Chapter 5.     Use of Humans in Biomedical Experimentation


Paul S. Swerdlow and Francis L. Macrina



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The general reference used in preparation of this chapter was the Code of Federal Regulations, Title 45 Part 46, Protection of Human Subjects. This is available online at the website of the U.S. Public Health Service Office for Human Research Protections (OHRP):

Human Subjects Regulations Decision Charts (OHRP):

The Belmont Report may be accessed online at

The Nuremberg Code may be accessed online at

The World Medical Association Declaration of Helsinki may be accessed online at

The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has created online resources containing recommendations for writing informed consent documents. The NCI’s stated need in publishing recommendations is based on its observation that “many informed consent documents have become too long and complex, and do not provide a sound basis for informed decision-making.” The website contains recommendations aimed at clarifying and simplifying informed consent documents. These recommendations are accompanied by model templates and a number of useful appendix materials including definition of terms, federal regulations, checklists to facilitate writing easy-to-read informed consent documents, communication tips, and a bibliography. The NCI website may be accessed at

IRB: Ethics and Human Research provides a wealth of practical and useful information for those interested in human research. This periodical is published by the Hastings Center (Hastings-on-Hudson, NY) and is available in most university and medical center libraries. The current table of contents of this publication may be found online at

A powerful bibliography of books, audiovisual materials, and journal articles relevant to ethical issues in human subjects experimentation may be found online at

The impact of the Health Insurance Portability and Accountability Act (HIPAA) on research is reviewed online at

NIH Guidelines for Human Stem Cell Research:

Registry listing human embryonic stem cell lines eligible for NIH funding:

Part II of U.S. Public Law 103-43 deals with Research on Transplantation of Fetal Tissue and may be accessed at

Appendix material

Appendix IV of this book contains the text of a human subject protocol as well as examples of informed consent forms.

Figure 5.1 A simple decision tree for determining whether IRB review and approval are needed for your proposed work. doi:10.1128/9781555818487.ch5.f5.1