Jeff Nisker

Medical students' first clinical experiences of death

Medical Education 2010: 44: 421–428

Non-Invasive Prenatal Testing: Ethics and Policy Considerations

New technologies analyzing fetal DNA in maternal blood have led to the wide commercial availability of non-invasive prenatal testing (NIPT). We present here for clinicians the ethical and policy issues related to an emerging practice option. Although NIPT presents opportunities for pregnant women, particularly women who are at increased risk of having a baby with an abnormality or who are otherwise likely to access invasive prenatal testing, NIPT brings significant ethics and policy challenges. The ethical issues include multiple aspects of informed decision-making, such as access to counselling about the possible results of the test in advance of making a decision about participation in NIPT. Policy considerations include issues related to offering and promoting a privately available medical strategy in publicly funded institutions. Ethics and policy considerations merge in NIPT with regard to sex selection and support for persons living with disabilities.

Moral presentation of genetics-based narratives for public understanding of genetic science and its implications:

The increasing number of sequenced genes that can be used to develop tests for inherited conditions has stimulated an increasing number of genetics-based narratives by journalists, novelists, playwrights, filmmakers, and health-care educators. Genetics-based narratives are to be welcomed if the public is to understand genetic science and its implications on persons, families, and communities. However, a number of important ethical issues insist caution in their research and presentation. Just as the requirements for informed consent to undergo genetic testing exceed the requirements for informed consent to undergo other types of medical testing because of the inherent complex relationships (such as between parent and child, gene carrier and other family members, gene carrier and ethnic community) and because of concerns regarding privacy and insurance discrimination, the requirements for informed consent to present a genetics-based narrative must exceed the requirements for informed consent to present other medical narratives. We recommend that a transmedia, multidisciplinary, international conference should be convened to develop guidelines for the moral presentation of genetics-based narratives, whose deliberations should be informed by the protections provided for narrative research participants, the requirements of consent for genetic testing (which include a counseling process involving all appropriate family members), and a professional obligation to do no harm to the persons and families whose genetics-based stories we present.

Wrongful birth litigation and prenatal screening

Canadian clinicians must be aware of new standards of care resulting from national clinical practice guidelines, both to ensure best practice[1][1],[2][2] and to avoid malpractice litigation.[3][3],[4][4] Clinical practice guidelines can reduce successful malpractice actions through physician

Public Perceptions of Ethical Issues Regarding Adult Predictive Genetic Testing

The purpose of this study was to explore the views of members of the general public regarding ethical issues in adult predictive genetic testing. The literature pertaining to ethical issues regarding to adult predictive genetic testing is largely restricted to the views of ‘experts’ who have emphasized informed consent, patent issues, and insurance discrimination. Occasionally the views of patients who have undergone genetic counselling and testing have been elicited, adding psychosocial and family issues. However, the general public has not had the opportunity to contribute. In order to explore theatre as a health policy research tool, 1,200 audience members attended the play ‘Sarah’s Daughters’ in seven Canadian cities, following which audience discussions were audiotaped. This study performed a secondary qualitative analysis of the data to identify the ethical issues of adult predictive genetic testing important to members of the general public. The identified issues were: (1) need for public education; (2) choice to undergo genetic counselling and testing; (3) access to genetic counselling and testing; and (4) obligations regarding the handling of genetic information. Audience members emphasized public education and access to information regarding potential choices, which was different from the emphasis on informed consent and other ethical issues prominent in the literature. Members of the general public emphasized ethical issues that were different than those identified by experts and patients. It is essential that members of the public be included in complex and controversial public policy decisions.

The Latest Thorn by Any Other Name: Germ-Line Nuclear Transfer in the Name of “Mitochondrial Replacement”

J Obstet Gynaecol Can 2015;37(9):829–831 O February 3, 2015, the Parliament of the United Kingdom approved the use of “mitochondrial replacement” for women wishing to have a genetically related child who might then be at risk for a mitochondrial disorder.1 The United States Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee is considering a proposal to allow “mitochondrial replacement” in 2015.2 What is actually happening in “mitochondrial replacement” is not mitochondrial replacement; instead, it is the transfer of the nucleus from the oocyte of an IVF patient seeking to be a genetic parent to the enucleated oocyte of a woman who is being paid to undergo IVF to provide an ooplasmic vessel containing supposedly healthy mitochondria. The new reproductive genetics term “mitochondrial replacement” being substituted for germ-line nuclear transfer is reminiscent of other euphemisms used in reproductive genetics to open prickly barn doors to human research, as well as to gain clinical and public acceptance.

Socially based discrimination against clinically appropriate care

The Human Rights Challenge filed Aug. 18 in Ontario by Amir Attaran with Anna Ilha brought national attention to discrimination against socially disadvantaged Canadian women/couples who are seeking clinically appropriate care. Ontario publicly funded in vitro fertilization (IVF) from 1985 to April

Informed Consent to Donate Embryos for Research Purposes

OBJECTIVE To develop guidance for clinicians participating in the informed choice process with respect to the donation of human embryos for research purposes. RECOMMENDATIONS 1. As indicated in the Canadian Institutes of Health Research Guidelines and the Assisted Human Reproduction Act, specific consent from both the gamete and embryo providers is required before embryos can be used for research purposes. The gamete donors may be different individuals than the embryo providers when donated gametes are used to create embryos. 2. The consent process should inform potential donors of the possible types of (and for final consent, the specific) research project(s) for which the embryos will be used; the risks involved in donating embryos to research, such as not having these embryos available for their reproductive purposes; the fact that the woman/couple will not benefit personally from donating embryos to research; the potential for commercial gain by others; the possibility that they will be contacted in future about the disposition of the embryos; the fact that confidentiality cannot be absolutely guaranteed. 3. Designation of cryopreserved embryos no longer be required for reproductive purposes to be donated to research, donated to another couple, or discarded should be discussed prior to gamete retrieval and made at the time of cryopreservation, with the understanding that in the future, final consent will be requested. The final decision as to the donation of cryopreserved embryos research should not be made until after the woman/ couple decide they no longer require the embryos for their reproductive purposes. The decision to end cryopreservation should be made separately from the decision regarding disposition of the embryos. The woman/couple will have to be re-contacted regarding the final disposition of their embryos. 4. As a result of lack of scientific data regarding the predictability of microscopic characterization of embryos and potential for pregnancy, it is recommended that all women/couples be offered the opportunity to cryopreserve all embryos not transferred during the treatment cycle and be informed that a failure to cryopreserve all embryos may increase the chance of having to undergo an additional in vitro fertilization cycle to achieve reproductive goals. 5. Research participants should be informed that they may withdraw their consent at any time before the embryos are thawed for research purposes, or, in the case of stem cell research, before a stem cell line is created. 6. Potential donors should be informed that their medical care will not be affected by their decision regarding embryo donation.

The Canadian Assisted Human Reproduction Act: Protecting Women’s Health While Potentially Allowing Human Somatic Cell Nuclear Transfer into Non-Human Oocytes

Caulfield and Bubela (2007) argue that the Canadian Assisted Human Reproduction Act (An Act Respecting Assisted Human Reproduction and Related Research (S.C. 2004, c.2) imposes a complete “criminal ban” on somatic cell nuclear transfer (SCNT) that is unwarranted because, they contend, the ban was based on concerns regarding the moral status of the human embryo, which is inappropriate in a “pluralistic society.”

Simple genetics language as source of miscommunication between genetics researchers and potential research participants in informed consent documents.

Informed consent is based on communication, requiring language to convey meanings and ensure understandings. The purpose of this study was to investigate the use of language in informed consent documents used in the genetics research funded by Canadian Institutes of Health Research and Genome Canada. Consent documents were requested from the principal investigators in a recent round of funding. A qualitative content analysis was performed, supported by NVivo7™. Potential barriers to informed consent were identified, including language that was vague and variable, words with both technical and common meanings, novel phrases without clear meaning, a lack of definitions, and common concepts that assume new definitions in genetics research. However, we noted that difficulties in comprehension were often obscured because the words used were generally simple and familiar. We conclude that language gaps between researcher and potential research participants may unintentionally impair comprehension and ultimately impair informed consent in genomics research.