Course Description:

Course "Clinical Trial Ethics - Right, wrong and the grey area in between" has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.

The concept of Clinical Trial Ethics is more than just following the rules set by a given regulatory body or institutional review board. A large proportion of the appropriate ethical environment surrounding the conduct of a clinical trial involves a steadfast resolve to view what we are doing from the perspective of the person who has volunteered to participate in the clinical trial.

Examples of situations where ethical considerations should be applied include ethical issues associated with the globalization of clinical trials, the cultural differences among study volunteers, the differences in the availability of routine clinical care, the nuances surrounding the truthful, accurate and complete reporting of clinical outcomes and adverse events, the practical issues related to changes in regulatory requirements, etc. The use of adaptive clinical trial designs and novel strategies for product development are examples of processes where ethical considerations should be discussed up front but these grey areas may be left untouched for lack of a clear process to document the considerations of the ethical risks.

This course will use case studies to aid in the development and understanding of the language of clinical trial ethics. We will explore the use of specific tools to improve ethical sensitivity and decision making. We will consider how to develop strong core competencies in individual ethical leadership which may be especially helpful when the individual is trying to influence the decisions and actions of others (without whining or feeling their job is at risk). Participants will learn systematic ways to approach difficult ethical issues. We will discuss how to incorporate solid ethical principles when discussing ethical issues and testing ethical decisions. Upon completion of this course attendees will have a set of pre-identified tools to use when working on ethical dilemmas in the clinical trial field.

Learning Objectives:

  • Understanding the language of ethics
  • Researching and identifying the ethical components of a given situation
  • Learning a systematic approach to document and appreciate the important details involved in those difficult ethical dilemmas where no obvious right or wrong answer exists
  • Developing an ethically sensitive perspective
  • Developing the ability to influence ethical decisions and to personify ethical leadership within your organization

Who should Attend:

  • Clinical Research Associates
  • Clinical Research Managers/Directors
  • Regulatory Affairs
  • Corporate compliance staff
  • Corporate management

Course Outline:

Day One     Day Two
  • Introductions - 15 Min
    • Instructor
    • Participants
  • Session 1: Language of Ethics Understanding the fundamental concept - 45 Min
    • Code of Ethics
    • Overriding Challenge
  • Session 2: Situational Ethics with Clinical Trials - 60 Min
    • Driving forces
    • Researching and identifying components and stakeholders
    • Ethically sensitive perspective
    • Company culture and tolerance
  • Break - 30 Min
  • Mini Case Studies: Clinical trial ethical dilemmas - 75 Min
  • Lunch - 60 Min
  • Session 3: Systematic Appr - 45 Min
    • Risk based approach
    • PLUS Tool
    • Buddy approach
  • Break - 30 Min
  • Case Study: Analyzing ethical situations systematically - 75 Min
  • Session 4: Ethics and Regulatory requirements - 45 Min
    • New models
    • Modified approval processes
    • Hot ethical topics

  • Day 1 Recap - 15 Min
  • Session 5: Ethical Leadership - 60 Min
    • Personifying ethical leadership
    • Leadership versus Authority
    • Influencing others
    • Revising corporate culture
  • Corporate Round Table: Open forum to discuss ethical issues participants may have - 45 Min
  • Break - 30 Min
  • Workshop: Developing a corporate code of ethics and culture change implementation plan 45 Min
  • Q&A and Conclusions - 45 Min

Meet Your Instructor

Dr Joy Frestedt
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson's Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.

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The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Clinical Trial Ethics - Right, wrong and the grey area in between" RAPS certificate will be issued to attendee.

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