Human Subjects Research

A Handbook for Institutional Review Boards

  • Robert A. Greenwald
  • Mary Kay Ryan
  • James E. Mulvihill

Table of contents

  1. Front Matter
    Pages i-xxiv
  2. Background and General Principles

    1. Front Matter
      Pages 1-1
    2. Joseph V. Brady, Albert R. Jonsen
      Pages 3-18
    3. Mary Kay Ryan
      Pages 29-38
    4. Jeffrey Cohen
      Pages 39-47
  3. The Review Process

    1. Front Matter
      Pages 49-49
    2. Robert A. Greenwald
      Pages 51-62
    3. Mary Kay Ryan
      Pages 63-77
    4. Robert A. Greenwald
      Pages 79-90
    5. Mary Kay Ryan, Lawrence Gold, Bruce Kay
      Pages 91-106
    6. Mary Kay Ryan
      Pages 107-123
    7. Stuart Wollman, Mary Kay Ryan
      Pages 125-136
  4. Special Problem Areas

    1. Front Matter
      Pages 137-137
    2. Gwen O’Sullivan
      Pages 139-150
    3. Dale H. Cowan
      Pages 151-167
    4. Myron E. Freund
      Pages 169-179
    5. Martin Roginsky
      Pages 181-192
    6. John M. Kane, Lewis L. Robbins, Barbara Stanley
      Pages 193-205
    7. Lawrence Susskind, Linda Vandergrift
      Pages 207-219
  5. Back Matter
    Pages 221-291

About this book


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.


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Editors and affiliations

  • Robert A. Greenwald
    • 1
  • Mary Kay Ryan
    • 1
  • James E. Mulvihill
    • 2
  1. 1.Long Island Jewish-Hillside Medical CenterNew Hyde ParkUSA
  2. 2.University of Connecticut Health CenterFarmingtonUSA

Bibliographic information