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PHS' SCIENTIFIC MISCONDUCT DEFINITION EXCLUDES "DECEPTION,"

Executive Summary

PHS' SCIENTIFIC MISCONDUCT DEFINITION EXCLUDES "DECEPTION," according to a final rule published by the Public Health Service in the Aug. 8 Federal Register. The agency also deleted from its definition of misconduct "material failure to comply with federal requirements that are uniquely related to the conduct of research." The provisions were included in a proposal published last September but deleted by PHS in response to comments on the proposed rule. PHS noted that it has also deleted from the definition "honest error or honest differences in interpretations or judgments of data." The final rule defines "scientific misconduct" as "fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research." The regulation outlines the responsibilities of awardee and applicant institutions for handling and reporting possible misconduct in science. As of Nov. 8, entities receiving PHS funds for biomedical and behavioral research must submit assurances on an annual basis that: (1) they have established an administrative process to review reports of scientific misconduct; and (2) they will report to the HHS Secretary "any investigation of alleged scientific misconduct that appears substantial." The assurances must be submitted to the Office of Scientific Integrity, which was established in the NIH Director's Office in March, "as soon as possible after Nov. 8, 1989, and no later than Jan. 1, 1990, and be updated thereafter on an annual basis." Reports of alleged misconduct are also to be reported to the Office of Scientific Integrity, rather than PHS as noted in the proposed rule. Awardee institutions will have the "primary responsibility for preventing, detecting, investigating, reporting and resolving allegations of scientific misconduct," the rule states. However, HHS "retains the ultimate responsibility and authority for monitoring such investigations" and becoming involved in them when appropriate. The Federal Register notice points out that other issues with respect to scientific integrity have yet to be addressed, including: "retention of laboratory data, authorship practices, the role of grantee institutions and funding agencies in the performance of audits or studies to prevent the occurrence of scientific misconduct, and the consistency of such policies across federal agencies." The notice adds that HHS "will continue to monitor institutions' responses and propose policies as may be necessary in the future." (PARAGRAPH)Other provisions in the proposed rule that address the appropriate timing of inquiries and investigations and reporting requirements are unchanged in the final rule. An inquiry into an allegation or other evidence of possible misconduct must be completed within 60 calendar days of its initiation "unless circumstances clearly warrant a longer period," the rule states. If an inquiry takes longer than 60 days, the record must include documentation as to why. The Office of Scientific Integrity must be notified within 24 hours of an institution "obtaining any reasonable indication of possible criminal violations." The office must be notified in writing of an institution's decision to initiate an investigation on or before the date the investigation begins. The rule states that an investigation should "ordinarily be completed within 120 days of its initiation."
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