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Scientific Record Keeping do and don’t issues to conduct good science Carmen S. Dence, MS Good record keeping (GRK) promotes accountability and integrity in research GRK is necessary for data analysis, publication, collaboration, peer review among others. GRK is necessary to support intellectual property claims. Can defend you against false allegations of research misconduct. Continue… GRK is important for the care of human subjects. GRK is necessary for members of your group or any other researcher to be able to duplicate your work, when needed. GRK is required by NIH and other granting institutions to meet policies and standards for the conduct of good science Data Authenticity and Integrity Authentic data represent the true results of work and observations. Carelessness, self-deception, deliberate misrepresentation will cause authenticity to be lost . Integrity is dependent on results being collected using well-chosen scientific methods carried out in the proper manner. What is really a lab book? Is a record of both physical and mental activity. Good records are complete, accurate and understandable to others. Each member of the research team is responsible for his/her records. The PI has the final responsibility for the laboratory records. Laboratory Notebooks Who did it. What you did. When you did it. What project the research was part of. How you did it (methodology). What materials were used. Findings. Your interpretation. The next step. Laboratory Notebooks Bound, serially numbered pages All entries should be dated Permanent ink Table of contents- First few pages Include the actual data, such as photographs, negatives, autoradiograms and printouts Data in Laboratory Notebooks Original data should be included. Photographs, negatives and similar can be glued or taped. Other materials can be inserted in plastic sleeves (including CD or DVD). Oversize material and magnetic media should be stored, with the location and coding scheme included in the lab book. Electronic Record Keeping ELN – Electronic Laboratory Notebook Database software Generic electronic notebooks Scientific electronic notebooks CENSA – Collaborative Electronic Notebook Systems Association The loose-leaf notebook The use of a ring-binder and loose-leaf sheets in acceptable for many academic investigators. Can be used as a supplement to bound NB Loose sheets should be dated and added to the binder in chronological order, to meet standards of good science and assure research integrity. Every lab book must include Subject matter. Experimental details. Sketches, diagrams. Control conditions. Test results and their explanations. Conclusions should be short and supported by the factual data. It is desirable to record… Discussions with others (time, names, issues). Good for future credit. Correspondence with colleagues (phone calls, e-mails). Names of individuals who have played any role in your research. Technicians in core laboratories are specially important So…you made a mistake They should be marked through with a single line and a full explanation of the error provided. Never obliterate mistakes with ink or cover them with corrective fluid. To a casual observer these actions may suggest improper reasons. How long to keep notebooks? NIH policy mandates 3 years after the end of the project (grant funding period). FDA policy mandates 10 years after use. Patent policy mandates 23 years after issue of the patent. How long to keep notebooks? The organization with the longest policy has priority. State law when present, usually overrides federal laws. Who owns the notebooks and data? When NIH awards a research grant to a university, any and all data collected as part of that funded project are owned by the grantee institution. Data books of all investigators (PI, postdocs, grad students, technicians) are the property of the institution. Who owns the notebooks and data? The principal investigator is the steward. If the PI resigns or moves to another institution: Equipment and all data belong to the initial institution. Permission can be obtained to transfer the award, equipment and data. Applicability Data produced with Federal support that are cited publicly and officially. Data collected by institutions of higher education, hospitals, and non-profit institutions Does not apply to commercial organizations. Does not apply to state and local governments Applies to new and competing awards made after the effective date of the amendment (11/8/1999) Research Data Recorded, factual material commonly accepted in the scientific community as necessary to validate research findings. Published Peer-reviewed scientific or technical journal. Cited by a Federal agency publicly and officially. Research Data Do Not Include: Preliminary analyses Drafts of papers Plans for future research Peer reviews Physical objects (samples, tapes) Trade secrets or commercial information Record Keeping in Clinical Research Clinical data carries additional responsibility: • Patient privacy and confidentiality. • Civil and criminal penalties associated with violations of the Privacy Act. •The PI of the study has ultimate responsibility for all clinical research records. Witnessing Data Less common in the academic world. A funding agency may require it for contract work such as clinical testing. Bridging basic and applied research may require it. Witnessing of data is necessary if the work may lead to a patentable discovery or invention. Witnessing Data The witness must be able to understand the work. The witness must not be a co-inventor. Co-inventors are not allowed to corroborate each other’s work. Another worker in the same lab could sign, assuming he/she understood the work but was not involved with it. Public Access to Data The Office of Management and Budget (OMB) revised the regulations regarding public access to experimental data in 1999 Circular A-110 included the revisions. The public can obtain access to experimental data through the Freedom of Information Act (FOIA). FOIA Request Must Include: Specific regulation or order citing the data Publication cited Grant number Description of the data being sought A statement that the data are being requested under the amendment to Circular A-110 What happens if the PI refuses to comply with the request? This would be viewed as a material failure to comply with the terms and conditions of the award. NIH would initiate appropriate enforcement action. This could include withholding future support to the institution. Best Practice Principles for Leaders of Research Groups • Set standards for record-keeping practices in their group. •Provide/assure training for group members •Emphasize the benefits of GRK and the problems with poor practices. •Provide examples of GRK practices. •Clarify data and research record ownership and access rights. Best Practice Principles for Leaders of Research Groups • Perform periodic reviews of the records of members of your group. •Delegate, as needed, oversight and training duties for group records to senior members. •Provide the tools for GRK. •Require adherence to GRK by group members. Best Practice Principles for Leaders of Research Groups • Promote communication of research information within the group. •Have a plan to assure the transmission of important research information from departing group members. •Update records standards as needed. Best Practice Principles for Department/School Level • “It is the policy of WU-STL to publish research results and to foster the use of University inventions, discoveries and other works for the common good..” An 18-page document is available: •Intellectual Property Policy: www.wustl.edu/policies/intelprop.html With care and attention to our work, we should avoid RETRACTION “We wish to retract our report (Science 2004; 303, 371) in which we reported that β-Nacetylglucosamine-serine can be biosynthetically incorporated at a defined site in myoglobin in E. coli. RETRACTION… Regrettably, through no fault of the authors, the lab notebooks are no longer available to replicate the original experimental conditions, and we are unable to introduce this amino acid into myoglobin with the information and reagents currently in hand…” Z. Zhang eta l., UT at Austin. Science 2009; 326, 1187. Sources of Information Guidelines for Scientific Record Keeping in the Intramural Research Program at the NIH. Scientific Record Keeping. Alan L. Goldin Academic Research Record-keeping: Best Practices for Individuals, Group Leaders and Institutions. Academic Med. 2006;81, 42-47. Scientific Record Keeping. Francis L. Macrina. Chapter 11, pp231-256. Additional Sources of Information Responsible Conduct of Research Education Consortium (RCREC) Web Site Office of Management & Budget Circular A100 (section 36) NIH Working Group Report on Research Tools Kanare HM. 1985. Writing the Laboratory Notebook, ACS, Washington, D.C.