BOX 5-2

Requirements for Research Funded by the Patient-Centered Outcomes Research Institute

The 2010 Patient Protection and Affordable Care Act created the Patient-Centered Outcomes Research Institute (PCORI), a nonprofit corporation intended to advance comparative effectiveness research. The act stipulates that research funded by PCORI, including systematic reviews, adhere to the following reporting and publication requirements:

  • For each research study, the following information should be posted on PCORI’s website:

    • A research protocol, including measures taken, methods of research and analysis, research results, and other information the institute determines appropriate.

    • The research findings conveyed in a manner that is comprehensible and useful to patients and providers in making healthcare decisions.

    • Considerations specific to certain subpopulations, risk factors, and comorbidities, as appropriate.

    • The limitations of the research and what further research may be needed as appropriate.

    • The identity of the entity and the investigators conducting the research.

    • Conflicts of interest, including the type, nature, and magnitude of the interests.

  • PCORI is required to:

    • Provide a public comment period for systematic reviews to increase public awareness, and to obtain and incorporate public input and feedback on research findings.

    • Ensure there is a process for peer review to assess a study’s scientific integrity and adherence to methodological standards.

    • Disseminate research to physicians, healthcare providers, patients, payers, and policy makers.

SOURCE: The Patient Protection and Affordable Care Act, Public Law 111-148, 111th Cong., Subtitle D, § 6301 (March 23, 2010).


Over the past decade, several international, multidisciplinary groups have collaborated to develop guidelines for reporting the methods and results of clinical research (reporting guidelines). Reporting guidelines exist for many types of health research (Ioannidis et al., 2004; Liberati et al., 2009; Moher et al., 1999, 2001a,b,

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