Children As Research Subjects : Science, Ethics, and Law: Science, Ethics, and Law

Forside
Program in Medical Ethics Michael A. Grodin Director, Leonard H. Glantz Associate Director and Professor of Health Law both at the Boston University Schools of Medicine and Public Health
Oxford University Press, USA, 8. feb. 1994 - 272 sider
Is using children as research subjects ever justified? Are there limits to such use? Does the fact that children are medically and psychosocially different from adults have implications for research? What can we learn from the history of the use and abuse of children as research subjects? Do parents have the authority to volunteer their children for research projects? How should children participate in the decision to be involved in research? How should research risks be assessed and balanced? These perplexing questions and others are addressed by a distinguished group of experts in the field of biomedical and behavioral research with children. This book adopts an integrated multidisciplinary approach which uses science, ethics, and law as guides for exploring these most difficult issues. The tension between acquiring important new knowledge and fulfilling the obligation to protect children from exploitation and harm is a recurring theme. As the first book to be devoted solely to the science, ethics, and law of research with children, it is an indispensable resource to physicians, psychologists, educators, lawyers, ethicists, Institutional Review Board members, child advocates and others involved in performing or reviewing research with children.

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Utvalgte sider

Innhold

Scientific Issues in Biomedical Research with Children
29
Scientific Issues in Psychosocial and Educational Research
47
Ethical Issues in Exposing Children to Risks in Research
81
The Law of Human Experimentation with Children
103
Assessment of Risk to Children
181
Vulnerable Children
193
Appendices
215
Federal Regulations Pertaining to the Protection of Human Subjects
224
Index
244
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Populære avsnitt

Side 234 - Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.1 17. (6) When appropriate, the research plan makes adequate Provision for monitoring the data collected to ensure the safety of subjects.
Side 232 - ... of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
Side 222 - In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal...
Side 52 - Research Not Otherwise Approvable Which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of Children...
Side 229 - IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution...
Side 222 - ... it offers hope of saving life, reestablishing health or alleviating suffering. 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. 3. In any medical study, every patient including those of a control group, if any should be assured of the best proven diagnostic and therapeutic method.
Side 241 - ... requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity,...
Side 52 - IRB finds that: a. the risk represents a minor increase over minimal risk; b. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; c. the intervention or procedure is likely to yield generalizable knowledge about the subjects...
Side 112 - Constitutional rights do not mature and come into being magically only when one attains the state-defined age of majority. Minors, as well as adults, are protected by the Constitution and possess constitutional rights.

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