Download presentation
Presentation is loading. Please wait.
Published byCalvin Tucker Modified over 6 years ago
1
LEGAL AND ETHICAL ISSUES IN HUMAN SUBJECT RESEARCH ALAN MILSTEIN SHERMAN SILVERSTEIN KOHL ROSE AND PODOLSKY
2
THERAPY VS RESEARCH EXPERIMENTAL THERAPY NONTHERAPEUTIC RESEARCH
CLINICAL TRIALS CHALLENGE STUDY THERAPEUTIC RESEARCH NEW VS. EXISTING THERAPY NO THERAPEUTIC ALTERNATIVE
3
ETHICAL REQUIREMENTS NUREMBERG CODE HELSINKI DECLARATION
BELMONT REPORT THE COMMON RULE FUNDAMENTAL RIGHT TO BE TREATED WITH ESSENTIAL HUMAN DIGNITY
4
EXPERIMENT MUST BE ETHICALLY DESIGNED
VALID PRECLINICAL UNDERSTANDING OF UNIVERSE OF HARM VALUABLE RISKS MINIMIZED AND OUTWEIGHED BY BENEFITS THERAPEUTIC: CLINICAL EQUIPOISE NONTHERAPEUTIC: SHOMEIR P’TAYIM
5
PRINCIPAL INVESTIGATOR
SCIENTIFICALLY QUALIFIED SUPERVISION BY CLINICALLY QUALIFIED MEDICAL PERSONNEL NO CONFLICTED INTERESTS
6
INFORMED CONSENT PURPOSE PROCEDURE RISKS BENEFITS SELECTION
ALTERNATIVES FINANCIAL INTERESTS
7
UNINFORMED CONSENT: MYTH OF INFORMED CONSENT
NOT THERAPEUTIC CONSENT EXPERIMENT THERAPEUTIC MISCONCEPTION PARENTS AND THEIR CHILDREN
8
RESPONSIBLE PROTECTORS OF HUMAN SUBJECTS
IRB MEMBERS: EXPERIENCED, AVAILABLE, INFORMED SUBJECT ADVOCATES RAC OHRP FDA ALL OF US
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.