No consent for brain death testing.

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Denials of Judicial Bypass Petitions for Abortion in Texas Before and After the 2016 Bypass Process Change: 2001-2018.

Objectives. To estimate the percentage of Texas judicial bypass petitions for abortion denied annually from 2001 to 2018, and to assess whether that fraction changed after the state's 2016 bypass process change.Methods. Because official statistics on Texas judicial bypass case counts and outcomes are only available for 2016 and later, we systematically reviewed monthly internal reports from Jane's Due Process (JDP), an organization providing legal representation to pregnant minors seeking bypass from 2001 to 2018. We report numbers and percentages of JDP cases denied for 2001 to 2018 and numbers and percentages of all cases denied from official Texas statistics for 2016 to 2018 (all available years).Results. At least 1 denial occurred in 11 out of 15 years observed before the bypass law changed in Texas (percentages = 0%-6.2%). After Texas made its bypass process more restrictive, the percentage denied increased (from 2.8% in 2015 to 10.3% in 2016 among JDP cases).Conclusions. We found the greatest percentages of judicial bypass for abortion petitions denied after the policy was implemented and after the bypass process changed. Judicial bypass for abortion may expose pregnant minors to judicial veto of their abortion decision.

Resolving Disagreement: A Multi-Jurisdictional Comparative Analysis of Disputes About Children's Medical Care.

Recently, the English courts have dealt with a number high-profile, emotive disputes over the care of very ill children, including Charlie Gard, Alfie Evans, and Tafida Raqeeb. It is perhaps fair to say such cases have become a regular feature of the courts in England. But is the situation similar in other jurisdictions? If not, are there lessons to be learned from these jurisdictions that do not seem to need to call on judges to resolve these otherwise intractable disputes? We argue that many of the differences we see between jurisdictions derive from cultural and social differences manifesting in both the legal rules in place, and how the various parties interact with, and defer to, one another. We further argue that while recourse to the courts is undesirable in many ways, it is also indicative of a society that permits difference of views and provides for these differences to be considered in a public manner following clear procedural and precedential rules. These are the hallmarks of a liberal democracy that allows for pluralism of values, while still remaining committed to protecting the most vulnerable parties in these disputes-children facing life-limiting conditions.

Case Comment: Re D (A Child) [2019] UKSC 42.

How (if at all) can the right to liberty of a child under Article 5 European Convention on Human Rights ('ECHR') be balanced against the rights of parents, enshrined both at common law and under Article 8 ECHR? Is there a limit to the extent to which parents can themselves, or via others, seek to impose restrictions upon their disabled child's liberty so as to secure their child's interests? This case considers the answers to these questions given by and the implications of the decision of the Supreme Court in September 2019 in Re D (A Child) [2019] UKSC 42.

Did Bioethics Matter? A History of Autonomy, Consent, and Intersex Genital Surgery.

This article argues that the rise of bioethics in the post-WWII era and the emergence of the legal doctrine of informed consent in the late 1950s should have had a greater impact on patients with intersex traits (atypical sex development) than they did, given their emphasis on respect for autonomy and beneficence toward patients. Instead, these progressive trends collided with a turn in intersex management toward infants, who were unable to provide autonomous consent about their medical care. Patient autonomy took a back seat as parents heeded physicians' advice in an environment even more hierarchical than we know today. Intersex care of both infants and adults continues to need improvement. It remains an open question whether the abstract ideals of bioethics-respect, patient autonomy, and the requirement of informed consent-are alone adequate to secure that improvement, or whether legal actions (or the threat of litigation) or some other reforms will be required to effect such change.

Parental consent: an unnecessary barrier to adolescent obstetrical care.

When adolescents in the United States become pregnant, these young mothers experience differential access to obstetrical services, including prenatal, intrapartum, and postpartum care. As of 2018, 13 states in the United States do not afford a pregnant minor rights to prenatal care without parental consent, and 13 states do not ensure confidentiality from parental disclosure. Because of this, young mothers may avoid seeking timely and medically necessary care, not to mention counseling regarding preventive health services and monitoring of underlying chronic conditions. Lack of access during these critical months leads to missed essential opportunities for intervention and increased pregnancy-related risks to the mother and infant. It is imperative for obstetricians and gynecologists to value, support, and advocate for adolescents' emerging autonomy and personal agency to make informed decisions about their own bodies during their pregnancies, but also in making the choice to prevent future pregnancies through contraception.

Emergency contraception in adolescents. A grey area in Italian legislation.

OBJECTIVE: To explore Italian legislation and the social climate regarding the issue of emergency contraception (EC) in adolescents. RESULTS: In recent years, in Italy, we have seen changes in the law and in attitudes towards EC. Since 2016, EC has been approved for sale as a non-prescription drug to women over the age of 18. However, the requirement for a prescription is still in force for women under 18. This raises questions such as the minor's ability to consent to family planning services to prevent pregnancy, and whether physicians require parental consent before providing an EC prescription to minors. This article explores these issues within the social and legislative context of adolescent reproductive health care, demonstrating a need for EC among Italian adolescents. CONCLUSION: Making EC difficult for minors to access seems to respond to a political stance that clashes with existing social needs and with medical evidence that shows that EC is safe and reliable for use in adolescents, and that the increased use of EC has no negative effects on regular, ongoing contraceptive use or encourages risky sexual behaviour. Future interventions by Italian policy-makers should target these themes in order to make EC easily available to adolescents throughout the country.

Obtaining waivers of parental consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health prevention research.

BACKGROUND: Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. PURPOSE: We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. METHODS: We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data. DISCUSSION: Standard consent policies may inadvertently exclude youth who are at high risk for negative health outcomes or may potentially put them at risk because of forced disclosure of sexual orientation. Securing a waiver addresses these concerns and allows for rich data, which is critical for providers to have a deeper understanding of their unique sexual health needs. CONCLUSION: To properly safeguard and encourage research informed by SMY, parental consent waivers may be necessary.

When can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data.

Informed consent and registry-based research - the case of the Danish circumcision registry.

BACKGROUND: Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision. DISCUSSION: This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent - Meta consent - aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.

Legal Barriers to Adolescent Participation in Research About HIV and Other Sexually Transmitted Infections.

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as preexposure prophylaxis, without parental permission hinges on state minor consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. Unclear state laws may lead to research cessation. We have summarized legal, ethical, and policy considerations related to adolescents' participation in HIV and sexually transmitted infection prevention research in the United States, and we have explored strategies for facilitating adolescents' access.

Harm is all you need? Best interests and disputes about parental decision-making.

A growing number of bioethics papers endorse the harm threshold when judging whether to override parental decisions. Among other claims, these papers argue that the harm threshold is easily understood by lay and professional audiences and correctly conforms to societal expectations of parents in regard to their children. English law contains a harm threshold which mediates the use of the best interests test in cases where a child may be removed from her parents. Using Diekema's seminal paper as an example, this paper explores the proposed workings of the harm threshold. I use examples from the practical use of the harm threshold in English law to argue that the harm threshold is an inadequate answer to the indeterminacy of the best interests test. I detail two criticisms: First, the harm standard has evaluative overtones and judges are loath to employ it where parental behaviour is misguided but they wish to treat parents sympathetically. Thus, by focusing only on 'substandard' parenting, harm is problematic where the parental attempts to benefit their child are misguided or wrong, such as in disputes about withdrawal of medical treatment. Second, when harm is used in genuine dilemmas, court judgments offer different answers to similar cases. This level of indeterminacy suggests that, in practice, the operation of the harm threshold would be indistinguishable from best interests. Since indeterminacy appears to be the greatest problem in elucidating what is best, bioethicists should concentrate on discovering the values that inform best interests.

Legal and Ethical Considerations in Allowing Parental Exemptions From Newborn Critical Congenital Heart Disease (CCHD) Screening.

Critical congenital heart disease (CCHD) screening is rapidly becoming the standard of care in the United States after being added to the Recommended Uniform Screening Panel (RUSP) 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.

What's new in ... The Process of Consent.

An understanding of mental capacity is fundamental to the process of obtaining valid consent. This article looks at the processes of both consent and capacity assessment, and highlights the importance of fully informed consent following recent changes in the law.

[Rights of the child, parents' rights, and state monitoring : When is state intervention in parental autonomy permissible?]. / Kinderrechte, Elternrechte und staatliches Wächteramt : Wann darf der Staat in die elterliche Autonomie eingreifen?

Children have their own rights from the outset. It is primarily their parents who are responsible for the implementation of these rights. But state instances also carry responsibility for child rights. The state should only intervene in the parental autonomy against the will of the parents when a child's well-being is endangered. The subject under investigation is whether the development of Frühe Hilfen may have led to a subtle bringing forward of the threshold to state intervention, and how this should be assessed from the perspective of the rights of the child. The relevant legal and sociological literature is surveyed and evaluated with this question in mind. Findings indicate that there has been no change in the threshold to state intervention on a legal level. However, there are obvious signs that with the application of existing norms, more than before, the state no longer waits to intervene until actual harm has been done to a child, but already does so when there is a concrete threat to the child's well-being. The discussion shows that from the rights of the child perspective there is no existing reason to bring forward the threshold to state intervention in the parental autonomy. However, there is need for improvement in regard to specialist as well as legal measures. It is suggested that an approach based on the child's rights should be established across all professional fields, the child's position in various points of social law, and the rights of the child anchored in constitutional law.

Refusal of potentially life-saving treatment for minors: The emerging international consensus by courts.

A series of decisions by superior courts exercising their parens patriae jurisdiction in Australia, New Zealand, the United Kingdom and Canada has overturned decisions by parents, and by minors, including some close to the age of 18, to decline life-saving treatment on the basis that such treatment is "in the best interests" of the children concerned. This article reviews the reasoning in such cases and analyses the justifications proffered for giving limited weight to the expressed wishes of children and even of their parents in such matters. It identifies that the issues have particularly arisen in respect of families that are Jehovah's Witnesses and also where there is strong opposition to the application of mainstream medicine in the context of burdensome treatment for life-threatening conditions. It acknowledges the seriousness of such decisions and the potential for collateral influences that are difficult to identify to exert significant impact upon wishes expressed in respect of children who are seriously ill. It also accepts the complexities of identifying the "real wishes" of children. However, it contends that in appropriate cases flexibility in determining children's overall best interests is necessary and that the autonomy otherwise given to mature minors should play a more significant role in courts' decision-making in respect of the authorisation of treatment that children have purported to decline.