backs storage and use of human biological materials
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.
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
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.
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.
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.
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.
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
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
providing the public (including potential research subjects) with
increased confidence in research.
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.
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.
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.
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.
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/bioeth_counter.pl
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."