1.This Act may be cited as
the Accelerating Cures Act of
2008
.
2.The table of contents
for this Act is as follows:
Part J—Accelerating cures
SUBPART 1—Pathways to Cures Subcommittee
Sec. 499A. Pathways to Cures Subcommittee.
SUBPART 2—Clinical effectiveness; FFRDC
Sec. 499B. Federally Funded Research and Development
Center.
SUBPART 3—Health advanced research projects program
Sec. 499C. Health Advanced Research Projects
Program.
SUBPART 4—Clinical trials
Sec. 499D. Grants for quality clinical trial design and
execution.
Sec. 499D–1. Streamlining the regulatory process governing
clinical research.
Sec. 499D–2. Clinical research study and clinical
trial.
SUBPART 5—Training clinical and translational researchers of
the future
Sec. 499E. Training translational and clinical researchers of
the future.
Sec. 499E–1. Translational research training
program.
SUBPART 6—The Valley of death
Sec. 499F. Small business partnerships.
Sec. 499F–1. Rapid access to intervention
development.
Sec. 499F–2. Translational Development Program for New
Innovations.
SUBPART 7—Translational Research Fund
Sec. 449G. Translational Research Fund.
Sec. 404I. Application of research
requirement.
.
3.
(a)Congress finds the following:
(1)The National
Institutes of Health (referred to in this section as the NIH
) is
the United States premier biomedical research investment with annual
appropriations exceeding $29,200,000,000.
(2)The goals of the
NIH are to—
(A)foster
fundamental creative discoveries, innovative research strategies, and their
applications as a basis to significantly advance the Nation's capacity to
protect and improve health;
(B)develop,
maintain, and renew scientific human and physical resources that will ensure
the Nation's capacity to prevent disease;
(C)expand the
knowledge base in medical and associated sciences in order to enhance the
Nation's economic well-being and ensure a continued high return on the public
investment in research; and
(D)exemplify and
promote the highest level of scientific integrity, public accountability, and
social responsibility in the conduct of science.
(3)Thus, the NIH is
tasked with applying basic science discoveries to protect and improve health.
This includes, translational research, which is the scientific work necessary
to develop a clinical application from a basic science discovery.
(4)The United States
translational research investment will be key to the Nation responding
effectively—
(A)to public and
population health threats;
(B)to the complex
nature of chronic diseases, which are responsible for 7 out of 10 deaths in the
United States, for 75 percent of the $2,300,000,000,000 spent annually on
healthcare in the United States, and for 16 percent of gross domestic
product;
(C)to research and
development vacuums in the private for-profit market, such as in the fields of
vaccine and antibiotic production, drugs for Third World diseases, orphan
drugs, and medical tools for pediatric populations; and
(D)to facilitate the
process of converting medical innovations into commercial products.
(5)Key components of
the translational research process include research prioritization, a
strengthening and maintenance of an expert workforce, multidisciplinary
collaborative work, strategic risk taking, support of small innovative
businesses caught along common pathways in the research and development Valley
of Death, simplification and promotion of the clinical research endeavor, and
early involvement of private entities that are skilled in the manufacturing and
marketing process in the translational research endeavor.
(6)A National
Academy of Sciences/Institute of Medicine report made recommendations for
reorganizing NIH to meet new challenges facing the biomedical research
endeavor. The committee report contained specific recommendations aimed at
strengthening clinical and translational research including: increasing
trans-NIH research, promoting innovation and risk taking in intramural
research, creating a special projects
program, and increasing
funding for research management and support.
(7)The Government
Accountability Office reported that although the pharmaceutical industry has
increased its research and development investment by 147 percent from 1993 to
2004, new drug applications to the Food and Drug Administration have only
increased by 39 percent; thus, the productivity of the industry’s research and
development expenditures is declining. The report cited that a limited
scientific understanding of how to translate research discoveries into safe and
effective drugs is contributing to the problem and recommended that training
researchers who can translate drug discoveries into effective medicines is
necessary.
(8)It is estimated
to take 17 years for a science discovery to be translated from the point of
proof of concept to clinical application. The percent of physicians engaged in
research has declined steadily from a peak of 4.6 percent in 1985 to 1.8
percent in 2003.
(9)A report by the
Infectious Disease Society of America cited concerns with the lack of new
antibiotics to treat infectious diseases. The report commended the NIH Roadmap,
but also recommended that NIH aggressively expand the translational research
components of the Roadmap, increase grants to small businesses, universities,
and nonprofits working in antibiotics research and development, and seek more
opportunities to partner with pharmaceutical and biotech companies.
(10)Clinical
effectiveness results provide patients, payers, and clinicians with tools to
evaluate the benefits versus risks of the ever evolving number of prevention,
diagnosis, and treatment strategies available.
(11)The Common Fund
is an annual set aside account created from an agreed upon percentage of the
annual budget that supports innovative and trans-NIH initiatives to improve and
accelerate research to impact health.
(12)The
Valley of Death
is a stage in biomedical development between
research and commercialization where the success of a product is dependent on
its profitability.
(b)The
purpose of this Act is to create a new pathway to curing disease by enhancing
public and private research to translate new discoveries from bench to
bedside.
4.Accelerating
Cures Act of 2008Title IV of
the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at
the end the following:
J
1Pathways to Cures Subcommittee
499A.Pathways to
Cures Subcommittee
(a)Definition of
translational researchIn
this section, the term translational research means research that
transforms scientific discoveries arising from laboratory, clinical, or
population studies into clinical application to reduce disease incidence,
morbidity, and mortality.
(b)Establishment
of Pathways to Cures SubcommitteeThere is established a Pathways
to Cures Subcommittee within the Council of Councils of the Office of Portfolio
Analysis and Strategic Initiatives of the National Institutes of Health that
shall convene not less frequently than twice a year to help advise and direct
the translational research priorities of the Office of Portfolio Analysis and
Strategic Initiatives (referred to in this part as the
OPASI
).
(c)
(1)The subcommittee established under subsection (b) may be
composed of the following members:
(A)The Director of
NIH and the Director of OPASI who shall be subcommittee co-chairs.
(B)The heads of the
institutes and centers of the National Institutes of Health.
(C)Heads from
Federal agencies, including—
(i)the Administrator
for the Substance Abuse and Mental Health Services Administration;
(ii)the Under
Secretary for Science and Technology of the Department of Homeland
Security;
(iii)the Commanding
General for the United States Army Medical Research and Materiel
Command;
(iv)the Director of
the Centers for Disease Control and Prevention;
(v)the Commissioner
of Food and Drugs;
(vi)the Director of
the Office of Science of the Department of Energy;
(vii)the President
of the Institute of Medicine;
(viii)the Director
of the Agency for Healthcare Research and Quality; and
(ix)the Director of
the Defense Advanced Research Projects Agency.
(2)The subcommittee established under subsection (b) shall
also include not fewer than 3 leaders from the small business medical research
community, 3 leaders from large pharmaceutical or biotechnology companies, and
3 leaders from academia and patient advocacy organizations, all of whom shall
be appointed by the Director of NIH.
(d)Recommendations;
coordination; funding
(1)The subcommittee established under subsection (b)
shall make recommendations to assist the Director of OPASI in setting
translational research priorities.
(2)In
making recommendations, the subcommittee shall—
(A)consider risk and
burden of disease as well as lines of research uniquely poised to deliver
effective diagnostics and therapies; and
(B)be mission-driven
and identify research that shows specific promise for a new treatment or cure
for a disease.
(3)The
subcommittee shall ensure sharing of research agendas among the institutes and
centers of the National Institutes of Health for the purpose of coordinating
translational research priorities, where appropriate, across such institutes
and centers.
(4)The
subcommittee and the Director of OPASI—
(A)shall identify
research with application or commercialization potential; and
(B)may fund such
research
(e)The
subcommittee established under subsection (b) shall submit an annual report to
Congress on progress towards finding new treatments and cures.
2Clinical effectiveness; FFRDC
499B.Federally
Funded Research and Development Center
(a)
(1)The Director of NIH, in conjunction with the Director of
the Agency for Healthcare Research and Quality (referred to in this subpart as
the AHRQ
), shall establish a Federally Funded Research and
Development Center (referred to in this subpart as the FFRDC
) on
clinical effectiveness research.
(2)Definition of
clinical effectiveness researchIn this section, the term
clinical effectiveness research
means research that—
(A)provides
information for health care decision makers, including patients, providers, and
public and private payers, to make evidence-based decisions about the delivery
of health care; and
(B)considers
specific subpopulations.
(3)The Director of NIH, in conjunction with the Director of
the AHRQ, shall appoint a Director of the FFRDC.
(b)Duties of the
Director of the FFRDCThe Director of the FFRDC shall—
(1)review,
synthesize, and disseminate clinical effectiveness research;
(2)set priorities
for, and fund, trials, such as randomized controlled trials, adaptive trials,
and practical trials, observational studies, secondary data analysis in areas
of clinical effectiveness research where evidence is lacking, systematic
reviews of existing research, as necessary, and cost-effectiveness
studies;
(3)make
recommendations regarding the findings of paragraphs (1) and (2);
(4)study the
differential outcomes of interventions on subpopulations within
diseases;
(5)use competitive
award processes, including, but not solely, competitive peer review, and
examine methods of rapid review cycles to reduce delays in funding
decisions;
(6)encourage the
development and use of electronic health data to conduct clinical effectiveness
research for the goal of improving clinical care delivery;
(7)support the
development of methodological standards to be used when conducting studies of
clinical effectiveness and value in order to help ensure accurate and effective
comparisons and update such standards not less frequently than annually;
(8)include, and
collaborate and consult with, as necessary, the Food and Drug Administration,
the Centers for Medicare & Medicaid Services, the Centers for Disease
Control and Prevention, the Department of Defense, the Department of Veterans
Affairs, and other Federal agencies, and the Institute of Medicine, as well as
private payers, insurers, pharmaceutical and device companies, patient advocacy
and public interest groups, professional societies, hospitals, academic
institutions, and health foundations;
(9)establish a
public review or hearing process, which includes the Food and Drug
Administration, to examine findings of studies;
(10)determine the
best approach to make available the findings resulting from subparagraphs (A)
and (B) to relevant Federal agencies, private and public stakeholders in the
health care system, and consumers;
(11)provide a public
forum for addressing conflicting guidelines and recommendations; and
(12)submit annual
reports to Congress on the research activities and findings of the
FFRDC.
(c)Clinical
effectiveness advisory board
(1)Establishment
and functionThe Director of the FFRDC shall establish, in
conjunction with the Director of NIH and the Director of the AHRQ, an
independent Clinical Effectiveness Advisory Board (referred to in this section
as the Advisory Board
), to include not more than 20 appointed
members, in order to provide expert advice and guidance on the research
priorities of the FFRDC.
(2)
(A)Membership on the Advisory Board shall be comprised
of—
(i)representatives
of the National Institutes of Health, the AHRQ, the Food and Drug
Administration, the Centers for Medicare & Medicaid Services, the Centers
for Disease Control and Prevention, the Department of Defense, the Department
of Veterans Affairs, and other Federal agencies, and the Institute of Medicine;
and
(ii)private payers,
insurers, pharmaceutical and device companies, patient advocacy and public
interest groups, professional societies, hospitals, academic institutions, and
health foundations.
(B)Membership
on the Advisory Board shall consist of leading experts from diverse
disciplinary areas, including physicians, social scientists, statisticians,
health services researchers, economists, and other health care
professionals.
(C)Terms
for members of the Advisory Board shall be fixed, multiyear, and
staggered.
(D)The
members of the Advisory Board who are described in subparagraph (A)(ii) shall
be appointed by the Director of the FFRDC, the Director of NIH, and the
Director of the AHRQ.
(E)The
Director of the AHRQ shall be chair of the Advisory Board.
(3)Members of the Advisory Board shall disclose any
financial, political, or organizational conflicts of interest in conducting the
work of the Advisory Board.
(4)The
Advisory Board shall—
(A)recommend
priorities for clinical effectiveness research to be undertaken by the FFRDC,
taking into consideration significant gaps in clinical effectiveness research,
including research needs for information on subpopulations and diverse
populations, including women, children, and racial and ethnic minorities, and
on individuals with comorbid diseases;
(B)identify existing
and novel research designs and methods that may be considered by the FFRDC in
conducting clinical effectiveness research;
(C)review clinical
effectiveness research methods;
(D)review the FFRDC
processes to determine whether the research conducted is objective, credible,
developed through a transparent process that includes consultations with
appropriate stakeholders, including consumers, patient organizations, and the
public, and is clinically relevant;
(E)make
recommendations to the AHRQ and the National Institutes of Health for the
effective dissemination of the findings of the FFRDC supported research to
clinicians, payers, and consumers, and patient organizations; and
(F)following the
first year, review current and previous research agendas and make
recommendations regarding research agendas.
(5)The initial meeting of the Advisory Board shall be no
later than 6 months after the date of enactment of the Accelerating Cures Act
of 2008.
(6)The recommendations of the Advisory Board shall not be
binding, but shall be considered by the Director of the FFRDC when developing
the clinical effectiveness research agenda.
(d)The Director of the FFRDC shall establish the research
agenda of the FFRDC, based on the priorities established by the Advisory Board,
and shall update such agenda not less frequently than annually, and
shall—
(1)focus on—
(A)identifying gaps
in clinical effectiveness research relating to medical procedures, medical
technologies, pharmaceuticals, health information technologies, and other
relevant services and products that significantly contribute to health care
outcomes and expenditures;
(B)funding trials,
studies, and reviews, and coordinating these efforts with ongoing research
efforts in the Federal Government, academic institutions, and private entities
to fill gaps identified under subparagraph (A);
(C)synthesizing and
reviewing clinical effectiveness research to fill gaps identified under
subparagraph (A); and
(D)supporting the
development of an evidence base for the development of clinical care guidelines
based on the results of clinical effectiveness research;
(2)convene such
working groups on clinical effectiveness research as the Director of the FFRDC
determines necessary;
(3)meet with members
representing the National Institutes of Health, the AHRQ, the Food and Drug
Administration, the Centers for Medicare & Medicaid Services, the Centers
for Disease Control and Prevention, the Department of Defense, the Department
of Veterans Affairs, and other Federal agencies, and the Institute of Medicine,
as well as private payers, insurers, pharmaceutical and device companies,
patient advocacy and public interest groups, professional societies, hospitals,
academic institutions, practice based research networks health foundations, and
the general public to promote communication and transparency; and
(4)notify the public
well in advance of any public meetings.
(e)
(1)Guidance or
recommendationsThe Director of the FFRDC, in conjunction with
the Director of NIH and the Director of the AHRQ, shall provide, not less
frequently than annually, guidance or recommendations to health care providers,
payers, and consumers, and Congressional committees of jurisdiction on the
comparative effectiveness of health care services.
(2)The Director of the FFRDC shall provide annual status
reports on the work of the FFRDC to Congressional committees of
jurisdiction.
(f)Availability of
research findingsThe Director of the FFRDC shall develop and
identify efficient and effective methods of disseminating the findings of the
clinical effectiveness assessments of medical procedures, technologies, and
therapeutics, including by making these available on the Internet. Any relevant
reports (including interim progress reports, draft final clinical effectiveness
reviews, and final progress reports on new research submitted for publication)
on the results of clinical effectiveness research supported by the FFRDC shall
be made available on the Internet, not later than 90 days after the report is
completed.
(g)Evaluations and
reports of FFRDCThe Director of NIH, in conjunction with the
Director of the AHRQ, shall enter into regular agreements with entities, such
as the Institute of Medicine, to—
(1)evaluate the
FFRDC and its functioning; and
(2)produce reports
on priority setting for the FFRDC, and on research methods developed and
employed by the FFRDC, among other purposes.
3Health advanced research projects program
499C.Health
Advanced Research Projects Program
(a)There
is established within the OPASI, a Health Advanced Research Projects Program
(referred to in this section as the Research Projects Program
)
that shall be headed by a Director of the Research Projects Program who is
appointed by the Director of NIH.
(b)The
Research Projects Program shall be composed of portfolio managers in key health
areas, which are determined by the Director of the Research Projects Program in
conjunction with the Director of OPASI, the Director of NIH, and the Pathways
to Cures Subcommittee established under section 499A.
(c)The
Research Projects Program shall be guided by and shall undertake grand
challenges that encourage innovative, multidisciplinary, and collaborative
research across institutes and centers of the National Institutes of Health,
across Federal agencies, and between public and private partners of the
National Institutes of Health.
(d)The Research Projects Program shall be guided by the
following management and organizing principles in directing the Research
Projects Program:
(1)Keep the Research
Projects Program small, flexible, entrepreneurial, and non-hierarchical, and
empower portfolio managers with substantial autonomy to foster research
opportunities with freedom from bureaucratic impediments in administering the
manager’s portfolios.
(2)Seek to employ
the strongest scientific and technical talent in the Nation in research fields
in which the Research Projects Program is working.
(3)Rotate a
significant portion of the staff after 3 to 5 years of experience to ensure
continuous entry of new talent into the Research Projects Program.
(4)Use, whenever
possible, research and development investments by the Research Projects Program
to leverage comparable matching investment and coordinated research from other
institutes and centers of the National Institutes of Health, from other Federal
agencies, and from the private and nonprofit research sectors.
(5)Utilize
supporting technical, contracting, and administrative personnel from other
institutes and centers of the National Institutes of Health in administering
and implementing research efforts to encourage participation, collaboration,
and cross-fertilization of ideas across the National Institutes of
Health.
(6)Utilize a
challenge model in Research Projects Program research efforts, creating a
translational research model that supports fundamental research breakthroughs,
early and late stage applied development, prototyping, knowledge diffusion, and
technology deployment.
(7)Establish metrics
to evaluate research success and periodically revisit ongoing research efforts
to carefully weigh new research opportunities against ongoing research.
(8)Support
risk-taking in research pursuits and tolerate productive failure.
(9)Ensure that
revolutionary and breakthrough technology research dominates the Research
Projects Program’s research agenda and portfolio.
(e)Using
the funds and authorities provided to the Director of NIH, the Research
Projects Program shall carry out the following activities:
(1)The Research
Projects Program shall support basic and applied health research to promote
revolutionary technology changes that promote health.
(2)The Research
Projects Program shall advance the development, testing, evaluation,
prototyping, and deployment of critical health products.
(3)The Research
Projects Program, consistent with recommendations of the Pathways to Cures
Subcommittee established under section 499A, with the priorities of OPASI, and
with the grand challenges that encourage innovative, multidisciplinary, and
collaborative research, shall emphasize—
(A)translational
research efforts, including efforts conducted through collaboration with the
private sector, that pursue—
(i)innovative health
products that could address acute health threats such as a flu pandemic, spread
of antibiotic resistant hospital acquired infections, or other comparable
problems;
(ii)remedies for
diseases afflicting lesser developed countries;
(iii)remedies for
orphan diseases for which the for-profit sector is not finding new
treatments;
(iv)alternative
technologies with significant health promise that are not well-supported in the
system of health research, such as adjuvant technology or technologies for
vaccines based on the innate immunological response; and
(v)fast track
development, including development through accelerated completion of animal and
human clinical trials, for emerging remedies for significant public health
problems; and
(B)other appropriate
translational research efforts for critical health issues.
(4)The Research
Projects Program shall utilize funds to provide support to outstanding research
performers in all sectors and encourage cross-disciplinary research
collaborations that will allow scientists from fields such as information and
computer sciences, nanotechnology, chemistry, physics, and engineering to work
alongside top researchers with more traditional biomedical backgrounds.
(5)The Research
Projects Program shall provide selected research projects with single-year or
multiyear funding and require researchers for such projects to provide interim
progress reports, including milestones on progress, to the Research Projects
Program on not less frequently than a biannual basis.
(6)The Research
Projects Program shall award competitive, merit-reviewed grants, cooperative
agreements, or contracts to public or private entities, including businesses,
federally funded research and development centers, and universities.
(7)The Research
Projects Program shall provide advice to the Director of OPASI concerning
funding priorities.
(8)The Research
Projects Program may solicit proposals for competitions to address specific
health vulnerabilities identified by the Director of NIH and the Director of
OPASI and award prizes for successful outcomes.
(9)The Research
Projects Program shall periodically hold health research and technology
demonstrations to improve contact among researchers, technology developers,
vendors, and acquisition personnel.
(10)The Research
Projects Program shall carry out other activities determined appropriate by the
Director of NIH.
(f)
(1)The
Director of the Research Projects Program, in hiring employees for positions
with the Research Projects Program, shall have the same hiring and management
authorities as described in section 1101 of the Strom Thurmond National Defense
Authorization Act for Fiscal Year 1999 (5 U.S.C. 3104 note).
(2)
(A)Except as provided in subparagraph (B), the term of such
appointments for employees of the Research Projects Program may not exceed 5
years.
(B)The
Director of the Research Projects Program may, in the case of a particular
employee of the Research Projects Program, extend the term to which employment
is limited under subparagraph (A) by not more than 2 years if the Director of
the Research Projects Program determines that such action is necessary to
promote the efficiency of the Research Projects Program.
(g)The
Director of the Research Projects Program shall have the authority to flexibly
fund projects, including the prompt awarding, releasing, enhancing, or
withdrawal of monies in accordance with the assessment of the Research Projects
Program and project manager.
4
499D.Grants for
quality clinical trial design and executionThe Director of OPASI—
(1)shall award
grants for clinical trial design and execution to academic centers and
practice-based research networks to fund multidisciplinary clinical research
teams, which clinical research teams may be composed of members who include
project managers, clinicians, epidemiologists, social scientists, and clinical
research coordinators; and
(2)may award grants
for clinical trial design and execution to researchers.
499D–1.Streamlining
the regulatory process governing clinical research
(a)Establishment
of centralized institutional review boards
(1)
(A)Establishment
and oversightThe Director of OPASI shall appoint a Director of
Centralized Institutional Review Boards (referred to in this part as the
Director of CIRBs
) who shall establish and oversee the
functioning and progress of a series of Centralized Institutional Review Boards
(referred to in this part as CIRBs
) to serve as human subject
safety and well-being custodians for multi-institutional clinical trials that
are funded partially or in full by public research dollars.
(B)The Director of CIRBs shall work with the Commissioner of
Food and Drugs to make regulations governing multi-site clinical trials and the
regulatory requirements of the Food and Drug Administration more consistent in
order to reduce barriers to commercialization of new treatments.
(2)Existing
guidelines and best practicesCIRBs shall be established in
accordance with professional best practices and Good Clinical Practice (GCP)
guidelines so that institutions involved in multi-institutional studies
may—
(A)use joint
review;
(B)rely upon the
review of another qualified institutional review board; or
(C)use similar
arrangements to avoid duplication of effort and to assure a high-quality of
expert oversight.
(b)Each
CIRB shall be housed—
(1)at the institute
or center of the National Institutes of Health with expertise on the subject of
the clinical trial; or
(2)at a public or
private institution with comparable organizational capacity, such as the
Department of Veterans Affairs.
(c)The
use of CIRBs shall be available, as appropriate, at the request of public or
private institutions and shall be funded through user fees of the CIRBs or the
National Institutes of Health's funds.
(d)
(1)Each CIRB shall review research protocols and subject
informed consent forms to ensure the protection of safety and well-being of
research participants enrolled in multi-institutional clinical trials.
(2)The
CIRB review process shall consist of contractual agreements between the CIRB
and the study sites of multi-institutional clinical trials. The CIRB shall act
on behalf, in whole or in part, of the bodies ordinarily responsible for the
safety of research subjects in a locality. In the case in which a locality does
not have such a body, the locality shall depend solely on the CIRB to oversee
the protection of human subjects and the CIRB shall assume responsibility for
ensuring adequate assessment of the local research context.
(e)
(1)Each CIRB shall review and package research applications
for facilitated electronic review by local institutional review boards
participating in a multi-institutional clinical trial.
(2)A local institutional review board may accept or reject a
CIRB review. In the case in which a local institutional review board accepts a
CIRB review, the CIRB shall assume responsibility for annual, amendment, and
adverse event reviews. If a local institutional review board elects to decline
participation in the CIRB, the local institutional review board shall appoint a
liaison to the CIRB.
(f)In the case in which a local institutional review board
works in concert with a CIRB, the local institutional review board shall be
responsible for taking into consideration local characteristics (including
ethnicity, educational level, and other demographic characteristics) of the
population from which research subjects will be drawn, which influence, among
other things, whether there is sound selection of research subjects or whether
adequate provision is made to minimize risks to vulnerable populations.
(g)Communication
of important informationEach CIRB shall regularly communicate
important information in electronic form to the local institutional review
boards or, in cases where a local institutional review board does not exist, to
the principal investigator, including regular safety updates or requirements to
change a research protocol in order to improve safety.
(h)Each
CIRB shall fully coordinate with the institute or center of the National
Institutes of Health that has specialized knowledge of the research area of the
clinical trial. Other Federal agencies and private entities undertaking
clinical trials may contract with the National Institutes of Health to use a
CIRB.
499D–2.Clinical
research study and clinical trial
(a)The Director of NIH
shall—
(1)commission the
Institute of Medicine to study the rules that protect patient safety and
anonymity so that in a contemporary clinical research context, a better balance
can be achieved between clinical research promotion and regulatory requirements
governing research subject safety and privacy;
(2)examine informed
consent processes; and
(3)request that the
Institute of Medicine issue a written report not later than 18 months after the
date of enactment of the Accelerating Cures Act of 2008 that shall—
(A)consider changes
to the Health Insurance Portability and Accountability Act of 1996 (Public Law
104–191) and the amendments made by such Act that further promote the clinical
research endeavor; and
(B)include
recommendations for changes that shall not be limited to legislation but shall
include changes to healthcare systems, including health information technology,
and to researcher practice that facilitate the clinical research
endeavor.
5Training clinical and translational researchers of
the future
499E.Training
translational and clinical researchers of the future
(a)
(1)The Director of
OPASI shall establish training programs to increase the number of, and maintain
existing, translational and clinical researchers, including researchers trained
in community-based research.
(2)The purpose of the training programs
described in paragraph (1) shall be to train a cadre of researchers in core
competencies in the translational and clinical sciences for the ultimate goal
of improving healthcare delivery, healthcare options to the public, the use of
healthcare by patients, and healthcare outcomes.
(b)
(1)The Director of OPASI shall award grants to, and enter
into contracts with, public and nonprofit educational entities to establish,
strengthen, or expand training programs for researchers to be trained in the
translational and clinical sciences.
(2)The Director of OPASI shall award grants to, and enter
into contracts with, applicants that—
(A)support
multidisciplinary approaches in training;
(B)utilize
collaborative strategies for conducting research across various disciplines to
translate basic science discoveries; and
(C)train researchers
focused on improving care and patient outcomes.
(3)The Director of OPASI shall award grants to, and enter into
contracts with, entities for the following purposes:
(A)To establish
training programs for M.D. and Ph.D. researchers in translational or clinical
research.
(B)To establish
training programs for individuals at predoctoral levels, including those in
medical school, and for allied health professionals, in translational or
clinical research.
(C)To establish
training programs for nurses in translational and clinical research.
(D)To strengthen or
expand existing training programs for translational or clinical
researchers.
(E)To establish a
wide range of training programs, including one-year training programs, summer
programs, pre- and postdoctoral clinical or translational research fellowships,
and advanced research training programs for mid-career researchers and
clinicians.
(F)To provide
stipends and allowances, including for travel and subsistence expenses, in
amounts the Director of OPASI determines appropriate, to support the training
of translational or clinical researchers.
(G)To provide
financial assistance to public and nonprofit educational entities for the
purpose of supporting the training of translational or clinical researchers,
through clinical education, curricula, and technological support, and other
measures.
(H)To measure the
impact of the translational and clinical research training programs on the
biomedical sciences and on clinical practice.
(c)The Director of OPASI may make funds available to
support training programs for translational or clinical researchers at the
National Institutes of Health for entities awarded grants or contracts under
subsection (b).
(d)The Director of OPASI shall convene, on not less
frequently than a biannual basis, members of training institutions to share
novel and best practices in training translational or clinical
researchers.
(e)A
trainee of a program funded under a grant or contract awarded under this
section may conduct part of the trainee's training at the Health Advanced
Research Projects Program.
(f)Consistent
definitions and methodologiesFor the purposes of funding
training programs for clinical researchers, the Director of NIH shall develop
consistent definitions and methodologies to classify and report clinical
research.
499E–1.Translational
research training programThe
Director of NIH shall ensure that each institute and center of the National
Institutes of Health has established, or contracted for the establishment of, a
translational research training program at the institute or center.
6
499F.Small
business partnerships
(a)An independent
advisory board shall be established at the National Academy of Sciences to
conduct periodic evaluations of the Small Business Innovation Research program
(referred to in this subpart as the SBIR program
) and the Small
Business Technology Transfer program (referred to in this subpart as the
STTR program
) of the Office of Extramural Research in the Office
of the Director of the National Institutes of Health for the purpose of
improving management of the programs through data-driven assessment. The
advisory board shall consist of the Director of NIH, the Director of the SBIR
program, senior National Institutes of Health agency managers, university and
industry experts, and program stakeholders.
(b)SBIR and STTR
grants and contracts
(1)
(A)Program
managers with sufficient expertiseNot less than 25 percent of
the grants and contracts awarded by each of the SBIR and STTR programs shall be
awarded on a competitive basis by an SBIR or STTR program manager who has
sufficient managerial, technical, and translational research expertise to
expertly assess the quality of a SBIR or STTR proposal.
(B)Experience of
program managersIn hiring new SBIR or STTR program managers, the
Director of NIH shall consider experience in commercialization or
industry.
(C)Emphasis on
grant and contract awardsIn awarding grants and contracts under
the SBIR program and the STTR program—
(i)each SBIR and
STTR program manager shall place an emphasis on applications that identify from
the onset products with commercial potential to prevent, diagnose, and treat
diseases, as well as promote health and well-being; and
(ii)risk-taking
shall be supported and productive failure shall be tolerated.
(2)Examination of
commercialization and other metricsThe independent advisory
board described in subsection (a) shall evaluate the success of the requirement
under paragraph (1)(A) by examining increased commercialization and other
metrics, to be determined and collected by SBIR and STTR programs.
(3)Each
recipient of a SBIR or STTR grant or contract, as a condition of receiving such
grant or contract, shall report to the SBIR or STTR program—
(A)whether there was
eventual commercial success of the product developed with the assistance of the
grant or contract; and
(B)on other metrics
as determined by the SBIR or STTR program to capture broader measures of
success.
(c)Potential
purchasers or investorsThe SBIR and STTR programs shall
administer nonpeer review grants and contracts pursuant to this section through
program managers who shall place special emphasis on partnering grantees and
entities awarded contracts from the very beginning of the research and
development process with potential purchasers or investors of the product,
including large pharmaceutical or biotechnology companies, venture capital
firms, and Federal agencies (including the National Institutes of
Health).
(d)The SBIR and STTR programs shall reduce the time period
between Phase I and Phase II funding of grants and contracts under the SBIR and
STTR programs to—
(1)6 months;
or
(2)less than 6
months if the grantee or entity awarded a contract demonstrates that the
grantee or entity awarded a contract has interest from third parties to buy or
fund the product development with the grant or contract.
(e)A SBIR or STTR program manager may petition the Director of
NIH for Phase III funding of a grant or contract for a project that requires a
boost to finalize procurement of a product. The maximum funding for Phase III
funding shall be $2,000,000 for each of a maximum of 2 years. Such Phase III
funding may come from the Common Fund of the NIH.
(f)Evaluation and
reporting requirementsIn order to enhance the evidence base
guiding SBIR and STTR program decisions and changes, the SBIR and STTR programs
shall—
(1)conduct regular
internal and external evaluations of the program;
(2)review current
data collection methods for the purpose of identifying gaps and deficiencies,
and develop a formal plan for evaluation and assessment of program success,
including operational benchmarks for success; and
(3)conduct a review
on the number of SBIR and STTR awards made to women and minorities and develop
outreach and review strategies to increase the number of awards to women and
minorities.
(g)
(1)The SBIR and STTR programs may initiate pilot programs,
based on the development of a formal mechanism for designing, implementing, and
evaluating pilot programs, to spur innovation and to test new strategies that
may enhance the effectiveness of the program.
(2)The
SBIR and STTR programs shall consider, among other issues, conducting pilot
programs on including individuals with commercialization experience in study
sections, hiring individuals with industry experience for staff positions,
separating the commercial and scientific review processes, and examining the
impact of the trend toward larger awards on the overall program.
(h)
(1)The SBIR and STTR programs shall keep a publicly
accessible electronic record of all SBIR or STTR investments in research and
development.
(2)The record described in paragraph (1) shall include, at a
minimum, the following information:
(A)The grantee or
entity awarded a grant or contract.
(B)A description of
the research being funded.
(C)The amount of
money awarded in each phase of SBIR or STTR funding.
(D)If applicable,
the purchaser of the product, current use of the product, and estimated annual
revenue resulting from the procurement.
(E)Dates of Phases
I, II, and III awards, as applicable.
(F)Other metrics as
determined by the SBIR or STTR programs.
(i)The
Director of NIH shall convene a meeting, not less frequently than annually,
consisting of the National Institutes of Health SBIR/STTR program coordinator
or manager and each institute and center of the National Institutes of Health
to share best practices, report on program activities, and review existing
policies.
(j)The Director of NIH shall submit an annual report to
Congress and the independent advisory board described in subsection (a) on the
SBIR and STTR programs' activities.
499F–1.Rapid
access to intervention development
(a)The Director of OPASI shall expand the existing Rapid
Access to Intervention Development Program (referred to in this subpart as the
RAID
) that—
(1)is designed to
assist the translation of promising, novel, and scientifically meritorious
therapeutic interventions to clinical use by helping investigators navigate the
product development pipeline;
(2)shall aim to
remove barriers between laboratory discoveries and clinical trials of new
molecular therapies, technologies, and other clinical interventions;
(3)shall aim to
progress, augment, and complement the innovation and research conducted in
private entities to reduce duplicative and redundant work using public
funds;
(4)shall coordinate
with the offices of the National Institutes of Health that promote
translational research in the pre-clinical phase across the National Institutes
of Health;
(5)shall identify,
for the OPASI, those research projects with promise for clinical application or
commercialization; and
(6)shall, in
collaboration with the Translational Development Program for New Innovations,
facilitate the translation of new innovations through the development
process.
(b)
(1)The RAID, in collaboration with the Director of OPASI,
shall carry out a program that shall select, in accordance with paragraph (2),
projects of eligible entities to receive access to laboratories, facilities,
and other support resources of the National Institutes of Health for the
preclinical development of drugs, biologics, diagnostics, and devices.
(2)Not
less than 25 percent of the projects selected under paragraph (1) shall be
selected on a competitive basis—
(A)by a program
manager with sufficient managerial, technical, and translational research
expertise to adequately assess the quality of a project proposal; or
(B)from a peer
review process.
(3)In this subsection, the term eligible
entity means—
(A)a university
researcher;
(B)a nonprofit
research organization; or
(C)a firm of less
than 100 employees in collaboration with 1 or more universities or nonprofit
organizations such as a community health center.
(4)The RAID may discontinue support of a project if the
project fails to meet commercialization success criteria established by the
RAID.
(c)Discoveries
from lab to clinical practiceThe program under subsection (b)
shall accelerate the process of bringing discoveries in medical technology and
drugs from the laboratory to the clinic.
(d)The RAID shall review, on an ongoing basis, potential
products and may not support products past the proof-of-principle stage.
499F–2.Translational
Development Program for New Innovations
(a)The Director of OPASI shall develop a Translational
Development Program for New Innovations to guide institutions of higher
education, small businesses, for-profits, nonprofits, or other such entities
through the translational research development process by facilitating the
following:
(1)Triage screening
of applications for promising innovations expected to reduce disease incidence,
morbidity, and mortality.
(2)Outlining the
tasks, timelines, and costs required to navigate and complete the development
process for such innovations.
(3)Providing project
management support for the recommended development tasks.
(4)Interfacing with
the Food and Drug Administration and the entity to devise a plan that safely
and rapidly brings new drugs, biologics devices, diagnostics, and other
interventions to approval.
(b)The
Translational Development Program for New Innovations shall—
(1)collaborate with
the RAID; and
(2)be comprised of
personnel with extensive experience with investigational new drug applications
and in commercialization.
7Translational Research Fund
449G.Translational
Research Fund
(a)There
is established an account to be known as the Translational Research Fund that
shall consist of amounts appropriated for translational research priorities as
described in subsection (b). Such account shall not be funded from amounts
otherwise provided to the National Institutes of Health.
(b)Authorization
of appropriationsFor each fiscal year, there is authorized to be
appropriated for the Translational Research Fund to carry out the activities
under this part an amount equal to the amount set aside for the Common Fund for
such fiscal year.
(c)Allotment to
Health Advanced Research Projects ProgramNot less than half of
the annual amount appropriated for the Translational Research Fund shall be
allotted to the Health Advanced Research Projects
Program.
.
5.Application of
research requirementPart A of
title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by
adding at the end the following:
404I.Application
of research requirementEach
application for, and summary of, a project, grant, or contract from the
National Institutes of Health, shall include a statement on the possible
application of the research for detecting, treating, or curing a health
condition or disease
state.
.