Human Subjects Research

Section I: Background and General Principles.- 1. The Evolution of Regulatory Influences on Research with Human Subjects.- Historical Antecedents.- Background of Abuses.- The National Commission.- The “Boundary Problem”.- Definition of Research.- The Risk/Benefit Ratio.- The Consent Doctrine.- Preconsent Procedures.- Some Contemporary Developments.- References.- 2. Legal Background of the Institutional Review Board.- Historical Overview.- Liability of IRB Members.- References.- 3. General Organization of the IRB.- The Source of IRB Authority.- Responsibilities and Selection of IRB Members.- Chairman.- Other Institutional Members.- Lay/Community Representatives.- Delegated IRB Review and Regional Organizations.- Delegated IRB Review.- IRB Organizations.- Institutional Resources Available to the IRB.- References.- 4. The Costs of IRB Review.- SUNY/Albany Costs.- Calculation of Costs.- IRB Activity.- Meeting Costs.- Administrative Cost.- Total Costs.- Costs at Other Institutions.- Effect of Recently Published Regulations.- Conclusions.- Summary.- References.- Section II: The Review Process.- 5. General Principles of IRB Review.- Components of IRB Review.- Scientific Merit.- Equitable Selection of Subjects.- Risk/Benefit Ratio.- Credibility.- Role of the Lay Reviewer.- References.- 6. IRB Procedures.- Compliance with Regulations.- History of Compliance Reviews.- Filing an Assurance.- Requirements for Assurances.- The Scope of IRB Review.- Student Research.- The Decision Making Process.- Full IRB or Subcommittee Review.- Appeals and Secondary Review.- The Review Process/Meetings/Voting.- Minutes/Continuing Review.- Notification to the Investigator.- Presence of the Investigator at Meetings.- Review of Advertising.- Compensating IRB Members.- Compensating Subjects.- Participation in Multiple Research Projects.- Conclusion.- References.- 7. Informed Consent.- Preparation of Consents.- Components of Consent.- Format of Consent.- Compensation Clause.- Financial Risk.- Payments to Subjects.- Additional Clauses.- Minimal Risk, Oral Consent, and Expedited Review.- Disposition of Consent Forms.- Signature of Witness.- Comprehensibility.- References.- 8. Research on Investigational New Drugs.- Genesis of Drug Laws.- Thalidomide and DES.- Potential Hazard of New Drugs.- Role of Medical Staff Committees.- When Is a Drug Investigational?.- Sources of Investigational Drugs.- Suggested Administrative Procedures for Investigational Drug Use.- “Automatic Stop” Orders.- General Administrative Procedures.- The Role of the Pharmacist.- Conclusion.- References.- 9. Research Involving Medical Devices.- Historical Overview.- Medical Devices Exempted from the Regulations.- The Role of the IRB: Determination of Risk.- Nonsignificant Risk Devices.- Significant Risk Devices.- Responsibilities of the IRB, Sponsor, and Clinical Investigator.- Responsibilities of the IRB.- Responsibilities of the Investigator.- Informed Consent Requirements.- Responsibilities of the Sponsor and Sponsor/Investigator.- Areas of Concern.- Informed Consent.- Confidentiality.- Procedural Difficulties.- The Ability of the IRB to Review Medical Devices.- Nature of Clinical Devices.- Impact on Future Developments in Medical Technology.- Conclusion.- References.- 10. Continuing Review of Research.- Overview.- Controversy over Review Requirements.- Benefits of the Review Process.- Procedures for Reviewing Research.- Goals of an IRB Review.- Government and the Audit of Human Research.- Practical Considerations.- Review Mechanisms.- Review Findings.- Conclusions.- References.- Section III: Special Problem Areas.- 11. Studies Involving Children.- Assessing Risk/Benefit Ratio.- Consent-Assent.- Children’s Consent.- Therapeutic vs. Nontherapeutic Procedures.- Reference Notes.- 12. Research on the Therapy of Cancer.- Research Design.- Balance of Benefits and Harms.- Competence of the Investigator.- Informed Consent.- Equitable Selection of Subjects.- Compensation for Injury.- General Considerations.- Reference Notes.- References.- 13. Surgical Research.- The Need for Surgical Research.- The Clinical Trial.- Cooperative Studies: Multicenter Trials.- Risk/Benefit Ratio and Surgical Risk.- Devices Used in Surgery.- IRB Monitoring Function in Relation to Surgical Research.- Surgical Specimens Used for Research.- Conclusion.- References.- 14. Clinical Trials of New Drugs.- Drug Termination.- Inclusion of the Posttrial Period within Informed Consent.- Consequences of Drug Withdrawal.- Emotional Consequences.- Negative Medical Consequences: The “Rebound Phenomenon”.- Long-Term Side Effects.- Use of Placebos.- The “Placebo Effect”.- Placebo Control.- Factors to Be Considered in Reviewing Placebo Research.- References.- 15. Psychiatric Research.- Tests of Competency.- Competency of Psychiatric Patients.- The Problem of Voluntariness.- Alternative Models of Consent.- Proxy Consent.- The Use of Third Party Observer to the Consent Process.- Confidentiality.- Consent Form/Consent Process.- The Physician-Patient Relationship.- Incomplete Disclosure.- The Role of the IRB.- References.- 16. IRBs and the Regulation of Social Science Research.- Potential Risks of Social Science Research.- Deception/Incomplete Disclosure.- Privacy/Confidentiality.- Exploitation.- Ethical Principles of Research: Problems in Social Science Research.- The Evidence to Date.- Additional Concerns of Social Scientists.- Other Ways of Thinking about the Issue.- Reference Notes.- References.- Annotated Bibliography.- Appendices.- 1. The Nuremberg Code.- 2. The Declaration of Helsinki.- 6. Statement of Investigator, FD Form 1573.- 7. Protection of Human Subjects Assurance/Certification/Declaration, HEW-596.- 8. Application for Approval of a Research Project.- 9. Sample Consent Form.- 10. IRB Reviewer’s Checklist.- 11. Request for an Investigational Drug.- 12. Investigational Drug Fact Sheet.- 13. Research Incident Report.- 14. Research Involving Children.- 15. Research Involving Cancer Patients.- 16. Research Involving Psychiatric Patients.- 17. Research Involving an Experimental Invasive Procedure.- 18. Research Involving an Investigational Medical Device.- 19. Research Involving an Investigational New Drug.- 20. Research Involving an Emotional Assessment Interview with Patients.- 21. Research Involving an Emotional Assessment Interview with Relatives of Patients.