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Scientific Misconduct: Part I - The Federal Rules (cont'd)

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Dealing with subjects of an inquiry/investigation

"When the OSI decides to initiate an inquiry or investigation, the individuals who are to be the subjects of the inquiry or investigation, the institutions where the subjects are currently employed and the institutions where they were employed at the time of the alleged misconduct, shall be notified of that fact before the inquiry or investigation commences, unless the OIG or a law enforcement agency conducting a related investigation requests otherwise. (See also s 1.7 (c)(2).) This notification will include information on the nature of the allegations or concerns and the focus of the inquiry or investigation. Subjects will also be informed of all allegations and issues that are being pursued in the inquiry/investigation and the opportunity to provide comments and other relevant information to the OSI, and, to be personally interviewed by OSI. Interviews are transcribed and interviewees are provided with a copy of the transcript and an opportunity to correct it and provide additional comments. Subjects of the inquiry or investigation may be represented by counsel, may propose witnesses to be interviewed, and may recommend members of any expert advisory panel convened by OSI to assist with the inquiry or investigation. No opportunity is provided for subjects to confront and cross- examine other witnesses interviewed by OSI. During the course of the inquiry or investigation, the subjects are provided access to any research data under review, may freely submit evidence to the OSI, both orally and in writing, and rebut issues and evidence under review by the OSI in the same manner, and are provided with an opportunity to review and comment on significant investigatory documents identified by OSI unless such disclosure would violate individual confidentiality or significantly impair the investigation. At the conclusion of the inquiry or investigation, subjects are provided with an opportunity to comment on and rebut the report and findings and subsequently to comment on proposed sanctions, if any." (PHS proposed rule 1.6 (b)(1))

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