CITI Developer Meeting Human Subjects Research October 23, 2009
CITI Worldwide Footprint 9-1-09 World wide n = 1324 International n = 65sites / 38 countries
CITI International • >1324 sites around the world • >65 international sites in 38 countries. (5%) • CITI Collaborating Centers • Develop sustainable CITI Programs for the international research community. • Latin America • Taiwan • Japan • Korea • India • Middle East • Canada
Multilanguage Course Site • Multi-language Course Site. 11-2007 • Updated in 2008 and 2009 to accommodate UTF-8 character sets. • Languages. • English • Spanish (NAID, FIC) • Portuguese (NAID, FIC) • Chinese • Japanese • French (NIAID) • Thai (US Army) • Russian (US Army) • Korean • Kartuli (FIC) • Arabic
CITI International Centers • CITI International Collaborating Centers • CITI - India Anil Sharma, MD • CITI - Korea - B.I. Chou Ph.D. • Caribbean/Latin America/South America – Sergio Litewka , MD • CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D. • CITI - Japan – Iekuni Ichikawa, MD • CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.
CITI India Anil Sharma MD
Initial Workshop • November 24,25,26 • SRU- Sri Ramachandra University • Prominent University in Chennai • More than 43,000 students • Has Medical, Pharmacy, Nursing and Dental Schools. • Affiliated with Harvard Medical International
Organizing Committee INDO - US WORKSHOP "PROMOTING RESEARCH ETHICS EDUCATION IN INDIA"Organized by Sri Ramachandra University, India andCITI Program, University of Miami, USANovember 24th to 26th 2009 http://srmc.edu/indo_us_2010/index.htm • Paul Braunschweiger • Mansoor Ahmed • Ram Agarwal • Anil Sharma • S.P. Thyagarajan • Melody Lin • Chiu Lin • Jerry Castellano
3 Day seminar • Researchers from Academia and industry are invited to discuss content development. • Over 100 researchers attending 3 day meeting. • Guest speakers include ICMR officials.
OHRP grant • We thank OHRP for their generous support to help start CITI India.
CITI International Centers • Update on Collaborations since October 2008– Paul Braunschweiger • CITI International Cooperative Centers • CITI - India Anil Sharma, MD • CITI - Korea - B.I. Chou Ph.D. • Caribbean/Latin America/South America – Sergio Litewka , MD • CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D. • CITI - Japan – Iekuni Ichikawa, MD • CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.
CITI-Korea B.I. Chou Ph.D.
Caribbean/Latin America/South America Sergio Litewka , MD
CITI - Taiwan Benjamin Kuo
HSP progress in Taiwan Benjamin I. Kuo, MD, DrPHCIP Secretariat, Joint Institutional Review Board
Future plan • Enhancement of CITI Chinese version to be more friendly for non-scientific IRB members. • Translation of Responsible Conduct Research (RCR) in CITI. • Set up of Humans Subject Protection Association in Taiwan (HuSPAT) – PRIM&R Taiwan version.
CITI - Japan Iekuni Ichikawa, MD
CITI – Canada Karen Arts, M.S.
CITI Developer Meeting Human Subjects Research October 23, 2009
Physiology Break 10:00 – 10:30
Course Updates HSR BioSafety International public access Lab Animal RCR Course.
Bio-Safety and Bio-SecurityBen Fontes, Yale University • Emergency Procedures • BBP • NIH rDNA Guidelines • Human gene transfer • Bio-security • Shipping* • Animal Biosafety • Select Agents, Bioterrorism Overview Lab acquired infections Risk Assessment Risk Management Work Practices PPE Engineering Controls Lab Design
Bio-safety and Bio-Security Course Reviewers • Eric Cook - Dartmouth U • Michael Spath - CUNY • Andy Cockburn - U. West Virginia • Marcia Finucane - U. Kentucky • Norma Epley - ECU • Jairo Betancourt - U of Miami • Paul Braunschweiger - U. Miami Reviews are due back to the office by 10-1-09. Course - ready for the PRIM&R meeting.
Bio-Safety and Bio-SecurityBen Fontes, Yale University • Emergency Procedures • BBP • NIH rDNA Guidelines • Human gene transfer • Bio-security • Shipping* • Animal Biosafety • Select Agents, Bioterrorism Reviews are due back to the office by 10-1-09. Course - ready for the PRIM&R meeting. Overview Lab acquired infections Risk Assessment Risk Management Work Practices PPE Engineering Controls Laboratory Design
International public access course • www.irbtrainining.org • Training for non-US collaborators on Us funded projects. • Developed in 2003-2004 through NIH funded “IRB enhancement grants” • Platform, translation tools and translations. • Materials in English, Spanish, Portuguese, Chinese and French languages • Move training database CITI platform
Lab Animal Welfare Course Mike Mann Ph.D.
Responsible Conduct of Research Course Paul Braunschweiger Ph.D. Funded by CITI and the ORI / DHHS.
CITI Program Content Library • RCR • Biomedical • Social and Behavioral Research* • Physical Sciences • Humanities* • Engineering • RCR and Science Administrators
New additions to the Program • The RCR with lab animals • Paul Braunschweiger Ph.D. • The RCR with human subjects. • Jason Borenstein Ph.D. • RC of scholarly activities in the humanities • Sharon Shriver Ph.D. • RCR in the social and behavioral sciences • Dan Vasgird Ph.D.
Content Editing • Hired a science and technology editor to resolve outstanding issues in the CITI RCR modules. • Comments regarding typos in the modules • Grammatical errors • Poor quiz question. • Deliver is November 14. • Reviewed and reconciled by December 1, 2009. • Implemented by 1-1-10
RCR Course Completion Reports (C.R.) awarded * 1-1-09 to 10-1-09, public access and institutional RCR set-ups * 86 new institutional RCR set-ups, 2009 10-1-09
RCR Course Completion Reports (C.R.) Awarded via The Public Access Portal. * 1-1-09 to 10-1-09
RCR Learner feedback RCR Satisfaction Survey
I believe that it is very important that the entire research team (PI, Investigators, staff, students and administrators) and not just the PI, should have a clear understanding of the responsible conduct of research, to insure that the data is collected and distributed with integrity and to the highest ethical standards. Strongly disagree strongly agree
Having completed the CITI Course in the Responsible Conduct of Research and gained a better understanding of how damaging research misconduct can be to students, to the institutions and to other investigators, I am now more likely to report a clear act of research misconduct to an appropriate person at my organization. Strongly disagree strongly agree
Rate the course. RCR L.A.W. Poor outstanding Poor outstanding H.S.P Poor outstanding
Research Survey Mentoring and Mentoring Experiences Participation in Human Subjects Research
New Modules Karen Hansen
Acknowledgements Karen, Paul, Sally and Susan
CITI Support Staff Not shown Pablo Velascelo and Ryan Roelans
The CITI HSR Program Contents Software updates Usage Learner Feedback
CITI Program Content Library • Human subjects • Biomedical • Community Member • ESCRO • Social and Behavioral • Good Clinical Practice • English • Spanish • Portuguese • Chinese • Thai • French, not posted. • HIPS
CITI Program Content Library • RCR • Biomedical • Social and Behavioral Research* • Physical Sciences • Humanities* • Engineering • RCR and Science Administrators • Bio-safety and Bio-security