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

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.

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

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

6

RCR: A Compliance-Faculty Instructional Partnership

Partnership of• skills and expertise• content areas

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.

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

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.

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

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)

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.

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

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

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.

16

Boston University Advanced RCR Program

Mentor/Trainee Responsibilities

Data Management and Ownership

Publication and Authorship

Peer Review

Collaborative Science and Data Sharing

Research Misconduct

Conflict of Interest and Conflict of Commitment

Workshop 1: Creating the research record and managing data

x x x x

Workshop 2: Research collaborations: ethics, collegiality and agreements

x x x x x

Workshop 3: Publication: What, When, How, By Whom?

x x x x x

Workshop 4: Objectivity in research: Oversight of Conflicts of Interest and Research Misconduct

x x x x x

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

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

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

20

WelcomeGeneral 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)”

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.

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

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

24

Program Evaluation

Anecdotal and positive feedback:• Surveys to participants • Surveys to facilitators• Observation of discussion• Summary reports from discussion

25

Advanced RCR Projections2011-12 Annual

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

Participants 65 average per occasion

260 total in program

GSAS: 70; MED: 65; ENG: 65; SPH: 30Other: 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: 15Other: 10

Course faculty for a full semester 1- or 2-credit course

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

oAcademic cultureoNumbersoMasters candidates