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MUSC research data ownership, record retention policy revised by Mike Wheeler University Compliance Office In June 2005, a new federal law was implemented that extends the statute of limitations to six years to bring forward an allegation of research misconduct. In response to this extension, research records must be retained for a longer period of time. Basically, research records must be retained as follows: Research records should be retained for a sufficient minimum period to allow evaluation and repetition by others of the results and to investigate an allegation of research misconduct. Usually, this minimum period is six years; For research involving children, this minimum period is six years or until the child reaches 21, whichever is later; and Records of research misconduct proceedings should be retained for seven years after completion of the proceeding or the completion of any proceeding involving the research misconduct allegation, whichever is later.   This law also states the destruction, absence of, or respondent’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution or The Department of Health and Human Services establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them or had the opportunity to maintain the records but did not do so.   In response to these new requirements, President’s Council approved a revised MUSC policy on Research Data Ownership & Record Retention. In addition to stating the above record retention requirements, this Research Data Ownership & Record Retention policy also: Establishes MUSC’s ownership rights to research records generated by MUSC faculty, scholars, staff, post-doctoral fellows, visiting scientists and students whether generated during scholarly activities or in conducting sponsored activities funded by external agencies. Establishes data management responsibilities to the principal investigator. The results of research should be carefully recorded in a form that will allow continuous access for analysis and review. Establishes MUSC’s right of access and right to make copies of records for all research performed at MUSC or supported by MUSC sponsored funds. Examples of MUSC’s right of access are to conduct compliance audits, investigate allegations of research misconduct, etc. Emphasizes the Health Insurance Portability and Accountability Act prohibition of removing research-related identifiable protected health information unless HIPAA specified criteria are met. Establishes a protocol for the disposition of research records in the event the principal investigator, students, post-doc fellows, etc. transfers or leaves MUSC. Establishes a protocol for arbitration of all disputes involving the ownership, retention and access to research records.   For questions concerning the Research Data Ownership and Record Retention Policy, contact the University Compliance Office at 792-8744.     Friday, Feb. 10, 2006 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Community Press at 849-1778, ext. 201.