Issues in Responsible Science: Scandal in Stem Cell Research

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1 Issues in Responsible Science: Scandal in Stem Cell Research Lida Anestidou and Elizabeth Heitman With contributions from Nancy Connell and Mohamed El Hadidi

2 Overview of the Stem Cell Scandal LEARNING GOAL To be able to use noteworthy cases in teaching Responsible Science LEARNING OBJECTIVES Recognize ethical problems in complex research exemplified in a noteworthy case Identify and make connections among important ethical issues in a noteworthy case

3 Active Learning Methods Low tech individual response system Group share, brainstorming (Concept map)

4 Woo Suk Hwang, DVM, PhD

5 Hwang s Rise to Fame Two landmark articles in Science: February 2004: First reported success in creating human embryonic stem cells by cloning using somatic cell nuclear transfer May 2005: 11 more stem cell cultures from cloned human embryos using same method One landmark article in Nature: August 2005:Nature: first to report cloning a dog ( Snuppy )

6 Origin of Embryonic Stem Cells embryonic stem cells Magnuson, Vanderbilt U.

7 Potential of Embryonic Stem Cells Kidney Bone osteoblasts Skin Blood blood cells Vessels endothelial cells Heart cardiomyocytes Muscle Pancreas Nervous System neurons astrocytes oligodendrocytes Liver liver cells insulin producing cells Magnuson, Vanderbilt Univ. 2006

8 1 st Landmark Stem Cell Publication International headlines 30 cloned blastocysts Harvested stem cells May 2004: ethical issues in egg donation >2200 eggs, 119 donors Science 2004; 303, 1669

9 Ethical concerns about oocyte donation in Hwang s stem cell research: Graduate student in lab donated eggs subordinate relationship and vulnerability; mentoring Junior researcher in lab donated eggs personal gain vs. altruism; vulnerability; mentoring Payment ($1,400 each) to 66/119 women for egg donation now illegal in Korea Insufficient information provided to egg donors about risks; informed consent Lack of written consent for repeated donations Denial/lack of awareness/lying by Hwang Eisenberg, Vanderbilt University

10 1 st Landmark Stem Cell Publication International headlines 30 cloned blastocysts Harvested stem cells May 2004: ethical issues in egg donation Science 2004; 303, Science ; 303, 1669 January 2005: Korean Bioethics and Biosafety Act 2005 regulated egg donation

11 2 nd Landmark Stem Cell Publication International headlines Stem cells specific to one person Disease specific stem cells Stem cell medicine Gerald Schatten Science 19 May 2005 (308, 1777) Senior author added credibility American science International collaboration Ethical issues at rest Also part of dog cloning paper

12 The Scandal Begins November 2005: One of Hwang s collaborators raised ongoing concerns regarding oocyte donations in Hwang's research and unethical conduct in acquiring egg cells in violation of the country's newly written bioethics law. Science Feb

13 The Crisis Unfolds 11/05: Schatten cuts ties 11/05 12/05: Problems found in 2005 paper 01/10/06: SNU Investigative Panel s interim report 01/12/06: Papers retracted 03/2006: Hwang loses stem cell research license and is fired from SNU Both Science papers contained fabricated and falsified data Intimate involvement in egg donations by his staff Number of oocytes used: > 2,000

14 Hwang s Fall January 2006: Seoul National University announced that all of Hwang's stem cell lines were fabricated and both Hwang's 2004 and 2005 Science papers were based on fabricated data. Snuppy was a real clone. Time cover Jan

15 Ethical Issues in Cloning Research with Dogs Creating Snuppy involved : 1095 eggs 123 surrogate mothers 3 pregnancies Risk vs. benefit

16 The International Collaborator February 2006: University of Pittsburgh found Schatten Not guilty of research misconduct, but Guilty of research misbehavior: Shirked senior author responsibilities Lobbied for publication in Science Benefited: reputation; patents; funds; honoraria Too fond of publicity

17 The Indictment and Trial May 12, 2006: Indictment Conduct and reporting of fraudulent research Embezzlement and misappropriation of funds Violation of Bioethics and Biosafety Act 2005 June 20, 2006: Trial June 28, 2006: Hwang will continue research at SNU October 26, 2009: Found guilty of embezzlement and ethics violations but not research fraud Science 5/19/2006

18 Question for individual responses Do you think Dr. Hwang should have been allowed to continue his work? A) Yes B) No C) Undecided

19 What is Dr. Hwang doing now?

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21 Dr. Hwang will clone your dead dog.

22 Activity 1 (10 minutes discussion + 5 minutes reporting) In your small group, discuss the following questions: What ethical issues stand out in this case? What lessons from the stem cell scandal can be used in teaching Responsible Science? Teaching methods: Group share, report, and general discussion

23 Some Concepts from the Stem Cell Scandal Regulation of research Research with human subjects Informed consent Oocyte donation Risk/benefit Scientific integrity Research misconduct RCR education Responsible authorship Fabrication of data Peer review of manuscripts Error versus intent Mentor trainee relations Reporting results Coercion and autonomy International collaborations International guidelines for responsible conduct of science

24 Overview of the Stem Cell Scandal LEARNING GOAL To be able to use noteworthy cases in teaching Responsible Science LEARNING OBJECTIVES Recognize ethical problems in complex research exemplified in a noteworthy case Identify and make connections among important ethical issues in a noteworthy case

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26 Research Misconduct Lida Anestidou and Elizabeth Heitman With contributions from Nancy Connell and Mohamed El Hadidi

27 Overview of the Stem Cell Scandal LEARNING GOAL (CONTINUED) To be able to use noteworthy cases in teaching Responsible Science LEARNING OBJECTIVES Describe examples of research misconduct Come to a consensus about elements for a definition of research misconduct

28 Activity 2 (10 minutes brainstorming & discussion + 5 minutes reporting) Identify and compose a list of aspects of the stem cell scandal that represent poor scientific practice. Beside each poor practice, note what good practice would be. Teaching methods: Brainstorming, small group discussion, and report

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30 Scientists behaving badly Vol June 2005

31 Activity 3 (5 minutes discussion + 5 minutes reporting) Compose a list of behaviors or actions to include in a definition of research misconduct o Which of Hwang s or Schatten s actions would fall into this category? Participants agree on the final list Teaching method: small group work, report out, and general discussion

32 Research Misconduct Definitions US Falsification Fabrication Plagiarism Australia Conflict of Interest Willful concealment or facilitation of research misconduct by others Finland Fraud in Science Fabrication Misrepresentation Plagiarism and misappropriation Misconduct in science Includes understatement of others contribution to publication; negligence in referring to earlier findings

33 Activity 4 (5 minutes brainstorming & discussion + 5 minutes reporting) In your small group, discuss how university faculty and administrators can create an environment that prevents misconduct. What seems to work? Teaching method: brainstormning, small group discussion, and report

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35 Publication Issues in the Stem Cell Scandal Elizabeth Heitman and Lida Anestidou With contributions from Nancy Connell and Mohamed El Hadidi

36 Publication Issues in the Stem Cell Scandal LEARNING GOAL To be able to give appropriate credit for intellectual contributions to scientific work and teach students to do so. LEARNING OBJECTIVES To be able to articulate: Why scientists publish Who can be an author How to acknowledge others contributions Types of plagiarism How to avoid plagiarism

37 Activity 5 (5 minutes brainstorming & shout out) From your table, suggest reasons for your group to answer the following question: Why do scientists publish?

38 The Stem Cell Scandal: Authorship and Accountability Journals want honest, complete, reproducible research. Both papers in Science used fabricated and falsified data. Reviewers rejected Dr. Hwang s first paper. He asked Dr. Schatten for advice. Dr. Schatten convinced the editor of Science to accept a revised version of the article. Dr. Schatten was listed as senior author of the 2 nd paper. When fabricated and falsified data were discovered, Dr. Schatten insisted that he had never seen the original data.

39 Question for Individual Responses Dr. Schatten spoke with Dr. Hwang about the data by phone but stated that he never saw the original data from the study on patient specific embryonic stem cells. Should he have been named as an author on the 2 nd paper in Science? A. Yes B. No

40 Patient Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts Science, New Series, Vol. 308, No (Jun. 17, 2005), doi: /science PMID Retracted PMID Authors: Woo Suk Hwang, Sung Il Roh, Byeong Chun Lee, Sung Keun Kang, Dae Kee Kwon, Sue Kim, Sun Jong Kim, Sun Woo Park, Hee Sun Kwon, Chang Kyu Lee, Jung Bok Lee, JinMee Kim, Curie Ahn, Sun Ha Paek, Sang Sik Chang, Jung Jin Koo, Hyun Soo Yoon, Jung Hye Hwang, Youn Young Hwang, Ye Soo Park, Sun Kyung Oh, Hee Sun Kim, Jong Hyuk Park, ShinYong Moon, & Gerald Schatten Drs. Hwang and Schatten had 23 co authors, including at least one trainee who provided oocytes for the research.

41 Question for Individual Responses At least one of Dr. Hwang s trainees provided oocytes to make embryos for the team s stem cell research. Should she have been an author on the 2 nd paper in Science? A. Yes B. No

42 Activity 6 (5 minutes brainstorming & discussion + 5 minutes reporting) What questions or complications with authorship have you encountered in your work? For example: What do you have to do on a research project to be an author on the paper? What does it mean to be 1 st author? Last author? Fifteenth in a list of 52 authors? Do group members agree on all answers?

43 Authoritative Standards for Scientific Publishing International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals World Association of Medical Editors, Editorial Policy Committee. Policy Statements Committee on Publication Ethics, Code of Conduct and Guidelines American Chemical Society, Ethical Guidelines to Publication of Chemical Research

44 ICMJE Criteria for Authorship 1. Substantial contributions to conception or design of the work; or the acquisition, analysis or interpretation of data for the work; 2. Drafting the work or revising it critically for important intellectual content; 3. Final approval of the version to be published; 4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part are appropriately investigated and resolved. All authors should meet conditions 1, 2, 3, and 4. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, December 2014,

45 Contributors who meet fewer than all 4 of the above criteria for authorship should not be listed as authors, but they should be acknowledged. International Committee of Medical Journal Editors Those who don t meet all 4 should be acknowledged, recognizing, for example, their contribution to: Acquisition of funding General supervision (such as department head) General administrative support Writing assistance, technical or language editing Care of patients or research participants These specific contributions should be identified, and those who are acknowledged should agree.

46 Failing to list a qualified author or contributor may constitute plagiarism. The act of using another person's words or ideas without giving credit to that person. Merriam Webster Online Dictionary webster.com/dictionary/plagiarism Appropriation of another person's ideas, processes, results, or words without giving appropriate credit. U.S. Office of Science and Technology Policy s Definition of Research Misconduct (65 FR , December 2000)

47 Accidental and intentional plagiarism are both misleading. Intentional plagiarism is misconduct.

48 Question for Individual Response: Which of these have you seen someone do? A) Yes B) No Forgetting to include an author. Forgetting to list a reference. Assuming that what (s)he knows is common knowledge. Repeating another person s method s section when using the same methods. Restating an idea, argument, or data without finding and citing the source. Copying and pasting text from a published source because those authors say it better. Patchwork writing, taking text from many papers without attribution. Re writing a student s thesis for publication without the student Submitting a published paper to a new journal with your name.

49 When in doubt, include the reference. Citation shows that YOU know the literature. Citation identifies the source and authority of the material, and gives credit and responsibility for the work. Direct quotes always need a citation, even quotes from a textbook, but direct quotes should be used only when the specific language is essential. Common knowledge and specialized terms may still need a citation. Formats for citation vary by field and journal check the Instructions to Contributors for guidance.

50 Questions for Final Consideration On Your Own 1. Do the journals that you read have formal criteria for authorship? If so, where can you find them? 2. How many authors do papers in your field usually have? What is a reasonable number of authors on a paper? 3. How can co authors be sure of the integrity of their colleagues work?

51 Publication Issues in the Stem Cell Scandal LEARNING GOAL To be able to give appropriate credit for intellectual contributions to scientific work and teach students to do so. LEARNING OBJECTIVES To be able to articulate: Why scientists publish Who can be an author How to acknowledge others contributions Types of plagiarism How to avoid plagiarism