LEGAL AND ETHICAL ISSUES IN HUMAN SUBJECT RESEARCH ALAN MILSTEIN SHERMAN SILVERSTEIN KOHL ROSE AND PODOLSKY WWW.SSKRPLAW.COM.

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Presentation transcript:

LEGAL AND ETHICAL ISSUES IN HUMAN SUBJECT RESEARCH ALAN MILSTEIN SHERMAN SILVERSTEIN KOHL ROSE AND PODOLSKY WWW.SSKRPLAW.COM

THERAPY VS RESEARCH EXPERIMENTAL THERAPY NONTHERAPEUTIC RESEARCH CLINICAL TRIALS CHALLENGE STUDY THERAPEUTIC RESEARCH NEW VS. EXISTING THERAPY NO THERAPEUTIC ALTERNATIVE

ETHICAL REQUIREMENTS NUREMBERG CODE HELSINKI DECLARATION BELMONT REPORT THE COMMON RULE FUNDAMENTAL RIGHT TO BE TREATED WITH ESSENTIAL HUMAN DIGNITY

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

PRINCIPAL INVESTIGATOR SCIENTIFICALLY QUALIFIED SUPERVISION BY CLINICALLY QUALIFIED MEDICAL PERSONNEL NO CONFLICTED INTERESTS

INFORMED CONSENT PURPOSE PROCEDURE RISKS BENEFITS SELECTION ALTERNATIVES FINANCIAL INTERESTS

UNINFORMED CONSENT: MYTH OF INFORMED CONSENT NOT THERAPEUTIC CONSENT EXPERIMENT THERAPEUTIC MISCONCEPTION PARENTS AND THEIR CHILDREN

RESPONSIBLE PROTECTORS OF HUMAN SUBJECTS IRB MEMBERS: EXPERIENCED, AVAILABLE, INFORMED SUBJECT ADVOCATES RAC OHRP FDA ALL OF US

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