Chapter 5.     Use of Humans in Biomedical Experimentation

 

Paul S. Swerdlow and Francis L. Macrina
 

Resources

Print

Altman LK. 1998. Who Goes First? The Story of Self-Experimentation in Medicine. University of California Press, Berkeley, CA.

Bankert E, Amdur R. 2005. Institutional Review Board Management and Function, 2nd ed. Jones and Bartlett, Boston, MA.

Beecher HK. 1966. Ethics and clinical research. N Engl J Med 274:1354–1360.

Fulford KW, Howse K. 1993. Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers. J Med Ethics 19:85–91.

Harth SC, Johnstone RR, Thong YH. 1992. The psychological profile of parents who volunteer their children for clinical research: a controlled study. J Med Ethics 18:86–93.

Jones JH. 1993. Bad Blood: the Tuskegee Syphilis Experiment. The Free Press, New York, NY.

Kahn JP, Mastroianni AC, Sugarman J (ed). 1998. Beyond Consent: Seeking Justice in Research. Oxford University Press, New York, NY.

Koren G, Carmeli DB, Carmeli YS, Haslam R. 1993. Maturity of children to consent to medical research: the babysitter test. J Med Ethics 19:142–147.

Presidential Commission for the Study of Bioethical Issues. 2012. A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948. Presidential Commission for the Study of Bioethical Issues, Washington, DC. http://bioethics.gov/sites/default/files/Study%20Guide.pdf.

Reverby SM. 2009. Examining Tuskegee: the Infamous Syphilis Study and Its Legacy. University of North Carolina Press, Chapel Hill, NC.

Sugarman J, Mastroianni AC, Kahn JP (ed). 1998. Ethics of Research with Human Subjects: Selected Policies and Resources. University Publishing Group, Frederick, MD.

Online

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):

    http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Human Subjects Regulations Decision Charts (OHRP):

    http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

The Belmont Report may be accessed online at

    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

The Nuremberg Code may be accessed online at

    http://history.nih.gov/research/downloads/nuremberg.pdf

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

    http://www.wma.net/en/30publications/10policies/b3/

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

    http://www.cancer.gov/clinicaltrials/conducting/simplification-of-informed-consent-docs/page2

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

    http://www.thehastingscenter.org/

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

    http://www.nlm.nih.gov/archive//20061214/pubs/cbm/hum_exp.html

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

    http://privacyruleandresearch.nih.gov

NIH Guidelines for Human Stem Cell Research:

    http://stemcells.nih.gov/policy/pages/2009guidelines.aspx

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

    http://grants.nih.gov/stem_cells/registry/current.htm

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

    http://www.hhs.gov/ohrp/policy/publiclaw103-43.htm.html

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

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