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Corporate Integrity Agreements

Corporate integrity agreements (CIAs) have become a significant means of compliance enforcement for the Office of the Inspector General (OIG) of the US Department of Health and Human Services. The objective of this review is to present in a factual manner common clauses from recent CIAs that affect publications, publication planning, and transparency. Fourteen CIAs issued to biopharmaceutical companies from January 1, 2009, through July 31, 2012, were reviewed. All documents were publicly accessible on the OIG website. Eight CIAs included similar verbiage relating to industry-sponsored publication activities and transparency. Each included specific recommendations for author agreements, publication plans, needs assessments, publication monitoring, posting of study results, and disclosure of relationships with authors. The publishing behaviors OIG seeks to effect are consistent with currently accepted guidelines described in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as prepared by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practices for Communicating Company-sponsored Medical Research (GPP2), as well as added training, monitoring, and reporting requirements. By making clear the importance of publication planning, needs assessments, adherence to ICMJE, and reporting of physician payments, and by becoming readily accessible to everyone, CIAs provide the industry not only with clear direction for, but also an expectation of, responsible behavior when it comes to sponsored medical publications.