Protection of Human Research Subjects: A Practical Guide to Federal Laws and Regulations

Regulations on human subjects research have evolved over a 20-year period and now provide a formal set of requirements for the conduct of federally sponsored studies. Over time, government regulations, like taboos in primitive societies, develop a life of their own, seemingly dissociated from their origins and justifica­ tions. When the investigator suffers the burdens of trying to comply with com­ plex rules, it is easy for him or her to lapse into a frustration that can be eased by being informed or reminded of why the rules were created in the first place and what they were designed to accomplish. Dennis Maloney's work provides a handy historical record of the processes by which the regulations were created and modified. He also recounts his own experience with research at Boys Town and provides instructions on how to cope with the system. It is difficult to find in one place the current status and appropriate citations for regulations as well as the contacts and know-how to obtain more information on the subject. In this respect, by providing a history and guide to interpretation and compliance, "Protection of Human Subjects" is a reference of importance and utility to the investigator entering into or working in the field of biomedical or behavioral research involving human 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.