Human Subjects Research: A Handbook for Institutional Review Boards

ISBN-13: 9781468441598 / Angielski / Miękka / 2012 / 291 str.

Robert A. Greenwald

Opis

For an increasing number of hospitals and universities the institutional review board (lRB) has become a way of life. Spurred into existence by public outcries about the unethical nature of certain modern scientific experiments, the IRB represents the most visible evidence of institutional commitment to ethical review of clinical research. However, this exponential growth of IRB activities has not occurred without growing pains. Like the Environmental Protection Agency, IRBs have had to develop procedures and standards without a clear consensus as to what would be optimal for science and society. Each IRB has perforce devised its own modus operandi, subject to general principles and guidelines laid down by others but still relatively free to stipulate the details of its functioning. Thus one can applaud the general idea as well as the overall performance of IRBs without asserting that the millenium has arrived. The composition, philosophy, efficiency, responsibilities, and powers of IRBs remain topics suit- able for debate. It is still possible (and appropriate) for IRB members to worry both about the propriety of their decisions and the personal costs of their service.

Spis treści

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.