Protection of Human Research Subjects

I: Guidelines for Research.- 1. Federal Commissions and Advisory Boards.- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- The National Research Act.- History.- Purpose.- Several Professions.- Impact.- Commission Procedures.- Commission Meetings.- Commission Reports.- Proposed Regulations.- Final Regulations.- The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.- The Ethics Advisory Board.- Who Does What?.- The Belmont Report.- Summary.- Appendix 1.1. The National Research Act.- Appendix 1.2. The Belmont Report.- Appendix 1.3. The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.- 2. Institutional Review Boards.- History of IRB Development.- Dual Function for IRBs.- Major Changes for IRBs.- 1974.- 1975.- 1976.- 1977.- 1978.- 1979.- 1981.- Health and Human Services and the Food and Drug Administration.- Summary.- Appendix 2.1. Regulations by the Department of Health and Human Services (HHS) for Institutional Review Boards and Informed Consent.- Appendix 2.2. Regulations by HHS for “Expedited Review”.- Appendix 2.3. Regulations by the Food and Drug Administration (FDA) for Operation of Institutional Review Boards.- Appendix 2.4. Regulations by FDA for “Expedited Review”.- Appendix 2.5. A Comparison of HHS and FDA Rules Governing Operation of Institutional Review Boards.- Appendix 2.6. A Comparison of HHS and FDA Rules Governing Operation of Institutional Review Boards for “Expedited Reviews”.- 3. Informed Consent.- History of Informed Consent.- 1974.- 1975.- 1978.- Informed Consent Today.- Elements of Consent.- Who Must Sign the Informed Consent Form.- Two Types of Written Consent.- Example of an Informed Consent Form.- The “Looking at Life” Study.- Was Written Consent Necessary?.- Correct Consent Elements in Example.- Consent Rules for the Food and Drug Administration.- Informed Consent for Treatment.- A Contract for Consent.- The National Teaching-Family Association.- Some Problems Associated with Informed Consent.- Researcher Resistance.- Subject Confusion.- Summary.- Appendix 3.1. Regulations by the Department of Health and Human Services for Informed Consent.- Appendix 3.2. Regulations by the Food and Drug Administration for Informed Consent.- Appendix 3.3. A Comparison of HHS and FDA Rules Governing Informed Consent.- 4. HOW to Get Research Approved by an Institutional Review Board.- Establishing an Institutional Review Board.- Obtaining Federal Approval of an IRB.- Correspondence with Federal Agency in Washington.- Institutional Review Boards Around the United States.- Special Assurance and General Assurance.- Special Assurance.- General Assurance.- Applying to an IRB for Approval.- Memo Describing IRB Review Steps.- Detailed Instructions for Preparing IRB Proposal.- IRB Roster.- Schedule of IRB Meetings.- Sample Forms.- The Researcher and the IRB: A Complicated Relationship.- A National IRB Survey.- IRB Survey Design.- Survey Results.- Summary.- Appendix 4.1. 61st Cumulative List of Institutions Which Have Established General Assurances of Compliance with HEW (now HHS) Regulations on Protection of Human Subjects.- Appendix 4.2. Regulations by the Department of Health and Human Services on General Assurance.- 5. Freedom of Information and Privacy.- Government Files Only.- The Freedom of Information Act (FOIA).- History.- FOIA Today.- The FOIA and The Privacy Act.- The Privacy Act.- The Privacy Act Today.- Basic Elements of the Privacy Act.- The Sunshine Act.- Basic Elements of the Sunshine Act.- Sunshine Act and the Researcher.- Confidentiality Certificates.- Research on Sensitive Issues.- Confidentiality Certificates in Health and Human Services.- Impact of Privacy Rules on Research.- Impact on Federal Agencies.- Impact on Researchers.- Summary.- Appendix 5.1. The Freedom of Information Act.- Appendix 5.2. The Privacy Act of 1974.- Appendix 5.3. Government in the Sunshine Act.- Appendix 5.4. Protection of Identity of Research Subjects.- II: Research with Special Populations.- 6. Children.- History.- 1978 Rules.- 1983 Rules.- Consent Issues for Children.- Assent versus Consent versus Permission.- Children as Wards of the State.- Extra Responsibilities for an IRB.- Research with Children and Minimal Risk.- Summary.- Appendix 6.1. Protection of Human Subjects in Research Involving Children.- 7. Students.- History.- 1965–1970.- Privacy and Student Records.- 1974: An Active Year.- 1979.- The Buckley Amendment.- After the Buckley Amendment.- Opposing Sides on Student Privacy.- Parents versus Students.- Educational Research.- Politics and Education Rules.- Summary.- Appendix 7.1. Protection of Human Subjects in Research Involving Students.- 8. Prisoners.- Health and Human Services.- Negative Findings.- Broad Scope of Restrictions.- Current Rules.- IRBs and Prisoner Research.- Food and Drug Administration.- History.- Current Rules.- Summary.- Appendix 8.1. Regulations by the Department of Health and Human Services for Protection of Prisoners as Research Subjects.- Appendix 8.2. Proposed Regulations by the Food and Drug Administration for Protection of Prisoners as Research Subjects.- 9. Fetuses, Pregnant Women, and In Vitro Fertilization.- Fetuses.- Pregnant Women.- In Vitro Fertilization.- In Vitro Fertilization and Embryo Transfer.- Legal Complications.- Regulatory History.- 1975.- 1978.- Summary.- Appendix 9.1. Regulations of the Department of Health and Human Services for Research with Fetuses, Pregnant Women, and In Vitro Fertilization.- 10. Persons Institutionalized as Mentally Disabled.- Regulatory History.- Definition of Mentally Infirm.- Community-based Settings.- Consent Conditions.- Risk Factors.- Summary.- Appendix 10.1. Proposed Regulations by the Department of Health and Human Services for Research Involving Persons Institutionalized as Mentally Disabled.- III: Keeping up with Changing Rules.- 11. How to be Informed and Involved.- How a Bill Becomes a Law.- of a Bill.- Debate in Congress.- Presidential Action.- The Bill Becomes Law.- How a Regulation Becomes a Regulation.- The Federal Register.- Code of Federal Regulations.- Looseleaf Services.- How Laws and Regulations Are Cited.- Finding Federal Laws.- Finding Federal Regulations.- Keeping Current.- Congressional Record.- Calendars.- Federal Register.- Commercial Services.- Retrieving Documents.- Computerized Systems.- Influencing the Process.- State Laws and Regulations.