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)  PRISONERS (1978)  BASIC RULES FOR IRB REVIEW (1981)  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