Page:United States Statutes at Large Volume 124.djvu/756

124 STAT. 730 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(ii) CONDITIONS FOR CONTRACTS.—A contract entered into under this subparagraph shall require that the agency, instrumentality, or other entity— ‘‘(I) 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; ‘‘(II) comply with the methodological standards adopted under paragraph (9) with respect to such research; ‘‘(III) consult with the expert advisory panels for clinical trials and rare disease appointed under clauses (ii) and (iii), respectively, of paragraph (4)(A); ‘‘(IV) subject to clause (iv), permit a researcher who conducts original research under the contract for the agency, instrumentality, or other entity to have such research published in a peer-reviewed journal or other publication; ‘‘(V) have appropriate processes in place to manage data privacy and meet ethical standards for the research; ‘‘(VI) comply with the requirements of the Institute for making the information available to the public under paragraph (8); and ‘‘(VII) comply with other terms and conditions determined necessary by the Institute to carry out the research agenda adopted under paragraph (2). ‘‘(iii) COVERAGE OF COPAYMENTS OR COINSUR- ANCE.—A contract entered into under this subpara- graph 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, such as in the case where the research project must be blinded. ‘‘(iv) REQUIREMENTS FOR PUBLICATION OF RESEARCH.—Any research published under clause (ii)(IV) shall be within the bounds of and entirely con- sistent with the evidence and findings produced under the contract with the Institute under this subpara- graph. If the Institute determines that those require- ments 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). ‘‘(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, 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,