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REGULATORY PROTECTIONS FOR HUMAN SUBJECTS

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

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REGULATORY PROTECTIONS FOR HUMAN SUBJECTS

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  1. REGULATORY PROTECTIONS FOR HUMAN SUBJECTS TERRENCE F. ACKERMAN, PH.D. PROFESSOR OF BIOETHICS CHAIR, UTHSC IRB

  2. 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

  3. HISTORICAL EVENTS

  4. 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

  5. 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

  6. 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

  7. THE NATIONAL COMMISSION & PROMULGATION OF THE FEDERAL REGULATIONS

  8. THE NATIONAL COMMISSION • BASIC ETHICAL PRINCIPLES FOR HUMAN RESEARCH • GUIDELINES AND PROCEDURES FOR IRB REVIEW • ADDITIONAL RULES FOR RESEARCH WITH VULNERABLE SUBJECTS

  9. KEY MORAL INTERESTS OF HUMAN SUBJECTS • RESPECT FORPERSONAL AUTONOMY • PROTECTION OF PERSONAL WELFARE • FAIR TREATMENT

  10. 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)

  11. THE STRUCTURE AND CONTENT OF FEDERAL REGULATIONS

  12. 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

  13. 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

  14. GENERAL CRITERIA FOR STUDYAPPROVAL (2) • INFORMED CONSENT WILL BE SECURED • INFORMED CONSENT WILL BE PROPERLY DOCUMENTED • SUBJECT PRIVACY & CONFIDENTIALITY WILL BE PROTECTED • SELECTION OF SUBJECTS IS EQUITABLE

  15. REGULATIONS ON SPECIAL POPULATIONS • PREGNANT WOMEN & FETUSES • PRISONERS • CHILDREN • INSTITUTIONALIZED MENTALLY ILL • (NOT IMPLEMENTED)

  16. 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

  17. COMPLIANCEMONITORING • 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

  18. SUMMARY • HISTORICAL VIOLATIONS OF THE RIGHTS & WELFARE OF HUMAN SUBJECTS LED TO FEDERALREGULATIONS • 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

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