---
kind: "section"
citation: "42 U.S.C. § 1320e"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320e"
heading: "Comparative clinical effectiveness research"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320e"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part D — Comparative Clinical Effectiveness Research"
---

# §1320e. Comparative clinical effectiveness research

- (a) **Definitions—** In this section:
  - (1) **Board—** The term “Board” means the Board of Governors established under [subsection (f)](#f).
  - (2) **Comparative clinical effectiveness research; research—**
    - (A) **In general—** The terms “comparative clinical effectiveness research” and “research” mean research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical [treatments](/usc/42/11851.md?p=11), services, and items described in [subparagraph (B)](#a-2-B).
    - (B) **Medical treatments, services, and items described—** The medical [treatments](/usc/42/11851.md?p=11), services, and items described in this subparagraph are health care [interventions](/usc/42/1397n–12.md?p=2), protocols for [treatment](/usc/42/11851.md?p=11), care management, and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals ([including](/usc/42/1301.md?p=b) [drugs](/usc/42/11851.md?p=4) and biologicals), integrative health [practices](/usc/42/17061.md?p=19), and any other strategies or items being used in the [treatment](/usc/42/11851.md?p=11), management, and diagnosis of, or prevention of illness or injury in, individuals.
  - (3) **Conflict of interest—** The term “conflict of interest” means an association, [including](/usc/42/1301.md?p=b) a financial or personal association, that have[^1] the potential to bias or have[^1] the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities under this section.
  - (4) **Real conflict of interest—** The term “real conflict of interest” means any instance where a member of the Board, the methodology committee established under [subsection (d)(6)](#d-6), or an advisory panel appointed under [subsection (d)(4)](#d-4), or a close relative of such member, has received or could receive either of the following:
    - (A) A direct financial benefit of any amount deriving from the result or findings of a study conducted under this section.
    - (B) A financial benefit from individuals or companies that own or manufacture medical [treatments](/usc/42/11851.md?p=11), services, or items to be studied under this section that in the aggregate exceeds $10,000 per year. For purposes of the preceding sentence, a financial benefit [includes](/usc/42/1301.md?p=b) honoraria, fees, stock, or other financial benefit and the current value of the member or close relative’s already existing stock holdings, in addition to any direct financial benefit deriving from the results or findings of a study conducted under this section.
- (b) **Patient-Centered Outcomes Research Institute—**
  - (1) **Establishment—** There is authorized to be established a [nonprofit](/usc/42/300s–3.md?p=3) [corporation](/usc/42/1301.md?p=a-4), to be known as the “Patient-Centered Outcomes Research Institute” (referred to in this section as the “Institute”) which is neither an [agency](/usc/42/1397n–12.md?p=1) nor establishment of the [United States](/usc/42/1301.md?p=a-2) Government.
  - (2) **Application of provisions—** The Institute shall be subject to the provisions of this section, and, to the extent consistent with this section, to the District of Columbia [Nonprofit](/usc/42/300s–3.md?p=3) Corporation Act.
  - (3) **Funding of comparative clinical effectiveness research—** For [fiscal year](/usc/42/619.md?p=3) 2010 and each subsequent [fiscal year](/usc/42/619.md?p=3), amounts in the Patient-Centered Outcomes Research Trust Fund (referred to in this section as the “PCORTF”) under section 9511 of the Internal Revenue Code of 1986 shall be available, without further appropriation, to the Institute to carry out this section.
- (c) **Purpose—** The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical [treatments](/usc/42/11851.md?p=11), services, and items described in [subsection (a)(2)(B)](#a-2-B).
- (d) **Duties—**
  - (1) **Identifying research priorities and establishing research project agenda—**
    - (A) **Identifying research priorities—** The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the [United States](/usc/42/1301.md?p=a-2) (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care [treatment](/usc/42/11851.md?p=11), strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H[^2] of the Public Health Service Act that are consistent with this section. Such national priorities shall include research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care [treatments](/usc/42/11851.md?p=11).
    - (B) **Establishing research project agenda—** The Institute shall establish and update a research [project](/usc/42/13641.md?p=2) agenda for research to address the priorities identified under [subparagraph (A)](#d-1-A), taking into consideration the types of research that might address each priority and the relative value (determined based on the cost of conducting research compared to the potential usefulness of the information produced by research) associated with the different types of research, and such other factors as the Institute determines appropriate.
  - (2) **Carrying out research project agenda—**
    - (A) **Research—** The Institute shall carry out the research [project](/usc/42/13641.md?p=2) agenda established under [paragraph (1)(B)](#d-1-B) in accordance with the methodological [standards](/usc/42/1320d.md?p=7) adopted under [paragraph (9)](#d-9) using methods, [including](/usc/42/1301.md?p=b) the following:
      - (i) Systematic reviews and assessments of existing and future research and evidence [including](/usc/42/1301.md?p=b) original research conducted subsequent to March 23, 2010.
      - (ii) Primary research, such as randomized clinical trials, molecularly informed trials, and observational studies.
      - (iii) Any other methodologies recommended by the methodology committee established under [paragraph (6)](#d-6) that are adopted by the Board under [paragraph (9)](#d-9).
    - (B) **Contracts for the management of funding and conduct of research—**
      - (i) **Contracts—**
        - (I) **In general—** In accordance with the research [project](/usc/42/13641.md?p=2) agenda established under [paragraph (1)(B)](#d-1-B), the Institute shall enter into contracts for the management of funding and conduct of research in accordance with the following:
          - (aa) Appropriate [agencies](/usc/42/1397n–12.md?p=1) and instrumentalities of the Federal Government.
          - (bb) Appropriate academic research, private sector research, or study-conducting entities.
        - (II) **Preference—** In entering into contracts under [subclause (I)](#d-2-B-i-I), the Institute shall give preference to the [Agency](/usc/42/1397n–12.md?p=1) for Healthcare Research and Quality and the National Institutes of Health, but only if the research to be conducted or managed under such contract is authorized by the governing statutes of such [Agency](/usc/42/1397n–12.md?p=1) or Institutes.
      - (ii) **Conditions for contracts—** A contract entered into under this subparagraph shall require that the [agency](/usc/42/1397n–12.md?p=1), instrumentality, or other entity—
        - (I) abide by the transparency and conflicts of interest requirements under [subsection (h)](#h) that apply to the Institute with respect to the research managed or conducted under such contract;
        - (II) comply with the methodological [standards](/usc/42/1320d.md?p=7) adopted under [paragraph (9)](#d-9) with respect to such research;
        - (III) consult with the expert advisory panels for clinical trials and rare disease appointed under clauses [(ii)](#d-2-B-ii) and [(iii)](#d-2-B-iii), respectively, of [paragraph (4)(A)](#d-4-A);
        - (IV) subject to [clause (iv)](#d-2-B-iv), permit a researcher who conducts original research, as described in [subparagraph (A)(ii)](#d-2-A-ii), under the contract for the [agency](/usc/42/1397n–12.md?p=1), instrumentality, or other entity to have such research published in a peer-reviewed journal or other publication, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate;
        - (V) have appropriate processes in place to manage data privacy and meet ethical [standards](/usc/42/1320d.md?p=7) for the research;
        - (VI) comply with the requirements of the Institute for making the information available to the public under [paragraph (8)](#d-8); and
        - (VII) comply with other terms and conditions determined necessary by the Institute to carry out the research agenda adopted under [paragraph (2)](#d-2).
      - (iii) **Coverage of copayments or coinsurance—** A contract entered into under this subparagraph may allow for the coverage of copayments or coinsurance, or allow for other appropriate measures, to the extent that such coverage or other measures are necessary to preserve the validity of a research [project](/usc/42/13641.md?p=2), such as in the case where the research [project](/usc/42/13641.md?p=2) must be blinded.
      - (iv) **Subsequent use of the data—** The Institute shall not allow the subsequent use of data from original research in work-for-hire contracts with individuals, entities, or instrumentalities that have a financial interest in the results, unless approved under a data use agreement with the Institute.
    - (C) **Review and update of evidence—** The Institute shall review and update evidence on a periodic basis as appropriate.
    - (D) **Taking into account potential differences—** Research shall be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care [treatments](/usc/42/11851.md?p=11), services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate.
    - (E) **Differences in treatment modalities—** Research shall be designed, as appropriate, to take into account different characteristics of [treatment](/usc/42/11851.md?p=11) modalities that may affect research outcomes, such as the phase of the [treatment](/usc/42/11851.md?p=11) modality in the innovation cycle and the impact of the skill of the operator of the [treatment](/usc/42/11851.md?p=11) modality.
    - (F) **Consideration of full range of outcomes data—** Research shall be designed, as appropriate, to take into account and capture the full range of clinical and patient-centered outcomes relevant to, and that meet the needs of, patients, clinicians, purchasers, and policy-makers in making informed health decisions. In addition to the relative health outcomes and clinical effectiveness, clinical and patient-centered outcomes shall include the potential burdens and economic impacts of the utilization of medical [treatments](/usc/42/11851.md?p=11), items, and services on different stakeholders and decision-makers respectively. These potential burdens and economic impacts include medical out-of-pocket costs, [including](/usc/42/1301.md?p=b) [health plan](/usc/42/1320d.md?p=5) benefit and formulary design, non-medical costs to the patient and family, [including](/usc/42/1301.md?p=b) caregiving, effects on future costs of care, workplace productivity and absenteeism, and healthcare utilization.
  - (3) **Data collection—**
    - (A) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall, with appropriate safeguards for privacy, make available to the Institute such data collected by the Centers for Medicare & Medicaid Services under the programs under subchapters XVIII, XIX, and XXI, as well as provide access to the data networks developed under section 937(f) of the Public Health Service Act [[42 U.S.C. 299b–37(f)](/usc/42/299b–37.md?p=f)], as the Institute and its contractors may require to carry out this section. The Institute may also request and obtain data from Federal, [State](/usc/42/619.md?p=5), or private entities, [including](/usc/42/1301.md?p=b) data from clinical databases and registries.
    - (B) **Use of data—** The Institute shall only use data provided to the Institute under [subparagraph (A)](#d-3-A) in accordance with laws and regulations governing the release and use of such data, [including](/usc/42/1301.md?p=b) applicable confidentiality and privacy [standards](/usc/42/1320d.md?p=7).
  - (4) **Appointing expert advisory panels—**
    - (A) **Appointment—**
      - (i) **In general—** The Institute may appoint permanent or ad hoc expert advisory panels as determined appropriate to assist in identifying research priorities and establishing the research [project](/usc/42/13641.md?p=2) agenda under [paragraph (1)](#d-1) and for other purposes.
      - (ii) **Expert advisory panels for clinical trials—** The Institute shall appoint expert advisory panels in carrying out randomized clinical trials under the research [project](/usc/42/13641.md?p=2) agenda under [paragraph (2)(A)(ii)](#d-2-A-ii). Such expert advisory panels shall advise the Institute and the [agency](/usc/42/1397n–12.md?p=1), instrumentality, or entity conducting the research on the research question involved and the research design or protocol, [including](/usc/42/1301.md?p=b) important patient subgroups and other parameters of the research. Such panels shall be available as a resource for technical questions that may arise during the conduct of such research.
      - (iii) **Expert advisory panel for rare disease—** In the case of a research study for rare disease, the Institute shall appoint an expert advisory panel for purposes of assisting in the design of the research study and determining the relative value and feasibility of conducting the research study.
    - (B) **Composition—** An expert advisory panel appointed under [subparagraph (A)](#d-4-A) shall include representatives of practicing and research clinicians, patients, and experts in scientific and health services research, health services delivery, and evidence-based medicine who have experience in the relevant topic, and as appropriate, experts in integrative health and primary prevention strategies. The Institute may include a technical expert of each manufacturer or each medical technology that is included under the relevant topic, [project](/usc/42/13641.md?p=2), or category for which the panel is established.
  - (5) **Supporting patient and consumer representatives—** The Institute shall provide support and resources to help patient and consumer representatives effectively participate on the Board and expert advisory panels appointed by the Institute under [paragraph (4)](#d-4).
  - (6) **Establishing methodology committee—**
    - (A) **In general—** The Institute shall establish a standing methodology committee to carry out the functions described in [subparagraph (C)](#d-6-C).
    - (B) **Appointment and composition—** The methodology committee established under [subparagraph (A)](#d-6-A) shall be composed of not more than 15 members appointed by the Board. Members appointed to the methodology committee shall be experts in their scientific field, such as health services research, clinical research, comparative clinical effectiveness research, biostatistics, genomics, and research methodologies. Stakeholders with such expertise may be appointed to the methodology committee. In addition to the members appointed under the first sentence, the [Directors](/usc/42/11851.md?p=5) of the National Institutes of Health and the [Agency](/usc/42/1397n–12.md?p=1) for Healthcare Research and Quality (or their designees) shall each be included as members of the methodology committee.
    - (C) **Functions—** Subject to [subparagraph (D)](#d-6-D), the methodology committee shall work to develop and improve the science and methods of comparative clinical effectiveness research by, not later than 18 months after the establishment of the Institute, directly or through subcontract, developing and periodically updating the following:
      - (i) Methodological [standards](/usc/42/1320d.md?p=7) for research. Such methodological [standards](/usc/42/1320d.md?p=7) shall provide specific criteria for internal validity, generalizability, feasibility, and timeliness of research and for health outcomes measures, risk adjustment, and other relevant aspects of research and assessment with respect to the design of research. Any methodological [standards](/usc/42/1320d.md?p=7) developed and updated under this subclause[^3] shall be scientifically based and include methods by which new information, data, or advances in technology are considered and incorporated into ongoing research [projects](/usc/42/13641.md?p=2) by the Institute, as appropriate. The process for developing and updating such [standards](/usc/42/1320d.md?p=7) shall include input from relevant experts, stakeholders, and decisionmakers, and shall provide opportunities for public comment. Such [standards](/usc/42/1320d.md?p=7) shall also include methods by which patient subpopulations can be accounted for and evaluated in different types of research. As appropriate, such [standards](/usc/42/1320d.md?p=7) shall build on existing work on methodological [standards](/usc/42/1320d.md?p=7) for defined categories of health [interventions](/usc/42/1397n–12.md?p=2) and for each of the major categories of comparative clinical effectiveness research methods (determined as of March 23, 2010).
      - (ii) A translation table that is designed to provide guidance and act as a reference for the Board to determine 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](/usc/42/300s–3.md?p=3), or other private and governmental entities with relevant expertise to carry out activities described in [subparagraph (C)](#d-6-C) and may consult with relevant 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)](#d-6-C). Reports shall contain recommendations for the Institute to adopt methodological [standards](/usc/42/1320d.md?p=7) developed and updated by the methodology committee as well as other actions deemed necessary to comply with such methodological [standards](/usc/42/1320d.md?p=7).
  - (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)](#d-2-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](/usc/42/1320d.md?p=7) adopted under [paragraph (9)](#d-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)](#d-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 composed 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)](#d-7-A) and [(B)](#d-7-B).
      - (ii) **Processes of appropriate medical journals—** The Institute may utilize the peer-review process of appropriate medical journals if such process meets the requirements under subparagraphs [(A)](#d-7-A) and [(B)](#d-7-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 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 providers in making health care decisions;
      - (ii) fully convey findings and discuss considerations 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) do not include 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 paragraph, the term “research findings” means the results of a study or assessment.
  - (9) **Adoption—** Subject to [subsection (h)(1)](#h-1), the Institute shall adopt the national priorities identified under [paragraph (1)(A)](#d-1-A), the research [project](/usc/42/13641.md?p=2) agenda established under [paragraph (1)(B)](#d-1-B), the methodological [standards](/usc/42/1320d.md?p=7) developed and updated by the methodology committee under [paragraph (6)(C)(i)](#d-6-C-i), and any peer-review process provided under [paragraph (7)](#d-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 [standards](/usc/42/1320d.md?p=7), 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)](#d-1-A) and methodological [standards](/usc/42/1320d.md?p=7) developed and updated by the methodology committee under [paragraph (6)(C)(i)](#d-6-C-i) that are adopted under [paragraph (9)](#d-9) during the preceding year;
    - (B) the research [project](/usc/42/13641.md?p=2) 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)](#d-7), without identifying them with a particular research [project](/usc/42/13641.md?p=2); and
    - (E) any other relevant information ([including](/usc/42/1301.md?p=b) information 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)](#e-2), the Board shall carry out the duties of the Institute.
  - (2) **Nondelegable duties—** The activities described in subsections [(d)(1)](#d-1) and [(d)(9)](#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](/usc/42/11851.md?p=5) of [Agency](/usc/42/1397n–12.md?p=1)[^4] for Healthcare Research and Quality (or the [Director](/usc/42/11851.md?p=5)’s designee).
    - (B) The [Director](/usc/42/11851.md?p=5) of the National Institutes of Health (or the [Director](/usc/42/11851.md?p=5)’s designee).
    - (C) At least nineteen, but no more than twenty-one members appointed by the Comptroller General of the [United States](/usc/42/1301.md?p=a-2) as follows:
      - (i) 3 members representing patients and health care consumers.
      - (ii) 7 members representing [physicians](/usc/42/1301.md?p=a-7) and providers, [including](/usc/42/1301.md?p=b) 4 members representing [physicians](/usc/42/1301.md?p=a-7) (at least 1 of whom is a surgeon), 1 nurse, 1 [State](/usc/42/619.md?p=5)-licensed integrative health care practitioner, and 1 representative of a [hospital](/usc/42/300s–3.md?p=1).
      - (iii) at least 3, but no more than 5 members representing private payers, of whom at least 1 member shall represent health insurance 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 Government or the [States](/usc/42/619.md?p=5), [including](/usc/42/1301.md?p=b) at least 1 member representing a Federal health program or [agency](/usc/42/1397n–12.md?p=1).
  - (2) **Qualifications—** The Board shall represent a broad range of perspectives and collectively have scientific expertise in clinical health sciences research, [including](/usc/42/1301.md?p=b) epidemiology, decisions sciences, health economics, and statistics. In appointing the Board, the Comptroller General of the [United States](/usc/42/1301.md?p=a-2) shall consider and disclose any conflicts of interest in accordance with [subsection (h)(4)(B)](#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](/usc/42/13641.md?p=2) 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 members first appointed, whose terms of appointment shall be staggered evenly over 2-year increments to the extent necessary to preserve the evenly staggered terms of the Board..[^5] Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed. 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 Comptroller General of the [United States](/usc/42/1301.md?p=a-2) shall designate a Chairperson and Vice Chairperson of the Board from among the members of the Board. Such members shall serve as Chairperson 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 title 5](/usc/5/5315.md)) and expenses incurred while performing 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 Executive [Director](/usc/42/11851.md?p=5) 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 consultants 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 personnel 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](/usc/42/1301.md?p=a-2) shall review the following:
      - (i) Not less frequently than on an annual basis, the financial audits conducted under [paragraph (1)](#g-1).
      - (ii) Not less frequently than every 5 years, the processes established by the Institute, [including](/usc/42/1301.md?p=b) the research priorities and the conduct of research [projects](/usc/42/13641.md?p=2), in order to determine whether information produced by such research [projects](/usc/42/13641.md?p=2) is objective and credible, is produced in a manner consistent with the requirements 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 networks established under section 937 of the Public Health Service Act [[42 U.S.C. 299b–37](/usc/42/299b–37.md)], [including](/usc/42/1301.md?p=b) the methods and products 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 299b–37 of this title](/usc/42/299b–37.md). Such review shall include the following:
        - (I) A description of those activities and the financial commitments related to research, training, data capacity building, and dissemination and uptake of research findings.
        - (II) The extent to which the Institute and the [Agency](/usc/42/1397n–12.md?p=1) for Healthcare Research and Quality have collaborated with stakeholders, [including](/usc/42/1301.md?p=b) provider and payer organizations, to facilitate the dissemination and uptake of research findings.
        - (III) An analysis of available data and performance metrics, such as the estimated public availability and dissemination of research findings and uptake and utilization of research findings in clinical guidelines and decision support tools, on the extent to which such research findings are used by health care decision-makers, the effect of the dissemination of such findings on changes in medical practice and reducing practice variation and disparities in health care, and the effect of the research conducted and disseminated on innovation and the health care economy of the [United States](/usc/42/1301.md?p=a-2).
      - (v) Not later than 8 years after March 23, 2010, the adequacy and use of the funding for the Institute and the activities conducted under section 937 of the Public Health Service Act, [including](/usc/42/1301.md?p=b) a determination as to whether, based on the utilization of research findings by public and private payers, funding sources for the Patient-Centered Outcomes Research Trust Fund under section 9511 of the Internal Revenue Code of 1986 are appropriate and whether such sources of funding should be continued or adjusted.
      - (vi) Not less frequently than every 5 years, any barriers that researchers funded by the Institute have encountered in conducting studies or clinical trials, [including](/usc/42/1301.md?p=b) challenges covering the cost of any medical [treatments](/usc/42/11851.md?p=11), services, and items described in [subsection (a)(2)(B)](#a-2-B) for purposes of the research study.
    - (B) **Annual reports—** Not later than April 1 of each year, the Comptroller General of the [United States](/usc/42/1301.md?p=a-2) shall submit to Congress a report containing the results of the review conducted under [subparagraph (A)](#g-2-A) with respect to the preceding year (or years, if applicable), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.
- (h) **Ensuring transparency, credibility, and access—** The Institute shall establish procedures to ensure that the following requirements for ensuring transparency, credibility, and access are met:
  - (1) **Public comment periods—** The Institute shall provide for a public comment period of not less than 45 days and not more than 60 days prior to the adoption under [subsection (d)(9)](#d-9) of the national priorities identified under [subsection (d)(1)(A)](#d-1-A), the research [project](/usc/42/13641.md?p=2) agenda established under [subsection (d)(1)(B)](#d-1-B), the methodological [standards](/usc/42/1320d.md?p=7) developed and updated by the methodology committee under [subsection (d)(6)(C)(i)](#d-6-C-i), and the peer-review process provided under [paragraph (7)](#d-7), and after the release of draft findings with respect to systematic reviews of existing research and evidence.
  - (2) **Additional forums—** The Institute shall support forums to increase public awareness and obtain and incorporate public input and feedback through media (such as an Internet website) on research priorities, research findings, and other duties, activities, or processes the Institute determines appropriate.
  - (3) **Public availability—** The Institute shall make available to the public and disclose through the official public Internet website of the Institute the following:
    - (A) Information contained in research findings as specified in [subsection (d)(9)](#d-9).
    - (B) The process and methods for the conduct of research, [including](/usc/42/1301.md?p=b) the identity of the entity and the investigators conducing[^6] such research and any conflicts of interests of such parties, any direct or indirect links the entity has to industry, and research protocols, [including](/usc/42/1301.md?p=b) measures taken, methods of research and analysis, research results, and such other information the Institute determines appropriate)[^5] concurrent with the release of research findings.
    - (C) Notice of public comment periods under [paragraph (1)](#h-1), [including](/usc/42/1301.md?p=b) deadlines for public comments.
    - (D) Subsequent comments received during each of the public comment periods.
    - (E) In accordance with applicable laws and processes and as the Institute determines appropriate, proceedings of the Institute.
  - (4) **Disclosure of conflicts of interest—**
    - (A) **In general—** A conflict of interest shall be disclosed in the following manner:
      - (i) By the Institute in appointing members to an expert advisory panel under [subsection (d)(4)](#d-4), in selecting individuals to contribute to any peer-review process under [subsection (d)(7)](#d-7), and for employment as executive staff of the Institute.
      - (ii) By the Board in appointing members of the methodology committee under [subsection (d)(6)](#d-6);
      - (iii) By the Institute in the annual report under [subsection (d)(10)](#d-10), except that, in the case of individuals contributing to any such peer review process, such description shall be in a manner such that those individuals cannot be identified with a particular research [project](/usc/42/13641.md?p=2).
    - (B) **Manner of disclosure—** Conflicts of interest shall be disclosed as described in [subparagraph (A)](#h-4-A) as soon as practicable on the Internet web site of the Institute. The information disclosed under the preceding sentence shall include the type, nature, and magnitude of the interests of the individual involved, except to the extent that the individual recuses himself or herself from participating in the consideration of or any other activity with respect to the study as to which the potential conflict exists.
- (i) **Rules—** The Institute,[^5] its Board or staff, shall be prohibited from accepting gifts, bequeaths,[^7] or donations of services or property. In addition, the Institute shall be prohibited from establishing a [corporation](/usc/42/1301.md?p=a-4) or generating revenues from activities other than as provided under this section.
- (j) **Rules of construction—**
  - (1) **8 Coverage—** Nothing in this section shall be construed—
    - (A) to permit the Institute to mandate coverage, reimbursement, or other policies for any public or private payer; or
    - (B) as preventing the [Secretary](/usc/42/1301.md?p=a-6) from covering the routine costs of clinical care received by an individual entitled to, or enrolled for, benefits under subchapter XVIII, XIX, or XXI in the case where such individual is participating in a clinical trial and such costs would otherwise be covered under such subchapter with respect to the beneficiary.

## Footnotes

[^1]: So in original. Probably should be “has”.
[^2]: See References in Text note below.
[^3]: So in original. Probably should be “clause”.
[^4]: So in original. Probably should be preceded by “the”.
[^5]: So in original.
[^6]: So in original. Probably should be “conducting”.
[^7]: So in original. Probably should be “bequests”.
[^8]: So in original. No par. (2) has been enacted.

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1181, as added and amended Pub. L. 111–148, title VI, § 6301(a), title X, § 10602, Mar. 23, 2010, 124 Stat. 727, 1005; Pub. L. 116–94, div. N, title I, § 104(d)–(h), Dec. 20, 2019, 133 Stat. 3098, 3099.)

## Notes

### Editorial Notes

### References in Text

The District of Columbia Nonprofit Corporation Act, referred to in subsec. (b)(2), is Pub. L. 87–569, Aug. 6, 1962, 76 Stat. 265, which is not classified to the Code.

The Internal Revenue Code of 1986, referred to in subsecs. (b)(3) and (g)(2)(A)(v), is classified generally to Title 26, Internal Revenue Code.

Section 399H of the Public Health Service Act, referred to in subsec. (d)(1)(A), probably means section 399HH of act July 1, 1944, which is classified to section 280j of this title.

### Amendments

2019—Subsec. (d)(1)(A). Pub. L. 116–94, § 104(d), inserted at end “Such national priorities shall include research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments.”

Subsec. (d)(2)(F). Pub. L. 116–94, § 104(e), added subpar. (F).

Subsec. (d)(6)(B). Pub. L. 116–94, § 104(g)(1), substituted “Board” for “Comptroller General of the United States”.

Subsec. (f)(1)(C). Pub. L. 116–94, § 104(f)(1)(A)(i), substituted in introductory provisions “At least nineteen, but no more than twenty-one members appointed” for “Seventeen members appointed, not later than 6 months after March 23, 2010,”.

Subsec. (f)(1)(C)(iii). Pub. L. 116–94, § 104(f)(1)(A)(ii), substituted “at least 3, but no more than 5” for “3”.

Subsec. (f)(3). Pub. L. 116–94, § 104(f)(2), in first sentence, substituted “members” for “the members” and inserted “to the extent necessary to preserve the evenly staggered terms of the Board.” before the period at end of first sentence, and inserted “Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed.” after first sentence.

Subsec. (g)(2)(A)(iv). Pub. L. 116–94, § 104(h)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: “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 practice variation and disparities in health care, and the effect of the research conducted and disseminated on innovation and the health care economy of the United States.”

Subsec. (g)(2)(A)(vi). Pub. L. 116–94, § 104(h)(2), added cl. (vi).

Subsec. (h)(4)(A)(ii). Pub. L. 116–94, § 104(g)(2)(A), substituted “Board” for “Comptroller General”.

Subsec. (h)(4)(B). Pub. L. 116–94, § 104(g)(2)(B), struck out “and of the Government Accountability Office” after “Institute”.

2010—Subsec. (d)(2)(B)(ii)(IV). Pub. L. 111–148, § 10602(1)(A), inserted “, as described in subparagraph (A)(ii),” after “original research” and “, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate” after “publication”.

Subsec. (d)(2)(B)(iv). Pub. L. 111–148, § 10602(1)(B), amended cl. (iv) generally. Prior to amendment, text read as follows: “Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years).”

Subsec. (d)(8)(A)(iv). Pub. L. 111–148, § 10602(2), substituted “do not include” for “not be construed as mandates for”.

Subsec. (f)(1)(C)(ii). Pub. L. 111–148, § 10602(3), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and representative of a hospital.”