1. Boston University RCR Program Creating a Single University-wide RCR Program, Across Two Campuses, based on Case Study Discussions Facilitated by Faculty Mentors Susan H. Frey, M.A.T, J.D. Assistant Provost for Research Compliance Boston University 85 E. Newton Street M840-B Boston University Medical Campus Boston, MA 02118 sfrey@bu.edu http://www.bu.edu/orc/rcr/

2. Outline Single Advanced RCR Program-Two campuses 2 - 5 RCR Partnership: Compliance and Faculty 6 - 11 Core Program Format 12 Alternative Program 13 Core Program Curriculum 14-18 Core Program Package for Participants 19 -21 Core Program Facilitators 22 - 23 Core Program Evaluation 24 Core Program Data 25 Challenges Ahead 26 2

3. Boston University Advanced RCR: a single program Commenced in current form on “Main” campus in 2004 2006 extended across two campuses-MED and “Main” Open to all doctoral students and postdoctoral researchers In all sciences and engineering Mandatory for individuals covered by NIH and NSF RCR requirements Cross campus registration-shuttle bus. 3

4. Boston University Facts 20 Schools and Colleges across two campuses (two miles apart-shuttle bus) At least 300 doctoral degrees awarded annually in the sciences (physical, biological, social, economic, behavioral) and engineering At least 100 new postdocs enter per year in basic science and engineering Advanced RCR – Target Audience (excluding masters candidates) about 400 – Current attendance (graduate students and postdoctoral fellows) is 200-250 4

5. Why a Single Program? Cross campus program builds community of integrity Quality of the program can be monitored and improved for the whole university Interdisciplinary audience ensures:  emphasis on general standards of responsible conduct common to all fields of science and engineering 5

6. RCR: A Compliance-Faculty Instructional Partnership Partnership of skills and expertise content areas 6

7. Nature of RCR RCR is a government initiated program not required to be part of academic curriculum RCR seeks to orient investigators to the concerns and expectations of the government and public about science Topics developed by NIH working with scientists, ethicists and social scientists and government RCR curriculum needs input from Compliance Officers as well as faculty. 7

8. Partnership of Content Areas RCR Topics involve both professional ethics of science and governmental regulation and law, e.g.: – Data recording involves Responsibility of scientists to create reproducible scientific literature based on peer review, integrity Responsibility of government and university to protect patentable inventions under law 8

9. Partnership of Skills and Expertise Teaching/mentoring skill and science knowledge -- faculty in science and engineering Institutional compliance experience -- administrative leaders – Compliance officers – Institutional lawyers – Research deans – Ombuds Other expertise -- faculty in ethics, sociology of professions, research public policy, etc. 9

10. Partnership in Oversight/Leadership Office of Research Compliance –Assistant Provost Frey RCR Education Advisory Committee – 11 Liaison Members – faculty appointed by deans to liaise with 11 participating schools and colleges of the University – 6 additional members from the faculty appointed to provide expertise in RCR education and regulation and to serve on RCR compliance subcommittee 10

11. RCR Challenges in the University Culture Tension between NIH and NSF  (NSF has not endorsed NIH/CITI RCR topics or requirements ) Echoes tension between culture of Arts and Sciences and Medicine and other professions  (Academic freedom concerns  Comfort with professional regulation) 11

12. BU Core Advanced RCR Program Includes 4 two-hour live workshops  Led by the administrative leader with a faculty co-leader  Each workshop is offered four times per year  All 4 workshops to be completed over not more than two years in any sequence. Workshop participants discuss two case studies  in small groups (5-8)  facilitated by faculty and postdoctoral researchers. 12

13. Alternative RCR at BU The RCREAC has established minimum guidelines for approval of Alternative Advanced RCR Programs  All RCR Topics; Use of cases ; at least 8 live hours  Proposals are reviewed for RCR content and method Currently two Alternative RCR Programs  Chemistry 2-credit course in professional skills  Computer science 2-credit course in professional skills plus attendance at RCR core workshop 4 13

14. Jisi Tang (GRS’14, ENG’14) (from left), Assaf Kfoury, a CAS computer science professor, Susan Frey, an assistant provost, and Karina Stavitsky (GRS’12) discuss ethics in research at a Responsible Conduct of Research program session. Photo by Kalman Zabarsky BU Core Advanced RCR 14

15. “Workshop1: “Creating the Research Record and Managing Data: How and Why” This unit explores data acquisition, data recording, data management, and data presentation. The case studies will involve ethical dilemmas that may arise (in any field of research) when planning for and creating a proper scientific record and selecting data for presentation. Workshop 2: "Research Collaborations. Sharing, ethics, collegiality and agreements“ This unit explores collaborative work, data sharing, scientific interactions, resource sharing, authorship, mentorship, proprietary data, collaborations between academia and industry. Workshop 3: "Publication: What, When, Why, How, by Whom“ This unit explores the duty to publish and the multiple responsibilities of authorship, who should be an author, and peer review. Workshop 4: "Objectivity in Research: Oversight of Conflicts of Interest and Scientific Misconduct“ This unit explores institutional procedures related to (1) reporting of "scientific misconduct" and (2) managing conflicts of interest affecting research that may arise when University researchers have financial interests that may be affected by their research. 15

16. Boston University Advanced RCR Program Mentor / Trainee Respons ibilities Data Manage ment and Ownersh ip Publication and Authorship Peer Review Collaborati ve Science and Data Sharing Research Misconduct Conflict of Interest and Conflict of Commitmen t Workshop 1: Creating the research record and managing data xx xx Workshop 2: Research collaborations: ethics, collegiality and agreements xx xx x Workshop 3: Publication: What, When, How, By Whom? xxxx x Workshop 4: Objectivity in research: Oversight of Conflicts of Interest and Research Misconduct xxx xx 16

17. Participant’s Preparatory Reading Program Preparation materials: Online Power Point (One hour)  Required quiz  links to additional resources Workshop preparation materials  required readings (but no test, except through participation in discussion)  online CITI modules recommended, particularly in diverse languages 17

18. Workshop Roles Large group: Co-leaders include Assistant Provost and a Faculty Member Discussion groups: – Individuals pre-assigned to assure variety of levels and disciplines – Each discussion group has  Facilitator  Recorder  Spokesperson 18

19. Workshop Participant Package RCR Program Welcome Agenda Workshop Discussion Guide Case studies (2) Flip chart for Summary  Case recommendations  Gray areas and unresolved questions for large group 19

20. Welcome General Information including: “Among the resources available to you in our community, for help with ethical issues relating to integrity in science, are: Your mentor, thesis advisor, thesis committee RCR Discussion Facilitators and Leaders The responsible Principal Investigator on a research project The Chairman or Center Director of the PI (if PI is unresponsive) The Dean or Associate Dean for Research (if chair is unresponsive) Also, available for confidential or anonymous help: The Assistant Provost for Research Compliance (Susan Frey, sfrey@bu.edu) The Ombuds for Boston University (Francine Montemurro, fmonte@bu.edu The BU Reporting Hotline (URL)” 20

21. Workshop : Small Group Discussion Guideline Key Principles of Responsibility List of Key Principles about Workshop Content Areas [A list of about 6 key principles of ethical conduct, e.g., Research collaborators should seek clear agreements about collaborative expectations before starting to collaborate; All those listed as a authors should have made a substantial intellectual contribution to the work; etc.] Discussion Group Goals Apply these and other ethical principals, learned from your reading and experience, to the case studies. Experience the challenges of applying these principles. Seek group consensus through participation of all members on recommendations for responsible conduct by key characters in the case studies, and other persons in the institution or scientific community who may be involved. Seek expanded awareness of the reasons why your recommendations are important to the individuals involved, the scientific community and other possible stakeholders such as sponsors, insitutions and journals. Work Products of Discussion Groups Case study 2-1: On Flip Chart Record – The Group’s consensus recommendations for conduct of key characters and why; and – A Challenging Question that your Group would like to pose to the large group about the case study or the topic of collaboration. Case study 2-2: On Flip Chart Record any agreements reached in your role-play negotiation and why. 21

22. Facilitator Preparation Facilitators receive case commentary (not given to participants) Facilitators are prepared by the RCR administrative leader 1 hour before workshop; attention to inclusiveness and participation; review of case analysis themes and case commentary. Since 2004, over 400 faculty mentors, from departments and centers as diverse as economics, bioinformatics, medicine, astronomy, applied linguistics, computer sciences, earth sciences, physical therapy, and many others, have been oriented and credited with service as discussion facilitators in Advanced RCR 22

23. Facilitator Recruitment RCREAC Liaison members request department chairs to recruit facilitators based on past participation of trainees from the department; personal touch needed RCR Compliance Coordinator tracks facilitator registration (beating the bushes) Department chairs are copied on thank you notes and requested to recognize the importance of facilitator service to the University 23

24. Program Evaluation Anecdotal and positive feedback: Surveys to participants Surveys to facilitators Observation of discussion Summary reports from discussion 24

25. Advanced RCR Projections 2011-12Annual Workshop Occasions Annual Totals Key Schools in Core Program Alternative RCR Programs Workshops 1, 2, 3 & 4 4 for each workshop 16 occasions per year Participants65 average per occasion 260 total in program GSAS: 70; MED: 65; ENG: 65; SPH: 30 Other: 30 Chemistry course: 25; Computer Science course: 15 Facilitator slots to fill; (3 hr. slot) 7 average slots per occasion 7 X 16= 112 slots per program year GSAS: 30; MED: 30; ENG: 30; SPH: 15 Other: 10 Course faculty for a full semester 1- or 2-credit course 25

26. Program Growth Since 2004, we have experienced continuous program growth, building from physical and biological sciences into behavioral and social sciences Challenges ahead  NSF requirements and greater extension of RCR to GSCAS o Academic culture o Numbers o Masters candidates 26