Page:United States Statutes at Large Volume 124.djvu/757

124 STAT. 731 PUBLIC LAW 111–148—MAR. 23, 2010 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 modalities that may affect research outcomes, such as the phase of the treatment modality in the innovation cycle and the impact of the skill of the operator of the treatment modality. ‘‘(3) DATA COLLECTION.— ‘‘(A) IN GENERAL.—The Secretary shall, with appro- priate safeguards for privacy, make available to the Institute such data collected by the Centers for Medicare & Medicaid Services under the programs under titles XVIII, XIX, and XXI, as well as provide access to the data net- works developed under section 937(f) of the Public Health Service Act, as the Institute and its contractors may require to carry out this section. The Institute may also request and obtain data from Federal, State, or private entities, including data from clinical databases and registries. ‘‘(B) USE OF DATA.—The Institute shall only use data provided to the Institute under subparagraph (A) in accord- ance with laws and regulations governing the release and use of such data, including applicable confidentiality and privacy standards. ‘‘(4) APPOINTING EXPERT ADVISORY PANELS.— ‘‘(A) APPOINTMENT.— ‘‘(i) IN GENERAL.—The Institute may appoint permanent or ad hoc expert advisory panels as deter- mined appropriate to assist in identifying research priorities and establishing the research project agenda under paragraph (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 agenda under paragraph (2)(A)(ii). Such expert advisory panels shall advise the Institute and the agency, instrumentality, or entity conducting the research on the research question involved and the research design or protocol, including 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 con- duct 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 feasi- bility of conducting the research study. ‘‘(B) COMPOSITION.—An expert advisory panel appointed under subparagraph (A) shall include representa- tives 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