This document discusses the various public, legal, scientific, religious, and ethical views and approaches regarding stem cell research. It outlines the main ethical issues that arise during different phases of stem cell research, such as donation of biological materials, destruction of embryos, and risks of clinical trials. It also examines the ethical debates around specific types of stem cell research like embryonic stem cells, induced pluripotent stem cells, fetal stem cells, and somatic cell nuclear transfer. The document emphasizes the need for institutional oversight committees to properly review stem cell research proposals and ensure ethical standards are followed.

1. Presesnted By,
Pavithra B (16BIOB12)
II.M.Sc.BIOTECHNOLOGY
PUBLIC VIEW AND ETHICAL
APPROACHES ON STEM CELL
RESEARCH

2. Legal
Scientific
Religious
Ethical

3. Introduction
 STEM CELL RESEARCH offers great promise for
understanding basic mechanisms of human
development and differentiation, as well as the
hope for new treatments for diseases such as
diabetes, spinal cord injury, Parkinson’s disease,
and myocardial infarction .
 However, human stem cell (hSC) research also
raises sharp ethical and political controversies.
 The reprogramming of somatic cells to produce
induced pluripotent stem cells (iPS cells) avoids
the ethical problems specific to embryonic stem
cells.

4. Ethical issues at different phases of
stem cell research
Phase of research Ethical issues
Donation of biological materials Informed and voluntary consent
Research with hESCs Destruction of embryos
Creation of embryos specifically for
research purposes
1. Payment to oocyte donors
2. Medical risks of oocyte retrieval
3. Protecting reproductive interests of
women in infertility treatment
Use of stem cell lines derived at
another institution
Conflicting legal and ethical standards
Stem cell clinical trials Risks and benefits of experimental
intervention
Informed consent

5. Stem cell research raised difficult
questions:
 Does life begin at fertilization, in the womb, or at
birth?
 Is a human embryo equivalent to a human child?
 Does a human embryo have any rights?
 Might the destruction of a single embryo be
justified if it provides a cure for a countless
number of patients?
 Since ES cells can grow indefinitely in a dish, in
theory, still grow into a human being?

6. Problem Solved?
 With alternatives to hES cells now available, the debate
over stem cell research is becoming increasingly
irrelevant.
 But ethical questions regarding hES cells may not
entirely go away.
 For now, some human embryos will still be needed for
research. iPS cells are not exactly the same as hES
cells, and hES cells still provide important controls: they
are a gold standard against which the "stemness"
of other cells is measured.
 An additional ethical consideration is that iPS cells have
the potential to develop into a human embryo, in effect
producing a clone of the donor.
 Many nations are already prepared for this, having

8. Multipotent Stem Cells
 Adult stem cells and cord blood stem cells do not raise
special ethical concerns and are widely used in
research and clinical care.
 However, these cells cannot be expanded in vitro and
have not been definitively shown to be pluripotent.

9. Embryonic Stem Cell Research
 Pluripotent stem cell lines can be derived from
the inner cell mass of the 5- to 7-d-old blastocyst.
However, human embryonic stem cell (hESC)
research is ethically and politically controversial
because it involves the destruction of human
embryos.
 Opposition to hESC research is often associated
with opposition to abortion and with the “pro-life”
movement.

10. A. Existing embryonic stem cell lines
 In 2001, President Bush, who holds strong pro-life views,
allowed federal National Institutes of Health (NIH) funding
for stem cell research using embryonic stem cell lines
already in existence at the time, while prohibiting NIH
funding for the derivation or use of additional embryonic
stem cell lines.
 This policy was a response to a growing sense that hESC
research held great promise for understanding and treating
degenerative diseases, while still opposing further
destruction of human embryos.
 Originally, the NIH announced that over 60 hESC lines
would be acceptable for NIH funding. However, the majority
of these lines were not suitable for research; for example,
they were not truly pluripotent, had become contaminated,

11.  As of January 2009, 22 hESC lines are eligible for NIH
funding. However, these lines may not be safe for
transplantation into humans, and long-standing lines
have been shown to accumulate mutations, including
several known to predispose to cancer.
 Currently, federal funds may not be used to derive new
embryonic stem cell lines or to work with hESC lines
not on the approved NIH list.

12. B. New embryonic stem cell lines from frozen
embryos
 Several ethical concerns come into play when a
frozen embryo is donated, including informed
consent from the woman or couple donating the
embryo, consent from gamete donors involved in the
creation of the embryo, and the confidentiality of
donor information.
1. Informed consent for donation of materials for
stem cell research.
2. Waiver of consent.
3. Consent from gamete donors.
4. Confidentiality of donor information

13. C. Ethical concerns about oocyte donation for research
 Concerns about oocyte donation specifically for research
are particularly serious in the wake of the Hwang scandal in
South Korea, in which widely hailed claims of deriving
human SCNT lines were fabricated.
 In addition to scientific fraud, the scandal involved
inappropriate payments to oocyte donors, serious
deficiencies in the informed consent process, undue
influence on staff and junior scientists to serve as donors,
and an unacceptably high incidence of medical
complications from oocyte donation
 In California, some legislators and members of the public
have charged that infertility clinics downplay the risks of
oocyte donation.
 1. Medical risks of oocyte retrieval.
 2. Protecting the reproductive interests of women in
infertility treatment.
 3. Payment to oocyte donors

14. Somatic Cell Nuclear Transfer
(SCNT)
 In SCNT, reprogramming is achieved after transferring
nuclear DNA from a donor cell into an oocyte from
which the nucleus has been removed. However,
creating human SCNT stem cell lines has not only
been scientifically impossible to date but is also
ethically controversial
Ethical concerns about SCNT
 1. Objections to creating embryos specifically for
research.
 2. Objections to human reproduction using SCNT.
 3. Use of animal oocytes to create SCNT lines
using human DNA.

15. Fetal Stem Cells
 Pluripotent stem cells can be derived from fetal tissue
after abortion. However, use of fetal tissue is ethically
controversial because it is associated with abortion.
 Under federal regulations, research with fetal tissue is
permitted provided that the donation of tissue for
research is considered only after the decision to
terminate pregnancy has been made.
 This requirement minimizes the possibility that a
woman’s decision to terminate pregnancy might be
influenced by the prospect of contributing tissue to
research.
 Currently there is a phase 1 clinical trial in Batten’s
disease, a lethal degenerative disease affecting
children, using neural stem cells derived from fetal

16. Induced Pluripotent Stem Cells (iPS
Cells)
 iPS cells avoid the heated debates over the ethics of
embryonic stem cell research because embryos or
oocytes are not used. Furthermore, because a skin
biopsy to obtain somatic cells is relatively
noninvasive, there are fewer concerns about risks to
donors compared with oocyte donation.
 The President’s Council on Bioethics called iPS cells
“ethically unproblematic and acceptable for use in
humans”. Neither the donation of materials to derive
iPS cells nor their derivation raises special ethical
issues

17. Stem Cell Clinical Trials
 Transplantation of cells derived from pluripotent stem
cells offers the promise of effective new treatments.
However, such transplantation also involves great
uncertainty and the possibility of serious risks.
 Some stem cell therapies have been shown to be
effective and safe, for example hematopoietic stem cell
transplants for leukemia and epithelial stem cell-based
treatments for burns and corneal disorders
 These clinical trials should follow ethical principles that
guide all clinical research, including appropriate
balance of risks and benefits and informed, voluntary
consent.

18. Risks and prospective benefits in stem cell clinical
trials
 The risks of innovative stem cell-based interventions
include “tumor formation, immunological reactions,
unexpected behavior of the cells, and unknown long-
term health effects”
 Evidence of safety and proof of principle should be
established through appropriate preclinical studies in
relevant animal models or through human studies of
similar cell-based interventions.
 In older clinical trials of transplantation of fetal
dopaminergic neurons into persons with Parkinson’s
disease, transplanted cells failed to improve clinical
outcomes

19. Institutional Oversight of Stem Cell
Research
 Human stem cell research raises some ethical issues
that are beyond the mission of institutional review
boards (IRBs) to protect human subjects, as well as
the expertise of IRB members.
 There should be a sound scientific justification for
using human oocytes and embryos to derive new
human stem cell lines. However, IRBs usually do not
carry out in-depth scientific review.

20. A. The stem cell research oversight committee
(SCRO)
 An institutional SCRO with appropriate scientific and
ethical expertise, as well as public members, should
be convened at each institution to review, approve,
and oversee stem cell research.
 The SCRO will need to work closely with the IRB
and, in cases of animal research, with the
Institutional Animal Care and Use Committee.
 Because of the sensitive nature of hSC research, the
SCRO should include nonaffiliated and lay members
who can ensure that public concerns are taken into
account.