Regulatory Protections for Human Subjects (Dr. Terrence Ackerman)
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Transcript Regulatory Protections for Human Subjects (Dr. Terrence Ackerman)
TERRENCE F. ACKERMAN, PH.D.
PROFESSOR OF BIOETHICS
CHAIR, UTHSC IRB
PLAN OF ANALYSIS
HISTORICAL EVENTS CREATING CONCERNS ABOUT
PROTECTION OF HUMAN SUBJECTS
THE WORK OF THE NATIONAL COMMISSION &
CREATION OF THE FEDERAL REGULATIONS
STRUCTURE & CONTENT OF REGULATORY
PROTECTIONS
THE NUREMBERG DOCTORS’ TRIAL
23 NAZI MEDICAL PERSONNEL TRIED FOR
CRIMES AGAINST HUMANITY
TEN PRINCIPLES ENUNCIATED BY THE COURT
AS THE BASIS FOR ITS DECISION
THE THALIDOMIDE TRAGEDY
DRUG PRESCRIBED TO WOMEN UNAWARE OF ITS
INVESTIGATIONAL STATUS CAUSES LIMB DEFECTS IN FETUSES
KEFAUVER-HARRIS AMENDMENTS OF 1962 REQUIRE
EVIDENCE OF EFFICACY FOR FDA DRUG APPROVAL
INFORMED CONSENT GENERALLY REQUIRED FOR
INVESTIGATIONAL USE OF DRUGS
RESEARCH SCANDALS OF THE 1960s
THE JEWISH CHRONIC DISEASE HOSPITAL
IMMUNOLOGY STUDY
BEECHER’S ARTICLE: “ETHICS IN CLINICAL
RESEARCH”
THE SAN ANTONIO BIRTH CONTROL STUDY
THE TUSKEGEE SYPHILIS STUDY
THE NATIONAL COMMISSION
BASIC ETHICAL PRINCIPLES FOR HUMAN
RESEARCH
GUIDELINES AND PROCEDURES FOR IRB
REVIEW
ADDITIONAL RULES FOR RESEARCH WITH
VULNERABLE SUBJECTS
KEY MORAL INTERESTS OF
HUMAN SUBJECTS
RESPECT FOR PERSONAL AUTONOMY
PROTECTION OF PERSONAL WELFARE
FAIR TREATMENT
PROMULGATION OF THE
FEDERAL REGULATIONS
PREGNANT WOMEN & FETUSES (1975)
BASIC RULES FOR IRB REVIEW (1981)
PRISONERS (1978)
CHILDREN (1983)
PERSONS INSTITUTIONALIZED AS MENTALLY INFIRM
(NOT IMPLEMENTED)
FRAMEWORK FOR THE REGULATORY
PROTECTIONS
INSTITUTIONS MUST HAVE AN IRB REVIEW ALL REGULATED
HUMAN RESEARCH
AN IRB MUST CONSIST OF AN INTERDISCIPLINARY GROUP OF
SCIENTISTS AND LAYPERSONS
CRITERIA FOR APPROVAL OF STUDIES ARE SET BY FEDERAL
REGULATIONS
IRB APPROVAL IS NECESSARY FOR RESEARCH TO OCCUR
GENERAL CRITERIA FOR PROTOCOL
APPROVAL (1)
RISKS TO SUBJECTS ARE MINIMIZED
RISKS ARE REASONABLE IN RELATION TO
ANTICIPATED BENEFITS
DATA WILL BE MONITORED TO ENSURE SAFETY OF
SUBJECTS
APPROPRIATE ADDITIONAL SAFEGUARDS ARE
USED TO PROTECT VULNERABLE SUBJECTS
GENERAL CRITERIA FOR STUDY
APPROVAL (2)
INFORMED CONSENT WILL BE SECURED
INFORMED CONSENT WILL BE PROPERLY
DOCUMENTED
SUBJECT PRIVACY & CONFIDENTIALITY WILL BE
PROTECTED
SELECTION OF SUBJECTS IS EQUITABLE
REGULATIONS ON SPECIAL POPULATIONS
PREGNANT WOMEN & FETUSES
PRISONERS
CHILDREN
INSTITUTIONALIZED MENTALLY ILL
(NOT IMPLEMENTED)
ADDITIONAL IRB REVIEW RESPONSIBILITIES
CONTINUING REVIEW OF PREVIOUSLY APPROVED
RESEARCH
REVIEW OF PROPOSED REVISIONS IN PREVIOUSLY
APPROVED RESEARCH
ASSESSMENT OF UNANTICIPATED PROBLEMS,
INCLUDING ADVERSE EVENTS
COMPLIANCE MONITORING
IRB MAY AUDIT STUDIES TO DETERMINE
COMPLIANCE WITH REGULATIONS & LOCAL IRB
POLICY
IRB HAS AUTHORITY TO SUSPEND OR TERMINATE
APPROVAL
SUSPENSION OR TERMINATION MUST BE
REPORTED TO INSTITUTIONAL & FEDERAL
OFFICIALS
SUMMARY
HISTORICAL VIOLATIONS OF THE RIGHTS & WELFARE OF
HUMAN SUBJECTS LED TO FEDERAL REGULATIONS
NATIONAL COMMISSION FORMULATED BASIC MORAL
PRINCIPLES & PROPOSED REGULATIONS
IRBs ARE RESPONSIBLE FOR APPROVING RESEARCH &
MONITORING REGULATORY COMPLIANCE
CRITERIA FOR IRB APPROVAL ARE SET BY FEDERAL
REGULATIONS & REFLECT BASIC MORAL PRINCIPLES FOR THE
CONDUCT OF HUMAN RESEARCH