Exam 4 Mfm Stem Cell Research And Ethics

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Fetal Research:

Study of ...
Use of fetal cells/tissues

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fetuses

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Fetal Tissue Transplantation Research:

Transplantation of ... cells/tissues

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multipotent

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In vitro Fertilization Research:

Reproduction of sperm and egg in ... setting

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laboratory

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Stem Cell Research:

Study of ... stem cells (stem cell that has the potential to differentiate into any of the 3 derm layers)

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pluripotent

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1. Fetal Research

A. Study of ... or the use of fetal cells/tissues obtained from spontaneous or induced abortions

B. Used in ... development and for the study of cell physiology and human development

C. Federally sanctioned in 1975
Prohibitions:
-1. Researchers are prohibited from having any involvement in a woman’s ... to terminate a pregnancy or assessing fetal viability
-2. Researchers is prohibited from altering the ... or ... of abortion
-3. ... for abortions is strictly PROHIBITED

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fetuses
vaccine
decision
timing
method
Payment

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2. Fetal Tissue Transplantation Research

A. Transplantation of ... cells/tissues obtained from spontaneous or induced abortions

B. Used to develop potential ... for diseases/disorders like diabetes and Parkinson disease

C. Federally sanctioned in accordance with the Health Revitalization Act (1993)

Safeguards in place to separate a women’s decision to ... from her decision to ... fetal tissue
1. Woman must first consent to abortion prior to the request and consent for the donation of fetal tissue
2. The option to donate fetal tissue is not to be discussed prior to a woman’s decision to abort, unless the information is specifically requested by the woman
3. ... is NOT provided for the fetal tissue
4. Separation is maintained between the abortion clinic and those involved in using the fetal tissue
5. Researchers are prohibited from altering the timing or method of abortion
6. Donors of fetal tissue are not allowed to designate a specific recipient of transplanted tissue (woman can't decide who receives that tissue)

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multipotent
treatments
abort
donate
Payment

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3. In vitro Fertilization Research

A. Fertilization of an egg by sperm ex utero under ... conditions

B. Used to understand and development treatments for ...; also used to derive ... cells

C. Moratorium in 1980 on federally funded IVF research

D. Derivation of stem cells prohibited by the Dickey-Wicker Amendment in 1995; blocked federal funding of any research that destroys, discards or subjects human embryos to serious risks

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laboratory
infertility
stem

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4. Stem Cell Research

A. Study of undifferentiated or ... stem cells

B. Used to understand factors in abnormal human development; potential use in treatment of genetic disorder or organ failure and transplantation

C. NIH guidelines permit use of stem cell lines previously derived from excess embryos created by IVF but deemed to be discarded; actual derivation of stem cells prohibited by the ... Amendment (forbids destruction of embryo for federally funded research)

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pluripotent
Dickey-Wicker

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1954-... in Medicine awarded to Enders, Weller and Robbins “for the discovery of the ability of poliomyelitis viruses to grow in cultures of various types of tissues”, first growth in human fetal brain tissue. Leads to the development of the polio vaccine.

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Nobel Prize

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1973-Roe vs. Wade ... of abortion

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legalization

Front 11

1974-National Research Act enacted as a result of the Tuskegee syphilis experiments
-protection of ... in research
-temporary moratorium on federally funded fetal research “before and after abortion”

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human subjects

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1975-DHHS issued regulations governing federally funded fetal research
-... treatment of fetuses; carried to term or those to be aborted
-funding allowed for research that poses “minimal risk” to fetus; anything of a greater risk prohibited

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equal

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1978-First ... baby born Louise Joy Brown
-born in Britain, July 25th
-questions arose regarding regulation of in vitro fertilization (IVF) research

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test-tube

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1979-Ethical Advisory Board (EAB) established
-approved IVF research as permissible
-use of ... funds; required each research application be reviewed and approved

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federal

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1980- EAB disbanded
-de facto moratorium on ... for IVF research and studies of early human embryos; still in effect today
-IVF continued in the ... sector without federal oversight or ethical review

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federal funding
private

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1988
-advent of techniques involving ... of fetal cells/tissues-Parkinson disease
-Reagan administration declared temporary moratorium on federal funding of fetal tissue transplantation research

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transplantation

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1993-Health Revitalization Act
-permitted ... funding of fetal tissue transplantation research

established safeguards and guidelines

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federal

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1994-Report of the Human Embryo Research Panel, Volume I
-considered various areas of research involving ex utero pre-implantation human embryos
-recommendations for federal funding of research for both embryos intended for and not intended for implantation
-Clinton only accepted recommendations for use of embryos that had been intended for implantation but were going to be ...

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discarded

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1995- ... Amendment
-banned use of federal funds for research in which a human embryo is created or destroyed
-Congress has actively renewed ban each year
-human embryo research remains in hands of private sector

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Dickey-Wicker

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1998-Creation of first human embryonic stem cell lines though ... funding
-James Thomson of the University of Wisconsin

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private

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1999-DHHS released legal conclusion that embryonic stem cells “ are not a human embryo within the definition”
-Dickey-Wicker Amendment as such does not apply
-allowed for ... funding

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federal

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2000-Publication of Clinton Administration guidelines
-Prohibited the ... of human embryos to derive stem cells
-Permitted research with stem cells derived from spare IVF embryos slated for destruction; sources were privately funded
-NIH began to accept proposals for stem cell research (not on embryos)

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destruction

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2001-Publication of Bush Administration guidelines
-withdrew funding guidelines Clinton administration authorized
-federal funding restricted to limited number of stem cell lines already ... by the private sector
-NIH told to stop review of applications

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created

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2002-Proposition 71 ... the first state to endorse human embryonic stem cell research
-... Stem Cell Research and Cures Act
-emphasis on stem cell and progenitor cell research

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California
California

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2004- ... establishes first state supported stem cell research facility

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New Jersey

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Moral issues surrounding various sources of stem cells (different types of stem cells):

... stem cells derived from pediatric/adult donors
-most people are not morally opposed
-tissue donation occur under appropriate conditions of consent
-downside is limited number of stem cells obtainable

... germ cell stem cells derived from aborted fetuses; spontaneous and induced
-least problematic ethically is the harvest of cells from spontaneous abortions
-technical problems include harvesting healthy cells (high incidence of fetal and chromosomal anomalies), amount of material limited, EG cells can only be obtained within first 8 weeks after fertilization (most spontaneous abortions during this period take place at home)

Embryos created through ... but not implanted in women treated for infertility

Embryos created through IVF for ... purposes

... Cell Nuclear Transfer

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Adult
Embryo
IVF
research
Somatic

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Significant moral questions arise around ... cells obtained by induced or elective abortions and the use of embryonic stem cells derived from embryos created by IVF:

1. Those who believe it is morally unacceptable to kill a fetus or embryo
-embryo is a person, meriting full and equal moral respect
-moment of fertilization/conception is the crucial beginning of personhood
-embryo has the same moral rights as any other human research subject

2. Those who believe that the pre-implantation embryo does not merit the same degree of moral protection given to children or adult human beings

3. Those who believe that personhood begins at different development stages:
A. Formation of the primitive streak
B. Onset of the heartbeat
C. Development of the nervous system
D. Commencement of brain activity
E. Sentience-ability to experience pain
F. Capacity for independent existence

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embryonic germ (EG)

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report of human embryo research panel (1994):

Research design must have significant or clinical benefit and conducted by qualified individuals

Research goals cannot be meet using animals or unfertilized gametes

Number of ... must be kept to a minimum

Donors must give ... to nature and purpose of research

No ... or ... of gametes or embryos

Research protocols/consent forms reviewed and approved

Equitable selection of donors among subgroups of pop (need representation of all populations in order for results to apply to all populations)

Research involving human embryos should not be permitted beyond appearance of ... (14 days)

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embryos
informed consent
purchase
sale
primitive streak

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Charge of the human embryo research Panel:

1. Consider research involving ex utero pre-implantation embryos and provide advice to areas that are acceptable for federal funding, warrant review, and are unacceptable for federal support.
2. Only encompasses research of embryos produced by ...; no research involving in utero human embryos

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IVF

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Panel's arguments for use of embryos as research subjects:

Study ... maturation; overcome need to hyperstimulate women undergoing IVF

Study of ... process; impact of freezing/thawing unfertilized eggs

Effect of harmful ... or chemicals on gametes/embryos

Need for adequate number of embryos to ... research of scientific or therapeutic value

... number of embryos remaining from IVF treatments

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oocyte
fertilization
drugs
validate
Limited

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Distinct ethical issues arise between the use of embryos created by IVF that are slated for destructed and those created for the sole intention as research subjects.

Many believe that embryos remaining from IVF are a “by-product of the otherwise well-intentioned act of trying to conceive a healthy child” while oocytes developed as research subjects lack even this “minimal justification”.

Others argue both types of embryos, those created as research subjects and those remaining from IVF treatments, have equivalent moral standing and should follow fall under the same research guidelines.

Panel argued there is a need to answer critical question in reproductive medicine. Allow for use of oocytes fertilized strictly for research purposes under the following two conditions:

1. Nature of research cannot be conducted validly otherwise
2. Necessary for ... of study that is potentially of outstanding scientific and therapeutic value

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validity

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2001 presidential press release on embryonic stem cell research:

Research ... funded for existing stem cell lines that were derived
-With informed consent of donor
-From excess embryos created solely for reproductive purposes
-Without ... compensation to donors

Ended up with 15 existing stem cell lines

Available for federally-funded research

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federally
financial

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“As a result of private research, more than 60 genetically diverse stem cell lines already exist” I have concluded that we should allow federal funds to be used for research on these existing stem cell lines “ where the life and death decision has already been made”, This allows us to explore the promise and potential of stem cell research” without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life.”
--George W. Bush
-reflects his commitment to preserve value and sanctity of human life
-promote vital medical ...
-does not sanction destruction of ... human embryos

NO ... funds will be used for
1. the derivation or use of stem cell lines derived from newly destroyed embryos
2. creation of any human embryos for research purposes
3. cloning of human embryos for any purposes

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research
additional
federal

Front 34

proposition 71: stem cell research

Creation of the ... Stem Cell Research and Cures Act
-3 million/year to fund stem cell research
-Priority given to stem cell research with greatest potential for therapies and cures (Focus on ... stem cell and progenitor cell research)
-Creation of Independent Citizen’s Oversight Committee (ICOC)
-Prohibits funding for human reproductive cloning

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California
pluripotent

Front 35

US law prohibits federal funds from being used on research that involves ... derived embryonic stem cell lines.
-Exemptions include: private sector funding AND state funding for biomedical research, including stem cells.

Approved 59.1% Disapproved 40.9%

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newly

Front 36

ICOC put forth following standards:
1. ...
-must be received from research donors, patients or participants
2. Controls on research involving ...
-based on the Institutional Review Board standards
3. Prohibition on compensation
-prohibits compensation to research donors, permits reimbursements of expenses
4. Patient privacy laws
-assures compliance with state and federal patient privacy laws
5. Limitations on payments for cells
-limits payments for purchase of stem cells or stem cell lines to reasonable payment for removal, processing, disposal, preservation, quality control, storage, transplantation or implantation
6. Time limits for obtaining cells
-limit on time during which cells may be extracted from blastocysts; #-# days after cell division begins

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Informed consent
humans
8-12

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where we are today:

# existing stem cell lines that are available for federally funded research
-Developed in the presence of mouse fibroblasts and maybe be contaminated with viruses or proteins

200,000-400,000 pre-implantation embryos slated for destruction in the US

A couple dozen stem cell lines established through ... funded sources
-Harvard, Juvenile Diabetes Research Foundation and Howard Hughes Medical Foundation

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privately