Sept. 10-16, 1999
Commission backs storage and use of human biological materials
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Presidential commission backs storage and use of human biological materials

Religious studies professor James Childress, left, shakes hands with President Clinton at a formal White House ceremony. Childress and other members of the National Bioethics Advisory Commission, which Clinton formed in 1995, were there to present one of four reports to the President.

By Rebecca Arrington

when medical procedures take place in hospitals and labs across the country, the biological materials retrieved -- biopsy specimens and organs and tissues removed during surgery -- aren't necessarily discarded. Instead, they may be kept and used for research purposes to increase knowledge about human diseases to better prevent, diagnose and treat them.

The use of such materials for research, however, raises a number of ethical issues. For example, these specimens can reveal clinical and sometimes personal information about individuals. Storage guidelines are also necessary, as there are now more than 282 million specimens of human biological material in laboratories, tissue repositories and health care institutions nationwide.

Such concerns prompted President Clinton in 1995 to establish the National Bioethics Advisory Commission (NBAC), a 17-member group of experts in the fields of law, medicine, public policy and biomedical ethics. Its charge has been to consider the rights and welfare of human research subjects and the management and use of genetic information. U.Va. religious studies professor James Childress is a member of the commission and has chaired its Human Subjects Subcommittee.

The commission solicited views from the science and research community, as well as the public, on the topic of human biological materials storage. In addition to Childress, two other U.Va. faculty members have been involved in the work of NBAC: Jonathan Moreno, professor and director of the Center for Biomedical Ethics, and John Fletcher, professor emeritus of biomedical ethics.

For the commission's report on "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance," delivered to President Clinton last month, NBAC focused on to what extent the existing Federal Policy for the Protection of Human Subjects fully meets its objective in research involving human biological materials. It also examined whether the policy provides clear direction to research sponsors, investigators, Institutional Review Boards (IRBs) and others regarding the ethical manner in which to conduct research using these materials.

In making its 23 recommendations, the commission focused its work on:

  • clarifying perceived difficulties in the interpretation of federal regulations and in the language of position statements of some professional organizations;
  • ensuring that research involving human biological materials will continue to benefit from appropriate oversight and review, while keeping additional burdens to a minimum;
  • providing investigators and IRBs with clear guidance regarding the use of human biological materials in research, particularly with regard to informed consent;
  • giving a coherent public policy for research in this area that will endure for many years and be responsive to new developments in science;
  • providing the public (including potential research subjects) with increased confidence in research.

"This report is a testament to the knowledge of, and interest in, these issues by patients, the research community, professional organizations and the public. Their input helped inform the commission's thinking and the report as a whole," Childress said.

The human biological storage report is NBAC's third. In 1997, the group issued its first report, on cloning humans. In 1998, it reported on "Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity." Moreno contributed a paper for that report and has served as a consultant for commission studies on other ethical issues in research involving human subjects. The commission's fourth report, on the ethics of research using human embryonic stem cells, was presented to President Clinton this week. Fletcher prepared a paper for that report.

Stem cells have generated great excitement among researchers because of their potential to continually reproduce themselves, according to the commission's report. The most fundamental type of stem cell, found in early embryos, has the ability to develop into nearly any cell type. The clinical promise of this new research is cell-replacement therapy for disorders caused by early cell death or injury, such as leukemia, diabetes, Alzheimer's, spinal cord injuries and liver and heart disease. Cell-replacement treatments could supplant such current practices as chemotherapy, organ transplants and hemodialysis.

Alongside such promising medical advances, however, are difficult moral and public policy concerns facing scientists, policy-makers and the public, ethicists said. Much of the controversy centers on the derivation of stem cells from fetal tissue following deliberate abortions or from embryos left over after in vitro fertilization (IVF). According to Childress, the commission has recommended that the ban on the use of federal funds for embryo research be modified to allow funding for research that derives and uses embryonic stem cells from embryos remaining after IVF, as long as several ethical guidelines are met.

Childress said he isn't sure whether NBAC will continue its work beyond October, when the group's charter is slated to expire. A record of the commission's work is online at http://www.bioethics. gov/cgi-bin/

"I've greatly enjoyed the past three years on the commission," Childress noted. "It's both exciting and difficult to try to resolve complex bioethical issues in a pluralistic society -- for instance, the topics of cloning humans and of human embryonic stem cell research that were thrust upon the commission because of new scientific developments. I have been especially interested in how religious and humanistic moral traditions can participate in shaping public policy in bioethics, while respecting divergent views."


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