In this module key ethical considerations and regulatory guidance that impact the design and conduct of clinical studies are introduced. Real world examples of current and past clinical studies are incorporated to illustrate key ethical principles among diverse study populations. This module explains the process of informed consent and the role of the Institutional Review Board.
This UCSF CME activity was planned and developed to uphold academic standards to ensure balance, independence, objectivity, and scientific rigor; adhere to requirements to protect health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA); and include a mechanism to inform learners when unapproved or unlabeled uses of therapeutic products or agents are discussed or referenced. This activity has been reviewed and approved by members of the UCSF CME Governing Board in accordance with UCSF CME accreditation policies. Office of CME staff, planners, reviewers, and all others in control of content have disclosed they have no relevant financial relationships. The speakers have disclosed they have NO financial interest/arrangement or affiliation with any commercial companies who have provided products or services relating to her presentation(s) or commercial support for this continuing medical education activity.
The University of California, San Francisco School of Medicine (UCSF) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Physicians: UCSF designates this enduring material for a maximum of 2.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Practitioners and Registered Nurses: For the purpose of recertification, the American Nurses Credentialing Center accepts AMA PRA Category 1 Credit™ issued by organizations accredited by the ACCME. Physician Assistants: The National Commission on Certification of Physician Assistants (NCCPA) states that the AMA PRA Category 1 Credits™ are acceptable for continuing medical education requirements for recertification. California Pharmacists: The California Board of Pharmacy accepts as continuing professional education those courses that meet the standard of relevance to pharmacy practice and have been approved for AMA PRA category 1 credit™. If you are a pharmacist in another state, you should check with your state board for approval of this credit.
As health disparities among racial and ethnic minorities and among foreign-born populations increase in the United States, government agencies develop strategies to increase awareness and provide standards for reducing this trend. Even though Americans in general are experiencing an improvement in health, minority populations continue to bear disease and illness disproportionately. CME focusing on cultural and linguistic competency is one way to ensure that physicians maintain the relevant professional development necessary to reflect the changing demographic profile of California. AB 1195 requires that CME curriculum address Cultural and Linguistic Competency in patient care with the goal of reducing health disparities among target populations. Please include in your presentation relevant information relating to age, gender, race, socio-economics, sexual orientation, religion, language, and/or ethnicity.
CLC Info and Resources
UCSF School of Medicine Office of Continuing Medical Education 3333 California Street, Suite 450 San Francisco, CA 94118
