Ethical Challenges in Research with Human Biological Materials

Background and Module Content

Method and Scenarios

Readings (recommended for discussion of scenarios)

Objectives

Bibliography (for further reading)

Relevant Web Resources

Background and Module Content

Samples of human tissue, organs, blood and other materials have been collected and archived for over a century. A presidential commission attempted to determine the number of such tissues and found that a conservative estimate was 282 million specimens, with over twenty million new ones being added each year. The great majority of these specimens contain identifying information tying them back to the person who was their source. Many specimens are accompanied by clinical details of the person's condition. Specimens correlated with diseases have proven enormously useful in scientific research. Recently, scientists were able to sequence almost ten percent of the genome of the virus responsible for the 1918 influenza pandemic that killed over twenty million people. They used archived autopsied tissue from 198 soldiers. Studies in the 1950's of abnormal cervical tissue revealed that dysplastic changes often foreshadowed the development of cervical cancer; those studies gave a push to the development of the PAP smear. The APC (adenomatous polyposis coli) gene was uncovered using blanked specimens from families with a history of polyps and from people with colorectal cancers. Oscar Auerbach's meticulous studies of autopsied tissue from lungs demonstrated a correlation between smoking exposures and progressive changes in the bronchial tissue.

New methods in molecular biology and genetics allow ever more information to be extracted from human biological material. The scientific value of such specimens continues to increase; in some cases, the tissue may have considerable commercial value as well. The more scientific uses we make of human biological materials, the greater the concern about ethical issues. What counts as adequate consent for the research use of archived tissue samples? Should the source of the specimen be contacted and asked to reconsent? When the specimens are drawn from identifiable groups, should that group's approval be sought? Numerous statements were issued with the intent of providing ethical guidance in the use of human biological materials, but the statements often disagreed, used incompatible definitions of terms, or addressed only parts of the larger problem. A report from the National Bioethics Advisory Commission proposed a distinction between specimens stored in pathology collections and other repositories, and the samples derived from those specimens and provided to researchers. With the number, uses and value-- scientific and commercial-- of human biological materials growing rapidly, the ethical issues become ever more urgent.

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Method and Scenarios

• Distribution of scenarios to the students and faculty:
  • Interpreting Consent for Research on Archived Tissue
  • When the Proposed Research May Be Objectionable to the Source of the Tissue
  • Balancing Scientific Usefulness with Privacy
  • Commercialization
• Panel discussion based on these scenarios and questions and any others that students or faculty wish to add.
• Identify local specimen repositories, obtain copies of their policies, and discuss those policies in light of the scenarios above.
• Obtain copies of the local academic medical center's consent form concerning research uses of human biological materials, and discuss the adequacy of the consents obtained via that form.

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Readings (recommended for discussion of scenarios)

• Explanation of Federal Regulations (45CFR46) on research with human subjects, Part I and Part II. Reading Questions for Federal Regulations on research with human subjects.
• National Bioethics Advisory Commission (NBAC). Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I: Report and Recommendations of the National Bioethics Advisory Commission. NBAC: Rockville, Maryland, 1999.

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Objectives

Participants using this module should be able to:

• provide an even-handed interpretation of the consent given by sources of human biological materials, and of the permissible and impermissible uses of those samples.
• identify research likely to be objectionable to sources of tissue.
• describe some of the difficulties in making research samples truly anonymous.
• discuss the tension between maximizing information accompanying research samples and protecting the confidentiality of tissue sources.
• identify ethical issues in the commercial uses of donated tissue.

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Bibliography (for further reading)

Campbell, C.S. "Body, Self, and the Property Paradigm." Hastings Center Report. 22(5): 32-4, 1992.

McEwen, J. E. and Reilly, P. R., "Stored Guthrie Cards as DNA `Banks.'" American Journal of Human Genetics. 56(6): 1477-1486, 1995.

Merz, J. P., Sankar, P., Taube, S., and Livolsi, V."Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows." The Journal of Investigative Medicine. 45: 252-257, 1997.

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Relevant Web Resources

National Bioethics Advisory Commission (NBAC)

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume II: Commissioned Papers. NBAC: Rockville, Maryland, 2000. See especially, the paper by Allen Buchanan, "An Ethical Framework for Biological Samples Policy."

National Information Resource on Ethics and Human Genetics

is included at this Georgetown site. 22,000 volumes and 130,000 cataloged articles that deal with issues in molecular biology and human genetics with extensive links and database access.