Transcript - Hintergrund-
GLP/GSP in the research lab?
GLP: GSP: Good laboratory practice Good scientific practice
GLP/GSP in the research lab?
GLP/GSP in the research lab?
GLP/GSP in the research lab?
How many retracted articels?
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14 ?
147 ? 1476 ?
Authors can retract or Editors can retract
For the paper by Di Lorenzo, et al., "Long-Term Outcome of Drug-Eluting Stents Compared With Bare Metal Stents…," Circulation. 2009;120:964–972, the editors have discovered that the authors violated Circulation’s Ethical Policy, as stated in our Instructions for Authors:
"Manuscripts are considered on the understanding that they contain original material, that the manuscript and material within the manuscript have not been published and are not being considered for publication elsewhere in whole or in part in any language, including publicly accessible web sites or e-print servers, except as an abstract.
The authors also certify that any and all other work in preparation, submitted, in press, or published that is potentially overlapping either in the actual data presented or in the conceptual approach is enclosed along with the original submission. Any material within the manuscript that has appeared elsewhere must be cross-referenced and permission to use or adapt the material must be received, in writing from the copyright holder."
The authors violated the policy stated above in three ways: The amount of original material in the Circulation manuscript is limited given the preceding publication, "The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial, J Am Coll Cardiol Intv 2009;2:515–23, from which original data has been taken and verbatim text excerpted.
No overlapping work, i.e., neither the JACC: Cardiovascular Interventions paper (J Am Coll Cardiol Intv 2009;2:515–23), nor a near simultaneous publication in the American Heart Journal (Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: Four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial, Am Heart J 2009;158:e43–e50) was submitted with the Circulation manuscript during the peer review process.
The previous publication of some material, e.g., Figure 1 in the JACC: Cardiovascular Interventions’ paper, was not acknowledged within the Circulation manuscript, and no permission from the original copyright holder for the material’s use in the Circulation paper was provided.
The Editors, hereby, retract the paper
GLP/GSP in the research lab?
How many retracted ”stem cells ”articels?
• • •
6 ?
69 ? 696 ?
Science. 2005 Jun 17;308(5729):1777-83. Epub 2005 May 19. Erratum in: Science. 2005 Dec 16;310(5755):1769. Retraction in: Kennedy D. Science. 2006 Jan 20;311(5759):335 .
GLP/GSP in the research lab?
Science. 2005 Jun 17;308(5729):1777-83 Science. 2006 Jan 20;311(5759):335
GLP/GSP in the research lab?
What do you think is ”scientific misconduct” ?
How many Pubmed hits ”scientific misconduct”
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36 ?
362 ?
3676 ?
Do you think it can affect you/your career?
Scientific misconduct –
in Lund ?
Scientific misconduct –
effects on YOUR own career ?
GLP/GSP in the research lab?
Is it O.K. to …… ?
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Leave out data? Exclude experiments from the analysis? Fill in data gaps? Present only the good experiments? „borrow“ your neighbours data? Can you think of other things that are NOT O.K ?
GLP/GSP in the research lab?
Principles for Good Scientific Practice
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Apply to:
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general scientific work (work, results, documentation) mentorship of the trainees cooperation and leadership in scientific groups publications
GLP/GSP in the research lab?
Principles for Good Scientific Practice
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work „lege artis“ Document everything you do, document all results (also negative and outliers) Keep records of primary data for 10 years Hard cover lab-book, pages numbered Lab books do not leave the lab, copies are allowed
GLP/GSP in the research lab?
Definition: Scientific misconduct, violation of good scientific practice (GSP)
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Falsification and fabrication of data Plagiarism Scientific misconduct Unjustified co-authorship Lacking or insufficient scientific activities in the group Insufficient mentorship of students Loss or insufficient documentation of original data Lack of instruction of new lab members regarding GSP
GLP/GSP in the research lab?
Lab Books
GLP/GSP in the research lab?
Lab Books
GLP/GSP in the research lab?
Lab Books
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Exp-ID (for example AT10605) Titel („Dose response Interleukin 12…) Materials
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DPBS, Baxter, FCS, PAA, lot no 123456 (see list of materials) Procedure
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Write what you have done Results
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Raw data
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refer to other sources if necessary Conclusions
GLP/GSP in the research lab?
Lab Books
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Property of the laboratory Used to record, in chronological order, any ideas conceived by the investigator Table of Contents, List of Materials, Protocols of indiv. Experiments (raw data!) No pencil!
Everything MUST be documented Do not remove anything from the lab book (e.g. pages)
GLP/GSP in the research lab?
Write a simple & short lab-protocol, exchange with your neighbour, read and discuss
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Exp-ID (for example AT10605) Titel („Dose response Interleukin 12…) Materials
• •
DPBS, Baxter, FCS, PAA, lot no 123456 (see list of materials) Procedure
•
Write what you have done Results
• •
Raw data refer to other sources if necessary Conclusions
Principles of GLP
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004
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GLP is a quality system concerned with the organisational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported
Principles of GLP
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Facility organisation and personnel Quality assurance programme Facilities Apparatus, material, and reagents Test systems Test and reference items SOPs Reporting of the study Reporting of study results Storage and retention of records and materials
Principles of GLP
Facility organisation and personnel
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Management:
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ensure that GLP principles are complied with Ensure the maintenance of a record of the qualifications, training, experience and job description for each individual
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Ensure that appropriate and technically valid SOP are established and followed
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Approve all original and revised SOPs
Principles of GLP
SOPs
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Written and approved Available for:
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Test and reference items Apparatus, materials and reagents Record keeping, reporting, storage, and retrieval Test system Quality assurance procedures
Principles of GLP
Storage and retention of records and materials
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Archive:
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Study plan, raw data, reference items, specimens, final report ..
Index material in the archive Only authorized personnel should have access to the archives Material movement in and out should be carfully recorded
Last (not least) – more G..Ps
GMP stands for:
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Good medical practice Good mental practice Good manufacuring practice And is applied in ….
Last (not least) – more G..Ps
GCP stands for:
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Good cleaning practice Good clinical practice Good cleavage practice And is applied in ….