REGULATORY PROTECTIONS FOR HUMAN SUBJECTS

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

HISTORICAL EVENTS

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 & PROMULGATION OF THE FEDERAL REGULATIONS

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)

PRISONERS (1978)

BASIC RULES FOR IRB REVIEW (1981)

CHILDREN (1983)

PERSONS INSTITUTIONALIZED AS MENTALLY INFIRM (NOT IMPLEMENTED)

THE STRUCTURE AND CONTENT OF FEDERAL REGULATIONS

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