the Uniform Guidance also included changes that
increased administrative burden without obviously increasing
accountability, such as the reduction of the micropurchase
threshold for competitive bids.
Two years ago, we held a hearing to review the findings and
recommendations from the National Science Board about reducing
the administrative burden on academic research.
Today we are reviewing two more recent reports, one from
the National Academies and the other from the GAO. In response
to these reports, and working closely with the stakeholder
community, I developed bipartisan legislation, H.R. 5583, to
implement some of the key recommendations to Congress. This
bill, the University Regulation Streamlining and Harmonization
Act, would address issues around researcher biosketches, the
micropurchase threshold, and other regulations on academic
research.
However, the most important part of the legislation is the
creation of a Research Policy Board at OMB. The board would
allow members of the research community to meet with agency and
OMB officials to suggest ways to streamline rules across
agencies. This board would not be able to overrule or delay any
actions taken by OMB, but rather would serve to give the
research community a seat at the table to help advise against
overly onerous research regulations both now and in the future.
This bill has received strong support from the research
community, including endorsements from the Association of
American Universities and the Council on Governmental Relations
among others. While the clock is ticking on this Congress, I
hope we will be able to implement at least some of these
proposals, if not this entire bill, before the end of the year.
Either way, I hope that OMB, OSTP, and federal research
agencies will continue to work on the issues identified in
these reports and in my legislation.
These hearings on administrative burden, along with the
legislative efforts offered by myself and Chairwoman Comstock,
should demonstrate clearly to the research community and agency
officials alike that this Committee is engaged on this issue
and will continue to provide oversight and fix problems as they
are identified.
With that, I want to thank today's witnesses for your
contributions to these efforts and for your testimony. I look
forward to a fruitful discussion, and I yield back.
[The prepared statement of Mr. Lipinski follows:]
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Chairwoman Comstock. Thank you, and I now recognize
Chairman Smith, who is with us here this morning, for his
statement, and he will also be introducing our first witness
from Texas.
Chairman Smith. Thank you, Madam Chairwoman.
Let me say on behalf of the witnesses and even on behalf of
the American people, I want to thank you and the Ranking
Member, Mr. Lipinski, for making a huge effort to be here this
morning. Not everybody may realize that because we finished
votes last night, and we will not be convening again as a
Congress until after the November election, we knew a lot of
people were going to be leaving town this morning and I thought
we were going to have to cancel this hearing, as important as
it was, and the fact that the Chairwoman and the Ranking Member
said that they would stay and be here enabled us to go forward
and have this hearing.
Now, I do want to point out that the Chairwoman has already
passed what we could call a regulatory relief bill, and
deserves congratulations for that, and there's more to come.
Mr. Lipinski has a bill that we're working on, and I do have to
question his motive for being here because he knows that by
being here we're going to be more favorably disposed towards
his legislation. But I do appreciate both his efforts to bring
some sanity to the regulatory process and what the Chairwoman
has done too.
The Committee has held many hearings on the regulatory
overreach of agencies during this Administration. Americans
from small business owners to scientists in the lab want to be
free from overly burdensome regulations, not tied up in more
red tape.
For several years, the research community has expressed
concern that time spent on administrative and reporting
requirements for federal research seriously cuts into lab time.
This negatively affects the science conducted under those
grants.
The Federal Government spends about $30 billion a year on
research and development at our Nation's colleges and
universities. Over time, a patchwork of federal laws,
regulations, rules, policies, and reporting requirements have
developed to manage this research.
A survey of universities found that up to 25 percent of
grant funding was spent on research-related regulatory
compliance--25 percent. We must ensure accountability and
scientific integrity when spending taxpayer dollars on
research. However, there are opportunities for Congress and
agencies to streamline regulations to optimize the Nation's
investment in research.
There are some commonsense recommendations to reduce
governmental hurdles for our scientists. For example, when a
researcher applies for a grant at the National Science
Foundation, they should be able to use the same biographical
information and format they use when applying for a grant at
the Department of Energy or other agencies. If a researcher has
a grant from the National Oceanic and Atmospheric
Administration and NASA, the format for research progress
reporting to both agencies should be the same.
Confusing, costly, and burdensome regulations take time and
money away from research. They also make it more difficult for
young, new innovators to apply and compete for federal funding.
We should not lose out on developing new breakthrough ideas or
new talent because of bureaucratic hurdles.
So I commend Chairwoman Comstock for holding this hearing
and for her previous work on tackling regulatory relief. I look
forward to working with you and our colleagues on both sides of
the aisle towards developing some legislative solutions, and I
mentioned Mr. Lipinski's bill a minute ago. We must continue to
ensure that our Nation's research investments are efficient and
effective.
Thank you, and I'll yield back.
[The prepared statement of Chairman Smith follows:]
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Chairwoman Comstock. I now recognize the Chairman to
introduce Dr. Faulkner.
Chairman Smith. Thank you, Madam Chairwoman.
It should be obvious why I'd like to, or asked to introduce
our first witness today because he is Dr. Larry Faulkner,
President Emeritus of the University of Texas at Austin.
I might interject here that at one point I represented all
of the University of Texas at Austin and now only represent a
part of it. I do have in my district the administration
building, and I also have all the sororities and fraternities,
and I haven't yet figured out why that was given to me, but
nevertheless, that's how it stands and I'm pleased to represent
at least part of----
Chairwoman Comstock. I have two sister-in-laws from those
sororities.
Chairman Smith. I mentioned that Dr. Faulkner had been
President of the University of Texas at Austin. Most recently
Dr. Faulkner chaired the National Academies Committee on
Federal Regulation of Research, which carried out a
comprehensive review and made numerous specific recommendations
for improving regulations, regulatory procedures, and
regulatory apparatus. As President of the University of Texas
at Austin, he oversaw a seven-year capital campaign that raised
over $1.6 billion, appointed and supported the work of the
Commission of 125, a citizens' group that provided guidance on
the future of the university and its relationship to the
public. Dr. Faulkner received a B.S. degree from Southern
Methodist University and was awarded a Ph.D. in chemistry from
the University of Texas at Austin. We welcome you, Dr.
Faulkner. It's nice to have you back, and I'll yield back.
Dr. Faulkner. Thank you, Mr. Chairman. It's a pleasure to
see you. I had the pleasure of being in your district at one
time.
Chairwoman Comstock. I'm sorry. I have to introduce the
other witnesses now, then we'll go through, so sorry for the
mix-up there.
Chairman Smith. I liked what he was saying about having
lived in my district, but we'll----
Chairwoman Comstock. Okay. Our second witness today is Mr.
John Neumann, Director, Natural Resources and Environment Team
at the Government Accountability Office. Mr. Neumann currently
leads efforts in the science and technology area including the
management and oversight of federal research and development
programs, protection of intellectual property, and federal
efforts to support innovation. He received his B.A. in
political science cum laude from the State University of New
York at Stony Brook and holds an MBA from American University
as well as a J.D. from Georgetown University.
Our third witness today is Mr. Jim Luther, Associate Vice
President for Finance and Compliance Officer at Duke
University. Mr. Luther's responsibilities include oversight of
the post-award areas for the university and School of Medicine,
management of fixed and movable assets, negotiation of Duke's
indirect cost and fringe benefit rates, and all aspects of
Duke's research cost and compliance program. Over the past
several years, he has instituted a research cost and compliance
program that includes mandatory training for faculty and
administrators, a comprehensive compliance certification
program, and a compliance monitoring program. Mr. Luther earned
his B.S. in engineering from the U.S. Naval Academy and an M.A.
from Duke University.
Our final witness today is Dr. Angel Cabrera, President of
George Mason University. Prior to joining George Mason in 2012,
he served as President of the Thunderbird School of Global
Management in Arizona and is Dean of the I.E. Business School
in Madrid. Dr. Cabrera has been recognized by the World
Economic Forum as a Young Global Leader, by the Aspen Institute
as a Henry Crown Fellow, by Business Week as a Star of Europe,
and by the Financial Times as one of the world's best business
deans. Dr. Cabrera earned his Ph.D. and M.S. from the Georgia
Institute of Technology and his B.S. and M.S. in computer and
electrical engineering from the Polytechnic University of
Madrid.
I now recognize Dr. Faulkner for five minutes to present
his testimony.
TESTIMONY OF DR. LARRY R. FAULKNER,
PRESIDENT EMERITUS,
THE UNIVERSITY OF TEXAS AT AUSTIN
Dr. Faulkner. Good morning, Chairwoman Comstock and Ranking
Member Lipinski, Chairman Smith. I thank you for your
invitation to testify on a congressionally mandated study
conducted by a committee of the National Academies.
The general message is that the continuing expansion of
federal regulation is decreasing the return on the federal
investment in research by diverting investigators' time and
other resources away from research toward administration and
compliance.
The committee has seven overarching findings: first, that
effective regulation is essential to the overall health of the
research enterprise; second, that most federal regulations,
policies and guidance represent efforts to address important
issues but often have unintended consequences needlessly
encumbering the Nation's research; third, in recent decades,
the amount of regulation has grown dramatically; fourth, this
continuing expansion of the regulatory system diminishes the
effectiveness of the Nation's investment in research; fifth,
universities receive research funding from multiple agencies
but approaches to similar tasks and goals such as the
submission of grant proposals are not harmonized across
agencies; six, that regulations sometimes have resulted when
universities did not respond appropriately to investigators'
transgressions; and seventh, the relationship between research
universities and institutions and federal funders has long been
considered a partnership yet there is no formal mechanism by
which senior stakeholders from both partners can review
existing or proposed policies.
Based on these findings, the committee offered four
overarching recommendations: first, that the regulatory regime
for federal research be reexamined and recalibrated. We
recommend that Congress, OMB, federal agencies and research
institutions take steps to improve efficiency. We provide many
detailed possibilities.
Second, research institutions should take action to
reinvigorate the research partnership and to re-instill trust.
Third, the responsibilities of the Inspector General should
be rebalanced so that consideration is given both to uncovering
waste, fraud, and abuse and to advising on economy, efficiency,
and effectiveness.
Fourth, the government-university research partnership
should be made more functional through changes in the
regulatory framework.
For the remainder of my remarks I will focus on human
subjects research and the proposed new regulatory framework.
Midway through the committee's work, the DHHS issued a Notice
of Proposed Rule Making on the Federal Policy for the
Protection of Human Subjects. Over 2,000 comments were
submitted in response. Most commentators brought up
deficiencies and indicated that if the rule were implemented as
written, it would create serious obstacles for research. From
testimony and much other evidence, the committee concluded that
the proposed rule is marred by omissions, an absence of
essential elements, and a lack of clarity. Given that a
national review has not taken place in almost forty years of
human subjects research, that related research has grown
tremendously, and that the complexity of the issues has greatly
increased, the committee recommends that Congress authorize and
the President appoint an independent, national commission to
examine and to recommend updates to the ethical, legal, and
institutional framework governing human subjects research.
Finally, the committee is calling upon the executive branch
to withdraw the NPRM, giving the proposed commission full scope
to meet its charge.
Let me turn last to the proposed new regulatory framework.
The goal is to provide a mechanism that can forestall
duplicative and incongruous regulations, streamline and
harmonize existing regulations, and provide a means to
eliminate ineffective regulations. We believe that the only
clear path to strengthening the U.S. research enterprise and
preparing it for continued leadership is through the
establishment of a new research policy board, which would act
as the primary analytical, anticipatory and coordinating forum
on regulatory policy, bringing together high-level stakeholders
from the research community and from federal funding agencies.
We further recommend that a new position of associate director
for the academic research enterprise be established in the
White House OSTP. This officer would perform an essential role
by focusing on the operational health of the research
partnership.
For nearly 70 years, that partnership has yielded
tremendous benefits for the American people, improving their
economic wellbeing, health, and security. It behooves all of us
to take steps to ensure that it continues to flourish.
Thank you for this opportunity.
[The prepared statement of Dr. Faulkner follows:]
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Chairwoman Comstock. Thank you.
Mr. Neumann.
TESTIMONY OF MR. JOHN NEUMANN, DIRECTOR,
NATURAL RESOURCES AND ENVIRONMENT TEAM,
GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Neumann. Chairwoman Comstock, Ranking Member Lipinski,
and Chairman Smith, I appreciate the opportunity to be here
today to discuss the findings from our recent report on
administrative requirements on federal research grants to
universities.
As you know, the federal government provides billions of
dollars each year to colleges and universities for research,
over $27 billion in fiscal year 2015 alone. To oversee the use
of these findings, Congress and federal agencies have
established a variety of administrative requirements. However,
the research community has raised concerns about the
administrative workload and costs for researchers and
universities to comply with these requirements.
Today, I would like to briefly highlight the three key
findings from our report. First, we looked at selected
administrative requirements to understand why they're put in
place and found that they fell into two general buckets: OMB's
Uniform Guidance for grants and agency-specific guidance. OMB's
guidance generally focuses on protecting against fraud, waste,
and abuse of funds. For example, it requires competition and
documentation of purchases made with grant funds. Agency-
specific guidance generally focuses on the quality and
effectiveness of research. For example, NIH-funded researchers
are required to disclose financial conflicts of interest to
promote objectivity in the research they conduct with federal
funds.
Our second key finding was that there are certain common
factors that add to the workload and cost for universities to
comply with these requirements. Specifically, we found that
agencies vary in how they implement the same requirements
causing universities to develop multiple processes to comply.
We also found that funding agencies require detailed
documentation as part of the grant application process, even
though the likelihood of getting funded is relatively low. And
some requirements have become more prescriptive such as recent
changes to the Uniform Guidance that will require universities
to use competitive procurement methods when purchasing any
goods or services costing $3,500 or more, which universities
told us will result in added workload and costs. Examples of
the workload and costs universities have include purchasing and
updating electronic grant management systems, hiring and
training administrative staff, and then the time spent by the
researchers themselves.
Our third key finding was that while OMB and the funding
agencies have made continuing efforts to reduce universities'
administrative workload and costs, these reductions have been
limited, and we found opportunities for further improvements in
a number of areas. For example, we found that agencies have not
standardized certain administrative requirements across
agencies such as unnecessary variations that remain in the
format and content of biographical sketches as well as in
budget forms and budget justifications. We also found that
several funding agencies have not fully considered
opportunities to streamline pre-award requirements. For
example, NSF has been piling efforts to postpone certain
requirements such as detailed budgets until after the grant has
been awarded but other agencies in our view have not conducted
agency-wide reviews for similar opportunities to postpone
requirements.
Lastly, we found several areas where funding agencies could
consider providing universities with more flexibility including
the OMB requirements on competing purchases and NIH conflict-
of-interest rules.
Based on these findings, we made four recommendations to
OMB and the agencies in our review--the Department of Energy,
NASA, NIH and NSF--to identify and pursue further opportunities
to streamline administrative requirements on research grants to
universities. The agencies generally agreed to take steps to
implement our recommendations.
Chairwoman Comstock, Ranking Member Lipinski and Chairman
Smith, this concludes my prepared remarks. I'm happy to respond
to any questions that you may have.
[The prepared statement of Mr. Neumann follows:]
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Chairwoman Comstock. Great.
I now recognize Mr. Luther for five minutes.
TESTIMONY OF MR. JIM LUTHER,
ASSOCIATE VICE PRESIDENT
FOR FINANCE & COMPLIANCE OFFICER,
DUKE UNIVERSITY
Mr. Luther. Good morning, Subcommittee Chairwoman Comstock,
Ranking Member Lipinski, and Chairman Smith. I'll be addressing
my comments both from a Duke University perspective but also I
serve as the Board Chair for the Council on Governmental
Relations, which is an associate of 190 research universities,
medical centers, and institutes, and I also co-chair the
Federal Demonstration Partnerships Administrative Cost Working
Group.
I'd like to start by expressing my gratitude for the
Subcommittee's interest in identifying opportunities to more
effectively regulate research. Congress has long supported the
research enterprise, providing almost $63 billion in research
funding for fiscal year 2014 alone. Congress has also expressed
concern about the amount of time and funding spent on
administrative processes required for federally funded
research.
The reports discussed today join several previous reports
on this topic. All have come to similar conclusions, number
one, that the regulation of research continues to steadily
increase; number two, that there is a lack of standardization
across agencies; and number three, that federally funded
research could be regulated much more efficiently.
Universities are committed to working with federal partners
to ensure effective oversight and efficient use of taxpayer
funds. This commitment has led to a number of successes
including a thoughtful development and rollout of the Uniform
Guidance, and we continue to work with OMB to overcome
challenges related to procurement and sub-recipient monitoring.
Successful engagement has historically been heavily dependent
on relationships with individual agency employees. These
relationships can be extremely productive, but when the
critical staff member departs, so does the productivity of the
relationship.
It also frequently is the case that the university
perspective is not sought and that regulations do not include
material changes recommended. An example is the Common Rule. A
COGR-APLU analysis of comments on the proposed changes found
that 74 percent of all responses and approximately 96 percent
of responses from patients and members of the research
community opposed proposed changes to the biospecimens on the
grounds that they would be detrimental to research and health.
The Academies report suggests that the proposed revisions are
marred by omissions, the absence of essential elements, and
lack of clarity, and ``could be detrimental to areas of
important research.'' The Academies report, the HHS Secretary's
Advisory Committee on Human Research Protections, and others
have called for the proposed rule to be withdrawn, yet we
understand that HHS is still trying to move forward with this
final rule.
Compounding the issue of engagement is a significant
increase in federal regulations, 5.8 new or substantially
changed regulations annually, according to the Academies
report. In the last four months alone, three regulations, two
significant policies, and a training requirement were issued.
These new regulations and policies will cost each university
anywhere from several hundred thousand to several million
dollars and result in significant increase in administrative
and faculty workload. Many associated costs will not be
reimbursed as administrative costs long ago exceeded the 26
percent threshold. At Duke, we are approximately $25 million
over this threshold annually, largely caused by the
proliferation of new regulations.
Regarding other major recommendations including in the
National Academies report, COGR and the Association of American
Universities have strongly endorsed H.R. 5583, the University
Regulatory Streamlining and Harmonization Act of 2016, and S.
2742, Promoting Biomedical Research and Public Health for
Patients Act. Both would create the Research Policy Board that
is the centerpiece of the Academies recommendation and the
former, the appointment of an Administrator for the Academic
Research Enterprise for Unified Oversight.
H.R. 5583 proposes that the Research Policy Board be
composed of federal and university officials charged with
reviewing existing and proposed regulations with the goal of
reducing regulatory burden. No mechanism currently exists to
serve this function with respect to research enterprise at
large or through many examples of non-federal entities serving
in a related capacity. Critical discussions with the research
community coupled with Congressional and GAO oversight would
support mutual accountability and increase the likelihood of
achieving thoughtful and effective policy outcomes. This
partnership is critical because universities' share of funding
for research now constitutes almost 24 percent of total
academic R&D.
In summary, COGR and universities like Duke support the
findings and recommendations of the Academies and GAO reports
and the legislation that would implement them. We can't rely on
a handful of strategic relationships to safeguard and ensure
the effectiveness of the Nation's $63 billion investment in
research, and as stated so appropriately in the Research and
Development Efficiency Act, administrative burden is ``eroding
funds available to carry out basic scientific research.'' With
your support, we can achieve thoughtful, effective regulations
that protect the taxpayers' dollars and maximize results.
Thank you for your time and interest, and I look forward to
answering any questions you may have.
[The prepared statement of Mr. Luther follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Comstock. Thank you.
I now recognize Dr. Cabrera for five minutes.
TESTIMONY OF DR. ANGEL CABRERA,
PRESIDENT, GEORGE MASON UNIVERSITY
Dr. Cabrera. Thank you so much, Chairwoman Comstock and
Ranking Member Lipinski. Thank you, Chairman Smith, for
delaying that departure and holding this very important
hearing.
I bring to you the views and feedback from dozens of
researchers at George Mason University. Just to set it in
context, we are the largest public university in Virginia, and
we are the newest and youngest member of that Carnegie tier I
group of highest research universities in the country. We
conduct research in areas from cybersecurity and computational
sciences to proteomics, economics, criminology, psychology and
many other areas, and we, like all of our peers in the group of
research universities, are a great example of how that research
translates not only into new cures and solutions but also into
new organizations and enterprises that are driving innovation
in our region and in our Nation.
Now, Chairwoman Comstock, you and some of your staff have
toured our Institute of Biomedical Innovation, and we really
appreciate that visit. You were able to talk with some of those
conducting the research and see firsthand how research advances
education, leads to jobs and to improved lives, and you saw a
glimpse of that wonderful research that happens in our
institution and in many others. I would be remiss, Mr.
Lipinski, if I did not extend the opportunity for you and your
staff to visit at your convenience and to show you what we do.
Now, it doesn't escape you that to do our work as a public
university, we rely on state investments and appropriations. We
rely also on private contributions and research grants, and
very importantly, we depend on student tuition. As the
investment from state has declined, the pressure on student
tuition is creating real issues of access. The issues of
regulatory efficiency and the costs that they generate at the
end of the day impact students and impact the social issues
around access to higher education.
Now, let me provide some specifics on the areas that the
GAO report highlighted. Many of our researchers do receive
awards from more than one agency. This means that they have to
spend an inordinate amount of time identifying and responding
to different requirements regarding proposal submissions,
conflict-of-interest purchasing, subrecipient monitoring,
reporting and closeout. This problem is compounded by the fact
that the success rate of awards in many agencies is getting
lower while the time and cost of applying is getting higher.
This paradox is discouraging faculty, many of whom balance
teaching, mentoring, and research loads from pursuing more
research opportunities.
In terms of export controls, the Academies report correctly
points out that universities including Mason continue to be
concerned about efforts by the State Department to modify the
definition of fundamental research in ITAR. If the result is a
restricted definition of fundamental research, that may cause
real problems in terms of driving innovation and bringing about
the resources from around the world that sometimes are
necessary to drive that innovation.
We have a great example of innovation in regulation with
effort reporting. In 2011, Mason was the first of four pilot
schools to participate in a payroll certification pilot under
the auspices of the Federal Demonstration Partnership, and
effort reporting is often cited as one of the most burdensome
administrative requirements for researchers. Effort incurred
across multiple activities is difficult to measure and track,
and administration is very inefficient and costly.
With payroll certification, we aim to improve the
efficiency and at the same time not diminish the
accountability. The result of that pilot at Mason was a
reduction in 85 percent in the reports produced without any
negative and adverse impact in the supervision in
accountability. That's a great example of how we can have
smarter processes that really reduce the cost.
Finally, the Academies report calls for Congress to create
a Research Policy Board, and there are many other
recommendations that we endorse and support. To some extent,
Madam Chair, your bill 1119, which passed the House, and your
bill, Ranking Member Lipinski, implement what the National
Academies is recommending, and we are grateful to both of you.
Your bills will allow for broader discussion of that monster
that lurks behind every rule, the law of unintended
consequences. By providing a pause button or the ability to
raise a red flag and means for redress and revisiting existing
rules, you have done a tremendous service to the research
enterprise and the Nation's future innovation.
Thank you so much.
[The prepared statement of Dr. Cabrera follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Comstock. Thank you, and I now recognize myself
for five minutes for questions.
First, I thank all of the witnesses, and again, we
appreciate you being here today despite it being a quieter day,
and this is an important topic, and we appreciate all that
you've been doing, and I did want to actually also echo the
invitation to come down to visit George Mason if you'd like
because--and in particular I really appreciate all the women
that you have working on the important research, and they've
spoken to my Young Women's Leadership program, and there's some
really exciting cancer research going on there as well as Lyme
disease, so I particularly appreciate that, although I had a
lot at the videogames place too at George Mason, so that was
pretty--which actually leads into some of these areas too
surprisingly. So when your kids are out there playing
videogames, you never know where it can lead to because there's
some pretty exciting things going on at George Mason, so I
always do remind everyone who gets upset about their kids
playing videogames, we've got exciting scientific research that
goes into medical areas and lots of other things. But I
digress.
So as you mentioned, Dr. Cabrera, George Mason University
recently rose in the ranks to be amongst the highest research
institutions in the country with the Carnegie classification of
institutions of higher education, an elite group of the top 115
research universities in the country, and congratulations on
that. I think it's exciting how things are changing. I think we
really see that kind of growth in so many of these areas so
we're happy that you're a part of it.
Does the regulatory burden and barriers for applying for
and managing federal grants make it more difficult for a
smaller or less resource-rich university to become competitive,
and if we really want to create this competitive ecosystem that
is going to be able to do the cutting-edge research that we
want, how is this regulatory burden impacting that?
Dr. Cabrera. Thank you, Chairwoman Comstock, and yes,
indeed, it makes it very difficult. In fact, if you look at
that cluster of 115 universities in that tier I Carnegie
classification, you won't see much change from time to time. It
tends to be a pretty big barrier of entry for universities that
are growing like ours that are really building a research
infrastructure. Our estimate is that we spend about $16 million
annually to provide administrative support to our PIs to help
comply with research regulations. Our estimate is that we don't
recover about $2 million of that, which by the way if you
compare the size of our research enterprise with Duke's, I
think our ratios are require similar, and which actually seems
to highlight that there doesn't seem to be much economies of
scale, even as your research enterprise and looks like the
burden continues to grow proportionately. So I think it does
create a big barrier, not just for a big college, not just for
existing large research enterprises, but for emerging ones like
George Mason.
Chairwoman Comstock. Could you all estimate maybe in your
individual institutions, so you have $60 million for the cost,
if it was streamlined like the pilot that you did, what kind of
savings do you estimate you would see? And then, of course, how
would that be plowed back into the research? And then the
others too, if you might address that?
Dr. Cabrera. Well, the pilot that we conducted, you can
consider that it's in a relatively smaller side of the many
aspects of regulation that we deal with, but our estimates that
might reduce--just by that simple change, we may be saving
north of $50,000 a year. So what this indicates is not just the
amount of this. If you expand that kind of thinking to all the
areas of regulation, those numbers very quickly add up.
Chairwoman Comstock. Okay. Mr. Luther?
Mr. Luther. Yes. I think what I'd add to that is, the
amount that departments and administrations support the
research mission at Duke is significant and growing, probably
$150 million, about $25 million of that that we don't recover.
It's over the administrative cap.
I think the other key issue, though, is the avoided costs,
right? As new policy comes down the pike, do we have to add
additional staff, do we have to add additional administration
and technology and business processes, because for every one of
these regulations, we have to figure out how to support it
centrally, how we have to roll it out to the departments, how
we train this, and then ultimately can we do this in a way that
doesn't further contribute to that 42 percent of the funded
faculty members' time. That's what this is all about from any
university's perspective is how can we do it in an efficient
way so as not to distract the faculty member from doing their
research.
Chairwoman Comstock. Exactly. Thank you.
And Dr. Faulkner or Mr. Neumann, if you have any comments
on that?
Dr. Faulkner. I'm not currently president of the University
of Texas so I don't have good, immediate numbers for you, but
let me just make the point that actually was introduced by Mr.
Luther that I think we would save money if we improved the
regulatory environment but we would also save the invaluable
time of faculty members and research investigators generally,
not just faculty members. But that intellectual power, the
power to carry forward research, can't be replaced. That's the
indispensable asset, and in order to maintain the capacity of
American research, we need to get as much of that brainpower as
possible dedicated----
Chairwoman Comstock. On task?
Dr. Faulkner. But on the resource side, the dollars that
institutions are putting into the support of compliance and
administrative activity is quite significant and has to come
from somewhere. So it competes with everything else that the
institution is doing including its ability to support students
including its ability to deliver quality undergraduate
programs, including its ability to deliver quality graduate
programs.
Chairwoman Comstock. Thank you.
Mr. Neumann. The only thing I'll add is that we didn't
focus specifically on the costs of some of these administrative
requirements but rather a little more deeply at the types of
things universities had to do to address them, and certainly
where they found things like the payroll certification pilot
where they could reduce those burdens, as Dr. Cabrera pointed
out, they had significant savings of administrative time, the
researchers' time. So that's, you know, the kind of--so we
tried to provide some examples of the things that universities
are doing to comply with these requirements to get a sense of
what's behind these numbers that we've been hearing about.
Chairwoman Comstock. Great. Okay. Now I've gone over my
time so I yield to Mr. Lipinski.
Mr. Lipinski. Thank you. Chairwoman Comstock, I'm intrigued
now by the videogames at George Mason and what the connection
is here.
Chairwoman Comstock. Game Institute.
Mr. Lipinski. Game Institute. Okay. I'll have to come out
and visit.
I want to say that obviously the purpose of regulations is
to make sure that there's accountability, we try to rid any
kind of waste or fraud but I think it's very important as Dr.
Faulkner had talked about in his statement. I just want to read
this from the National Academies report here. I think it's very
important to make sure we focus on ``Continuing expansion of
the federal regulatory system and its ever-growing requirements
are diminishing the effectiveness of the Nation's research
investment.''
As I said in my opening statement, we are unfortunately
seeing the flattening out and sometimes diminishing of research
dollars at the federal level, unfortunately, and we cannot
afford to diminish those dollars further through regulation,
and I think it's important that everyone understands what this
really means, and as Dr. Faulkner talked about, the waste of
time of researchers, that really is a great loss not just to
those individuals but to our entire research enterprise and in
our country, and so I think it's very important that we make
sure that people realize that.
I wanted to have a couple of our witnesses expand on a
couple of the points that were--that they made. The Research
Policy Board, I want to ask Mr. Luther first, what do you see
as the value of the Federal Government? Can you just expand on
the value of the Federal Government working closely with
institutions in developing the regulations and requirements for
research?
Mr. Luther. Thank you. You know, as I was preparing for
this and reviewing the materials, I think to many of us, both
at the university level as well as at COGR, the Research Policy
Board is kind of the enabler for everything else, right?
There's other organizations. There's the research business
models. There's the Federal Demonstration Partnership. But the
Research Policy Board, the way it's been suggested, is the one
group that has all of the appropriate stakeholders at the table
to develop it and talk through the implementation, and what
we're seeing is, that transparency of the development process
as well as input into the implementation process is so critical
to the efficiency of it but also to the accountability of it,
the accountability going both ways to good policy as well as
how can institutions do it in an effective way and meet the
goals of that. And I think creation of a board like this that
has the same objectives of efficient, quality policy
development and implementation is so critical, and as we look
specifically at the Common Rule and the biospecimens, I have
absolutely no doubt that the NIH has good reasons for the
position they're taking right now as they look at this, but
again, in the APLU-COGR review, there's 96 percent of the
respondents both at universities and research subjects that
basically are questioning this and questioning the impact this
would have on research.
And so again, I'm sure the NIH has good reason for the
position they're taking, but again, if universities and other
stakeholders are the table to evaluate this and participate in
it, it would be a much more transparent and accountable
process.
Mr. Lipinski. Thank you.
Dr. Faulkner, do you have anything you want to add on that?
Dr. Faulkner. Well, that was a beautiful speech that Mr.
Luther just gave. Let me just add two points, though. One is,
I'd like to emphasize the word ``anticipatory,'' which is--it's
used in that report, and I believe I'm speaking accurately
about the sentiments of the committee who wrote the report that
they believe that the ability to anticipate new issues and to
be able to work those issues before they really have to reach
regulatory implementation is the key to maintaining a sane and
functional overall regulatory burden, and that's one of the
things that we wanted to achieve with the RPB.
And I had a second point, which has flown out of my mind,
so I'll just turn my microphone off.
Mr. Lipinski. That happens to me all the time.
Dr. Cabrera, do you have anything to add? You don't have
to.
Dr. Cabrera. No, just to emphasize--and I think the way you
articulated question, I couldn't agree more with that preamble
and since I don't think none of the recommendations from these
reports question the importance of good regulation, of good
accountability, and no one is, I guess, advocating for weak
accountability. On the contrary, I think the words that even
both of your bills use, you know, harmonize, streamline,
eliminate duplication, improving coordination, those are the
right directions to take in all these efforts and that can only
be done with these coordinating bodies like the ones that your
bill endorses.
Mr. Lipinski. Well, if I can take a little more time, I
wanted to at least briefly touch on something else that Dr.
Faulkner raised about the Inspector General. The 1978 Inspector
General Act says the purpose of the IG also is to promote
economy, efficiency and effectiveness in the administration of
programs, and you touched upon that in your statement. Can you
expand on that? Obviously you don't think that--or it seems to
me that you are saying that that's not always the understanding
that the IG brings to part of what their job is.
Dr. Faulkner. Well, I think that the committee fully
recognizes the need for the Inspectors General to focus on
waste, fraud, and abuse. What we also recognize, however, is
that the research enterprise in the United States as it's
implementing in the research partnership with academic
institutions already has a large volume of audit involved in
it. Every institution is audited every year on its research
activity. The history of Inspector General engagement with the
research enterprise is not one that has yielded large trophies
in terms of recovered funds. There are, of course, isolated
cases where problems have been explored and where remediation
has been required, but that's not the ordinary story. A more
common story is that Inspectors General and the agency that
they're supporting or engaged with have different
interpretations of what federal policy ought to be or federal
practice ought to be in financial management of research
grants, and the dispute which is essentially between two
federal actors, will get fought out on a battle ground in an
institution that then has to spend large amounts of money to go
through the process of the audit that's being used to fight the
battle. This, in our judgment, is not really constructive. The
battle between the federal players should be fought out here
and not there.
And we do recognize also that in the charter that you read,
Representative Lipinski, there is a direct reference to giving
the responsibility to the Inspectors General for the
improvement of efficiency and effectiveness and we're simply
asking for a rebalancing of the approach in this area where
there's already so much audit activity to pay attention to that
part of the mission.
Mr. Lipinski. Does the two months' summary salary issue at
NSF fall into this?
Dr. Faulkner. Well, that's been one of the areas where
there's a dispute between the IG and the agency itself over
what the policy should be. They have to settle what the policy
is and we carry it out.
Mr. Lipinski. Thank you very much, and I thank the
Chairwoman for being here. I know you didn't have to be here
this morning, so I appreciate it.
Chairwoman Comstock. We appreciate the professor too being
here with his expertise.
Let's see. I wanted to see if we could maybe draw a picture
for us. I'm thinking when I visited George Mason, Dr. Luchini I
guess was named one of the 40 most brilliant people in the
world working on Lyme disease research, I think some cancer
research, because the nanotechnology is kind of coming together
in some ways, or Dr. Petricoin, who was also with us on some of
those visits. How is their day and time--because when I think
of having the asset of one of the 40 most brilliant people in
the world working on these important diseases and chronic
conditions that we want to cure and find, you know, new
information on, how is their day impacted? How is their work
impacted because of these regulations? Maybe if you can give us
a picture of what Dr. Luchini or Dr. Petricoin have to do as a
result of these regulations, that helps sort of give us the
urgency of, we want them on task, and having seen some of those
brilliant things that they're working on, I really don't like
the thought of them having to do much else besides put their
brains to this good work.
Dr. Cabrera. Sure. Dr. Luchini, by the way, is one of those
thousands of bright scientists from outside of the United
States that every year choose to come and join our universities
because this is where the tools and the environments that they
think were they can have the biggest impact, and her
recognition indeed was not just as a top scientist but as a top
young scientist, and this is very important because I believe
when I talk to our faculty, it is young scientists that suffer
the burden of these regulations more directly and more
personally. I'm guessing that people like Dr. Petricoin and
well-seasoned scientists have somehow developed their own
survival routines, on how to deal with all these things, and
they figure out a way to do it.
My concern is that the younger scientists may see this as
yet another unsurmountable barrier to do what they want to do,
which is to spend time in the lab trying to explore how to best
test people for Lyme disease or how to come up with a new
personalized treatment for cancer. So just like I mentioned
earlier that I believe that this complex regulatory machinery
creates a burden for young universities that are building the
research infrastructure at a more micro level, it does the same
for younger researchers.
Chairwoman Comstock. No, that's great, and seeing how she
inspires the students too and to get to capture their
imagination and stay in working in this, I think we need bring
the Uber economy to the scientific research, right? Get a
little bit more flexibility.
Okay. We wanted to cover some of the things that others who
aren't here might have covered.
Dr. Faulkner, the centerpiece of the Academies report is
the creation of a self-funded Research Policy Board to include
members of both the research community and government agencies.
Did the study committee have any concerns that it would be just
another layer of bureaucracy? Because as we come in and look at
these things, that's what I'm trying to figure out, you know,
what is the ideal picture of a day in the life of these
researchers and how we're going to provide accountability
without interrupting the important work? So as we come up with
these solutions, how can we make sure we're not adding more
bureaucracy instead of peeling it back?
Dr. Faulkner. Well, I think that's a good question, Madam
Chairwoman. The goal certainly is not to add a layer, and I
believe that with the design we've laid out, that would not
happen. This is not an approval body. It's not I think in the
line of what would be required to get things done, but it is
meant to be a coordinating body, and as I emphasized earlier,
an anticipatory body.
One of the points that Representative Lipinski made earlier
is that the volume of regulatory activity has grown over time
and continues to grow. We can bet that it's going to continue
to grow because as research goes on, it uncovers issues that
require attention. We can all sit here today and recognize that
in the years ahead, we're going to have to more regulatory
activity that addresses some of the genetic issues that are
clearly in the field of view right now.
So we know that as research goes on, new issues come into
the picture. We need more coordination and some capacity for
the whole community, the researchers' side and the funders'
side, to get together and try to find ways to get to the
optimal regulatory picture, which is going to take continuous
editing as we have to bring in the capacity for additional
things, and perhaps we can develop other devices that speed up
or simplify or lower the cost of some of the things we're
already doing.
So I guess the answer I would give you is, we desperately
need the coordination, and the coordination and the
anticipation is the key to keeping this as sane as we can keep
it going forward.
Chairwoman Comstock. You know, one of the things that I've
heard from researchers as we talk about particularly in the
area of medical research and some of the rapid pace that things
are developing, the doctors, you know, if you're in any
particular field, you can't possibly know everything that's
going on that's out there, and we all get in our silos and all,
and they talk a lot about--I mean, some of the researchers and
technology people now--we've had--in my area we see people who
are very engaged in the technology committee are merging into
the medical area and wanting to, you know, use technology with
medicine and find ways to get information out there, and they
talk a lot about having more transparency, which is very
different from how our medical research is done today. You
know, you're in a study, you don't know all the other things
that are going on in the patients, and we don't have this
transparent process, you know, for good--I know there are
reasons why we don't but I have seen people now in the medical
area talk more about just getting more of this information out
there, you know, just having it all out there for everyone to
kind of come in and look at and, you know, you kind of have
that check and balance by having information out there instead
of having to have all these boards, having, you know, all this
regulatory process that you really get it out there and you
have the vast public being able to check it. You know, it's
like a spell check system out there because everybody else gets
to look at what you're doing and saying hey, did you connect
this with this and, you just have a lot more people in there
helping you, and is there--and I know, I'm not articulating
this very well--but this is what I had expressed to me in some
way from the technology side of this is, how do we open this up
a lot more and change that way of thinking in research that
it's just going to be open source type of information. Is it
something that you all have discussed in some way or heard
about too? Just any of you to address.
Dr. Faulkner. Shall I try?
Chairwoman Comstock. Sure.
Dr. Faulkner. I think actually you're addressing the
question of the sort of review and self-correction of science
as it occurs. You know, historically we've published things in
journals and people read the journals and they may do verifying
or testing experiments or other kinds of activity of their own.
As the scientific enterprise has gotten more complicated, and
as information technology has dramatically improved, the
possibility exists of providing larger amounts of information
including original data, which by and large has not been part
of that publication proceeding activity over the years. So I
think there is a lot of discussion in the scientific world
about whether by being more open with a larger fraction of what
investigators have produced including their original data we
might not be ahead. The Academy committee really didn't address
that issue. We're addressing not the question of review for
validity of scientific work; we're talking about true
regulation, I mean, financial regulations, what you can do with
human subjects and that sort of thing. So our work was all on
the other side here.
Chairwoman Comstock. Okay.
Mr. Luther. If I can add to that, you know, there is, I
think it's a 2013 OSTP requirement that for federal agencies
with over $100 million in annual expenditures, there's a public
access process, and I think the rollout of that is going to be
ripe for something like a Research Policy Board because that
regulation requires that for all peer-reviewed publications
that all supporting digital data as well as all the metadata be
made available. It requires that it's stored for long-term
preservation and publicly accessible to search, and it
requires--with a goal of maximizing the potential to create the
new business opportunities. And I think that's wonderful,
right? The Federal Government has funded this research, it's
data that can be leveraged to do other wonderful things, but as
we look at how we're going to execute on that, one example that
we've discussed with a faculty member is that the imaging data
related to one mouse is terabytes upon terabytes upon terabytes
of data, and that would have to be made publicly available with
metadata and supported for future research, wonderful idea, but
how we do that and how we execute on that and how it happens
and orders of magnitude. We've talked to peers out in the
Midwest that do weather research. Well, the quantity of weather
research and the data they create or the space program is just
orders of magnitude. So the concept is wonderful but the idea
behind a Research Policy Board that's where all the players at
the table are working towards the same strategic goal and
thinking through how to operationalize that is what's so
critical because if the regulation just comes out and says do
it, it's the faculty member that's going to have to, that's
going to know the data. We as administrators are going to try
to help but we don't have the tool set, and it will create an
immense amount of burden.
Dr. Cabrera. Just to add to that, I mean, the possibilities
that are created by new technologies are simply phenomenal in
terms of access to data and immediacy of that data, not having
to wait the number of months and sometimes years that a
traditional publication cycle would enforce. The key and I
think some of the biggest debates we're having in scientific
communities is how to balance that desire for immediacy in
access with the power of the peer-review process, which is
really one of the central pillars of the scientific enterprise
and not lose that because that's one of the most important sort
of research quality control processes that we've developed
throughout the years.
Chairwoman Comstock. Great. Thank you. And I will yield to
Mr. Lipinski.
Mr. Lipinski. I think we've covered many things here. I
just want to see if there's anything--I'll open up. Usually the
Chair probably would do this, but are there any--anything that
any of the witnesses would like to add that they think we
haven't covered here that are important to get on the--to get
on the record? Any additional--Dr. Cabrera?
Dr. Cabrera. If any--the only thing, I think it's been
said, but I just wanted to emphasize the tremendous amount of
consensus and agreement that the NAS report has generated, so
this is not just an isolated point of view. I think it really
reflects the point of view of the research universities of this
country.
Mr. Lipinski. Thank you.
Mr. Luther. I was just going to add that I think the GAO
report set out, you know, to really look at the university
community's concerns and in a sense validated those concerns,
and if agencies take action based on our recommendations, we
think they can continue to make some progress in this area
which, you know, we did identify a couple of areas that really
do need further look, you know, in terms of streamlining,
standardizing some of these requirements and delaying some and
doing things that make more sense based on the risk like, you
know, the purchase requirement. So I think that would be really
important. I'm glad that you're holding this hearing, and I
think having this will ensure that agencies will take action
based on our recommendations.
Mr. Lipinski. Thank you.
Mr. Luther?
Mr. Luther. Yes. Thank you. I would just like to say I hope
you sense the commitment from universities, certainly from our
comments as well as, you know, the communications that COGR and
AAU and FDP and many of the other organizations have had. It's
all about the commitment to support the research and make it
better, and we do things internally. In fact, at Duke, we have
in essence kind of a research policy board internally that
reviews policies. We have a couple of senior leaders that meet
every Tuesday morning and have met for about the last ten years
to look specifically at research issues, and it's a combination
of financial, administration and faculty leadership, and it's
there to address those issues, to address the resource needs
and so forth.
And then my final comment would be, as I mentioned in my
opening statement, there are lots of examples of highly
functioning relationships of where we've worked through things,
the uniform guidance with NIH, we've had NIH, NSF and DOD.
We've had some really positive discussion about the closeout
process and subaccounting. But as I mentioned, much of that is
very relationship-based. There's a handful of absolutely
wonderful people that are just as committed, if not more than
we are, to work through this. We would hope that that research
board, research policy board, is structured that same way, to
have the committed individuals that are accountable that push
the objectives of good, effective policy.
Dr. Faulkner. I think we've done well with the subject
today, so I won't add anything further.
Mr. Lipinski. I completely agree. I thank the witnesses for
your testimony. I think all of you did a very good job of
explaining the real need for regulatory relief when it comes to
academic research and the regulations. So thank you all for
your testimony.
Chairwoman Comstock. Thank you. And I also thank the
witnesses for their testimony, and Mr. Lipinski for joining me
here today and bringing his expertise to bear here.
It is really exciting to hear from people on the front
lines, and I invite you to continue the dialog with us on how
we can best help you best utilize the resources that we're
providing and make sure we have the best policies in place for
you to be able to do the good work that your researchers are
doing because there is so--you know, I think we are on the cusp
of some really incredible research developments that are out
there, and we want to make sure we are putting the best
policies we can in place, so we have no pride of authorship on
our end. We'd love to have you come and help us improve that.
You know, we're looking at Mr. Lipinski's bill too, so I think
we want to make sure we have the best ideas in place. So we
really, really appreciate your expertise and talent and the
importance of attracting that talent and making sure we have
the best talent here working and working on task.
So I thank you, and the record will remain open for two
weeks for additional written comments and any written questions
from Members who are here or not able to be here.
So thank you again, and the hearing is adjourned.
[Whereupon, at 11:17 a.m., the Subcommittee was adjourned.]
Appendix I
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Answers to Post-Hearing Questions
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Appendix II
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Additional Material for the Record
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