BIO 591, Introduction to Research Ethics Fall 2009 Class meets for 10 weeks on Monday afternoons. 9/14/2009 - 11/23/2009 Time: 3:05PM - 4:20PM Location: Life Sciences A-wing, Room 119 One credit Dr. Karin Ellison karin.ellison@asu.edu LSC 270, 727-7111 Office hours: by appointment Course Description Have you wondered whether scientists who conduct research with animals should engage animal rights activists? Or, what sustainability means for your research? This course introduces students to the ethical and regulatory issues in the conduct of research. It covers the nine core areas of responsible conduct of research (RCR), as defined by the National Institutes of Health. The areas are: 1. 2. 3. 4. 5. 6. 7. 8. 9. Animal welfare Collaborative science Conflict of interest and commitment Data acquisition, management, sharing, and ownership Human subjects Mentor/trainee responsibilities Peer review Publication practices and responsible authorship Research misconduct In addition, students will explore the two topics that highlight the moral dilemmas and issues that collectively confront the scientific enterprise—sustainability and military funding of university research. Discussion of real and hypothetical cases will tie broad ethical considerations to current concern of scientists. Student Learning Objectives Students will develop their capacities in: Identifying ethical dilemmas in research Identifying norms, policies, and regulations that speak to those ethical dilemmas Using problem solving skills to generate and select options for action in the face of such dilemmas Assignments This is a hybrid online and classroom course. The assignments for this course are online readings and quizzes, nine one-page case analyses, attending class, and actively participating in class discussions. 1. Readings Reading materials, available through BlackBoard, must be completed before each class session so that discussion can draw on your knowledge of the readings. The majority of the materials come from the CITI (Collaborative Institutional Training Initiative) 2 Program. With the new NSF training requirements in RCR, the CITI Program is quickly becoming the most widely used source for introductory RCR information. Each CITI module has a quiz at the end. When you complete all the modules and pass all the quizzes, you be able to print a completion certificate. Your completion certificate will be due the last class session. 2. Case analyses In addition to introducing common ethical concerns and norms in the life sciences, this course aims to help students to develop their ability to reason through difficult situations with ethical dimensions. Towards this end, we will discuss numerous cases using a general approach commonly used in applied ethics. The approach consists of the following steps: 1. Indentifying the interested parties and their rights and moral obligations 2. Articulating relevant norms and standards, including regulations 3. Considering whether additional information would help you formulate a response to the situation and, if so, determining how to obtain the information 4. Determining whether the situation poses one or more ethical dilemmas 5. Recognizing desired outcomes 6. Generating options for action 7. Projecting consequences of potential actions For a fuller description of case analysis, see the article by Elizabeth Heitman posted on BlackBoard. Students will submit nine one-page partial analyses of cases. For each session in which an analysis is due, students will be given a case to consider and one of the seven aspects of case analysis listed above to discuss. The course schedule gives the case and step to discuss for each assignment. Students should submit the one-page discussion via BlackBoard before the class session in which the assignment is due. Evaluation and the Fine Print I will generally calculate grades for this course as follows: a. b. c. d. e. Attendance and thoughtful contributions to class discussion: 150 pts (15 pts/session) CITI RCR Curriculum Completion Report: 120 pts (15 pts/module) Dual Use Dilemma module completion certificate: 15 pts Protecting Human Research Participants completion certificate: 15 pts Case analyses: 135 pts (15 pts/assignment) I calculate course grades using a 15-point scale. I will convert your point total to the scale below. I reserve the right to assign any student a final grade that is higher than merited by strict calculation based on academic criteria, such as improvement in grades over the semester or atypical and explainable poor performance on a single assignment. A A- 15 14 3 B+ B BC+ C D E 12 11 10 8 7 3 0 I only accept late assignments in rare circumstances. These include professional conflicts, major and documented illnesses, personal or family crises, etc. Should any of these arise, you are responsible for discussing the circumstances with me ASAP, before you miss a deadline if at all possible. Disabilities If you have a significant disability condition (e.g., physical, learning, psychiatric, vision, hearing, etc.) and want to arrange reasonable accommodations, you must contact me at the beginning of the course. Academic Integrity Under the ASU Student Academic Integrity Policy (http://provost.asu.edu/academicintegrity), “[e]ach student must act with honesty and integrity, and must respect the rights of others in carrying out all academic assignments.” This policy also defines academic dishonesty and sets a process for faculty members and colleges to sanction dishonesty. Violations of this policy fall into five broad areas that include but are not limited to: 1. 2. 3. 4. 5. Cheating on an academic evaluation or assignment Plagiarizing Academic deceit, such as fabricating data or information Aiding Academic Integrity Policy violations and inappropriately collaborating Falsifying academic records I welcome any questions you may have concerning academic integrity and will do my best to help you understand the standards of academic scholarship. I also sanction any incidents of academic dishonesty in my courses using University and CLAS guidelines. 4 Case Analysis Due Date 9/14/09 9/21/09 9/28/09 10/5/09 Topic(s) Plagiarism, Evaluation pre-test Approaches to the Ethics of Scientific Research Misconduct, Responding to Problems Data Management 10/12/09 Authorship, Peer Review 10/19/09 Sustainability 10/26/09 Mentors and Trainees, Collaboration in Research 11/2/09 Conflicts of Interest 11/9/09 Science and the Military 11/16/09 Animal Subjects 11/23/09 Human Subjects, Evaluation post-test Reading Case None None Analysis step to discuss None Resnik, "Standards of Ethical Conduct." Greenwood, "Attributes of a Profession." Moral Reasoning in Scientific Research: The Charlie West Case. 1. Interested parties CITI Module: Biomedical Research Misconduct, Gunsalus, "How to Blow the Whistle." CITI Module: Data Acquisition and Management - Biomedical. CITI: Case Study - Truth or Consequences Biomedical. 2. Norms and standards CITI: Research subjects' potential ownership of cell lines and DNA. (The link is the data module under "The Bayh-Dole Act of 1980.") 3. Additional information CITI Module: Responsible Authorship and Publication - Biomedical. CITI Module: Responsible Peer Review - Biomedical. Raven, "Science, Sustainability, and the Human Prospect." Salamanca-Buentello, "Nanotechnology and the Developing World." Farrell, "Sustainability and the Design of Knowledge Tools." CITI Module: Responsible Mentoring. CITI Module: Responsible Conduct of Collaborative Science Module – Biomedical. CITI: Introductory Video Case: "It Is Great to See Your Name In Print." (The link is in the authorship module.) Chang, "In Study, Researchers Find Nanotubes May Pose Health Risks Similar to Asbestos." Sanderson, “Migrating Nanotubes.” 4. Ethical dilemmas CITI: Mentoring Case Study: The Graduate Student Laborer. 6. Options CITI Module: Biomedical Science Conflicts of Interest and Commitment Module. Online Training in Ethical and Legal Issues in Biological Research, The Dual-Use Dilemma in Biological Research. Goolsby, “Ethics and Defense Agency Funding.” CITI Module: Conducting Research With Laboratory Animals. CITI: CoI -The Case of the Entrepreneurial Clinician -biomedical. Pollack, "Scientists Create a Live Polio Virus." 7. Consequences 2. Norms and standards The Gladiator Sparrow, www.onlineethics.org/CMS/2963/rescases/gra dres/gradresv4/gladiator.aspx None 4. Ethical dilemmas NIH, "Protection Human Research Participants." 5. Desired outcomes None