80023058: Course on Research Ethics (C.O.R.E.) July

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 Credits™ (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.

Course Description:


The 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 designed to address key concepts in human subjects protection in specific research communities.

CORE consists of three parts and provides practical information on the ethical issues involved in research protocol development and implementation:



• a web-based pre-conference knowledge assessment found at the compliance training website https://secure.lwservers.net
• a one-day instructor-led course consisting of lectures and small group discussions
• a post-conference web-based portion found at the compliance training website https://secure.lwservers.net


Course Objectives:
Following this program, the participant should be able to:

• describe the context for the development of research ethics at the national and local levels
• recognize aspects of study design that can be ethically problematic including subject selection, research-related risks, conflicts of interest, and use of vulnerable populations
• describe the key concepts in informed consent, including respect for autonomy, voluntariness, decision-making capacity, disclosure of information, and understanding
• describe methods of protecting privacy and confidentiality in the context of human subjects research
• 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


If you have questions concerning the instructor led portion of the course, please contact:

Carolyn Burke
Conference Coordinator
Office of Continuing Medical Education
Email: cburke12@jhmi.edu

Phone: 410-955-3988

or

Mark T. Hughes, MD
Course Director
Email: mthughes@jhmi.edu
Phone: 410-955-1733

If you have questions regarding access to the web-based portion of the course, please contact:

Office of Research Administration

Phone: 410-955-1566
https://secure.lwservers.net

For registration information contact:

Office of Continuing Medical Education
Turner 17
Phone: 410-955-2959 or 410-955-3169
Fax: 410-955-0807


If you can provide documentation that you have completed one of the other research ethics courses below, you will not need to complete the C.O.R.E. requirement. To obtain a C.O.R.E. exemption, please send a copy of your transcript or CME certificate to Karen Justice-White in the Research Administration at Johns Hopkins University School of Medicine, 1629 Thames Street, Ste. 200, Baltimore, MD 21231

Research Ethics 550.860.01 (School of Public Health)
Research Ethics and Integrity: US and International Issues 306.665.01 (School of Public Health)
Science of Clinical Investigation: Ethical and Regulatory Issues in Clinical Research
Instructors Dr. Norm Fost and Dr. N. Franklin Adkinson.



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). 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.