5. TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH IN THE UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (CTSI) K PROGRAM Recent NIH policy (NIH NOT-OD-10-019) requires that training in responsible conduct of research be an integral part of all research training, that trainees are actively involved at a level appropriate to their career stage, and that research faculty participate in training. To address these requirements, the University of California, San Francisco (UCSF) has designed the program described below for early stage faculty holding NIH Career Development Awards. The program includes UCSF faculty designed online instruction in the principles of research ethics with human subjects, conflict of interest, mentor and mentee responsibilities, collaborative research, peer review, data acquisition, research misconduct, responsible authorship and the scientist as a responsible member of society. This new course was modeled on the course taught for over 20 years at UCSF by Dr Bernard Lo. The course (Epidemiology 201) Responsible Conduct of Research, includes 8 hours of lecture recorded by Dr. Bernard Lo, Professor of Medicine Emeritus at UCSF, Director of the Greenwall Foundation and an international expert on research ethics and Dr. Deborah Grady, Professor of Medicine and Director of the CTSI Training Programs. The required text for the course is, Ethical Issues in Clinical Research: A Practical Guide by Bernard Lo, Lippincott Williams & Wilkins, 2009.The course also includes readings, exercises, and online interactive case discussions that are moderated by UCSF faculty. On average, students spend about 30 hours completing course assignments. In addition, all UCSF faculty members are required to complete the UCSF Collaborative Institutional Training Initiative (CITI) Research Ethics online module every three years. The CITI course includes an overview of the regulations that govern human subject research, as well as training modules on the Health Insurance Portability and Accountability Act as it applies to research. The UCSF CTSI K Scholar program also includes structured face-to-face discussion of issues related to responsible conduct of research during regular seminars and works-in-progress sessions (WIPS) led by senior research faculty. K Program seminars include panel discussions led by research faculty that address conflict of interest, mentor and mentee responsibilities, collaborative research, peer review, research misconduct, responsible authorship and the scientist as a responsible member of society. Finally, regular WIPS led by research faculty address ethical issues related to each trainees research and include regular discussion of contemporary ethical issues in research.

5.1 Format: I completed Responsible Conduct of Research (Epidemiology 201) in XXXX. To ensure general proficiency, I will retake the course described above at least every four years. I will maintain up-to-date training with the CITI Research Ethics module. In addition to this formal coursework, I will attend the CTSI K Scholar program seminars and WIPS that address the topics described above.

5. 2 Subject Matter: As described above, formal courses, K scholar seminars and WIPS address principles of research ethics with human subjects, conflict of interest, mentor and mentee responsibilities, collaborative research, peer review, data acquisition, research misconduct, responsible authorship and the scientist as a responsible member of society.

5.3 Faculty Participation: The formal course in Responsible Conduct of Research is currently co-led by Barbara Koenig PhD, Professor of Health and Aging in the School of Nursing and Winston Chiong MD, PhD, Assistant Professor of Neurology in the School of Medicine. These instructors bring their expertise in bioethics, genetic testing, conflict of interest, neurosciences, and philosophy to bear on the cases discussed during the course. K Program seminars and WIPS are led by experienced faculty engaged in research, as well as faculty who focus on ethical issues in research.

5.4 Duration of Instruction: Epi 201 includes 8 hours of lecture recordings given by Drs Lo and Grady and students spend approximately 30 hours completing readings, viewing lectures, and participating in interactive case discussions. CTSI K Scholar Program seminars (1 hour) and WIPS (1.75 hours) occur weekly in the scholar’s first year, biweekly in subsequent years. I also had over nine hours of training in the EPI 201 course (Tuesdays 9-10:15am for seven weeks) in 2007.

5.5 Frequency of Instruction: I received intensive instruction in responsible conduct of research as part of the Masters Program in Clinical Research. I will complete the Responsible Conduct of Research course in Summer 2013 and every four years thereafter. In addition, I will complete CITI module every three years. K Program seminars and WIPS will occur for the duration of the career development award. I will also receive guidance in matters related to responsible conduct of research from her mentors and scientific advisors throughout all five years of this proposal.