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Innovative Surgery: Informed Consent and Ethics

Expiration Date
Aug 02, 2025
Media Format
Interactive
MOC Approved
Yes
Activity Type
Online
Est. Duration
1 hour
Credits
CME: 1.00

$150


ACCESS EXPIRES IN 95 DAY(S)

Target Audience

All surgical specialties. Other interested healthcare practitioners are also welcome to participate.

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 Outcomes/Objectives

Upon completion, participants should be able to:

  1. Describe the differences between innovation and research. 
  2. Discuss additional elements that should be added to the informed consent discussion for an innovative or experimental procedure. 
  3. Utilize methods for evaluating the ethical soundness of offering a new surgical technique to patients. 

Release Date:
October 19, 2016
Last Review Date:
August 02, 2022
Expiration Date:
August 02, 2025

Copyright Information

Copyright © 2016-2022

CME Information

This activity is sponsored by LAMMICO/Medical Interactive.

LAMMICO/Medical Interactive designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Statement

LAMMICO/Medical Interactive is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Learning Assessment

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

Method and Medium

To obtain CME credit, view the entire online presentation, complete the evaluation and posttest and print your certificate online.

Resident Information

Residents will earn a certificate of completion.

State Requirements

This course may meet specific CME requirements for the following states. It is the user's responsibility to confirm whether content meets the user's state's specific requirements:

  • 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

MOC Approval Statement

Through the American Board of Medical Specialties ("ABMS") ongoing commitment to increase access to practice relevant Maintenance of Certification ("MOC") Activities through the ABMS Continuing Certification Directory, Innovative Surgery: Informed Consent and Ethics has met the requirements as an MOC Part II CME Activity (apply toward general CME requirement) and/or an MOC Part II Learner Assessment Activity for the following ABMS Member Boards:

MOC Part II CME Activity

  • American Board of Urology
  • American Board of Radiology
  • American Board of Plastic Surgery
Note: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement (only). Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Learner Assessment Program Requirements.

ABOHNS

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to meet the expectations of the American Board of Otolaryngology’s Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of recognizing participation.

ABOHNS MOC points can only be submitted if the participant provides his/her ABOHNS member number and date of birth to this provider.

ABS

Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

ABS MOC points can only be submitted if the participant provides his/her ABS member number and date of birth to this provider.

ABTS

Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME requirements of the American Board of Thoracic Surgery’s Maintenance of Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABTS credit.

ABTS MOC points can only be submitted if the participant provides his/her member information as requested to this provider.

Analyzing decades of medical malpractice claim data has led the MI faculty to narrow our focus to pinpoint the most important roots of patient safety issues across a host of medical specialties. When we boil down our collection of risk management education topics, these key concepts most keenly respond to the roots of patient safety issues: 

Risk Management Concept: Cognition - Icon of human head with cog for brain

Cognition

Error in the mental action or process of learning can lead to adverse events stemming from inaccurate or incomplete thinking, perceiving, experiencing, recognizing, remembering and judging. Courses marked with this designation indicate that information presented within that specific education activity will illuminate actionable ways to improve analysis and synthesis of information, diagnosis and clinical decision making. 


Risk Management Concept: Communication - Icon of speech bubbles

Communication

Misunderstandings can lead to adverse events arising from errors in written, verbal and non-verbal information exchange. Courses marked with this designation indicate that concepts presented within that specific education activity will feature actionable ways to improve mutual understanding between healthcare providers and/or between medical professionals and their patients. 


Risk Management Concept: Performance - Icon of spedometer

Performance

Reactive behavior resulting in inaccuracy, incompletion, expensive and untimely tasks can lead to adverse events arising from poor execution of an action and/or fulfillment of a request. Courses marked with this designation indicate that the specific education activity will present realistic ways to apply learning, implement changes in a medical practice, improve competencies, critically assess performance, and utilize and incorporate evidence-based best practices. 


Risk Management Concept: Professionalism - Icon of people

Professionalism

Breach of competency standards and ethical values can result in adverse events stemming from a misunderstanding of professional expectations. Courses marked with this designation indicate that the education activity will clarify professional expectations in an effort to improve advocacy and participation, provider wellness, ethical decisions, cultural competence, professional organization participation, and adherence to patient care guidelines. 


Risk Management Concept: System - Icon of Cogs

System

System errors in medicine primarily consist of interrelated and interdependent components that habitually influence one another, and can often result in adverse consequences. Courses marked with this designation indicate that the education activity will present ways to address legal and regulatory issues, coordination of care and teamwork, electronic health record IT issues, policies and procedures, cost and risk benefits, and quality improvement activities. 

Disclosure Policy

LAMMICO/Medical Interactive requires planners, speakers, faculty and all those who influence the content of a CME activity to disclose any financial relationships they have with ineligible companies that are relevant to the 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 Statement

The authors, editors, reviewers and planning committee members for this activity have no relevant financial relationships to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

Author(s)

James P. Farwell, JD, DCLS - Read Bio

Editor(s)

Joseph T. D. Tran, JD, CIPP/US - Read Bio

Amanda Martin-Sanchez, MEd, BSN, RN, CNOR - Read Bio

Medical Expert Reviewer(s)

David L. Meyers, MD, FACEP - Read Bio

Managing Editor(s)

Dawer Azizi, MHA, BSN, RN, CPHRM, LAMMICO Director of Risk Management

Sharon Cusanza, MSN, RN, NEA-BC, LAMMICO Senior Risk Management Education Specialist

Content Advisors/Planning Committee Members

Dawer Azizi, MHA, BSN, RN, CPHRM, LAMMICO Director of Risk Management

Geri Cook, RHIA, CPHRM, LAMMICO Risk Management Manager

Sharon Cusanza, MSN, RN, NEA-BC, LAMMICO Senior Risk Management Education Specialist

Carol A. Curran, RNC, MS, OGNP, LAMMICO Senior Perinatal Educator and Medical Interactive Business Specialist

Karen K. Davis, MA, CPHRM, LAMMICO CME/CNE Writer/Editor

Amanda Martin-Sanchez, MEd, BSN, RN, CNOR, LAMMICO CME/CNE Educator

Lynda Sanders, LAMMICO Continuing Education Specialist

Karen Tong, Patient Representative and LAMMICO Communication Strategist

Joseph T. D. Tran, Associate General Counsel

Lynne Vega, RN, LAMMICO Hospital RM Specialist

Electronic Hardware and Software Requirements

To view our online presentations, your computer must meet the requirements below:

Hardware: Participants must have a personal computer with internet connection and speakers or an iOS or Android phone.

Operating System

Windows or Mac OS for desktop computers.

iOS or Android for mobile devices

Browser (Internet Explorer is NOT recommended as a browser for any MI courses since it is no longer supported by Microsoft)

Firefox 55 or above

Chrome 60 or above

Safari 11 or above

Microsoft Edge

Bandwidth

High Speed or DSL

Web Master Contact Information

For assistance, contact Shea Ivey at (866) 398-1038 or help@medicalinteractive.com