Arrogance of 'but all you need is a good index finger': A narrative ethics exploration of lack of universal funding of PSA screening in Canada.

This narrative ethics exploration stems from my happy prostate-specific antigen (PSA) story, though it should not have been, as I annually refuse my family physician's recommendation to purchase PSA screening. The reason for my refusal is I teach ethics to medical students and of course must walk the talk, and PSA screening is not publicly funded in the province of Ontario, Canada. In addition, I might have taken false comfort in 'but all you need is a good index finger' to detect prostate cancer, expounded by a senior physician at a national medical conference in 2010, and applauded by the large audience of physicians. I was compelled to begin this exploration out of survivor guilt, although I will not be a survivor for long, and as a mea culpa to the men similarly situated to me in having late diagnosis of prostate cancer, aggressive tumours and multiple metastases, but who unlike me are dead because they did not experience the physician-educator-based exceptionisms and coincidences that permit me to still be alive. Although my PSA story will always be a happy story, even when my life ends in a few years, the initiation of public funding of PSA screening for all men over 50 would make my PSA story an even happier story.

A brief and personal history of 'what's in a name' in reproductive genetics.

Although Juliet's claim, 'What's in a name? That which we call a rose by any other name would smell as sweet', may apply to family names, 'that which we call' embryos and procedures in reproductive genetics often smell sweet because the names were created to perfume not-so-sweet-smelling practices. Reproductive-genetic scientists and clinicians, including myself, have used perfumed names to make our research smell sweet for research ethics boards, research grant funders, government regulators, hospital administrators and the general public. The sweet-smelling names in reproductive genetics explored here include 'pre-embryo', preimplantation genetic 'diagnosis', 'normal' embryo, 'suitable' embryo, 'healthy' embryo, preimplantation genetic 'testing', 'non-invasive prenatal testing', 'donation', and most recently 'mitochondrial replacement therapy', a sweet-smelling name for germline nuclear transfer prohibited in antireproductive cloning legislation in most countries. In order for informed choices to occur for women who come to clinicians for information regarding reproductive genetics, and for transparency of scrutiny by research ethics boards, governmental regulators and the general public, it is essential that we consider the real meaning of sweet-smelling names in reproductive genetics.

Dissolution of Canada's Single-Tiered Health System Would Threaten the Health of Women with Disabilities.

Dissolution of Canada's single-tiered health system is now before the Supreme Court of British Columbia and will soon be before the Supreme Court of Canada. If our Supreme Court justices are persuaded to dissolve the Canada Health Act, financially advantaged Canadians will be permitted to purchase privileged access to physicians, diagnostic tests, and surgical facilities. This queue jumping will diminish access for the socioeconomically disadvantaged, among whom women are overrepresented, including women living with disabilities, women of Indigenous heritage, and women who have recently immigrated to Canada. For example, women with disabilities receive fewer Pap tests and mammograms, as do women of First Nations communities, who are also reported to have a higher incidence of cervical cancer deaths. The option for physicians to "opt out" of public care is particularly problematic in Canada because we have one of the lowest physician-to-patient ratios of "developed" countries. Social justice in health promotion in Canada is threatened by those who would dissolve the Canada Health Act in neoliberal-thinking ink because social justice can flourish only when the prevailing imperatives in our health system are equality and not wallet size, access and not gatekeeping, fairness and not finance. Social justice in health promotion insists on improving the social determinants of health of all Canadians, not just financially better-off Canadians who already have access to better health outcomes through better nutrition, better environments, and better access to health professionals.

Women's perspectives on the ethical implications of non-invasive prenatal testing: a qualitative analysis to inform health policy decisions.

BACKGROUND: Non-Invasive Prenatal Testing (NIPT) is a technology which provides information about fetal genetic characteristics (including sex) very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women's social and ethical values. We approach the need for ethical policy-making by studying the use of NIPT and emerging policy in the province of Ontario, Canada. METHODS: Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. RESULTS: The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. CONCLUSIONS: Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area.

Clinical Research With Pregnant Women: Perspectives of Pregnant Women, Health Care Providers, and Researchers.

Limited clinical research with pregnant women has resulted in insufficient data to promote evidence-informed prenatal care. Charmaz's constructivist grounded theory methodology was used to explore how research with pregnant women would be determined ethically acceptable from the perspectives of pregnant women, health care providers, and researchers in reproductive sciences. Semistructured interviews were conducted with a purposive sample of 12 pregnant women, 10 health care providers, and nine reproductive science researchers. All three groups suggested the importance of informed consent and that permissible risk would be very limited and complex, being dependent on the personal benefits and risks of each particular study. Pregnant women, clinicians, and researchers shared concerns about the well-being of the woman and her fetus, and expressed a dilemma between promoting research for evidence-informed prenatal care while securing the safety in the course of research participation.

"Mitochondrial Replacement" Technologies and Human Germline Nuclear Modification.

In 2015 the United Kingdom became the first jurisdiction to approve "mitochondrial replacement techniques" (MRT), thereby dropping prohibitions against creating human embryos with a permanently altered genetic make-up for purposes of reproduction. MRT is a misnomer because in fact it is the nucleus of the oocyte of the woman who wants a genetically related child that is transferred to the enucleated oocyte of a woman paid to undergo IVF to provide the oocyte. MRT thus constitutes nuclear transfer, which is prohibited by criminal sanctions under sections of laws on reproductive cloning in Canada, the United States, Australia, and European countries that regulate assisted reproduction. By adopting policies permitting the use of MRT, the United Kingdom has become the first jurisdiction to counteract an international consensus prohibiting germline modification. Analyses of the legal, ethical, and societal implications of MRT in assisted human reproduction are essential.

Implications of Applying Minimal Risk Standards in Clinical Research to Information Provision in Prenatal and Pre-conception Care.

BACKGROUND: There have long been minimal risk thresholds beneath which risks may not need to be discussed in clinical research. This threshold concept may be applied to clinical practice. Our research explored application of minimal risk standards in research regulations to providing information in prenatal and pre-conception care. METHODS: A case study approach applied minimal risk standards in research regulations to prenatal and pre-conception care with respect to the risks of excess alcohol consumption, folic acid insufficiency, exposure to phthalate plasticizers, and exposure to brominated flame retardants (BFRs). RESULTS: Excess alcohol consumption and folic acid insufficiency were found to be above the minimal risk standards as outlined in research regulations, while exposure to phthalates and BFRs requires more evidence to determine whether they are above minimal risk. However, applying the minimal risk standard based on the daily life of a healthy adult or a fetus in a healthy pregnant woman, phthalates and BFRs are at the minimal risk threshold regardless of their potential harm since all pregnant women may be exposed to these chemicals in their daily life. Nevertheless, if there is demonstration of sufficient evidence of harm, they may be above minimal risk if such harm can be reduced by individual choice to avoid exposure. CONCLUSION: The minimal risk concept in research regulations as applied to clinical practice may be useful to help clinicians and professional organizations determine what risks need be discussed in prenatal and pre-conception care.

Feelings of Women With Strong Family Histories Who Subsequent to Their Breast Cancer Diagnosis Tested BRCA Positive.

OBJECTIVE: Family physicians in Canada as reported in several studies do not recognize the importance of family history in relation to breast/ovarian cancer and thus Canadian women with strong family histories continue to develop early-onset breast cancer without the knowledge of or ability to make choices regarding increased surveillance or preventative strategies. This study explored the feelings of women who learned about their hereditary risk only after their diagnosis younger than 52 years and who eventually tested positive for a BRCA gene mutation. METHODS: Thirty-four such women were mailed an invitation to participate in this research including a letter of information, consent form, and discussion prompts for their written narrative response. Rigorous mixed method analyses were performed using Charmaz-based qualitative analyses as well as quantitative analyses. RESULTS: Thirteen women (38.2%) responded with narratives for qualitative analysis from which 4 themes were coconstructed as follows: I, types of emotions; II, emotional response; III, coping with emotions; and IV, advice to women at similar risk. Women felt they should have learned about their hereditary risk from their family physician and through public education before their diagnosis. Although not experienced at the time of diagnosis, anger, frustration, and regret were experienced after receiving their BRCA results. These emotions arose from our research participants' lack of opportunity for prior genetic counseling and testing opportunity for genetic counseling and testing. CONCLUSIONS: With increased public and physician education, it is hoped that women with significant family histories of breast/ovarian cancer will be identified before diagnosis and given options regarding cancer surveillance and risk reduction strategies.

Pregnant women's navigation of information on everyday household chemicals: phthalates as a case study.

BACKGROUND: Current developments in science and the media have now placed pregnant women in a precarious situation as they are charged with the responsibility to navigate through information sources to make the best decisions for her pregnancy. Yet little is known regarding how pregnant women want to receive and use health information in general, let alone information regarding the uncertain risks to pregnancy in everyday household products such as phthalates found in cosmetics and canned food liners. Using phthalates as an example, this study investigated how pregnant women obtain, evaluate, and act on information regarding their pregnancy. METHODS: Pregnant women were recruited using pamphlets and posters distributed in prenatal clinics, prenatal fairs and physician offices in Southwestern Ontario Canada. Research participants were engaged in 20 to 40 min semi-structured interviews regarding their use of information sources in pregnancy, particularly regarding phthalates in cosmetics and canned food liners. Interviews were transcribed verbatim and analyzed using constructivist grounded theory techniques supported by NVivo 9™ software. RESULTS: Theoretical sufficiency was reached after 23 pregnant women were interviewed and their transcripts analyzed. Three overlapping themes resulted from the co-constructed analysis: I-Strength of Information Sources; II-Value Modifiers; and III-Deciding to Control Exposure. The research participants reported receiving information from a wide range of sources that they perceived varying in strength or believability. They then described the strategies employed to increase the validity of the message in order to avoid risk exposure. Pregnant women preferred a strong source of information such as physician, government but frequently used weak sources such as the internet or the opinions of friends. A model was developed from the relationship between themes that describes how pregnant women navigate the multiple sources of information available to them. CONCLUSION: Our study provides insight into how pregnant women receive, appraise, and act on information regarding everyday household chemicals. Clinicians and their professional organizations should produce specific educational materials to assist women in understanding exposure to everyday products in pregnancy.

Implications of the concept of minimal risk in research on informed choice in clinical practice.

The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients.

Tensions between anonymity and thick description when "studying up" in genetics research.

Anonymity, according to Tilley and Woodthorpe, refers to removing or obscuring participant information, whereas "confidentiality refers to the management of private information." Both are major considerations for ethics review boards, but can be challenges when "studying up" in qualitative research because of the depth, precision, and uniqueness of the information, and the prominence of research participants. In anthropology, providing detailed and nuanced accounts of particular spaces, events, and conditions is essential. Actions taken to hide or gloss over these particulars would impede the ability to demonstrate authenticity, validity, and verisimilitude. As social science moves into field sites such as cutting-edge genomics, where when studying up, participants through their particular contributions might be identified, strategies to decrease the friction between descriptive methodologies and the requirement for anonymity need to be developed. We conclude with recommendations for researchers and members of research ethics boards regarding how to anticipate and mitigate this tension.

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.

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.

Les nouvelles techniques qui font appel à l'analyse de l'ADN fœtal dans le sang maternel ont mené à l'élargissement de la disponibilité commerciale du dépistage prénatal non effractif (DPNE). Nous présentons ici, à l'intention des cliniciens, les questions d'éthique et de politique qui sont associées à une option de pratique émergente. Bien que le DPNE offre des possibilités aux femmes enceintes (et particulièrement aux femmes qui sont exposées à des risques accrus de donner naissance à un enfant présentant une anomalie ou qui sont autrement susceptibles d'avoir recours au dépistage prénatal effractif), il donne lieu à des défis considérables en matière d'éthique et de politique. Les multiples aspects de la prise d'une décision éclairée (comme l'accès à des services de counseling au sujet des résultats possibles du test avant la prise d'une décision quant à la participation au DPNE) font partie des enjeux éthiques. Parmi les considérations en matière de politique, on trouve les questions liées à l'offre et à la promotion, au sein d'établissements subventionnés par l'État, d'une stratégie médicale offerte au privé. Les considérations en matière d'éthique et de politique s'entremêlent dans le cas du DPNE, pour ce qui est des questions relevant de la sélection du sexe et de l'offre d'un soutien aux personnes qui vivent avec des incapacités.

Views of pregnant women and clinicians regarding discussion of exposure to phthalate plasticizers.

OBJECTIVE: This study explores the views of pregnant women and clinicians regarding discussion of exposure to phthalate plasticizers during pregnancy, subsequent to the 2011 Health Canada ban of certain phthalates at a concentration greater than 1000 mg/kg in baby toys. This occurred with no regulation of products to which pregnant women are exposed, such as food packaging and cosmetics. METHODS: Pregnant women, physicians and midwives were recruited through posters and pamphlets in prenatal clinics in Southwestern Ontario for a semi-structured interview. All interviews were audiotaped, transcribed, and subjected to rigorous qualitative analysis through a grounded theory approach, supported by NVIVO™ software. Themes emerged from line by line, open, and axial coding in an iterative manner. RESULTS: Theoretical sufficiency was reached after 23 pregnant women and 11 clinicians had been interviewed. The themes (and subthemes from which they arose) were: Theme I-Information Provision (IA-Sources of Information, IB-Standardization, IC-Constraints, ID-Role of Government); Theme II-Risk (IIA-Significant Risk, IIB-Perceived Relevance, IIC-Reconciliation); and Theme III- Factors Influencing Level of Concern (IIIA-Current Knowledge, IIIB-Demographic Factors). CONCLUSION: To respond to the increasing media and research attention regarding risk of phthalates to women, and pregnant women in particular, national professional organizations should provide patient information. This could include pamphlets on what a pregnant woman should know about phthalates and how they can be avoided, as well as information to clinicians to facilitate this discussion.