In the 1960s, newborn screening programs tested for a single very rare but serious disorder. In recent years, thanks to the development of new screening technology, they have expanded into panels of tests; a federally sponsored expert group has recommended that states test for twenty-nine core disorders and twenty-five secondary disorders. By the standards used to decide whether to introduce new preventive health services into clinical use, the decision-making in newborn screening policy has been lax.

Scientific and technological advances are lending pressure to expand the scope of newborn screening. Whereas this has great potential for improving child health, it also challenges our current perception of such programmes. Standard newborn screening programmes are clearly justified by the fact that early detection and treatment of affected individuals avoids significant morbidity and mortality. However, proposals to expand the scope and complexity of such testing are not all supported by a similar level of evidence for (...) unequivocal benefit. We argue that screening for genetic susceptibility to complex disorders is inherently different from standard screening and, while of potential value, must be considered separately from conventional testing. (shrink)

ObjectiveTo investigate the attitudes of Chinese parents regarding the storage of dried blood spots collected for newborn screening (NBS) and their use in research.MethodsWe conducted a hospital-based survey of parents and examined parental attitudes regarding (a) allowing NBS sample storage, (b) permitting use of children’s NBS samples for research with parental permission, and (c) permitting use of children’s NBS samples for research without parental permission.ResultsThe response rate was 52 percent. Of parents surveyed, 68 percent would permit their infant’s (...) NBS sample to be stored for at least some length of time. If permission is obtained, 69 percent of parents “strongly agreed” or “agreed” to permit use of the NBS sample for research. If permission is not obtained, only 14 percent of parents “strongly agreed” or “agreed.” There was no significant association between permitting use of NBS samples for research and parental gender, education, household income, number of children, or site of residence.ConclusionsThis is the first survey of Chinese parents regarding the use of NBS samples for different types of research, with results indicating that most parents would permit their infant’s sample to be stored and would support the use of NBS dried blood spots for research purposes. (shrink)

Debates about expanding newborn screening with whole genome sequencing are fueled by data about public perception, public opinion, and the positions taken by public advocates and advocacy groups. One form of evidence that merits attention as we consider possible uses of whole‐genome sequencing during the newborn period is parents’ (and children's) diverse experiences with existing expanded screening protocols. What do we know about this experience base? And what implications might these data have for decisions about how (...) we use whole genome sequencing and how we assess its impact in the future? Although the broader literature on genetic susceptibility testing suggests that testing usually does not have adverse effects on children's psychosocial well‐being, certain newborn screening results have been demonstrated to cause distress, alter behavior, and even to influence the formation of new parental and family identities. (shrink)

In their article, Dees and Kwon (2013) describe the case of newborn screening for Krabbe disease and argue compellingly that a mandatory newborn screening program for this disease is problematic in several respects. Therefore, they submit, testing on Krabbe disease should only be offered on a voluntary basis, under a research protocol. In my opinion, Dees and Kwon are correct to point out the problematic character of a mandatory screening program for Krabbe disease. Their move (...) toward a research paradigm is however problematic. More specific, their proposal presents problems for the role of informed consent in Krabbe testing. (shrink)

Newborn screening consists of taking a few drops of blood from a baby's heel in the first week of life and testing it for a list of disorders. In the United States and most countries in Europe, newborn screening programs began in the 1960s and 1970s with screening for phenylketonuria (PKU), a rare metabolic disease that causes severe and irreversible mental retardation unless treated before problems arise. As knowledge about rare diseases expanded and new (...) class='Hi'>screening technologies were introduced—such as the tandem mass spectrometer and high‐performance liquid chromatography—the same blood sample could be used to test for a whole list of disorders. In general, screening programs in most countries have tended to expand, but in different countries they have expanded in different ways. Regulation also varies. In some states, screening is mandatory, whereas in others—Wyoming and Maryland—parents are asked for their informed consent. Germany and France have adopted an explicit informed consent procedure, whereas other European countries have a more informal “opt‐out” procedure that does not require signing an informed consent form. Whether newborn screening requires informed consent is an ongoing issue in bioethics. In this article, we will focus on the tension between informed consent and the problem of compliance in newborn screening. Asking for informed consent—allowing parents to opt out—is often thought to pose a threat to compliance. Building on the work of Onora O'Neill on informed consent and trust, however, as well as on work she coauthored with Neil Manson, we will argue that informed consent procedures may actually help maintain trust in newborn screening and may therefore support compliance. (shrink)

The experience of newborn screening for Krabbe disease in New York State demonstrates the ethical problems that arise when screening programs are expanded in the absence of true understanding of the diseases involved. In its 5 years of testing and millions of dollars in costs, there have been very few benefits, and the testing has uncovered potential cases of late-onset disease that raise difficult ethical questions in their own right. For these reasons, we argue that Krabbe (...) class='Hi'>screening should only be continued as a research project that includes the informed consent of parents to the testing. (shrink)

Newborn screening (NBS) began in the 1960s by testing all newborns for a single condition—phenylketonuria, or PKU—which, when identified and treated early, significantly reduces morbidity. Over the...

Objects: With the advent of genetic technologies, many genetic/metabolic disorders can be detected asymptomatically but might be untreatable, and the benefits and risks of screening for them are not fully known. The purpose of this study is to explore current practice with regard to the parental consent process in newborn screening .Design: Staff in 23 obstetric clinics/hospitals that conduct NBS in one city of southern Taiwan were interviewed. Using content analysis, 15 interview transcripts, eight completed questionnaires, and (...) other relevant documents from the 23 clinics/hospitals were analysed to reveal the framework of the parental consent process in NBS in southern Taiwan.Main measures: Three categories—informed consent, informed dissent, and no informed/consent—were developed to analyse the parental consent process in NBS.Results: The parental consent procedures in NBS and the quality of the information provided before obtaining consent vary widely. Because the traditional NBS was incorporated into routine paediatric practices in most clinics/hospitals, the most frequently encountered consent model is “informed dissent” and “no informed/consent” ; while an “informed consent” model is the frequent model for screening rare metabolic/genetic disorders.Conclusions: Specific guidelines to regulate the parental consent process for NBS are essential. Further studies should investigate parental responses to NBS, taking these as the basis on which to establish an informed consent model in Taiwan. (shrink)

Most babies born each year in the U.S. undergo mandatory newborn screening to detect serious medical conditions that can cause devastating effects if treatment is not initiated prior to the onset of symptoms. Not all of the blood collected from newborns is used during routine newborn screening, and many states retain the residual dried blood samples. DBS have a broad range of potential uses, from program evaluation to public health and biomedical research unrelated to newborn (...) screening. State laws vary regarding whether parental consent is required to use DBS for secondary research, but federal now requires parental consent for the use of DBS in federally funded research. (shrink)

Advances in genomic medicine have lead to debate about the potential inclusion of genetic tests for susceptibility to common complex disorders in newborn screening programmes. Empirical evidence concerning psychosocial reactions to genetic testing is a crucial component of both ethical debate and policy development, but while there has been much speculation concerning the possible psychosocial impact of screening newborns for genetic susceptibilities, there remains a paucity of data. The aim of the study reported here is to provide (...) some of this missing empirical evidence, using type 1 diabetes as an example of a common disorder with multiple significant genetic contributors to its aetiology. Semi-structured interviews were conducted with 11 parents of babies who had received increased risk results in a study that involved newborn screening for genetic susceptibility to type 1 diabetes. Interpretative phenomenological analysis was used to evaluate the data. The interview data suggest that the probabilistic nature of results of genetic susceptibility tests impacts upon all aspects of parents' psychosocial reactions, resulting in a complex and dynamic process quite different to that described in relation to current newborn screening programmes. While parents generally reported fairly minor levels of concern in response to news of their child's increased genetic risk, these worries frequently recurred, and perception of risk also varied and fluctuated over time. Both individual and contextual factors appeared to interact with the inherent uncertainty of the test result to contribute to the dynamic nature of parental reactions, and their behavioural responses. The implications of these findings for future research and for the debate concerning potential expansion of newborn screening are discussed. (shrink)

Newborn screening involves the collection of blood from the heel of a newborn baby and testing it for a list of rare and inheritable disorders. New biochemical screening technologies led to expansions of NBS programs in the first decade of the 21st century. It is expected that they will in time be replaced by genetic sequencing technologies. These developments have raised a lot of ethical debate. We reviewed the ethical literature on NBS, analyzed the issues and (...) values that emerged, and paid particular interest to the type of impacts authors think NBS should have on the lives of children and their families. Our review shows that most authors keep their ethical reflection confined to policy decisions, about for instance the purpose of the program, and its voluntary or mandatory nature. While some authors show appreciation of how NBS information empowers parents to care for their children, most authors consider these aspects to be ‘private’ and leave their evaluation up to parents themselves. While this division of moral labor fits with the liberal conviction to leave individuals free to decide how they want to live their private lives, it also silences the ethical debate about these issues. Given the present and future capacity of NBS to offer an abundance of health-related information, we argue that there is good reason to develop a more substantive perspective to whether and how NBS can contribute to parents’ good care for children. (shrink)

Some state‐based newborn screening programs in the United States already use sequencing technology, as a secondary screening test for individual conditions rather than as a broad screening tool. Newborn screening programs sequence an individual gene, such as the cystic fibrosis transmembrane conductance regulator, which causes cystic fibrosis, after an initial biochemical test suggests that a baby might have a condition related to that gene. The experiences of state public health departments with individual‐gene sequencing illustrate (...) both the usefulness of the technology and its complexities. Here I discuss how newborn screening programs investigate cystic fibrosis and, as another example, adrenoleukodystrophy through individual gene sequencing. (shrink)

For over four decades, knowledge that symptoms of some inherited diseases can be prevented or reduced via early detection and treatment in newborns has underpinned state-funded screening programs in most developed countries. Conditions for which newborn screening is now a recognized preventative public health initiative include phenylketonuria, congenital hypothyroidism, and, more recently, cystic fibrosis and sickle cell disorder. The use of tandem mass spectrometry to detect conditions such as amino-acidopathies and fatty-acid oxidation defects is also becoming increasingly (...) prevalent. a. (shrink)

Hom and colleagues (2016) argue in favor of allowing religious exemptions to congenital critical heart disease (CCHD) newborn screening, but the logic of their position is at odds with the moral ju...

AimTo explore new mothers' knowledge of newborn screening, and their attitudes towards issues surrounding sample retention and the potential for blood screening samples to be used for research.MethodsA self-administered mail survey was sent to women who gave birth in Perth, Western Australia during January 2005. A total of 600 women completed the survey.ResultsIt was found that women were aware of newborn screening, however desired further information in order to acquire a more comprehensive knowledge of the (...) test. Further, women reported discomfort with the long-term storage of cards, but they were supportive of using blood samples for medical research, contingent upon the samples being de-identified and parental consent provided.ConclusionsNew mothers need to be provided with comprehensive information about the newborn screening test at a time which is conducive for the assimilation of this information. In addition, whilst supporting health related research using newborn screening samples, new mothers are keen for ethical issues to be sufficiently addressed prior to samples being systematically stored for extended periods of time. (shrink)

Objectives: To gather information about the practices and attitudes of providers of maternity care with respect to informed consent for newborn screening .Methods: A questionnaire concerning information provision and parental consent for NBS was sent to all 1036 registered lead maternity carers in New Zealand.Results: 93% of LMC in New Zealand report giving parents information concerning NBS, most frequently after delivery and in the third trimester . The majority of LMC currently obtain some form of consent for NBS (...) from parents and consider this to be the ideal approach . Despite this a significant minority of LMC reported considering that NBS should be mandatory. Of those in our survey who believed that NBS should be mandatory, paradoxically most still believed that some form of parental consent should be obtained; of those who believed testing should not be mandatory, only a small proportion would accept parental refusal without question.Conclusions: When the results of this survey are considered in conjunction with existing evidence there appears to be a consensus that good quality information in the prenatal period should be an integral part of any NBS programme. The issue of consent is more complex and there is less agreement on the preferred degree of parental involvement in decisions to allow babies to undergo NBS. A policy that both strongly recommends NBS but also allows parental choice appears to be most consistent with the views of LMC in this survey. (shrink)

Massively parallel sequencing, also known as next‐generation sequencing, has the potential to significantly improve newborn screening programs in the United States and around the world. Compared to genetic tests whose use is well established, sequencing allows for the analysis of large amounts of DNA, providing more comprehensive and rapid results at a lower cost. It is already being used in limited ways by some public health newborn screening laboratories in the United States and other countries—and it (...) is under study for broader and more widespread use, including as a core part of newborn screening programs. Sequencing technology has the potential to significantly improve these essential public health programs. For many of the conditions that newborns are already screened for, sequencing can return more specific and more sensitive results. The technology could also enable newborn screening programs to expand the list of rare pediatric conditions that they look for, thereby identifying more infants who can benefit from immediate care. (shrink)

Background: Expanded newborn screening generates incidental results, notably carrier results. Yet newborn screening programmes typically restrict parental choice regarding receipt of this non-health serving genetic information. Healthcare providers play a key role in educating families or caring for screened infants and have strong beliefs about the management of incidental results. Methods: To inform policy on disclosure of infant sickle cell disorder (SCD) carrier results, a mixed-methods study of healthcare providers was conducted in Ontario, Canada, to understand (...) attitudes regarding result management using a cross-sectional survey (N = 1615) and semistructured interviews (N = 42). Results: Agreement to reasons favouring disclosure of SCD carrier results was high (65.1%–92.7%) and to reasons opposing disclosure was low (4.1%–18.1%). Genetics professionals expressed less support for arguments favouring disclosure (35.3%–78.8%), and more agreement with arguments opposing disclosure (15.7%–51.9%). A slim majority of genetics professionals (51.9%) agreed that a reason to avoid disclosure was the importance of allowing the child to decide to receive results. Qualitatively, there was a perceived “duty” to disclose, that if the clinician possessed the information, the clinician could not withhold it. Discussion: While a majority of respondents perceived a duty to disclose the incidental results of newborn screening, the policy implications of these attitudes are not obvious. In particular, policy must balance descriptive ethics (ie, what providers believe) and normative ethics (ie, what duty-based principles oblige), address dissenting opinion and consider the relevance of moral principles grounded in clinical obligations for public health initiatives. (shrink)

As a psychologist and an ethicist, we have explored empirically newborn screening consent and communication processes. In this paper we consider the impact on families if newborn screening uses whole genome sequencing. We frame this within the World Health Organization’s definition of health and contend that proposals to use whole genome sequencing in newborn screening take into account the ethical, practical and psychological impact of such screening. We argue that the important psychological processes (...) occurring in the neonatal phase necessitate a clear justification that providing risk information at this stage provides a health benefit. We illustrate how research on current newborn screening can inform whole genome sequencing debates, whilst highlighting important gaps. Obtaining explicit, voluntary, and sufficiently informed consent for newborn screening is challenging, however we stress that such consent is ethically and legally appropriate and psychologically and practically important. We conclude by outling how this might be done. (shrink)

Virtually every infant in the United States (U.S.) undergoes a heel stick within the first week of life to test for a variety of metabolic, endocrine, and hematological conditions as part of state-run universal newborn screening (NBS) programs. In the U.S., NBS began in the 1960s for phenylketonuria (PKU), a metabolic condition that causes intellectual disability if left untreated. I review the history of how NBS came to be a mandatory public health program that did not require parental (...) consent1 and examine whether the policy was morally justifiable. I then examine how three changes to NBS programs are prompting a re-evaluation of the mandatory nature of NBS. The three changes are: (1) the implementation of .. (shrink)

The possible integration of genomic sequencing (including whole‐genome and whole‐exome sequencing) into the three contexts addressed in this special report—state‐mandated screening programs, clinical care, and direct‐to‐consumer services—raises related but distinct legal issues. This essay will outline the legal issues surrounding the integration of genomic sequencing into state newborn screening programs, parental rights to refuse and access sequencing for their newborns in clinical and direct‐to‐consumer care, and privacy‐related legal issues attending the use of sequencing in newborns.

Background Residual dried blood spots (rDBS) from newborn screening programmes represent a valuable resource for medical research, from basic sciences, through clinical to public health. In Hong Kong, there is no legislation for biobanking. Parents’ view on the retention and use of residual newborn blood samples could be cultural-specific and is important to consider for biobanking of rDBS. Objective To study the views and concerns on long-term storage and secondary use of rDBS from newborn screening (...) programmes among Hong Kong Chinese parents. Methods A mixed-method approach was used to study the views and concerns on long-term storage and secondary use of rDBS from newborn screening programmes among Hong Kong Chinese parents of children 0–3 years or expecting parents through focus groups (8 groups; 33 participants) and a survey (n = 1012, 85% mothers) designed with insights obtained from the focus groups. We used framework analysis to summarise the themes as supportive factors, concerns and critical arguments for retention and secondary use of rDBS from focus group discussion. We used multiple logistic regression to assess factors associated with support for retention and secondary use of rDBS in the survey. Results Both in focus groups and survey, majority of parents were not aware of the potential secondary use of rDBS. Overall secondary use of rDBS in medical research was well accepted by a large proportion of Hong Kong parents, even if all potential future research could not be specified in a broad consent. However parents were concerned about potential risks of biobanking rDBS including leaking of data and mis-use of genetic information. Parents wanted to be asked for permission before rDBS are stored and mainly did not accept an “opt-out” approach. The survey showed that parents born in mainland China, compared to Hong Kong born parents, had lower awareness of newborn screening but higher support in biobanking rDBS. Higher education was associated with support in rDBS biobanking only among fathers. Conclusion Long-term storage and secondary use of rDBS from newborn screening for biomedical research and a broad consent for biobanking of rDBS are generally acceptable to Hong Kong parents given their autonomy is respected and their privacy is protected, highlighting the importance of an accountable governance and a transparent access policy for rDBS biobanks. (shrink)

Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require (...) precise definition and documentation, which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening. (shrink)

Newborn screening programmes began in the 1960s, have traditionally been conducted without parental permission and have grown dramatically in the last decade. Whether these programmes serve patients’ best interests has recently become a point of controversy. Privacy advocates, concerned that newborn screening infringes upon individual liberties, are demanding fundamental changes to these programmes. These include parental permission and limiting the research on the blood samples obtained, an agenda at odds with the viewpoints of newborn (...) class='Hi'>screening advocates. This essay presents the history of newborn screening in the USA, with attention to factors that have contributed to concerns about these programmes. The essay suggests that the rapid increase in the number of disorders screened for and the addition of research without either public knowledge or informed consent were critical to the development of resistance to mandatory newborn screening and research. Future newborn screening initiatives should include public education and comment to ensure continued support. (shrink)

When deciding what disorders to screen newborns for, we should be guided by evidence of real effectiveness, take opportunity cost into account, distribute costs and benefits fairly, and respect human rights. Current newborn screening policy does not meet these requirements.

If I told you that screening technologies are iteratively transforming how people experience pregnancy and early parenting, you might take notice. If I mentioned that a new class of newborn patients was being created and that particular forms of parental vigilance were emerging, you might want to know more. If I described how the particular stories told about screening in public, combined with parents’ fierce commitment to safeguarding their children’s health, make it difficult for problematic experiences with (...) screening to translate into negative opinions about it, you would most likely be intrigued. An extensive qualitative literature documents all these social phenomena, and more, in connection with the spread of prenatal and newborn screening. So why is it, then, that commentators frequently assert that the predicted psychosocial impact of increased screening and testing associated with “the genomic revolution” has been far less severe and worthy of attention than predicted? How can or should social science “evidence” that sits outside adopted measurement conventions be considered? Why is it that summary statements about the psychosocial impact of genomic information often ignore qualitative evidence, or sideline it as relevant only for improving communication among patients, clinicians, and public health systems? This essay addresses such questions, using qualitative research on prenatal and newborn screening as a case study for illustrating the broad methodological, ideological, and dialogical issues at stake. (shrink)

There may be compelling reasons to return to parents a limited subset of results from research conducted using residual newborn screening dried blood samples. This article explores the circumstances under which research results might be returned, as well as the mechanisms by which state newborn screening programs might facilitate the return of research results. The scope of any responsibility to return results of research conducted using DBS should be assessed in light of the potential impact on (...) the primary mission of state newborn screening programs. (shrink)

Newborn screening involves a complex logistical process, which depends on the close cooperation of many professionals, such as midwives, laboratory technicians, general practitioners and pediatricians. These professionals may encounter moral problems in the process, which have not been systematically studied before. This study fills this gap. We conducted interviews with 36 professionals involved in NBS in the Netherlands and made an inventory of the moral problems they encounter, as well as of the ways in which they tend to (...) respond to them. The moral problems professionals encounter stem from interpersonal conflicts and intrapersonal conflicts. Given the complexity of the work of NBS professionals, the study suggests that the moral problems that occur on the work floor cannot easily be solved by means of offering better or more stringent policy guidelines. Rather, it should be appreciated that professionals contribute significantly to shaping the morality of NBS with the help of their daily choices, and they should be supported in carrying out this task—for example with the help of a moral training or regular multidisciplinary moral deliberation, facilitated by an ethicist. (shrink)

In recent years, as newborn screening has expanded to include conditions for which treatment is questionable, new rationales for screening have proliferated. One such rationale is the potential reproductive benefit to parents from the detection of a genetic condition or carrier status in infants. An unanticipated consequence of invoking knowledge of reproductive risk as a major benefit of screening has been to open newborn screening to the charge that it constitutes state‐sanctioned eugenics. Thus, an (...) endeavor that had been viewed as the converse of state programs of selective breeding has come to be seen in some quarters as yet another of its incarnations. The result has been serious and self‐inflected harm to the reputation of newborn screening programs. (shrink)

Now widely adopted, SCID newborn screening has proven effective for early identification and treatment of SCID. In addition, screening has improved our understanding of SCID and related disorders, which are more diverse than originally believed. Newborn screening for SCID illustrates how adding new disorders to newborn screening panels can be enormously beneficial if evidence‐based guidelines are adhered to and if mechanisms are in place to track outcomes and learn along the way. These lessons (...) should guide all additions to newborn screening, including those involving sequencing. (shrink)

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents, healthcare professionals and policy decision makers in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, (...) decision-making and information attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities ; parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs. (shrink)

Newborn screening has evolved to include an increasingly complex spectrum of diseases, raising concerns that screening should be optional and require parental consent. Early detection of disorders like PKU and MCAD is essential to prevent serious disability and death in affected children. These are examples of high benefit-risk ratio disorders because of the irrefutable health benefits of early detection, coupled with the low risks of treatment. The dire consequences of not diagnosing an infant with a treatable disorder (...) because of parental refusal to screen are wholly unacceptable. Thus, we believe that newborn screening for disorders with high benefit-risk ratios should continue to be mandatory. (shrink)

Newborn screening is the programme through which newborn babies are screened for a variety of conditions shortly after birth. Programmes such as this are individually oriented but resemble traditional public health programmes because they are targeted at large groups of the population and they are offered as preventive interventions to a population considered healthy. As such, an ethical tension exists between the goals of promoting the high uptake of supposedly ‘effective’ population-oriented programmes and the goal of promoting (...) genuinely informed decision-making. There is, however, a lack of understanding with regard to how parents experience the tension between promoting uptake and facilitating informed choice. This paper addresses this issue, and data are presented to show how aspects of the timing, presentation of information and procedural routinisation of newborn screening serves to impact on the decisions made by parents. (shrink)

Screening of newborns for permanent congenital or early-onset hearing impairment has emerged as an essential component of neonatal care in developed countries, following favourable outcomes from early intervention in the critical period for optimal speech and language development. Progress towards a similar programme in developing countries, where most of the world’s children with hearing impairment reside, may be impeded by reservations about the available level of support services and the possible effect of the prevailing healthcare challenges. Ethical justification for (...) the systematic introduction of screening programmes for hearing in newborns based on the limitations in current primary prevention strategies, lack of credible alternative early-detection strategies and the incentives for capacity-building for the requisite support services is examined. (shrink)

Critical congenital heart disease screening is rapidly becoming the standard of care in the United States after being added to the Recommended Uniform Screening Panel in 2011. Newborn screens typically do not require affirmative parental consent. In fact, most states allow parents to exempt their baby from receiving the required screen on the basis of religious or personally held beliefs. There are many ethical considerations implicated with allowing parents to exempt their child from newborn screening (...) for CCHD. Considerations include the treatment of religious exemptions in our current legal system, as well as medical and ethical principles in relation to the rights of infants. Although there are significant benefits to screening newborns for CCHD, when a parent refuses for religious or personal beliefs, in the case of CCHD screening, the parental decision should stand. (shrink)