Ethical issues in stem cell research and application

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1 Ethical issues in stem cell research and application Dr. Jeff Blackmer MD MHSc FRCPC Vice President Medical Professionalism Canadian Medical Association Ottawa, ON May 2016

2 Outline Ethics and stem cells Umbilical cord blood banking

3 Ethics What is ethics?

4 Dictionary.com: 1. a system of moral principles 2. the rules of conduct recognized in respect to a particular group or culture: e.g. medical ethics 3. that branch of philosophy dealing with values relating to human conduct, with respect to the rightness and wrongness of certain actions

5 Medical Ethics A system of applying ethical concepts and principles to the practice of medicine Every doctor agrees to abide by a Code of Ethics that sets forth the ethical norms and expectations of the profession

6 Canada

7 CMA Code of Ethics First adopted in 1868 Undergoes regular revisions to ensure it remains up to date Referenced by physician licensing bodies and Canadian courts All Canadian physicians are expected to abide by its contents

8 Importance of ethics in science Without considering the ethical implications of medicine, science and research we are missing a critical piece of the whole picture With rapid technological advances, taking the time to perform a critical ethical analysis is more important than ever History is full of examples where significant harm occurred to research subjects as a result of unethical research trials (WWII, Tuskegee and dozens of others)

9 Just because we can do something does not mean we should do it

10 Ethical issues in stem cell therapy The overarching ethical concern involves the destruction of an embryo to obtain stem cells While legally the debate (in most countries) has been settled as to when life actually begins, morally the issue is far from clear

11 If life begins at delivery, then there are no significant moral qualms because the developing embryo is not a human being and has no true moral status beyond its potentiality If life begins at conception, the issue becomes much more complicated

12 Pro-life groups feel that embryonic stem cell research and treatment represent destruction of one human being (or at the very least a potential human being) to help another and are therefore morally unacceptable The ends do not justify the means

13 Summary of ethical issues in stem cell research (Lo B End Rev 2009) Phase of research Donation of biological materials Research with hescs Use of stem cell lines derived at another institution Stem cell clinical trials Ethical issues Informed and voluntary consent 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 Conflicting legal and ethical standards Risks and benefits of experimental intervention Informed consent

14 The Canadian Institute for Health Research (CIHR) has created guidelines for human stem cell research to help address these ethical issues Available online at

15 Umbilical cord blood banking: Public versus private There has been a lot of recent attention paid to umbilical cord blood (UCB) banking UCB is a rich source of stem cells that most consider to be relatively ethically uncontroversial Prior to the baby s birth, parents can opt to donate the blood to a public UCB bank, or store it, for a cost, in a private UCB bank

16 Public UCB banks Advantages: Potentially, all patients who need the blood and are a match could benefit No individual costs Encourages altruism and societal engagement

17 Increases the number and diversity of cord blood units available for all patients Widespread donations by minorities will expand the available pool of minority cord blood units in the public system and make it easier for these groups to find matches

18 Disadvantages: Very costly, which limits the number of public banking options Does not reward individual donors, they cannot usually access their own UCB later on

19 Private UBC banks Advantages: Individual donors can always access their own blood later on, optimizing the chance of successful treatment (especially for a sibling) Generally indicated if an infant has a full sibling with a malignant or genetic condition treatable with cord blood transplantation or if there is a family history of malignant or genetic conditions that might benefit from cord blood stem cells

20 Theoretical possibility of future use for conditions such as Parkinson s, Alzheimer s, etc

21 Disadvantages: Expensive: initial costs and yearly storage fees Not accessible by all those in need Arguably not in keeping with the spirit of the Canadian health care system

22 Largely unregulated No universal guidelines, so there may be concerns regarding quality control (US experience) Only 1/2700 chance of actually needing the blood

23 Stem cell transplant using an individual s own cord blood (autologous transplant) cannot be used for genetic disorders such as sickle cell disease and thalassemia, because the genetic mutations which cause these disorders are also present in the baby's cord blood

24 Other diseases that are treated with stem cell transplant, such as leukemia, may also already be present in a baby s cord blood The SOGC, AAP and the AMA recommend against privately storing cord blood as a form of "biological insurance, because the potential benefits are too remote to justify the costs

25 Informed consent Three components: Patient capacity Disclosure of all information required Voluntariness

26 Challenges to informed consent in UCB banking: Vulnerability of new parents If you really love your baby, you ll do this. The way information is disclosed and statistics are presented What happens when parents disagree with each other

27

28 Summary Basic ethical principles can be used in medical and research ethics to help guide physicians and researchers to do the right thing Science without ethics has a great potential to do harm to individuals and to society

29 There are important ethical issues inherent in stem cell research and stem cell therapy that need to be considered This includes informed consent and the advantages and disadvantages of public and private UCB banking options

30

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