Johns Hopkins Medicine Continuing Medical Education Presents Course on Research Ethics (C.O.R.E.) Wednesday, January 13, 2010 Wednesday, March 17, 2010 Monday, May 24, 2010 Wednesday, July 21, 2010 Tuesday, October 19, 2010 The Johns Hopkins University School of Medicine Thomas B. Turner Building Baltimore, Maryland Course on Research Ethics (C.O.R.E.) The Johns Hopkins University School of Medicine Description he Johns Hopkins University is deeply committed to the protection of human research subjects. This commitment begins with comprehensive compulsory education and training of its faculty, student, and staff researchers who conduct human subjects research. The Course on Research Ethics (C.O.R.E.) is a one-day activity in the School of Medicine designed to address key concepts in human subjects protection in specific research communities. C.O.R.E. combines lectures and small group discussions to provide practical information on the ethical issues involved in research protocol development and implementation. Who Should Attend This activity is intended for faculty and fellows engaged in human subjects research, but available to all members of the research team. Objectives After attending this activity, the participant will demonstrate the ability to: m Describe the context for the development of research ethics at the national and local levels m Recognize aspects of study design that can be ethically problematic including subject selection, research-related risks, conflicts of interest, and use of vulnerable populations m Describe the key concepts in informed consent including respect for autonomy, voluntariness, decision-making capacity, disclosure of information, and understanding m Describe methods of protecting privacy and confidentiality in the context of human subjects research m Recognize the key concepts in the responsible conduct of research, including data acquisition and management, mentor/trainee responsibilities, publication practices and authorship standards, conflicts of interest and commitment, and scientific misconduct Accreditation Statement The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 8.75 AMA PRA Category 1 Creditsª (1.00 credit hour for the web-based pre-course survey and pre-knowledge assessment, 3.75 credits for the morning general session, 3.0 credits for the optional afternoon fellows program, and 1.00 credit hour for the post-knowledge assessment and web-based course evaluation.) Physicians should only claim credit commensurate with the extent of their participation in the activity. Policy On Speaker and Provider Disclosure It is the policy of The Johns Hopkins University School of Medicine that the speaker and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the activity handout materials. Activity Director Mark T. Hughes, MD, MA Assistant Professor of Medicine The Johns Hopkins University School of Medicine Small Group Facilitators may include: Mary Catherine Beach, MD, MPH Associate Professor of Medicine and Health, Behavior and Society JHM ? IRB 3 Ethicist Joseph Carrese, MD, MPH Associate Professor of Medicine Chair of IRB 5 JHM ? IRB 5 Ethicist Kenneth J. Cohen, MD, MBA Associate Professor of Oncology and Pediatrics Clinical Director of Pediatric Oncology JHM ? IRB 3 Co-Chair David Cornblath, MD Professor of Neurology and Neurosurgery JHM ? IRB 2 Chair Gail Geller, ScD, MHS Professor of Medicine and Health, Behavior and Society The Johns Hopkins University Berman Institute of Bioethics Former Ethicist Member of JHM ? IRB 1 Emily Germain-Lee, MD Associate Professor of Pediatrics Division of Pediatric Endocrinology JHM ? IRB 2 Member Marie T. Nolan, MPH, PhD, RN Associate Professor Director, PhD Program, School of Nursing Berman Institute of Bioethics Stephanie Poe, MScN, RN Assistant Director of Nursing Clinical Quality and Informatics JHM ? IRB 2 Alternate Member Laura Rocco, RN, MS Research Associate Clinical Pharmacology JHM ? IRB X Chair Holly Taylor, PhD, MPH Assistant Professor Johns Hopkins Bloomberg School of Public Health Berman Institute of Bioethics Peter Terry, MD, MA Professor of Medicine Associate Professor of Anesthesiology and Critical Care Medicine Johns Hopkins Bloomberg School of Public Health JHM ? IRB X Ethicist Morning Program For Faculty, Fellows, House Staff, and Students Prior to the day of the activity, registrants are to complete the Pre-Course Survey and Pre-Knowledge Assessment found at the compliance training website located at https://secure.lwservers.net/. Morning 7:30 8:00 Registration and Continental Breakfast 8:00 8:05 Conference Goals Mark T. Hughes, MD, MA 8:05 8:45 Setting the Stage: Research Ethics at the Local and National Levels 8:45 9:40 Scientific Integrity and Mentorship 9:40 10:30 Workshop1: Responsible Conduct of Human Subjects Research 10:30 10:40 Refreshment Break 10:40 11:30 Workshop 2: Issues in Human Subjects Protection 11:30 11:55 Overview of Research Ethics Topics 11:55 12:00 Summary 12:00 Faculty Adjourn Immediately following the activity registrants are to complete the Post-Knowledge Assessment and on-line Course Evaluation found at the compliance training website located at https://secure.lwservers.net. Afternoon Program For Fellows, House Staff, and Students (Faculty Optional) Required attendance for Fellows, House Staff and Students. Faculty attendance is optional for the afternoon. Please note this on the registration form. Afternoon 12:05 1:00 Lunch for Fellows and Students Only 1:00 1:15 Animal Research Ethics 1:15 1:45 Responsible Conduct of Research 1:45 2:30 Conflicts of Interest and Commitment 2:30 2:45 Refreshment Break 2:45 3:15 Privacy and Confidentiality 3:15 3:30 Ownership of Research Data 3:30 4:00 Publication, Authorship and Peer Review 4:00 4:15 Summary 4:15 Conclusion for Fellows and Students Immediately following the activity, registrants are to complete the Post-Knowledge Assessment and on-line Activity Evaluation found at the compliance training website located at https://secure.lwservers.net. The Johns Hopkins University School of Medicine takes responsibility for the content, quality and scientific integrity of this CME activity. This schedule is subject to change For Further Information To Register Or For Further Information To Fax your Registration (866) 510-7088 Confirmation/Certificates (410) 502-9634 General Information (410) 955-2959 To e-mail the cmenet@jhmi.edu Office of CME General Information Registration Registration will open at 7:30 a.m. on the morning of your selected activity date. Location Thomas B. Turner Building The Johns Hopkins University School of Medicine 720 Rutland Avenue Baltimore, Maryland 21205 The Turner Building is located on Rutland Avenue at Monument Street. Directions and campus parking information are available on our website under the Contact and Travel Information section at www.HopkinsCME.edu. Handicapped parking is available in the nearby Rutland Garage. Johns Hopkins is smoke-free. REGISTRATION CUT-OFF DATE ? 10 days prior to your selected activity date. Methods of Payment: Payment by check or credit card must accompany the registration form prior to the activity. Due to the pre-course requirements, we are not able to accept on-site registrations. Payment must accompany registration form. No on-site registrations will be accepted. A $50 late fee applies to registrations received after 5:00 p.m. EST 10 days prior to your selected activity date. Foreign payments must be by credit card or with a U.S. Dollar World Money Order. The registration fee includes instructional materials, continental breakfast, refreshment breaks and lunch only for Fellows, House Staff, and Students attending the afternoon session. Fees Faculty..................................................................$ 350 House Staff*/Fellows/Students*............Complimentary *with verification of status ? clear copy of Hopkins ID badge or letter from department head You will receive a confirmation by e-mail if you have provided your e-mail address. Otherwise confirmation will be sent by mail. If you have not received it five days prior to your selected activity date, call (410) 502-9634 to confirm that you are registered. Certificates of attendance will be mailed upon completion of the on-line portion of the activity. The Johns Hopkins University reserves the right to cancel or postpone any activity due to unforeseen circumstances. In this event, the University will refund the registration fee but is not responsible for travel expenses. Additionally, we reserve the right to change the venue to a comparable venue. Under such circumstances registrants will be notified as soon as possible. Refund Policy A handling fee of $50 is deducted for cancellation. Refund requests must be received by fax or mail five days prior to your selected activity. No refunds will be made thereafter. Transfer of registration to another Johns Hopkins conference in lieu of cancellation is not possible. Activity Evaluation An activity evaluation form will be available to attendees to evaluate each session and each speaker?s presentation, as well as to identify future educational needs. Outcomes Survey An Outcomes Survey will be sent to all physician attendees within three months post activity to assist us in determining what impact this activity had on the attendee?s practice Emergency Calls On the day of this activity only, direct emergency calls to the Hopkins registration desk, (410) 955-3673. Messages will be posted for participants. Americans With Disabilities Act The Johns Hopkins University School of Medicine fully complies with the legal requirements of the ADA and the rules and regulations thereof. Please notify us if you have any special needs. Registration Form ( h Select One Activity ) h 80023060 Wednesday, January 13, 2010 h 80023056 Wednesday, March 17, 2010 h 80023059 Monday, May 24, 2010 h 80023058 Wednesday, July 21, 2010 h 80023057 Tuesday, October 19, 2010 Course on Research Ethics (C.O.R.E.) By phone: (410) 502-9634 (credit card only) By fax: (866) 510-7088 Or mail this form to The Johns Hopkins University, Office of Continuing Medical Education, P.O. Box 64128, Baltimore, Maryland 21264-4128. Include check payable to HOPKINS/Activity Number or include credit card information below. PAYMENT MUST ACCOMPANY FORM TO CONFIRM YOUR REGISTRATION. Please type or print clearly: _________________________________________________________________________ last name first name middle initial _________________________________________________________________________ primary degree (for name badge) primary specialty _________________________________________________________________________ preferred mailing address _________________________________________________________________________ city state zip + 4 code country _________________________________________________________________________ daytime telephone fax number business e-mail address __ /__ /__ /__ /__ /__ /__ /__ /__ /__ /__ /__ /__ /__ You will receive confirmation notice by e-mail if you provide your e-mail address. h Check here if you wish to receive e-mail and/ or fax notices about upcoming CME activities. Registration Fees: (Check one) h Physicians...........$350 h House Staff*/Fellows/Students*........ Complimentary *with verification of status ? clear copy of Hopkins ID badge or letter from department head h FACULTY ONLY - I will attend the afternoon session For registrations received after 5:00 p.m. EST 10 days prior to your selected activity, include a $50 late fee. No on-site registrations will be accepted. Specify Research Specialty ____________________________________________ Morning Workshops ? List in Order of Preference. Only one will be assigned. ___ Clinical Investigation: Drug Trial ___ Research on Stored Data ___ Clinical Investigation: Diagnostics and Surgical Techniques ___ Research on Children ___ Behavioral and Social Science Research ___ Research on Vulnerable Populations ___ Research on Stored Tissue Total amount enclosed $_________ What do you hope to learn by attending this course? _______________________ Please notify us if you have any special needs. ______________________________ JHU Faculty/Staff Only: Complete registration form and return with appropriate form below to OCME, Turner 20. h Payment by Internal Order Number: The ION Data Request Form, can be found online at http://www.hopkinscme.edu/pdfs/IonRequest.pdf. h Payment by Tuition Remission: To apply for TR, go to: http://benefits.jhu.edu/ EduBenefits/tuitionRemission.cfm This is a non-credit professional development activity. Name as it appears on card ____________________________________________ Please print clearly Signature ______________________________________________ Date_______ Credit Card Registrations h VISA h MASTERCARD h DISCOVER h AMEX Card # ___ ___ ___ ___ - ___ ___ ___ ___ - ___ ___ ___ ___ - ___ ___ ___ ___ Exp. Date ___________________________________________________________ Wednesday, January 13, 2010 Wednesday, March 17, 2010 Monday, May 24, 2010 Wednesday, July 21, 2010 Tuesday, October 19, 2010 Johns Hopkins Medicine Continuing Medical Education Course on Research Ethics (C.O.R.E.) The Johns Hopkins University School of Medicine Thomas B. Turner Building Baltimore, Maryland Office of Continuing Medical Education The Johns Hopkins University School of Medicine Turner 20, 720 Rutland Avenue Baltimore, Maryland 21205-2195 Non-Profit Org. US Postage PAID Baltimore, MD Permit No. 5839