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Stem Cell Ethics .pptx
- 1. Stem Cells Ethics Zahraa A. Watad Bpharm, MBA, MPharm zahraawatad@gmail.com
- 2. Outline Introduction Ethical Status Of Human Embryos Legality Of Human Embryo Research Patenting And Intellectual Property Informed Consent Stem Cell Therapy Medical Tourism
- 3. Introduction The use of human embryonic stem cells to replace damaged cells and tissues promises future hope for the treatment of many diseases. However, many countries now face complex ethical and legal questions as a result of the research needed to develop these cell-replacement therapies. Embryonic stem (ES) cell research offers the hope of cell- replacement therapy for diseases such as Parkinson disease, diabetes and cardiac myopathy. scientific and clinical challenges must be overcome before such therapies could become available These scientific efforts are also complicated by ethical concerns
- 4. Introduction SCIENTIFIC AND CLINICAL CHALLENGES : • Scientists need to learn how to direct pluripotent ES cells to differentiate into the required cell or tissue type. • Clinicians must then determine the transplanted cells’ immune compatibility with the host, and where, and in what amounts, to replace cells in diseased organs to achieve a therapeutic effect.
- 5. Introduction ETHICAL CONCERNS: • Obtaining human ES cells from aborted fetuses or from the destruction of early human embryos • Commodification of human reproductive materials • Fears about the possibility for human reproductive cloning • Uncertainties relating to the creation and use of human–animal hybrids and chimeras for research
- 6. Ethical Status Of Human Embryos
- 7. Ethical Status Those who believe that preimplantation human embryos are themselves persons or subjects with rights are against the destruction of embryos for research - Intentional destruction of an embryo is equivalent to murder Those who view the embryo as too rudimentary in development to have an inherent moral status generally permit this research - Believe that the embryo is different from ordinary human - Embryo is an object or thing can be invested with meaning, even if it lacks rights. “ Special Respect”
- 8. Ethical Status | Perspectives In Vitro Fertilization (IVF) treatment, for example, the generation of more embryos than can be safely transferred to the uterus is widely accepted as not being unduly disrespectful of human life, because it enables children to be born to infertile couples Similarly, destroying embryos that are left over from IVF procedures to develop cell-replacement therapies should also be ethically acceptable, for the goal of treating disease and saving life justifies the symbolic loss that arises from destroying embryos in the process Commercialization of Human embryos or using them in cosmetic-toxicology testing seems to be disrespectful of the symbolic meaning that many people attach to embryos because those uses fulfil no life-affirming, or other important, purpose.
- 9. Legality Of Human Embryo Research
- 10. The Use of ESC in Research The United States, the United Kingdom and many other countries permit the use of human fetal tissue for research when a woman’s decision to donate fetal tissue is clearly separate from the decision to abort Legal treatment of the use of human fetal tissue or the destruction of human embryos to obtain ES cells for research varies widely throughout the world. United Kingdom at present only permits human embryos to be used to study infertility, contraception and birth defects. Germany and France prohibit destructive embryo research. Other European union members are split on the question
- 11. Jurisdictions Of Stem Cell Research • Gene Therapy Advisory Committee • The Embryo Research Licensing Committee of the NHMRC (the Licensing Committee) • National Statement on Ethical Conduct in Human Research • Institutional (or Embryonic) Stem Cell Research Oversight Committees (ISCROs/ESCROs) • National Institutes of Health Guidelines for Research Using Human Stem Cells • CIHR Guidelines for Human Pluripotent Stem Cell Research • The Stem Cell Oversight Committee (SCOC). Canada Untied States UNITED KINGDOM Australia
- 12. Additional Jurisdictions Of Stem Cell Research In Canada, Protocols are subject to approval by a national research oversight body in addition to established research ethics reviews. “ Dual Review model” Institutions are required to establish special oversight committees In Australia, a requirement to obtain a specific license for certain types of embryo and stem cell research
- 13. Patenting And Intellectual Property Issues
- 14. Patentability An invention is patentable if it meets the relevant legal conditions to be granted a patent Requirments: • Patent-eligible subject matter • New • Useful • Nonobvious.
- 15. Patentability | United States The patentability of stem cells and stem cell research tools is dictated by U.S. Patent laws. In the light of, intellectual property protection of stem cell discoveries, there is one controversial question whether DNA is is patent-eligible subject matter. The supreme court held that isolated DNA is an unpatentable product of nature while cDNA is a non-naturally occurring genetic sequence and is patentable under the statute. Extrapolating to intellectual property rights in regenerative medicine, and use of stem cells in therapeutics, patentability of stem cells depend on the human manipulation of them in the lab It is recommended that researchers work very closely with their patent practitioners to ensure that their products are outside of the nature exception
- 16. Patentability | European Union EU Biopatent Directive was meant to assure harmonized patent protection for bio- technological inventions in the EU. Exemptions from patentability: Art. 6(1) of the directive states that “patents contrary to order, public and morality are excluded from patentability. Stem cell– based inventions Art. 6 (2) (c), which states that “uses of human embryos for industrial or commercial purposes” shall be excluded from patentability.
- 17. Patentability | European Union Court of Justice of the European Union (CJEU) voiced one exception, that the use of a human embryo for therapeutic or diagnostic purposes that were applied to the human embryo and were useful to it is patentable. The court found that where an invention does not itself “use” human embryos but relates to “a product whose production necessitates the prior destruction of a human embryo or a process that requires a base material obtained from such destruction,” that invention would not be patentable as it would constitute use within the meaning of article 6(2)(c) of the directive.
- 18. Informed Consent
- 19. Informed Consent • Informed And Voluntary Consent in research is required to fulfill the ethical principle of respect for persons. • This requirement is fundamental in international standards, such as the Helsinki Declaration • Stem-cell-specific standards from the International Society For Stem Cell Research. • Exception in US regulations : allows existing biological materials to be used for research without consent if they are de-identified
- 20. The Importance Of Informed Consent Two types of future research with stem cells—transplantation and reproductive research 1- Transplantation: solid organs, tissues, or allogenic cord blood. Reasons for obtaining consent: • Some people refuse to donate their organs to others, while other people accept. • The safety of transplant recipients. * Consent for recontact should be obtained
- 21. The Importance Of Informed Consent Two types of future research with stem cells—transplantation and reproductive research 1- Reproductive research: useful both for understanding gametogenesis and as a potential infertility treatment Reasons for obtaining consent: • Some people believe that embryos should not be created specifically for research purposes • Some people believe that IVF violates the natural law, they would object to such reproductive research using gametes derived from their somatic cells
- 22. Informed Consent • Researchers Must Respect Persons Who Donate Materials • Exhaustive disclosure of the details of research may be confusing and counterproductive. • Blanket consent or general consent might be objectionable . • It is recommended obtaining permission to recontact donors in the future, subject to IRB approval.
- 23. Stem Cell Medical Toursim
- 24. Medical Tourism . • Medical tourism: when a patient travels to another country for a medical care. • Reasons For Medical Tourism: 1. Affordable 2. Available 3. Timely 4. Acccesible Healthcare
- 25. Stem Cell Therapy Medical Tourism . • Medical tourism: when a patient travels to another country for a medical care • Stem Cell Medical Tourism: patients with a variety of diseases unresponsive to conventional treatment go abroad to receive stem-cell therapies Ethical concerns Unproven Unregulated Potentially dangerous or even fraudulent
- 26. Medical and Financial Risks Risk of receiving an unproven treatment Infectious disease transmission Complications associated with ineffective stem therapy Severe financial and socioeconomic consequences Lack of follow-up after treatment Importation of multidrug-resistant bacterial strains
- 27. Recommendations Educating patients and caregivers Informed healthcare consent Demonstrating an evidence-based understanding of the advantages and disadvantages
- 28. References. • Stem Cells: Intellectual Property Issues in Regenerative Medicine • Human embryonic stem cell research: ethical and legal issues • https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1000042 • International stem cell tourism: a critical literature review and evidence-based recommendations • Obtaining Consent for Future Research with Induced Pluripotent Cells:
Editor's Notes
- The primary cause of controversy remains the use and destruction of human embryos to derive stem cells or create human embryonic stem cell (hESC) lines, The resulting controversy has delayed or stopped human ES cell research in some countries,
- 1- The primary cause of controversy remains the use and destruction of human embryos to derive stem cells or create human embryonic stem cell (hESC) lines, The resulting controversy has delayed or stopped human ES cell research in some countries, 2- the potential for exploitation of donors (e.g. women donating eggs for the derivation of hESC lines 3- Human Cloning : the practice of creating or attempting to create a human being by transferring the nucleus from a human cell from whatever source into a human egg cell from which the nucleus has been removed 4- inserting human tissues or organs inside animals to study them.
- 1- those who view the human preimplantation embryo as a person or subject with rights and interests believe that the intentional destruction of an embryo is equivalent to murder. If that position is correct then the beneficial goal of saving or prolonging life would not matter, for no life may be taken to preserve the life of one or even many persons. **The neural development that is essential to have inherent moral status and interests in one’s own right is not present in the undifferentiated cells of preimplantation embryos. ES cells are derived from Inner Cell Mass. Only after implantation in the uterus does the embryo proper begin to establish its body plan, events that are later followed by the development of the nervous system 2-he embryo is a person but believe that the embryo is different from ordinary human tissue because of the unique potential it has to develop into a new human being Denial of the early embryo’s inherent moral status does not mean that the embryo is perceived as having no value. They consider as An object or thing can be invested with meaning, even if it lacks rights or interests in itself, special respect,’ this attitude towards human embryos shows or symbolizes our respect for human life generally
- The distinction between rights/duties and symbols explains many of the laws and regulations that exist in countries that permit embryo research.
- Policies vary by country, by region and even by university. American states permit ES cell research that requires the destruction of human embryos. creating new human embryonic stem cell lines and conducting research on them is legal, so long as federal funding is not used. Federal law prohibits the direct funding of embryo destruction to obtain such cells. Federal law permits the funding of research on human embryonic tissue that has been derived with private funds Austerila : has a mixture of position, in Victoria states its banned whereas in other states its permitted.
- ensure that research protocols in this complex and controversial area conformed to specific policy requirements Dual review: a situation in which more than one Institutional Review Board (IRB) oversees and reviews the same parts of a study
- laws of nature, natural phenomena, and abstract ideas are not patent-eligible subject matter. nonobvious : means your invention is not obvious to someone who is in the same industry, A new invention needs to be unexpected or surprising and cannot be anticipated by looking at the existing technology or prior art.
- In the United States, laws of nature, natural phenomena, and abstract ideas are not patent-eligible subject matter. In US , inventions involving stem cells are recognized as patent-eligible subject matter. The court went on to explain that “complementary DNA” was patent eligible as it is created in the laboratory, since a stem cell is a sophisticated, living organism and thus more complex than an isolated string of nucleobases. Much, however, may depend on the extent of human manipulation of the stem cell in the laboratory and how the subject matter of the discovery can be translated into meaningful claims in a patent The extent of “manipulation” required by this standard will depend on how removed from the “natural state” the isolated stem cell is, bearing in mind the unique abilities of stem cells.
- the patentability of biotechnological inventions in Europe is governed by the EU Directive
- the patentability of biotechnological inventions in Europe is governed by the EU Directive the only relevant standard to determine whether the patent violated of the German Patent Act was whether there are ways to harvest stem cells from a human embryo without destroying it
- The rationale for this exception is that there is no risk of physical harm to donors, and de-identifying materials greatly reduces the risk of breaches of confidentiality The exception might raise concerns becauxe of confidentialty
- Reason one: some people may not want their cells to become an integral, growing part of another person. While many people are eager to give the “gift of life,” others choose not to donate organs. Prior consent or general consent for unspecified research would not resolve the problem, because donors may not have considered the possibility of transplantation when providing somatic cells. Reason two: The interval between the original donation of the somatic cells and the proposed stem cell transplantation might be many years. If the donor developed cancer, or if a strong family history of cancer was recognized during this time, the risks to recipients might be increased. Screening the materials to be transplanted would fail to identify some risks to recipients, because the genetic basis of many inherited cancers has not been identified. it would be desirable to periodically obtain an updated medical and family history from the donor of a somatic cell line that is being used for repeated transplantations. Recontacting donors without their prior permission, however, might be considered an invasion of privacy. Hence, consent for recontact should be obtained
- some people strongly believe that embryos should only be created through sexual intercourse and that in vitro fertilization violates natural law . explicit, separate consent from donors of somatic cells should be required for reproductive research
- to avoid ethical issues Exhaustive consent contain a lot of details, a donor might refuse to donate. And he might a unique donor. a donor with a rare condition or mutation that would be extremely valuable to study may not agree to large-scale genome sequencing or injection into animals, even after attempts to explain the importance of such downstream research. Blanket consent or general consent, in which donors agree to all unspecified future studies using their materials, may be uninformed if donors are not told about the kinds of projects that might be considered objectionable. The ability to recontact donors offers the opportunity to discuss future research that is so innovative that it cannot be anticipated today . Obtaining consent for fundamental downstream research with iPS cells, together with offering the options of allowing recontact by researchers and giving permission for additional sensitive types of future research, will show respect for somatic cell donors, promote public trust in stem cell research, and allow optimal use of scientific discoveries. It would be a simpler if widely distributed cell lines could be used for all the procedures/ types of research rather than imposing different restrictions on different lines
- That is not present in their country. cost, perceived quality of care, long waiting times, domestic restrictions, inability to participate in clinical trials and lack of access to unapproved treatments.
- patients need to travel because the therapy is approved in only some countries; by way of example, on 1 July, Korea was the first country that approved the clinical use of adult stem cells to treat heart attack victims therapies are often unproven in clinical trials (Even well- proven therapies can lead to tumour formation, tissue rejection, autoimmunity, permanent disability and death . Other patients obtain unproven stem-cell treatments by participating in scientifically valid, legally sanctioned clinical trials, any patients pursue these treatments in desperation12 and when conventional medicine fails to adequately alleviate their symptoms.
- 2-As the majority of clinics offering these unproven treatments are based in low- and middle-income countries 2- coupled with the risk of travel-related illnesses from both communicable and non-communicable 3-complications such as infection, rejection, tumorigenesis and death 4-stem cell treatment is between US$10 000 and US$60 000, excluding travel expenses 5-This has wide-reaching economic implications for patients’ native health- care systems , if patients require follow-up care to treat complications and infections 6-global public health security implications through the heightened risk of importation of multidrug-resistant bacterial strains from countries with lower levels of antimicrobial stewardship.
- 1-. Educating patients and caregivers can help them make better informed healthcare decisions. patient autonomy must be respected, clinicians have a responsibility to provide patients with all relevant information to enable them to make a genuinely informed decision regarding their own care. 2- Informed healthcare consent is important because it helps to safeguard patient autonomy, empower patients during the course of their care and cultivate trust between physicians and their patients physician can demonstrate an evidence-based understanding of the advantages and disadvantages that these therapies entail,28 it will help to foster transparency and enhance the physician-patient relationship. Properly educating patients about the fraudulent claims made by stem cell clinics will ultimately protect against their exploitation.4