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