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Innovative Surgery: Informed Consent and Ethics (1 hour Monograph)

Hours: 1.00

Best suited for: All surgical specialties. Other interested healthcare practitioners are also welcome to participate.

Original Release Date: October 19, 2016
Review Date: April 19, 2019
Expiration Date: October 19, 2019

Description: Generally accepted therapies occasionally prove insufficient to treat certain diseases or specific patient populations. In such cases, physicians often turn to procedures or devices normally used in other ways or in other settings. All new interventions and procedures must be properly assessed in comparison to the currently accepted methods. Surgical innovation has long enjoyed a privileged status in the evolving evidence-based medicine paradigm because double blind studies are impossible and because surgery is often considered to be as much an art as a science. As such, many aspects of surgical practice have remained beyond the reach of formal peer-reviewed evaluation. Off-label innovative surgical applications can carry a number of unknowable potential risks and uncertain benefits, given the lack of evidence and oversight supporting their use. In some cases, innovation blends into research in a continuum, and the surgeon must be able to tell the difference in order to utilize the correct consent procedures. The surgeon in the patient consent conversation must ethically consider whether the proposed therapy is research or innovation, and the conversation should include both what is known and what is unknown about the proposed therapy. 

Learning Outcome: Upon completion, participants should be able to:
1) Describe the differences between innovation and research
2) Describe additional elements that should be added to the informed consent discussion for
    an innovative or experimental procedure
3) Explain methods for evaluating the ethical soundness of offering a new surgical technique to

Learning Assessment: There will be a post test for this activity with a minimum performance requirement of 8 out of 10 correct answers.

Estimated time to complete activity: 1 hour

Residents will earn a certificate of completion. Physicians will earn CME credit. 

CME Information - Read

Method and Medium: To obtain CME credit, view the entire online presentation, complete the evaluation and post test and print your certificate online.

CME Credit: 1.0

State Requirements: Based on information from state licensing authorities published by the AMA, this program meets specific CME requirements for the following states:

Connecticut - This activity includes content in Risk Management
Massachusetts - This activity includes content in Risk Management
Pennsylvania - This activity includes content in Risk Management / Patient Safety
Texas - This activity includes content in Ethics and/or Professional Responsibility

CME Disclosure Policy: LAMMICO requires planners, speakers, faculty and all those who influence the content of a CME activity to disclose any financial relationships they have with commercial interests that are relevant to the CME activity. The disclosures shall be reviewed for any conflict of interest and subject to a mechanism for resolution of conflict of interest. A disclosure statement of relevant financial relationships will be made to the audience prior to the activity.

Disclosure: The author, editors and planning committee members for this activity have no relevant financial relationships to disclose.

About the Author: James P. Farwell, JD, DCLS - Read Bio

Expert Reviewer: James Giordano, PhD - Read Bio

Editor: Karen C. Duncan, RN, Attorney at LawRead Bio

Managing Editors: Dawer Azizi, MHA, CPHRM, LAMMICO Director of Risk Management and Sharon Cusanza, MSN, RN, NEA-BC, LAMMICO Senior Risk Management Education Specialist

Content Advisors/Planning Committee Members - Read

Electronic Hardware and Software Requirements - Read

Web Master Contact Information: For assistance, contact Shea Ivey at 866/398-1038 or help@medicalinteractive.com

Disclaimer: This activity is presented as risk management education. It is not legal advice, nor does it establish medical standards of care. Standards of care vary depending on the unique presentation of each patient. The information contained herein is not a substitute for the reasonable discretion of skilled and informed clinicians at the point of care.

Copyright Information: Copyright © 2016

Member and Subscriber Access
Interested in a CME program like this for your team or facility? Contact us to schedule it and talk about pricing.

This course is offered through Experix, a wholly owned subsidiary of Physicians Insurance, and is based on more than 30 years' experience in providing continuing medical education. This course is complimentary for Physicians Insurance members.

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