International Psoriasis Council

Chapters

Opening
Introduction
Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson
Chapter 2
It Takes a Village to Conduct a Clinical Trial
Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases
Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials

Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee
Chapter 6
Be Informed About Informed Consent
Chapter 7
Practical Advice for Following Good Clinical Practice
Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial
Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial
Chapter 10
The Subject of Recruitment and Retention
Chapter 11
The Investigational Compound - Like Handling Kryptonite
Chapter 12
Budgets and Contracts - Show Me the Money
Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation
Chapter 14
Audits/Inspections - Be Prepared for Anything
Chapter 15
Conducting Clinical Trials Without Ending Up on Trial

Ethics Bios

Carolyn Ells, PhD

Carolyn Ells, PhD, is a philosopher specializing in bioethics. She is Associate Professor of Medicine and a Member of the Biomedical Ethics Unit at McGill University, and Clinical Ethicist at the Jewish General Hospital in Montreal, Canada. She has served and chaired on research ethics committees since 2000. Her publications and teaching on research ethics focus on national and international policy that guides ethical research and the research ethics review process. See for example her articles in the British Medical Journal, International Journal of Feminist Approaches to Bioethics, Journal of Medical Ethics, and Canadian Journal of Sociology. Dr Ells is a founding member of the McGill Qualitative Health Research Group. She is co-creator of five, on-line, bilingual tutorials on research ethics for research ethics committees and support staff in the health sector of Quebec, Canada. She served on the International Network of Feminist Approaches to Bioethics Committee on the Declaration of Helsinki, which submitted recommendations to the World Medical Association in advance of the WMA’s 2008 revision of the Declaration of Helsinki.