IBMS 500 On Being a Professional Scientist: The Responsible Conduct of Research Meeting Times: Fridays 2-3:30, each meeting begins in lecture hall, then moves to small group room. Meeting Locations: Lectures will take place in the School of Nursing NOA 31A (Lower Level) This lecture will last from approximately 2:00-2:40. Students will be given 10 minutes to walk to the small group rooms and the small groups will take place from 2:50-3:30. Lecture Discussions School of Nursing – Lower Lever - 31A Small groups A: T501 B: T503 C: E739 Neuroscience Conf Room D: BRB 732 E: W-331 F: BRB 1033 Course Directors: Tracy Wilson-Holden, Office of Research Administration, tjw18@case.edu, 368-6131 Description: The life of a professional scientist is complicated, and it is not always easy to know how to "do the right thing" with respect to one's data, one's colleagues, and one's subjects. Scientific moral uncertainty, far from being the sign of a character flaw, is increasingly the sign of a conscientious research professional struggling to give proper priority to many competing demands. Responsible conduct of research is an essential component of research training. Active involvement in the issues of responsible conduct of research should occur throughout a scientist’s career. Instruction in responsible conduct of research should therefore be appropriate to the career stage of the individuals receiving training. We assume that instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. The goal of this course is to introduce new biomedical graduate students to a variety of research ethics topics through lectures and small group case vignettes led by professional scientists and ethicists. The course seeks to highlight research issues for individual exploration and leadership, rather than place students within a set of “rules” or cultivate an atmosphere of suspicion. Students will be brought up to date on the current state of professional policy and federal regulation regarding research, and, through the case studies, will discuss practical strategies for preventing and resolving ethical problems in their own work. Students will be introduced to the resources within the Case Western Reserve University system regarding scientific integrity and compliance. This is a required introductory course for School of Medicine biomedical graduate students based on basic issues involved in the responsible conduct of research, that are often built upon in follow-on activities within training programs. Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden 1 After completing this course, students will be aware of key issues in responsible conduct of research, local resources for reporting and compliance queries, and have some experience applying relevant professional norms and ethical principles in their scientific research. Required Text: Scientific Integrity by Francis L. Macrina, Third Edition. Students must be able to bring the text to class. The text can be purchased at the CWRU bookstore, Amazon, or check whether your program has made copies available for your use. Some copies are available in the HSLibrary. In each case, students and facilitators should have completed the indicated Assignments section before each class meeting and be prepared for discussion. Additional required materials will be posted in Blackboard Participant Expectations: Students and facilitators are expected to prepare in advance for the small groups. In general, this means attending the lecture, and obtaining and completing the assignments and bringing those materials to class for reference. Most materials can be accessed through Blackboard, and textbooks may be purchased at the Campus Bookstore or through Amazon. Small group discussions often begin with introductions among the facilitator and students, and general questions about student experiences with the day's topic (i.e. what did you think of Dr. X's comment in lecture? Have you had an experience with publications you would like to share? Do you use electronic notebooks? etc). These questions often generate great interest for discussion. The facilitator is not to feel he/she must be an expert on a subject, but should feel free also to share experiences and perspectives while promoting student conversation. The conversation may go on to a review of discussion questions, and selection of particular cases to read aloud and discuss. Facilitators are asked to identify any students who have not done the assignment, or who do not contribute to discussion. Grade: Attendance is required at all classes to receive credit for the course. Students will be expected to sign in at the beginning of each lecture and at the start of small group case discussions. Attendance and participation are mandatory. Anyone not signing in to three or more of the activities will receive a “No Pass” grade. Opportunities for any make-up activities for excused absences must be communicated to the course director and completed before the end of the semester. All assignments must be completed and emailed to tjw18@case.edu by APRIL 29th - no exceptions will be granted. Session Outline and Activities: 1: January 16, 2015: Introduction to IBMS & Defining Scientific Integrity, Tracy Wilson-Holden In this session, we will discuss the need for a program on Research Ethics and Regulation. We will review a history of research abuses and discuss the development of the research oversight system, focusing on how IBMS fits into the rest of your research ethics curriculum within Case Western Reserve University, your program, and federal funding agencies…this is only the beginning! We will review logistics of the course, blackboard, and introduce the idea of training in the responsible conduct of research. 2 Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden 2. January 23, 2015: Mentorship, Sana Loue What should you expect from a graduate mentor? From yourself? How is a mentor different from a boss or a friend? How do you manage mentoring relationships, and whose advice do you seek? Assignment: Chapter 3 Macrina pp 39-55, Small group discussion: Begin with a discussion of why we still struggle with ethics as a research community and how to “calibrate” your own ethics in practice. Mentorship: Macrina Discussion questions p55, Case Studies 3.2, 3.4, 3.7, 3.9, 3.10 3. January 30, 2015: Live Animal Subjects, Ron Conlon In this session, we will give an introduction to animal research oversight, including the Animal Research Laboratory and the IACUC as well as a comprehensive review of the federal policies applying to live vertebrate animal subjects and safe laboratory practices. Assignment: Browse Chapter 6 Macrina (pgs. 128-147), read the Nature article at http://www.nature.com/news/report-slams-university-s-animal-research-1.14329 and watch the Youtube video at http://youtu.be/DSjBNcwqlZI (This video is graphic and can be disturbing to watch, please come prepared to discuss your reactions and thoughts.) Small group discussion: Chapter 6 Macrina pp 148-152 Use of Animals: Holding to a higher standard than Mother Nature; Human treatment of animals: Rushing to get results; Minimizing harm: How much doubt is enough to raise an objection? 4. February 6, 2015: Data management, Noa Noy Why we keep records? What are data and who owns them? How do you keep a laboratory notebookwhat’s in, what’s not? What is an electronic laboratory notebook? What can you take with you, what remains at CWRU? Assignment: Chapter 11 Macrina; sample lab notebook pages, for critique Small group discussion: Questions and Cases at the end of Chapter 11: 11.1, 11.4, 11.6 and 11.8 5. February 13, 2015: Research Misconduct and Policies, Tracy Wilson-Holden In this session, we will discuss the official definition of scientific misconduct: fabrication, falsification, plagiarism. We will review CWRU policies for responsible conduct of research, and provide examples of when and how things get off track. The Office of Research Administration and other campus resources and procedures will also be discussed. Assignment: Read p 8-16 Macrina and additional articles in blackboard. See also the online tool on image manipulation http://ori.hhs.gov/education/products/RIandImages/default.html Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden 3 Small group discussion: "Truth and Consequences," "Familiar Words," and "Doctor Falsifies" (Found on Blackboard) 6. February 20, 2015: Commercialization and Intellectual Property, Steve Behm We will discuss the impact of the Bayh Dole Act in 1980 and the unique set of issues that arise when researchers collaborate with industry sponsors. Issues regarding data ownership and the rights of graduate students regarding their work will also be covered. We will also cover the history of commercialization in research, industry sponsorship and collaborations and data acquisition and laboratory tools, including management, ownership and control over materials. Assignment: Macrina Chapter 9 Small Group Discussion: TBA 7. February 27, 2015: Safe laboratory practices: Mary Ellen Scott, PhD Why do we do safety training at CWRU, how are incidents reported to community and to CWRU? What is OSHA? Who should we contact if we have concerns? The Mission statement of EHS, the Chain of Responsibility and what happens when the Chain Breaks. Assignment: Macrina pg 387-391 Taken for Granted: The Burning Question of Laboratory Safety http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2009_05_01/caredit.a0 900054 Keeping Safe: Some Cautionary Tales http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2006_08_04/noDOI.92 80662141629900561 Small group discussion: Who is responsible for making sure PPE is worn? If you have a member of your laboratory that refuses to follow rules what should you do? If your Primary Investigator asks you to perform a procedure that is unsafe what should you do? What is the difference between negligence and a willful act? How does this affect the UCLA ruling? Negligence? How do these factors affect the UCLA case, the Dartmouth Case? 8. March 6, 2015: Spring Break, no class 9. March 13, 2015: Spring Break, no class 10. March 20, 2015: Responsible authorship and publication and peer review, Nicole Deming Who is first author? How much work must you do to be on a paper? Do you have to know the whole paper? Who decides? What does a journal mean by open-access? Do you really have to share materials? When do I need copyright release on my own paper (see CWRU ETD guidelines) What if my PI asks me to review a paper he got from a journal? What if I see a problem? What’s confidential in peer review? Assignment: read Chapter 4 in the Macrina text: pgs 61-73 and consider the following questions: How do we decide who is first author? How much work must you do to be on a paper? Do you have to know Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden 4 the whole paper? Who decides? What does a journal mean by open-access? Do you really have to share materials? When do I need copyright release on my own paper (see CWRU ETD guidelines) Small group discussions: Macrina: Discussion Questions 2-4 on pg 84 and cases from 84-89. 11. March 27, 2015: Conflict of interests – personal, professional, and financial. Richard Cole What is a conflict of interest? How is that different than a conflict of effort? How researchers manage competing interests. CWRU institutional policies and procedures for COI reporting, oversight and management. What is a sponsored project, what is pre-award, post-award Assignment: Macrina Ch 7 Small group discussions Macrina Ch 7, p 181-184 12. April 3, 2015: Human Subjects: IRBs, Tissue and Databank Research, Phil Cola Introduction to basic framework of human subjects research regulation Application of regulation to human tissue research; Large scale databank research, besides tissue research; What is HIPAA Assignment: Chapter 5 Macrina Small group discussions Macrina Ch 5 114-119 (Discuss the Declaration of Helsinki that follows if time permits) 13. April 10, 2015: Collaborative Research, Mark Chance In this session we will discuss the vision of research at CWRU School of Medicine. How do we find collaborators and build effective teams? How do we best use institutional core facilities and who gets “credit” from collaborative research? Assignment: Chapter 8 Macrina Small group discussion: Macrina Case studies 8.1, 8.4, 8.6, 8.8, 8.10 12. April 17, 2015: Self Promotion in Science and Social Media, Research ShowCASE Instead of holding class this week, students will be required to participate in or attend Case Western Reserve University’s event, Research ShowCASE in the Veale Convocation Center, between 9 am and 3 pm. Students will be required to spend time reviewing scientific posters and talking with presenters to get a sense of how best one can promote his or her science to others who may not have knowledge of the work. Location of a sign in sheet will be announced in class prior to the event, and students are expected to spend class time there. 13: April 26: The scientist as a responsible member of society, Tracy Wilson-Holden Contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research. what responsibilities do I have regarding future education on research and how will I meet these expectations? When am I done learning about ethics? Small Group: You will discuss the article The State of State Science (pages 1-7) and posted discussion 5 Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden questions. You may also discuss any of the following questions; What RCR topics need to be covered in more detail regarding my field? How often should RCR be given/mandated while in your program? For new investigators? For experienced investigators? Please create a proposal for the next level of RCR answering the following questions: - What topics should be covered? - Who should be required/invited to take this training? - How do we create something that is relevant and specific to different labs and areas of research? - What are the main challenges? - Who should be responsible for creating these courses? Course Evaluation will be emailed to students (prior to the end of the course). Case Western Reserve University | IBMS 500 Spring 2015, Wilson-Holden 6