124 STAT. 732 PUBLIC LAW 111–148—MAR. 23, 2010 in integrative health and primary prevention strategies. The Institute may include a technical expert of each manu- facturer or each medical technology that is included under the relevant topic, project, or category for which the panel is established. ‘‘(5) SUPPORTING PATIENT AND CONSUMER REPRESENTA- TIVES.—The Institute shall provide support and resources to help patient and consumer representatives effectively partici- pate on the Board and expert advisory panels appointed by the Institute under paragraph (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). ‘‘(B) APPOINTMENT AND COMPOSITION.—The method- ology committee established under subparagraph (A) shall be composed of not more than 15 members appointed by the Comptroller General of the United States. 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 methodolo- gies. Stakeholders with such expertise may be appointed to the methodology committee. In addition to the members appointed under the first sentence, the Directors of the National Institutes of Health and the Agency for Healthcare Research and Quality (or their designees) shall each be included as members of the methodology com- mittee. ‘‘(C) FUNCTIONS.—Subject to subparagraph (D), the methodology committee shall work to develop and improve the science and methods of comparative clinical effective- ness research by, not later than 18 months after the establishment of the Institute, directly or through sub- contract, developing and periodically updating the fol- lowing: ‘‘(i) Methodological standards for research. Such methodological standards shall provide specific criteria for internal validity, generalizability, feasibility, and timeliness of research and for health outcomes meas- ures, 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 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 evalu- ated in different types of research. As appropriate, such standards shall build on existing work on meth- odological standards for defined categories of health interventions and for each of the major categories of Deadline.
