H. R. 3590—615 
comparative clinical effectiveness research methods 
(determined as of the date of enactment of the Patient 
Protection and Affordable Care Act). 
‘‘(ii) A translation table that is designed to provide 
guidance and act as a reference for the Board to deter-
mine research methods that are most likely to address 
each specific research question. 
‘‘(D) CONSULTATION AND CONDUCT OF EXAMINATIONS.— 
The methodology committee may consult and contract with 
the Institute of Medicine of the National Academies and 
academic, nonprofit, or other private and governmental 
entities with relevant expertise to carry out activities 
described in subparagraph (C) and may consult with rel-
evant stakeholders to carry out such activities. 
‘‘(E) REPORTS.—The methodology committee shall 
submit reports to the Board on the committee’s performance 
of the functions described in subparagraph (C). Reports 
shall contain recommendations for the Institute to adopt 
methodological standards developed and updated by the 
methodology committee as well as other actions deemed 
necessary to comply with such methodological standards. 
‘‘(7) PROVIDING FOR A PEER-REVIEW PROCESS FOR PRIMARY 
RESEARCH.— 
‘‘(A) IN GENERAL.—The Institute shall ensure that there 
is a process for peer review of primary research described 
in subparagraph (A)(ii) of paragraph (2) that is conducted 
under such paragraph. Under such process— 
‘‘(i) evidence from such primary research shall be 
reviewed to assess scientific integrity and adherence 
to methodological standards adopted under paragraph 
(9); and 
‘‘(ii) a list of the names of individuals contributing 
to any peer-review process during the preceding year 
or years shall be made public and included in annual 
reports in accordance with paragraph (10)(D). 
‘‘(B) COMPOSITION.—Such peer-review process shall be 
designed in a manner so as to avoid bias and conflicts 
of interest on the part of the reviewers and shall be com-
posed of experts in the scientific field relevant to the 
research under review. 
‘‘(C) USE OF EXISTING PROCESSES.— 
‘‘(i) PROCESSES OF ANOTHER ENTITY.—In the case 
where the Institute enters into a contract or other 
agreement with another entity for the conduct or 
management of research under this section, the 
Institute may utilize the peer-review process of such 
entity if such process meets the requirements under 
subparagraphs (A) and (B). 
‘‘(ii) PROCESSES
OF
APPROPRIATE
MEDICAL
JOUR-
NALS.—The Institute may utilize the peer-review 
process of appropriate medical journals if such process 
meets the requirements under subparagraphs (A) and 
(B). 
‘‘(8) RELEASE OF RESEARCH FINDINGS.— 
‘‘(A) IN GENERAL.—The Institute shall, not later than 
90 days after the conduct or receipt of research findings 
under this part, make such research findings available
H. R. 3590—616 
to clinicians, patients, and the general public. The Institute 
shall ensure that the research findings— 
‘‘(i) convey the findings of research in a manner 
that is comprehensible and useful to patients and pro-
viders in making health care decisions; 
‘‘(ii) fully convey findings and discuss consider-
ations specific to certain subpopulations, risk factors, 
and comorbidities, as appropriate; 
‘‘(iii) include limitations of the research and what 
further research may be needed as appropriate; 
‘‘(iv) not be construed as mandates for practice 
guidelines, coverage recommendations, payment, or 
policy recommendations; and 
‘‘(v) not include any data which would violate the 
privacy of research participants or any confidentiality 
agreements made with respect to the use of data under 
this section. 
‘‘(B) DEFINITION OF RESEARCH FINDINGS.—In this para-
graph, the term ‘research findings’ means the results of 
a study or assessment. 
‘‘(9) ADOPTION.—Subject to subsection (h)(1), the Institute 
shall adopt the national priorities identified under paragraph 
(1)(A), the research project agenda established under paragraph 
(1)(B), the methodological standards developed and updated 
by the methodology committee under paragraph (6)(C)(i), and 
any peer-review process provided under paragraph (7) by 
majority vote. In the case where the Institute does not adopt 
such processes in accordance with the preceding sentence, the 
processes shall be referred to the appropriate staff or entity 
within the Institute (or, in the case of the methodological stand-
ards, the methodology committee) for further review. 
‘‘(10) ANNUAL
REPORTS.—The Institute shall submit an 
annual report to Congress and the President, and shall make 
the annual report available to the public. Such report shall 
contain— 
‘‘(A) a description of the activities conducted under 
this section, research priorities identified under paragraph 
(1)(A) and methodological standards developed and updated 
by the methodology committee under paragraph (6)(C)(i) 
that are adopted under paragraph (9) during the preceding 
year; 
‘‘(B) the research project agenda and budget of the 
Institute for the following year; 
‘‘(C) any administrative activities conducted by the 
Institute during the preceding year; 
‘‘(D) the names of individuals contributing to any peer- 
review process under paragraph (7), without identifying 
them with a particular research project; and 
‘‘(E) any other relevant information (including informa-
tion on the membership of the Board, expert advisory 
panels, methodology committee, and the executive staff 
of the Institute, any conflicts of interest with respect to 
these individuals, and any bylaws adopted by the Board 
during the preceding year). 
‘‘(e) ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), the Board shall 
carry out the duties of the Institute.
H. R. 3590—617 
‘‘(2) NONDELEGABLE DUTIES.—The activities described in 
subsections (d)(1) and (d)(9) are nondelegable. 
‘‘(f) BOARD OF GOVERNORS.— 
‘‘(1) IN
GENERAL.—The Institute shall have a Board of 
Governors, which shall consist of the following members: 
‘‘(A) The Director of Agency for Healthcare Research 
and Quality (or the Director’s designee). 
‘‘(B) The Director of the National Institutes of Health 
(or the Director’s designee). 
‘‘(C) Seventeen members appointed, not later than 6 
months after the date of enactment of this section, by 
the Comptroller General of the United States as follows: 
‘‘(i) 3 members representing patients and health 
care consumers. 
‘‘(ii) 5 members representing physicians and pro-
viders, including at least 1 surgeon, nurse, State- 
licensed integrative health care practitioner, and rep-
resentative of a hospital. 
‘‘(iii) 3 members representing private payers, of 
whom at least 1 member shall represent health insur-
ance issuers and at least 1 member shall represent 
employers who self-insure employee benefits. 
‘‘(iv) 3 members representing pharmaceutical, 
device, and diagnostic manufacturers or developers. 
‘‘(v) 1 member representing quality improvement 
or independent health service researchers. 
‘‘(vi) 2 members representing the Federal Govern-
ment or the States, including at least 1 member rep-
resenting a Federal health program or agency. 
‘‘(2) QUALIFICATIONS.—The Board shall represent a broad 
range of perspectives and collectively have scientific expertise 
in clinical health sciences research, including epidemiology, 
decisions sciences, health economics, and statistics. In 
appointing the Board, the Comptroller General of the United 
States shall consider and disclose any conflicts of interest in 
accordance with subsection (h)(4)(B). Members of the Board 
shall be recused from relevant Institute activities in the case 
where the member (or an immediate family member of such 
member) has a real conflict of interest directly related to the 
research project or the matter that could affect or be affected 
by such participation. 
‘‘(3) TERMS; VACANCIES.—A member of the Board shall be 
appointed for a term of 6 years, except with respect to the 
members first appointed, whose terms of appointment shall 
be staggered evenly over 2-year increments. No individual shall 
be appointed to the Board for more than 2 terms. Vacancies 
shall be filled in the same manner as the original appointment 
was made. 
‘‘(4) CHAIRPERSON
AND
VICE-CHAIRPERSON.—The Comp-
troller General of the United States shall designate a Chair-
person and Vice Chairperson of the Board from among the 
members of the Board. Such members shall serve as Chair-
person or Vice Chairperson for a period of 3 years. 
‘‘(5) COMPENSATION.—Each member of the Board who is 
not an officer or employee of the Federal Government shall 
be entitled to compensation (equivalent to the rate provided 
for level IV of the Executive Schedule under section 5315 of
H. R. 3590—618 
title 5, United States Code) and expenses incurred while per-
forming the duties of the Board. An officer or employee of 
the Federal government who is a member of the Board shall 
be exempt from compensation. 
‘‘(6) DIRECTOR AND STAFF; EXPERTS AND CONSULTANTS.— 
The Board may employ and fix the compensation of an Execu-
tive Director and such other personnel as may be necessary 
to carry out the duties of the Institute and may seek such 
assistance and support of, or contract with, experts and consult-
ants that may be necessary for the performance of the duties 
of the Institute. 
‘‘(7) MEETINGS AND HEARINGS.—The Board shall meet and 
hold hearings at the call of the Chairperson or a majority 
of its members. Meetings not solely concerning matters of per-
sonnel shall be advertised at least 7 days in advance and 
open to the public. A majority of the Board members shall 
constitute a quorum, but a lesser number of members may 
meet and hold hearings. 
‘‘(g) FINANCIAL AND GOVERNMENTAL OVERSIGHT.— 
‘‘(1) CONTRACT FOR AUDIT.—The Institute shall provide for 
the conduct of financial audits of the Institute on an annual 
basis by a private entity with expertise in conducting financial 
audits. 
‘‘(2) REVIEW AND ANNUAL REPORTS.— 
‘‘(A) REVIEW.—The Comptroller General of the United 
States shall review the following: 
‘‘(i) Not less frequently than on an annual basis, 
the financial audits conducted under paragraph (1). 
‘‘(ii) Not less frequently than every 5 years, the 
processes established by the Institute, including the 
research priorities and the conduct of research projects, 
in order to determine whether information produced 
by such research projects is objective and credible, 
is produced in a manner consistent with the require-
ments under this section, and is developed through 
a transparent process. 
‘‘(iii) Not less frequently than every 5 years, the 
dissemination and training activities and data net-
works established under section 937 of the Public 
Health Service Act, including the methods and prod-
ucts used to disseminate research, the types of training 
conducted and supported, and the types and functions 
of the data networks established, in order to determine 
whether the activities and data are produced in a 
manner consistent with the requirements under such 
section. 
‘‘(iv) Not less frequently than every 5 years, the 
overall effectiveness of activities conducted under this 
section and the dissemination, training, and capacity 
building activities conducted under section 937 of the 
Public Health Service Act. Such review shall include 
an analysis of the extent to which research findings 
are used by health care decision-makers, the effect 
of the dissemination of such findings on reducing prac-
tice variation and disparities in health care, and the 
effect of the research conducted and disseminated on