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FORSKNINGSETIK T5 HT 2012 Kristina Hug Avdelningen för medicinsk etik med.lu.se.

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1 FORSKNINGSETIK T5 HT 2012 Kristina Hug Avdelningen för medicinsk etik med.lu.se

2 INTRODUKTION TILL FORSKNINGSETIK EFTERMIDDAGENS PLAN:  Vad är forskningsetik och varför vi behöver det  Historiska exemplar av oetisk forskning  Användning av resultat som framkommit av oetisk forskning  Vetenskaplig oredlighet

3  Klinisk etik inkluderar medicinsk etik i snäv mening ("läkaretik") och vårdetik. Fokus i båda fallen är på relationerna mellan patienter och vårdpersonal.  Forskningsetik behandlar etiska problem vid insamling, bearbetning och publicering av data i medicinsk forskning.  Socialetik undersöker fördelningen av resurser i hälso- och sjukvården och vem som har rätt till vilken vård.  OLIKA FOKUS AV MEDICINSK ETIK

4 Principer och riktlinjer som hjälper forskaren att fatta svåra beslut angående sin forskning och vilka mål är mest viktiga när man måste väga olika värden mot varandra på ett rättvist sätt FORSKNINGSETIK: VAD ÄR DET?

5  Varför är det viktigt att känna till historiska exemplar?  Nazi experiment  ”Milgram Study”  Thalidomide studie  Obehandlat Syphilis studie  Radioaktiv behandling experiment  Vipeholmsstudie  Fler exemplar? OETISK FORSKNING: NÅGRA HISTORISKA EXEMPLAR

6 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER? (1)  Beroende belägenhet av forskningspersoner  Betraktning av några människor som terminala och som kan förbrukas

7 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER? (2)  Uppfattning att vissa människor är ”utanför” social omsorg

8 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER? (3)  Extrem likgiltighet och brist på medlidande för forskningspersoner

9 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER? (4)  Nationell behov eller regerings påtryckning efter mer forskning  Brådskande vetenskaplig behov

10 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER (5)  Forskares makt och inflytande på vetenskaplig samhälle  Hemlighet  Brist på oberoende övervakande av forskning

11 VAD BIDRAR TILL POTENTIELL MISSBRUK AV FORSKNINGSPERSONER? (6)  Uteslutning av några grupper från deltagning i forskning.  Misslyckande att försörja kompensation för skador i forskningen. Begränsning av försökspersoners tillgång till terapi medan forskning pågår.  Forskning på sårbara individer när samma forskning kunde utföras på icke sårbara.  Berövning av sjuka från etablerade terapier för att testa nya terapier.

12 BÖR RESULTAT SOM FRAMKOMMIT I OETISK FORSKNING ANVÄNDAS? Tänk på följande scenarios:  Resultatet är vetenskapligt pålitligt OCH  Resultatet är av stor betydelse till samhället OCH/ELLER  Forskningen var gjort länge sedan

13 ETT EXTREM EXEMPEL  I nazisternas koncentrationsläger: nedkylnings- experimenten där människor sänktes ned i kar med isbitar för att utröna hur länge de kunde överleva.  Livsvästar utrustas med krage: det visade sig att den som skyddar förlängda märgen kan överleva längre i kallt vatten.

14 ”Snäva” definitioner  Fabricering av data  Manipulering av data  Plagiat  Stöld av data/ideer ”Breda” definitioner Oärlighet mot sponsorn Överdrivning av egna goda egenskaper i t.ex. ansökan om medel Publicering av samma resultat i olika kontexter Sabotage av kollegas arbete Avvikelse från riktlinjer VETENSKAPLIG OREDLIGHET

15 An East Coast geneticist and a West Coast biochemist are engaged in a productive, well-defined collaborative project. The geneticist prepares and abstract, approved by his collaborator, for submission to a large international genetics meeting. The scientific content of the abstract reflects equal contributions of both collaborators. Within 1 month, the biochemist prepares an abstract of the same work to be submitted to a national biochemistry meeting. The two abstracts have different titles and different wording, but they report the same experiments and same results and interpretations. The abstracts submitted to both of these meetings will be published in journals of the respective societies as ”meetings proceedings”. (Francis L. Macrina. Scientific Integrity, 3rd ed. Text and Cases in Responsible conduct of Research. Washington DC 2005) ÄR DET VETENSKAPLIG OREDLIGHET?

16  Varför forskarna falsifierar eller plagierar?  Vem som kan skadas av vetenskaplig oredlighet?  Hur bör sådana forskarna straffas? ? DISKUSSIONSFRÅGOR

17 Eric is writing a grant application. It is very important for his future career that the application is funded. The deadline for submission is in 2 days. Everything is written except the large chapter with litterature review. Unfortunately, Eric’s wife and three small children are suffering from a bad flu, and he is the only person to take care of them all. In addition, he has an important task to finish at work. There is simply no time to write the litterature review. Eric remembers he reviewed a similar grant application 1 year ago. He searches among his papers and finds the application. 95% of the litterature review in this application would perfectly suit his own application. He can complete the remaining 5% during the remaining 2 days and submit his application in time. He is tempted to copy the literature review from the anonymous application he once reviewed, make changes where necessary, and add his own 5% of text. VAD BÖR ERIC GÖRA?

18 You discover that one of your older colleagues in the department has falsified a series of measurements in a minor publication, with no very sensational results. He is close to retirement. When you raise the matter with him, he breaks down crying and blames the head of the department demand for ”at least one paper per year”. If he fails to meet that target, he will not get a share of the ”special research resource” and will have to teach 400 hours a year. The man is in poor health and has no great talent for teaching. (Vetenskapsrådet, Good Research Practice – What is it?, VAD BÖR MAN GÖRA?

19 Exemplar: Riktlinjer för dokumentation av forskningsresultat Riktlinjer för arkivering av forskningsprotokoll Klargöra vem har vilken ansvar Undervisning av forskningsetik Revidering av system av akademiska meriter VAD KAN GÖRAS FÖR ATT FÖREBYGGA VETENSKAPLIG OREDLIGHET?

20 A doctor carried out a study to establish whether high- dose chemotherapy followed by bone marrow transplantation could improve the survival of a certain group of patients with breast cancer. The results were questioned, however, and the doctor was unable to produce the patient records and source data to conform them. Other researchers then tried to repeat the results, without success. It is one person’s word against another’s but primary data that could clear the doctor’s name are not available. (Vetenskapsrådet, Good Research Practice – What is it?, VEM BÖR GÖRA VAD?

21 När vetenskaplig oredlighet misstänks:  ”Whistle-blowing”  Kolla att misstanke är välgrundat När vetenskaplig oredlighet är bevisat:  Olika sanktioner  Publicering av errata  Ta bort publicerat artikeln från en tidskrift (”retraction”) VAD BÖR GÖRAS NÄR VETENSKAPLIG OREDLIGHET MISSTÄNKS?

22 Your colleague, a productive researcher, tells you in a private party that he does not like to do research any longer, even more, that he can hardly stand it. When asked why he continues anyway, he replies that he does not know to do anything else and must support his numerous family. A few days later a promising student that you are supervising tell you that she wants to start doctoral studies and thinks to choose your colleague as a supervisor, because he is ”so enthusiastic” about his research (Vetenskapsrådet, Good Research Practice – What is it?, BÖR MAN GÖRA NÅGONTING?

23 Varje granskare bör deklarera om det finns intressekonflikt i samband med ansökan / artikel man ska granska. Situationer som kan leda till en potentiell intressekinflikt, t ex:  Granskare är från samma institution som personen vems arbete granskas  Granskare har nyligen jobbat tilsammans med personen vems arbete granskas  Det finns antagonism mellan granskare och personen vems arbete granskas INTRESSEKONFLIKT

24 Dr Michael Frank recently began his postdoctoral training at West Coast University in the lab of Dr Roy Levy. Levy strongly suggests that Michael submit a postdoctoral research grant to the Clary Foundation, a philantropic organization that competitively awards small grants to young investigators at West Coast U. The foundation relies on independent peer review to determine proposal merit. Applicants are asked to provide with their materials and the names of two or three scientists who could provide expert reviews of the proposals. Michael prepares his proposal and suggests Drs Ben Bradley and Forrest Oscar as appropriate reviewers. Both Bradley and Oscar were members of Michael’s doctoral dissertation committee at East Coast University but have recently taken new positions in other states. Michael does not disclose these previous relationships to the foundation. (Francis L. Macrina. Scientific Integrity, 3rd ed. Text and Cases in Responsible conduct of Research. Washington DC 2005) FINNS DÄR INTRESSEKONFLIKT? HUR KAN DET HANTERAS?

25 Substantiell bidrag till: Koncept & design, eller analys & interpretering av data OCH Skrivning av artikel eller kritisk revidering av intellektuell innehåll OCH Slutlig godkännande av slutlig version som skickas till tidskriften (International Committee of Medical Journals Editors, ”Uniform requirements for manuscripts submitted to biomedical journals”) KRAV FÖR FÖRFATTARSKAP

26 Prior to a meeting of a PhD examining committee, one of the members discovers that three of the articles making up the thesis have a co-author who died three and a half years ago. The articles concerned were published this year or have recently been submitted. The author in question had in other words been dead for at least two years before the papers were completed. The data were collected around five years ago, however, so the person concerned may have had a hand in planning the project and collecting the data, but hardly in their analysis and interpretation. Still less was he in a position to influence the drafting of the articles or to choose not to be listed as a co-author if he had felt unable to accept the contents. And obviously he could not have approved the final versions of the texts. (Vetenskapsrådet, Good Research Practice – What is it?, BÖR DENNA FÖRFATTARE INKLUDERAS?

27  Media vill engagera läsaren och vill därför betona det som kan fånga läsarens uppmärksamhet mest  Det finns en risk att forskningsresultat kan interpreteras på ett fel sätt  Forskaren bör inte publicera preliminära resultat som ännu inte är granskade av oberoende granskare FORSKARE OCH MEDIA

28 C – communism: samhälle har rätt att få forskningsresultat U – universalism: forskningsresultat ska bara vara dömd från vetenskaplig synpunkt D – disinterestedness: att söka ny kunskap (och ingenting annat) ska vara motivation för att göra forskning OS – organised scpeticism: man ska ständigt ifrågasätta forskning men döma forskningen bara från vetenskaplig synpunkt MERTONS CUDOS KRAV

29 Objektivitet – när man söker kunskap Skepticism – när man kritiskt utvärderar andras vetenskapligt arbete Ärlighet angående eget arbete, även när resultat inte blir vad man har förväntat sig Aktsamhet – man ska vara noggrann i sin forskning – t ex när man samlar och sparar data, och rapporterar forskningsresultat Ödmjukhet – inför sitt ämne och inför sina kollegor Modighet – att erkänna när man själv har gjort fel, att våga göra det rätta, särskilt när det inte är populärt eller svårt EGENSKAPER AV EN BRA VETENSKAPLIG FORSKARE

30 Researcher A is close to a breakthrough in his research. A research position may soon be available. He studies the properties of certain proteins. The results of his measurements sometimes are not what he expected and he changes them somewhat before he records them with non-erasable ink in the lab-book used to record all experiments. A’s competitor B sees the figures in this book, suspects that not everything is right, goes to the laboratory on a Sunday afternoon to reproduce some of A’s experiments. He fails. When A’s paper is published, B suspects that A has conflated some statistical concepts, which makes the results misleading. B tells this to the chairman of the department. VEM BÖR GÖRA VAD?

31 A doctoral candidate at Lund University leaves draft of his dissertation to a colleague in Copenhague for comments. They are working in the same area and have met at an earlier Lund- Copenhagen seminar and got to know and like each other. The colleagues uses some material and ideas in the work of his friend in his own dissertation. The Copenhagen colleague presents his doctoral dissertation before his colleague has finished his. The Lund researcher then becomes accused of plagiarism. VAD BÖR DESSA DOKTORANDER GÖRA?

32 A dissertation in Sweden is published in a well- known Acta series. 2 years later it is discovered that a similar dissertation has been published in the US – without the US author acknowledging the existence of the Swedish dissertation. The Swedish researcher becomes very upset, contacts his chair and the US researchers. ÄR DET PLAGIAT?

33 Ben, a student, has been working on a research project that involved an important new experimental technique. For a national meeting in his discipline, Ben wrote an abstract and gave a brief presentation that mentioned the new technique. After his presentation, he was surprised and pleased when Dr Freeman, a leading researcher from another university, engaged him in extended conversation. Dr Freeman asked Ben extensively about the new technique, and Ben described it fully. Ben’s own faculty advisor often encouraged his students not to keep secrets from other researchers, and Ben was flattered that Dr Freeman would be so interested in his work. 6 months later Ben found an article by Dr Freeman in a journal. It described an experiment that clearly depended on the technique that Ben had developed. But there was no reference to Ben in the citations. FINNS DET EN MÖJLIGHET FÖR BEN ATT FÅ KREDIT FÖR HANS ARBETE?

34 A journalist interviews you for a national newspaper following a new discovery, and the resulting article paints you as a hero and hugely exxagerates your contribution, particularly compared with researchers abroad. You protested when you saw the draft – but the published version is still over the top. You consider writing a letter to the editor to correct it and, if it is not accepted, sending copies to the researchers concerned and others. Next week the Research Council is to decide whether your research group is to receive a ”grant of excellence”. (Vetenskapsrådet, Good Research Practice – What is it?, BÖR MAN SKICKA BREVETS KOPIA TILL VETENSKAPSRÅDET?

35 You realize that you have made a brilliant discovery, but you also realize that a foreign member of your research team intends to announce it to the media and will then get all the credit for it. You yourself would like to wait until the results have been peer-reviewed, but your head of department points out that the department will miss out on some useful publicity and be left behind if the discovery becomes old news. (Vetenskapsrådet, Good Research Practice – What is it?, BÖR MAN KONTAKTA MEDIA?

36 Anna, a student, has recently finished her research position and is leaving for a new job. She wants to pick up her notebooks from the lab she is leaving and to pick up where she left off with two uncompleted projects she worked on before. Her supervisor forbids her to take the notebooks arguing that they belong to the lab. Anna says she did the work and cannot follow up on it without the notebooks. The supervisor says that all the work she did was funded by the money he brought via grants and that’s why the notebooks belong to the lab, and the work will be continued in the lab. Annas’s friend suggests she should photocopy the notebooks during the weekend when the supervisor is not there. BÖR ANNA KOPIERA LABORATORIEBÖCKER?

37 A student working in the laboratory of her mentor is gathering data for a publicly funded project on which the mentor serves as a principal investigator. The student is, of course, going to use the data for thesis work. The student and mentor have a terrible falling out. The student leaves the lab and finds a new advisor. The original advisor notices that data and materials related to the student’s project are missing. The student readily admits to removing the tissue sections, gels, and computer disks but asserts that they are ”hers” – the product of her sweat and blood. (från Francis L. Macrina. Scientific Integrity, 3rd ed. Text and Cases in Responsible conduct of Research. Washington DC 2005) VEM ÄGER DATA?

38 For far too long now, in your applications to the Research Council and at various international conferences, you have been talking about a major work that is soon to be finished, and of which you are rightly proud. Now you are finally going to publish it – and not before time, because you have heard that a group in Hamburg have a similar publication in the pipeline. Then one of your colleagues discovers an irritating error in one of your computer programs. Probably it is of no significance, but it will take at least 6 months to fully investigate the consequences. If your work is not published before the next application round, the Hamburg group beat you to it, the livelihoods of a post-doc scholarship holder and a postdoctoral research fellow funded from your council grant will be in jeopardy. (Vetenskapsrådet, Good Research Practice – What is it?, VAD BÖR MAN GÖRA?


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