1. CITI RCR Developer Meeting October 4, 2007 Seattle, Washington 10-04-07

2. CITI RCR Agenda Welcome and IntroductionsWelcome and Introductions –Paul Braunschweiger Ph.D. CITI Course Site Update.CITI Course Site Update. –Paul Braunschweiger Ph.D., Mike Fallon DVM Daniel Vallero, Ph.D - Duke UniversityDaniel Vallero, Ph.D - Duke University –“Beyond RCR: New Pedagogies to Address Macroethics of Emerging Technologies” RCR for EngineersRCR for Engineers –Jason Borenstein Ga. Tech University The LANGURE ProjectThe LANGURE Project –Gary Comstock, Ph.D. N.C. State University International RCR.International RCR. –Nick Steneck, Ph.D. and Sergio Litewka MD-. CITI Lab Animal Welfare Program.CITI Lab Animal Welfare Program. –Mike Mann, Ph.D. – Breakout Groups – Group Leaders.Breakout Groups – Group Leaders. New initiatives and future directions.New initiatives and future directions. –Dan Vasgird Ph.D. Univeraity of nebraska Conclusions and AdjournmentConclusions and Adjournment

3. CITI RCR Program Meeting Welcome and Introductions

4. 21st Century Competitiveness Act. August 2007 Title VII, National Science Foundation –Title VII, National Science Foundation – –SEC. 7008. POSTDOCTORAL RESEARCH FELLOWS. (a) Mentoring.--The Director shall require that all grant applications that include funding to support postdoctoral researchers include a description of the mentoring activities that will be provided for such individuals………. Mentoring activities may include career counseling, training in preparing grant applications, guidance on ways to improve teaching skills, and training in research ethics.(a) Mentoring.--The Director shall require that all grant applications that include funding to support postdoctoral researchers include a description of the mentoring activities that will be provided for such individuals………. Mentoring activities may include career counseling, training in preparing grant applications, guidance on ways to improve teaching skills, and training in research ethics. –SEC. 7009. RESPONSIBLE CONDUCT OF RESEARCH Grant proposal must have a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students and postdoctoral researchers participating in the proposed research project.Grant proposal must have a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students and postdoctoral researchers participating in the proposed research project.

5. CITI RCR Program Meeting CITI Program Update

6. CITI Administration 4+ FTE in the Office4+ FTE in the Office –Adiper Santos – Office Manager –Marcos Souza - Help Desk Technician –Eddie Menjivar - Help Desk Technician –Regina Smith - Help Desk Technician –Chris Simmons – Programmer (40%) –2 TBN - Help Desk Technician (October 2006)

7. Monthly Site Usage CITI Monthly Activities 0 5,000 10,000 15,000 20,000 25,000 30,000 May August November February May August November February May August November February Registrants and Course Completions May August November 2004 2007 35,000

8. RCR course site update 831 participating institutions (650)831 participating institutions (650) 100 new institutions since the Miami meeting.100 new institutions since the Miami meeting. Learners from >322 organizations have used the P.A. RCR course.Learners from >322 organizations have used the P.A. RCR course. 13,698 completed at least 1 RCR module13,698 completed at least 1 RCR module –PA - 7279 –Member - 6419 RCR Course Completion ReportsRCR Course Completion Reports –1973 public access site 1248 public access site since Miami Meeting.1248 public access site since Miami Meeting. –2049 CITI member institutions

9. CITI Course Completions 4-1-07 to 10-1-07 HSR Basic and Refresher Courses128,523 Lab Animal Welfare 5,926 RCR~2,700 Good Clinical Practice2,074 HIPS762 Total140,005 Completed Courses

10. Top 10 RCR Course Site User CITI Member Organizations Purdue University 318 Ohio State University 215 Children's National Medical Center 185 Clemson University 167 University of Miami 149 AIDS Clinical Trials Group (ACTG) 108 Translational Genomics Research Institute 92 Medical College of Georgia 59 Medical University of South Carolina 49 Grand Canyon University 47 Organization CRs

11. RCR P. A. Site Registrations since 4-1-07 N=3361 N=7279 since 1-1-07

12. RCR Course Completions Public Access Course N=1983 completions Completion since 4-1-07 = 1243 Completion before 4-1-07 = 740

13. N=215

14. Review of the embedded case studies. A few cases.A few cases.40% None of the cases.None of the cases.24% At least one case per module.At least one case per module.21% All of the cases.All of the cases.13% The cases, were un-interesting or not helpful.The cases, were un-interesting or not helpful.2% N=214

15. Review of the video presentations? All of the video presentations reviewedAll of the video presentations reviewed6% A few of the videos, they were very helpful.A few of the videos, they were very helpful.17% Viewed some of the videos, but, they were not very helpful.Viewed some of the videos, but, they were not very helpful.11% Didn't review any of the videos.Didn't review any of the videos.66% N=218

16. I plan to take a more active role in promoting ethical research practices by : I intend to do little more than I am currently doing.I intend to do little more than I am currently doing.33% Becoming a mentor to a student or young faculty memberBecoming a mentor to a student or young faculty member21% Attending more ethics related seminarsAttending more ethics related seminars18% Encouraging my institution to adopt a formal RCR education requirement for students and facultyEncouraging my institution to adopt a formal RCR education requirement for students and faculty11% Taking an advanced research ethics courseTaking an advanced research ethics course10% Adding a research Ethics module to a course I teachAdding a research Ethics module to a course I teach8% N=213

17. n=211 7%

18. Course Site Improvements

19. CITI Administration Server CapacityServer Capacity –Server and Software consultants analyzed the configuration and code. 2 New web servers added for load balancing. –Several server and software modifications since 5-07. Update ASP version.Update ASP version. Code optimization..Code optimization.. –>1100 concurrent users. 2000 concurrent users2000 concurrent users Safety limitation is 1500.Safety limitation is 1500. –2 nd Database server added for back-up.

20. Site Improvements New Features LearnerNew Features Learner –New Home Page –Login process streamlined. –Learner Menu Updated, Info Buttons Optional and Elective modules less confusing.Optional and Elective modules less confusing. Changes in display of completed modulesChanges in display of completed modules New Features coordinatorNew Features coordinator –Reports structure –Completion report data by time and group –Completion reports that will soon expire –Download links that can be used with protocol management software. Features yet to implemented.Features yet to implemented. –Suite of quiz utilities. Pool of questions –Non-English language templates. –Update enrollment question process. –FAQ search engine –Portal system access and User verification

21. CITI NEWSLETTER

22. CITI Software Updates Michael Fallon DVM

23. “Beyond RCR: New Pedagogies to Address Macroethics of Emerging Technologies” Daniel Vallero, Ph.D Duke University

24. RCR for Engineers Jason Borenstein Georgia Tech. University

25. The LANGURE Project Gary Comstock, Ph.D. North Carolina State University

26. International Initiatives in the RCR Nick Steneck Ph.D. Sergio Litewka MD

27. Lab Animal Welfare Program Michael Mann Ph.D.

28. CITI RCR Working Group Leaders Research MisconductResearch Misconduct –Marianne Elliott Data Acquisition and ManagementData Acquisition and Management –Reid Cushman Ph.D. Authorship and Peer ReviewAuthorship and Peer Review –Ken Goodman Ph.D. Conflict of InterestConflict of Interest –Ruth Fischbach Ph.D. Collaborative ResearchCollaborative Research –Paul Braunschweiger Ph.D.

29. Agenda for breakout sessionsAgenda for breakout sessions –Review comments from the user survey –Review text –Review and edit quiz questions. –Review case studies –Review new public access materials available. RCR Course Update Collaborative Science

30. CITI RCR Program Meeting “Working Group Breakout Sessions”

31. Breakout Group Assignments

33. Agenda for breakout sessionsAgenda for breakout sessions –Review comments from the user survey –Review text –Review and edit quiz questions. –Review case studies –Review new public access materials available. RCR Course Update Collaborative Science

34. Current Treatment of the topicCurrent Treatment of the topic –Introduction From Introduction to The Responsible Conduct of Research by Nick SteneckFrom Introduction to The Responsible Conduct of Research by Nick Steneck –5 versions of the module Biomedical, SBR, Physical Science, Humanities, GenericBiomedical, SBR, Physical Science, Humanities, Generic Materials from the Columbia U site and from NIU.Materials from the Columbia U site and from NIU. –5 Case studies. Collaborations Between InvestigatorsCollaborations Between Investigators Why Can’t We All Just Get AlongWhy Can’t We All Just Get Along When Collaborators Become CompetitorsWhen Collaborators Become Competitors Marriage Has It’s AdvantagesMarriage Has It’s Advantages When Collaborators DisagreeWhen Collaborators Disagree

36. The Future of RCR CITI Program Dan Vasgird Ph.D.

37. Meeting Summary Paul Braunschweiger