University of Washington Biomedical Research Integrity Cases Teaching Cases & Background Materials

University of Washington Biomedical Research Integrity Cases Teaching Cases & Background Materials TABLE OF CONTENTS Faculty Guide to Ethics & Small Group Teaching Planning a Research Study Collaborative Science Conflict of Interest and Commitment Mentor/Trainee Responsibilities Implementing a Research Study Animal Use in Research Data Acquisition, Management, Sharing and Ownership Human Subjects Research Reporting Research Results Peer Review Publication Practices and Responsible Authorship 10 Research Misconduct General Web Resources for Responsible Conduct of Research Appendix: Case Sources and Credits UW BRI CASES | Table of Contents, Acknowledgements | Page i University of Washington Biomedical Research Integrity Cases Teaching Cases & Background Materials ACKNOWLEDGEMENTS: This work was funded by a small contract from the Office of Research Integrity (#02T200051) A word about our process to develop these materials with the help of the grant award, we were able to test existing ethics cases against the practical experiences of trainees and researchers Our primary goal was to draft case material that would be relevant to trainees and target issues of importance to them in their professional development We would like to thank Jena Iffert, graduate student in Bioethics, for her work compiling cases and drafting teaching materials Ms Iffert was also instrumental in organizing and running the focus groups for the development and review of these cases The dozens of trainees and scientists who participated in our focus groups were also critical to the completion of this project Wylie Burke, MD PhD, Principal Investigator Professor and Chair Department of Medical History and Ethics Kelly Fryer-Edwards, PhD Assistant Professor Department of Medical History and Ethics UW BRI CASES | Table of Contents, Acknowledgements | Page ii UW BRI Cases Faculty Guide to Ethics and Small Group Teaching Faculty Guide Strategies for Leading an Ethics Discussion .2 Case Study Approach Brief Overview of Ethical Frameworks .6 In order to support your facilitation of the BRI Discussion Sessions, we have developed a few materials for your review Strategies For Leading An Ethics Discussion This outline walks through a standard small group discussion, from set-up to wrap-up We have added BRI specific notes throughout For example, one issue that has come up for faculty is how to facilitate a discussion with trainees doing quite different kinds of research Case-Study Approach One way to structure an ethics discussion can be to use a standardized process to working through a case We suggest a decision-making process adapted from the Hastings Center By using this approach to facilitate and guide discussion, you can move past a hasty ‘simple’ solution to a case For example, break-out sessions of 2-3 students can be asked to explore different steps in the analytic process, followed by a group discussion of all steps Our goal is to promote consideration of complexities in these case scenarios Brief Overview of Ethical Frameworks and Principles Referring to specific approaches to ethical reasoning and to basic principles of biomedical research ethics can help to ground the discussion These basic approaches can also help justify the best solutions to the cases UW BRI CASES | Mentor/Trainee Responsibilities | Page Strategies For Leading An Ethics Discussion Set The Context For Discussion  Explain objectives and purpose of discussion  Outline how the time will be spent  Remind participants that this is a group discussion and not a didactic session (they are responsible for discussion, not you) Facilitator’s Role In Small Group Discussion  Let the learners the work to figure out how to resolve the case The facilitators’ job is to ask the questions to motivate the group to want to resolve the problem, and to focus them on the key issues The CaseStudy Approach (attached) can help with focus  Help learners see the complexity that exists in the case (some learners quickly jump to conclusions without appreciating other considerations)  Help the learners acquire a systematic approach to dealing with difficult cases (which they can use to deal with future cases)  Assist learners in making connections with other kinds of research (if it is an animal research case, when similar issues arise in bench research or human subjects research?) Working Through A Case  Ask someone to read the case so that all are on the same page  Ask the group if they have factual questions (emphasizes the importance of facts in resolving what are often a combination ethical, legal and psychosocial problems)  An effective focusing tool is to ask the learner why he/she wants the information he/she is requesting UW BRI CASES | Mentor/Trainee Responsibilities | Page  Use the Case-Study Approach to guide discussion Consider different stakeholders (e.g mentor, trainee, funder, subject) and what values each person seems to be holding Are there values in conflict? Are there principles in conflict? What problems or issues are raised by the case?  When considering multiple solutions, compare the options in terms of their capacity to serve key values Justify the choice compared to alternatives Strategies For Leading An Ethics Discussion (continued) Tips For Leading A Discussion  Let participants most of the talking  Help to build the discussion by introducing new questions or controversies Use questions, probes, and case variations to focus the discussion  Where appropriate provide your own experiences or comments, but avoid acting as an expert See if other participants can correct misconceptions first  Use strategies to prevent one person from dominating the conversation “Thank you John, any thoughts from anyone …”  Invite everyone to participate “John, you have any thoughts or comments?”  Make sure your goals and purposes are being met—if not, try to redirect the conversation  Provide closure Summarize what was learned or discussed Refer to other resources available on handout and BRI website UW BRI CASES | Mentor/Trainee Responsibilities | Page Case-Study Approach This particular ethical decision making model was developed at the Hastings Center.1 The six-steps to be completed either individually or collaboratively within a group are: Step 1: Gathering and assessing relevant facts The second step in the decision making process involves assessing the facts that are available to decision-makers At this step it is important to address the non-ethical issues raised within the case For example, one may need to know the legal constraints of the decision Since it is impossible to include all facts in a case-study, frequently students will have to make assumptions based on the information that they have If students have longer then one class period to work on the casestudy, they can identify research areas to find out more information at this point Step 2: Identifying the Stakeholders At this step, all stakeholders in the decision should be identified As with Step 1, think broadly and generate a list of all possible individuals, groups, or entities (e.g the environment) who will be affected by the decisions to be made In the next steps, students will be able to weigh the stakeholders’ positions and assign priorities to the various groups Step 3: Identifying the values that are at stake Identifying the values at stake in the decision can be challenging, as this language is more often foreign to students Values are concepts, goals, or standards that are important to consider when choosing between competing courses of action These include, but are not limited to, beneficence, justice, autonomy, truth telling, integrity, and preserving relationships Some stakeholder values may include supporting a family (self-preservation), or winning an election (self-interest) While each of the values identified should be considered, they will vary in their importance depending upon the circumstances and the facts of the case at hand It can help at this step to identify values that work together The model and notes can be accessed as part of the ELSI module under Teacher Resources from the University of Washington High School Human Genome Program: http://hshgp.genome.washington.edu/ UW BRI CASES | Mentor/Trainee Responsibilities | Page or values that conflict Step 4: Identifying the ethical issues raised in the case The first step involves identification of the ethical problems the case raises It can help to start with an exhaustive list and then focus attention on specific issues that should be considered from there Many issues will arise, not all of which will be ethical issues Certain key terms may suggest when a question is an ethical question (e.g “right,” “responsibility,” “duty,” “ought,” and “should.”) A common element to Case-Study Approach (continued) ethical questions is that they raise concerns about what is appropriate conduct in a given situation and/or directly refer to the rights or interests of others Step 5: Identifying possible solutions At this stage, students should develop and assess multiple ways to resolve the issues involved with the decision They should consider “what could be done” This list can be open-ended and include solutions that are not possible (thinking about the reasons why something is not possible, or is ethically unacceptable, can be very useful) Step 6: Choose and justify the better solution In step 6, students should consider “what should be done” Alternative solutions from Step can be identified and justified in terms of the values that the solutions support UW BRI CASES | Mentor/Trainee Responsibilities | Page Brief Overview of Ethical Frameworks and Principles What is the right act? And what makes it so? Principles of Bioethics Since Hippocratic times, the profession of medicine has identified a version of these four primary principles as guides in their practice The biomedical research community has also adopted these principles in the Belmont Report (1979)  Beneficence: How can I be of benefit?  Nonmaleficence: How can I minimize harm?  Respect for Persons: How can I treat people as if they matter?  Justice: How can I act fairly? Frameworks for Ethics These three approaches are used in most arguments It can help to be explicit about which framework is being used, otherwise the argument will not go anywhere (if rules are being countered with consequences, for example) Each framework is valid It can be useful to review justifications for alternative solutions from each perspective:  Principle or Rule-Based An action is right if it follows fundamental moral rules The reasoning process here involves identifying the appropriate moral rule for the situation Rules and principles may come from multiple sources, including one’s profession, society, religion, or an institution Rules or principles, even from within the same system, may come into conflict at any one time Justifying why one principle might be privileged over another in a given situation is much of the work of ethics in this model  Consequence-Based An action is right if the good outweigh bad consequences The reasoning process here involves identifying specific anticipated, as well as unintended, outcomes of various options Deciding which consequences to consider, and how to ‘weigh’ them against one another, is the challenge of this approach  Virtue-Based UW BRI CASES | Mentor/Trainee Responsibilities | Page An action is right if it enacts a core purpose The reasoning process in this approach involves identifying what role the decision maker will take in the situation (is it one of citizen? Policymaker? Scientist? Teacher? Mother?) From there, one must decide what the core values are for that Brief Overview of Ethical Frameworks and Principles (continued) What is the right act? And what makes it so? position These core values should capture the core purpose (e.g as a mother, my core purpose is to protect my children from harm) The challenge of this approach is negotiating competing interpretations of core purpose and resolving conflicts between roles Skills to Teach in Ethics Education Ethics is a skill-based activity Four components must be addressed:  SENSITIVITY: Can you recognize the issues?  REASONING: Can you reason through the dilemma?  MOTIVATION: What is your responsibility? (As a trainee? As a scientist?)  ACTION: What will you do? UW BRI CASES | Mentor/Trainee Responsibilities | Page UW BRI Cases Primary Discussion Topic: Collaborative Science Additional Discussion Topics: Publication/Authorship, Data Acquisition, Management, Sharing and Ownership Cases & Notes for Faculty Facilitators Collaborative Science Objectives Resources .8 Case Case Variations 10 Case 11 Case Variations 12 Case Teaching Supplements 13 Case Teaching Supplements 15 Objectives for case discussion: Understand that good collaborative relationships are the result of developing the relationship, addressing issues as they arise, and clearly defining expectations regarding the research project and the collaboration Distinguish different kinds of “data” and “ownership” Understand the guidelines for data ownership within team relationships Understand the guidelines for data ownership for projects involving external funding Develop strategies for establishing authorship Resources: NIH Grants Policy Statement (2001) http://grants1.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm Ownership of Data UW Attorney General Office (2002) http://depts.washington.edu/or/dataowndership.html University of California, San Diego Collaboration and Mentoring http://ethics.ucsd.edu/courses/integrity/assignments/collaboration.html American Academy of Microbiology Dynamic Issues in Scientific Integrity: Collaborative Research http://www.asmusa.org/acasrc/pdfs/research.pdf http://www.washington.edu/medical/som/research/ethics.html UW BRI CASES | Mentor/Trainee Responsibilities | Page Case 2: Unintended Support by Way of Plagiarism A senate committee has published a report in support of a controversial public health education policy Upon publication, two individuals came forward indicating that documents they had previously written had been plagiarized in the writing of the report One document is a student’s recently published thesis, the others are articles written by a journalist Substantial sections of the thesis were put into the report, including typing and grammatical errors Additionally, both original authors have made allegations that figures they used have been altered The original authors take a different stance regarding the policy than the senate committee The journalist has expressed his discomfort and concern regarding his work being used to encourage a policy he does not support  Is this an example of plagiarism?  What limitations are there, or should there be, on the use of the work of other authors in one’s own work? UW BRI CASES | Mentor/Trainee Responsibilities | Page 98 Case 2: Variations Unintended Support by Way of Plagiarism The following variations in this case can be used to further explore the issues  Suppose the report was properly referenced Do the authors have a legitimate claim that their work was misused? UW BRI CASES | Mentor/Trainee Responsibilities | Page 99 Case Supplement: Teaching Materials Teaching Points:  Learners should take into account that most researchers not intend to fabricate or falsify data Those who are found to have committed a form of research misconduct have often done so without meaning to Technology that allows for “clean up” of images, etc adds further difficulties in determining how far or how much is too much clean-up While this dose not absolve researchers who engage in research misconduct it should increase learners awareness that such misconduct is not always intended and that they should take precautions so as not to inadvertently misrepresent their own research  Researchers should not rely solely on the reproducibility of results as the means of deterring research misconduct Appropriate mentorship plays a role in what trainees learn to consider suitable action Both formal mentorship by official advisors and by more informal mentorship or observation of senior students, contributes greatly to the research practices of junior researchers These individuals have a responsibility to conduct research responsibly thus setting an example for learners Guiding principles:  The Federal definition of research misconduct is currently under review and revision (see http://ori.dhhs.gov/html/policies/fed_research_misconduct.as p for an update) An example of widely accepted definitions is: o “"Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research Included is retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad UW BRI CASES | Mentor/Trainee Responsibilities | Page 100 faith It does not include honest error or honest differences in interpretations or judgments of data (Indiana University)."  By Federal law researchers must keep all relevant data (data which supports and verifies the findings of the research) for at least three years Researchers must also keep records of how their work is proceeding with “sufficient detail” that their work can be accurately repeated at some point in the future UW BRI CASES | Mentor/Trainee Responsibilities | Page 101 Case Supplement: Teaching Materials (continued)  David Resnik in The Ethics of Science (1998) identifies twelve ethical principles associated with scientific research.16 Among these are: o Honesty: Scientists "should be objective, unbiased, and truthful in all aspects of the research process." o Carefulness: Scientists "should minimize experimental, methodological, and human errors and avoid self-deception, bias, and conflicts of interest." o Credit: "Credit should be given where credit is due but not where it is not due." 16 Summarized on the Eastern Michigan University website: http://www.rcr.emich.edu/module5/e4_respon_conduct.html UW BRI CASES | Mentor/Trainee Responsibilities | Page 102 CASE Supplement: Teaching Materials Teaching Suggestion: Encourage the participants to take a stand on this case and to justify their position Discuss what steps a trainee can take if he/she suspects plagiarism of his/her own work Teaching Points:  If this situation were to occur in a medical journal, a legitimate claim of plagiarism could be made  It is the responsibility of researchers to make sure the information they present is a fair representation of the research they did There are many ways to clean up data or images, some of which are within the scope of what is acceptable and some of which are not Learners ought to determine those which might obscure or misrepresent ones research and those which present and accurate yet clarified account  The scientific process of reproducibility will identify mistakes, fabrication or falsification of data or analysis However this process alone should not be relied upon to identify research misconduct or irresponsible publication It is the responsibility of the individuals involved in the research to present accurate, timely and appropriate information to the scientific community Guiding principles:  Plagiarism is the copying of ideas, images, concepts or text without proper citation and/or paraphrasing An individual who commits plagiarism takes that which belongs to someone else and presents it as his own This is akin to theft  In addition to attribution, authors should be cited in ways that not distort their views or conclusions and which not indicate endorsement of a view they not hold However data can be cited to argue against an author’s original point UW BRI CASES | Mentor/Trainee Responsibilities | Page 103 UW BRI CASES | Mentor/Trainee Responsibilities | Page 104 UW BRI Cases a General Web Resources Institute of Medicine National Research Council Integrity in Scientific Research (2002): The National Academies Press, Washington, D.C http://www.nap.edu/books/0309084792/html/ International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals http://www.icmje.org/ National Academy of Sciences On Being a Scientist: Responsible Conduct of Research (1995): http://www.nap.edu/readingroom/books/obas/ National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report, 1979) http://ohrp.osophs.dhhs.gov/humansubjects/guidanc e/belmont.htm National Institutes of Health Grants Policy Statement (2001) http://grants1.nih.gov/grants/policy/nihgps_2001/nih gps_2001.pdf Office of Research Integrity Responsible Conduct of Research Instructional Resources http://ori.dhhs.gov/html/programs/instructresource.a sp ADDITIONAL WEB-BASED RCR PROGRAMS: Case Western Reserve University Online Ethics Center for Engineering and Science www.onlineethics.org Eastern Michigan State University Responsible Conduct in Research Instruction http://www.rcr.emich.edu/index.html Ethical Dilemmas in Research Integrity http://radio.weblogs.com/0116640/ UW BRI CASES | General Web Resources | Page Appendix University of California, San Diego Scientific Integrity: An Online Course in Responsible Conduct of Research http://ethics.ucsd.edu/courses/integrity/about.ht ml Vanderbilt University Responsible Conduct of Research and Certification Program http://bret.mc.vanderbilt.edu/rcr/asp_files/RCR_c ourse.asp UW BRI CASES | General Web Resources | Page Appendix UW BRI Cases b Appendix: Case Sources and Credits In developing this resource, we frequently began with cases from existing Responsible Conduct of Research educational materials to elicit discussion within focus groups Focus group participants suggested variations and modifications that often improved the realism or raised complexities in the case Other cases were contributed by members of our research team To assure appropriate attribution, we provide a listing of the original case sources below Faculty Guide PLANNING A RESEARCH STUDY Collaborative Science Case Multi-Site Research Collaboration Original case Case Continuation of a Previous Students Work Original case Conflict of Interest Case Conflict of Interest and Disclosure Submitted by Michael Corn, Director of Regulatory Guidance, University of Washington Case Multi-Institutional Involvement Original case Mentor Trainee Responsibilities Case Inappropriate Use of a Trainee’s Work? Case based on Advisor’s Ownership of Mentored Work http://radio.weblogs.com/0116640/stories/2002 /12/02/advisorsOwnershipOfMentoredWork.htm l Case Collaboration Original case UW BRI CASES | General Web Resources | Page Appendix UW BRI CASES | General Web Resources | Page Appendix UW BRI Cases b Appendix: Case Sources and Credits (continued) IMPLEMENTING A RESEARCH STUDY Animal Subjects Research Case If You Were an IACUC Committee Member Scenario a written by Gerald Schneider, http://www.onlineethics.org/ Scenario b, “A Question of Sacrifice” http://www.onlineethics.org/ Scenario c,“Unexpected Adverse Events” http://www.onlineethics.org/ Case Amending the Protocol? Adapted from a case by Francis L Macrina, Scientific Integrity: An Introductory Text with Cases, First Edition (American Society for Microbiology, 1995), p 128 Data Acquisition, Management, Sharing and Ownership Case Confidentiality and Data Access Case by Caroline Whitbeck, www.onlineethics.org Case Data Ownership Case adapted from “Rights to Mentored Research Concepts and Results,” http://radio.weblogs.com/0116640/stories/2002 /12/02/rightsToMentoredResearchConceptsAnd Results.html Human Subjects Research Case Informed Consent Original case Case Incentives and Coercion for Researchers Original case UW BRI CASES | General Web Resources | Page Appendix UW BRI CASES | General Web Resources | Page Appendix UW BRI Cases Appendix: Case Sources and Credits (continued) REPORTING RESEARCH RESULTS Peer Review Case A Problematic Site Visit Original case Case Peer Review of a Scientific Publication Case adapted from “Confidentiality of Material Being Reviewed,” http://radio.weblogs.com/0116640/stories/2002 /12/07/confidentialityOfMaterialBeingReviewed html Publication Practices and Responsible Authorship Case Who is an Author? Original case Case Data Clean Up and Publication Delay Based on the following cases found on www.onlineethics.com: Data Clean Up, Withholding or Misrepresentation of Data, Who is Where on the Author List? 10 Research Misconduct Case Expedience, Misrepresentation, or Falsification Case by Michael Kalichman, http://rcr.ucsd.edu/tools/cases/ucsd7.htm©200 The Regents of the University of California All Rights Reserved http://rcr.ucsd.edu Case Unintended Support by Way of Plagiarism Originally the Tony Blair Iraq Dossier news paper article (www.mirrorco.uk/news/allnews February 2003) changes made through UW BRI CASES | General Web Resources | Page Appendix meetings UW BRI CASES | General Web Resources | Page Appendix .. .University of Washington Biomedical Research Integrity Cases Teaching Cases & Background Materials ACKNOWLEDGEMENTS: This work was funded by a small contract from the Office of Research Integrity. .. authorship of scientific publications Resources: Grants Information Memorandum 10 of the University of Washington? ??s Significant Financial Interest Disclosure Policy http://www .washington. edu /research/ gcs/gim/gim10.html... conflicts of interest exist, other than financial considerations? Teaching Points:  The potential for conflicts of interest is a reality in the field of biomedical research  Conflicts of interest