Part C
Specific Research Policies and Practices

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Part C Specific Research Policies and Practices

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II This page in the original is blank.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II 12 Policy for Recording and Preserving Scientific Data Dana-Farber Cancer Institute INTRODUCTION It is both necessary and appropriate that the Dana-Farber Cancer Institute unequivocally identify and establish specific guidelines and a policy related to the development and maintenance of the scientific record. The underlying principle is the uncontestable fact that original experimental data must be recorded and retained in a form which will readily permit independent analysis, verification of originality and authenticity, and validation of interpretations and conclusions. Equally uncontestable is the Institute's ownership and stewardship of the scientific record. This responsibility is clearly based on the assignment to the Institute of ''all ideas, inventions, discoveries, improvements and the like, whether patentable or not (including all data and records pertaining thereto) and all right, title, and interest … therein" by the individual on executing the Institute's Invention Agreement. This agreement applies to all individuals associated with the Institute in the conduct of research and utilizing the Institute's resources. POLICY As the legal owner of the scientific record, the Institute requires that all primary scientific data generated within its facilities and with its resources be accurately and faithfully recorded, responsibly maintained, and permanently retained. NOTE: Issued in October 1987; reprinted with permission from the Dana-Farber Cancer Institute, Boston, Mass.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II GUIDELINES The following will serve as guidelines for implementation of the policy. Where required, specific procedures and individual responsibilities are identified. Recording of Data—All primary data are to be entered into a notebook provided by the Institute for this purpose. The investigator is responsible for all data entries. The notebook will contain lined, numbered pages; no pages are to be removed or made illegible. Entries must be dated and signed. Data generated as printouts must be permanently fixed to the notebook pages. Data in other forms, such as photographs or data on computer disks, must either be included in the notebook or be maintained physically with the notebook. Unusual problems associated with data records will be resolved on consultation with the director for research. Further guidance on record keeping procedures will be found in Appendix E of the Harvard Medical School Guide to Protecting and Managing Intellectual Property. Retention of Data—The laboratory chief is responsible for maintaining and preserving all laboratory notebooks. All investigators within the laboratory are responsible to the laboratory chief for notebooks assigned to them. On leaving the Institute, investigators are required to deposit the original notebooks with the laboratory chief. Similarly, the laboratory chief, on leaving the Institute, is required to deposit all original notebooks from the laboratory with the director for research. The laboratory chief must arrange with the director for research for the safe storage of notebooks no longer needed in the immediate laboratory area. Access to Data—The investigator will have ready and complete access to all notebooks which he employed during his association with the Institute. On leaving the Institute, the investigator is entitled to a copy of the notebooks, but not the original notebooks, which will be permanently retained by the Institute. The Institute president, or his appointed representative(s), similarly will have ready and complete access to all notebooks currently in use or retained by the laboratory chief. Such access will be immediate on request to the laboratory chief and will be for reasonable cause as determined by the Institute president.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II IMPLEMENTATION This policy is effective immediately; a supply of notebooks is available at the Research Administration Office. Notebooks will be issued without charge to individual investigators. An inventory record of notebooks issued to individuals will be maintained and, on leaving the Institute, the individual will be required to clear the record, either returning the notebooks or transferring responsibility to another individual.