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Protection of Human Research Subjects

A Practical Guide to Federal Laws and Regulations

  • Book
  • © 1984

Overview

Authors:
  1. Dennis M. Maloney

    1. Boys Town USA Program, USA

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Table of contents (11 chapters)

  1. Front Matter

    Pages i-xxi
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  2. Guidelines for Research

    1. Front Matter

      Pages 1-1
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    2. Federal Commissions and Advisory Boards

      • Dennis M. Maloney
      Pages 3-46

    3. Institutional Review Boards

      • Dennis M. Maloney
      Pages 47-115

    4. Informed Consent

      • Dennis M. Maloney
      Pages 117-169

    5. How to Get Research Approved by an Institutional Review Board

      • Dennis M. Maloney
      Pages 171-253

    6. Freedom of Information and Privacy

      • Dennis M. Maloney
      Pages 255-310

  3. Research with Special Populations

    1. Front Matter

      Pages 311-312
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    2. Children

      • Dennis M. Maloney
      Pages 313-325

    3. Students

      • Dennis M. Maloney
      Pages 327-342

    4. Prisoners

      • Dennis M. Maloney
      Pages 343-360

    5. Fetuses, Pregnant Women, and in Vitro Fertilization

      • Dennis M. Maloney
      Pages 361-375

    6. Persons Institutionalized as Mentally Disabled

      • Dennis M. Maloney
      Pages 377-389

  4. Keep up with Changing Rules

    1. Front Matter

      Pages 391-391
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    2. How to Be Informed and Involved

      • James Sweetland
      Pages 393-415

  5. Back Matter

    Pages 417-420
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Keywords

About this book

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.

Authors and Affiliations

  • Boys Town USA Program, USA

    Dennis M. Maloney

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