Systematic reviews and assessments of existing and future research and evidence including original research conducted subsequent to March 23, 2010.

Primary research, such as randomized clinical trials, molecularly informed trials, and observational studies.

Any other methodologies recommended by the methodology committee established under paragraph (6) that are adopted by the Board under paragraph (9).

Appropriate agencies and instrumentalities of the Federal Government.

Appropriate academic research, private sector research, or study-conducting entities.

abide by the transparency and conflicts of interest requirements under subsection (h) that apply to the Institute with respect to the research managed or conducted under such contract;

comply with the methodological standards adopted under paragraph (9) with respect to such research;

consult with the expert advisory panels for clinical trials and rare disease appointed under clauses (ii) and (iii), respectively, of paragraph (4)(A);

subject to clause (iv), permit a researcher who conducts original research, as described in subparagraph (A)(ii), under the contract for the agency, 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;

have appropriate processes in place to manage data privacy and meet ethical standards for the research;

comply with the requirements of the Institute for making the information available to the public under paragraph (8); and

comply with other terms and conditions determined necessary by the Institute to carry out the research agenda adopted under paragraph (2).

Methodological standards for research. Such methodological standards 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 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 by the Institute, as appropriate. The process for developing and updating such standards shall include input from relevant experts, stakeholders, and decisionmakers, and shall provide opportunities for public comment. Such standards shall also include methods by which patient subpopulations can be accounted for and evaluated in different types of research. As appropriate, such standards shall build on existing work on methodological standards for defined categories of health interventions and for each of the major categories of comparative clinical effectiveness research methods (determined as of March 23, 2010).

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.

evidence from such primary research shall be reviewed to assess scientific integrity and adherence to methodological standards adopted under paragraph (9); and

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).

convey the findings of research in a manner that is comprehensible and useful to patients and providers in making health care decisions;

fully convey findings and discuss considerations specific to certain subpopulations, risk factors, and comorbidities, as appropriate;

include limitations of the research and what further research may be needed as appropriate;

do not include practice guidelines, coverage recommendations, payment, or policy recommendations; and

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.

3 members representing patients and health care consumers.

7 members representing physicians and providers, including 4 members representing physicians (at least 1 of whom is a surgeon), 1 nurse, 1 State-licensed integrative health care practitioner, and 1 representative of a hospital.

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.

3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.

1 member representing quality improvement or independent health service researchers.

2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

Not less frequently than on an annual basis, the financial audits conducted under paragraph (1).

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 requirements under this section, and is developed through a transparent process.

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], including 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.

A description of those activities and the financial commitments related to research, training, data capacity building, and dissemination and uptake of research findings.

The extent to which the Institute and the Agency for Healthcare Research and Quality have collaborated with stakeholders, including provider and payer organizations, to facilitate the dissemination and uptake of research findings.

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.

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 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.

Not less frequently than every 5 years, any barriers that researchers funded by the Institute have encountered in conducting studies or clinical trials, including challenges covering the cost of any medical treatments, services, and items described in subsection (a)(2)(B) for purposes of the research study.

By the Institute in appointing members to an expert advisory panel under subsection (d)(4), in selecting individuals to contribute to any peer-review process under subsection (d)(7), and for employment as executive staff of the Institute.

By the Board in appointing members of the methodology committee under subsection (d)(6);

By the Institute in the annual report under subsection (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.