GLP/GSP in the research lab? Good laboratory practice Good scientific practice GLP: GSP:

GLP/GSP in the research lab?GLP/GSP in the research lab?

Good laboratory practice

Good scientific practice

GLP:

GSP:



• 14 ?14 ?

How many retracted articels?

• 147 ? 147 ?

• 1476 ?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

• 6 ?6 ?

How many retracted ”stem cells ”articels?

• 69 ? 69 ?

• 696 ?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.

http://www.ncbi.nlm.nih.gov/pubmed/16410485?ordinalpos=5&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


Science. 2005 Jun 17;308(5729):1777-83Science. 2006 Jan 20;311(5759):335

• 36 ?36 ?

How many Pubmed hits ”scientific misconduct”

• 362 ?362 ?

• 3676 ?3676 ?


What do you think is ”scientific misconduct” ?

Do you think it can affect you/your career?

Scientific misconduct – Scientific misconduct – in Lund ?in Lund ?

Scientific misconduct – Scientific misconduct – effects on YOUR own career ?effects on YOUR own career ?

• Leave out data? Leave out data?

Is it O.K. to …… ?

• Exclude experiments from the analysis? Exclude experiments from the analysis?

• Fill in data gaps? Fill in data gaps?


• Present only the good experiments? Present only the good experiments?

• „„borrow“ your neighbours data? borrow“ your neighbours data?

Can you think of other things that are NOT O.K ?

Principles for Good Scientific PracticePrinciples for Good Scientific Practice

• Apply to:Apply to:

• general scientific work (work, results, documentation)general scientific work (work, results, documentation)

• mentorship of the traineesmentorship of the trainees

• cooperation and leadership in scientific groupscooperation and leadership in scientific groups

• publicationspublications


Principles for Good Scientific PracticePrinciples for Good Scientific Practice

• work „lege artis“work „lege artis“

• Document everything you do, document all results (also negative Document everything you do, document all results (also negative

and outliers)and outliers)

• Keep records of primary data for 10 yearsKeep records of primary data for 10 years

• Hard cover lab-book, pages numberedHard cover lab-book, pages numbered

• Lab books do not leave the lab, copies are allowedLab books do not leave the lab, copies are allowed


Definition: Scientific misconduct, violation Definition: Scientific misconduct, violation of good scientific practice (GSP)of good scientific practice (GSP)

• Falsification and fabrication of dataFalsification and fabrication of data

• PlagiarismPlagiarism

• Scientific misconductScientific misconduct

• Unjustified co-authorshipUnjustified co-authorship

• Lacking or insufficient scientific activities in the groupLacking or insufficient scientific activities in the group

• Insufficient mentorship of studentsInsufficient mentorship of students

• Loss or insufficient documentation of original dataLoss or insufficient documentation of original data

• Lack of instruction of new lab members regarding GSPLack of instruction of new lab members regarding GSP


Lab BooksLab Books


Lab BooksLab Books


Lab BooksLab Books


• Exp-ID (for example AT10605)Exp-ID (for example AT10605)

• Titel („Dose response Interleukin 12…)Titel („Dose response Interleukin 12…)

• MaterialsMaterials

• DPBS, Baxter, FCS, PAA, lot no 123456DPBS, Baxter, FCS, PAA, lot no 123456

• (see list of materials)(see list of materials)

• ProcedureProcedure

• Write what you have doneWrite what you have done

• ResultsResults

• Raw dataRaw data

• refer to other sources if necessaryrefer to other sources if necessary

• ConclusionsConclusions

Lab BooksLab Books

• Property of the laboratoryProperty of the laboratory

• Used to record, in chronological order, any ideas conceived Used to record, in chronological order, any ideas conceived

by the investigatorby the investigator

• Table of Contents, List of Materials, Protocols of indiv. Table of Contents, List of Materials, Protocols of indiv.

Experiments (raw data!)Experiments (raw data!)

• No pencil!No pencil!

• Everything MUST be documentedEverything MUST be documented

• Do not remove anything from the lab book (e.g. pages)Do not remove anything from the lab book (e.g. pages)


Write a simple & short lab-protocol, exchange Write a simple & short lab-protocol, exchange with your neighbour, read and discusswith your neighbour, read and discuss


• Exp-ID (for example AT10605)Exp-ID (for example AT10605)

• Titel („Dose response Interleukin 12…)Titel („Dose response Interleukin 12…)

• MaterialsMaterials

• DPBS, Baxter, FCS, PAA, lot no 123456DPBS, Baxter, FCS, PAA, lot no 123456

• (see list of materials)(see list of materials)

• ProcedureProcedure

• Write what you have doneWrite what you have done

• ResultsResults

• Raw dataRaw data

• refer to other sources if necessaryrefer to other sources if necessary

• ConclusionsConclusions

Principles of GLPPrinciples of GLP

• GLP is a quality system concerned with the organisational GLP is a quality system concerned with the organisational

process and the condition under which non-clinical health and process and the condition under which non-clinical health and

environmental safety studies are planned, performed, monitored, environmental safety studies are planned, performed, monitored,

recorded, archived and reportedrecorded, archived and reported

Directive 2004/10/EC of the European Parliament and of the

Council of 11 February 2004


• Facility organisation and personnelFacility organisation and personnel

• Quality assurance programmeQuality assurance programme

• FacilitiesFacilities

• Apparatus, material, and reagentsApparatus, material, and reagents

• Test systemsTest systems

• Test and reference itemsTest and reference items

• SOPsSOPs

• Reporting of the studyReporting of the study

• Reporting of study resultsReporting of study results

• Storage and retention of records and materialsStorage and retention of records and materials


• Management:Management:

• ensure that GLP principles are complied withensure that GLP principles are complied with

• Ensure the maintenance of a record of the qualifications, Ensure the maintenance of a record of the qualifications,

training, experience and job description for each individualtraining, experience and job description for each individual

• Ensure that appropriate and technically valid SOP are Ensure that appropriate and technically valid SOP are

established and followedestablished and followed

• Approve all original and revised SOPsApprove all original and revised SOPs

Facility organisation and personnel


• Written and approvedWritten and approved

• Available for:Available for:

• Test and reference itemsTest and reference items

• Apparatus, materials and reagentsApparatus, materials and reagents

• Record keeping, reporting, storage, and retrievalRecord keeping, reporting, storage, and retrieval

• Test systemTest system

• Quality assurance proceduresQuality assurance procedures

SOPs


• Archive:Archive:

• Study plan, raw data, reference items, specimens, final reportStudy plan, raw data, reference items, specimens, final report

• ....

• Index material in the archiveIndex material in the archive

• Only authorized personnel should have access to the archivesOnly authorized personnel should have access to the archives

• Material movement in and out should be carfully recordedMaterial movement in and out should be carfully recorded

Storage and retention of records and materials

Last (not least) – more G..PsLast (not least) – more G..Ps

• Good medical practiceGood medical practice

GMP stands for:

• Good mental practiceGood mental practice

• Good manufacuring practiceGood manufacuring practice

And is applied in ….

Last (not least) – more G..PsLast (not least) – more G..Ps

• Good cleaning practiceGood cleaning practice

GCP stands for:

• Good clinical practiceGood clinical practice

• Good cleavage practiceGood cleavage practice

And is applied in ….

Documents

GLP/GSP in the research lab? Good laboratory practice Good scientific practice GLP: GSP: