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NCPHS - Research Involving ChildrenREPORT AND RECOMMENDATIONSResearch Involving Children THE NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH REPORT AND RECOMMENDATIONS Research Involving Children DHEW PUBLICATION NO. (OS) 77-0004 For sale by the Superintendent of Documents, U.B. Government Printing Office Washington, D.C. 20402 Stock No. 062-003-004111-3 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Westwood Building, Room 125 5333 Westbard Avenue Bethesda, Maryland 20016 September 6, 1977 The President The White House Washington, D.C. 20500 Dear Mr. President: On behalf of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, I am pleased to transmit our Report and Recommendations: Research Involving Children. This is one of several topics of study identified in the mandate to Commission under Public Law 93-348, which directs the Commission to submit its reports and recommendations to the President, the Congress, and the Secretary of Health, Education, and Welfare. The involvement of children in research raises particular ethical concerns because of their reduced autonomy and their incompetency to give informed consent. Such concerns would not be answered simply by restricting participation in research to persons who are competent to consent, for the conduct of research involving children is necessary not only to develop new treatment or preventive methods for conditions that jeopardize the health of children, but also to protect children from accepted though unvalidated practices that may be harmful to them. The Commission has therefore sought to answer the following two questions: under what conditions is the participation of children in research ethically acceptable, and under what conditions may such participation be authorized by the subjects and their parents. The Commission's answers to these questions are reflected in the recommendations set forth at the outset of our report. Substantial background materials, including legal and ethical discussions and statements of members of the Commission regarding the recommendations, are also presented in the report. An appendix volume contains a number of papers and reports to the Commission that were used in our deliberations. The Commission continues to find its work most challenging and to be grateful for the opportunity to provide assistance in areas of wide concern. Sincerely yours,
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