[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]





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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

                              ----------                              


                      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:]
    
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    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:]
    
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    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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