Background The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues (...) like sexual behaviour or substance use. Discussion South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. Conclusion Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies. (shrink)

To be autonomous, a person must also have authentic moral values. She must act on her own values, not on values that were improperly pressed upon her. To respect a patient's autonomy, then, a caregiver must do more than carry out her requests. The caregiver must honor the patient's authentic requests. But how to do that?

(1984). Discretionary waiver of juvenile court jurisdiction: An invitation to procedural arbitrariness. Criminal Justice Ethics: Vol. 3, No. 2, pp. 41-50.

Nowadays global inequalities in access to vaccines seem to be a growing problem. Intellectual Property Rights have been playing an important role both in causing and worsening them. Firstly,...

Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research to proceed without patient consent. This (...) article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients’ perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment. (shrink)

Section 1115 of the Social Security Act is misconstrued as a mechanism to foster state flexibility, when in fact it is a narrow pilot program authority. HHS has exceeded the scope of this authority to approve harmful projects. Courts will not grant the agency broad deference when reviewing this abuse of authority.

In a familiar interpretation, the Non-Identity Problem claims that persons whose existence depends on a seemingly harmful action cannot in fact be harmed through such an action. It is often objected that the persons in question can nevertheless be wronged through a violation of their rights. However, this objection seems to fail because these persons would readily waive any violated right in order to come into existence. The present article will analyze this Waiver Counter Argument in detail and show (...) why it does not succeed. First, it is necessary to distinguish between a prospective and a retrospective waiver scenario. In the prospective scenario an imagined person must consider whether she wants to waive a right in order to come into existence. In the retrospective scenario a person is asked whether she would prefer a wronged existence to never having been born. In both scenarios the conditions of a legitimate waiver of rights are not met, but for different reasons. On this basis, an argument against NIP can be developed. (shrink)

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

Parental consent poses challenges to needed research with adolescents who identify as lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ+) and are at heightened risk for negative health outcomes. Obtaining parental consent in studies focused on LGBTQ+ issues can prove arduous if adolescents have not yet disclosed their identity or have unsupportive guardians. Institutional Review Boards (IRBs) may be hesitant to grant waivers of parental consent, yet research suggests that studies requiring parental consent deter the participation of adolescents who identify (...) as LGBTQ+. In this article, ethical considerations regarding waivers of parental consent in the context of the American Psychological Association’s (APA) general ethical principles are reviewed and recommendations for psychological researchers seeking waivers of parental consent are offered. A vignette is used to demonstrate a question-and-answer guide to help determine if a waiver of parental consent is ethically justified. (shrink)

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a (...) principle of respect for patient autonomy is presented as being vacuous. Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy. Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model. (shrink)

This case is about a study of burn patients that included a request to the IRB for a waiver of consent for perianal specimen collection–a request which ultimately was not approved by a reviewing IR...

Research Ethics, Volume 18, Issue 2, Page 151-162, April 2022. In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics (...) committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent (...) from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

The Common Rule governs research on human subjects and attempts to balance respect for individual decision-making with efficiency when research risks are low. The regulations allow research to be conducted without consent if the data or biospecimens collected in a study are deidentified, and consent can be waived for identifiable data and biospecimens if the risks of the research are minimal and consent is deemed impracticable. These approaches have been widely used for research using clinical databases and residual clinical and (...) research biospecimens, and they have proven remarkably successful over the past twenty-five years, if success is measured by a lack of adverse events.But the landscape is changing. (shrink)

If federal health reforms continue to rely on employer-sponsored health care coverage, ERISA preemption reform should be part of the next steps. State-level reform has acquired greater urgency, while the justifications for preempting that source of reform has eroded. This article recommends a statutory waiver for ERISA preemption as a feasible way to adapt to these circumstances. It offers proposed statutory text for reformers inclined to pursue ERISA reform as health reform.

Inequality is the defining feature of our times. Many argue that it calls for a policy response, yet the most obvious policy responses require legislative action. And if inequality is the defining feature of our times, partisan acrimony and gridlock are the defining features of the legislature. That being so, it is worth considering what role administrative agencies, and administrative law, might play in ameliorating or exacerbating economic inequality. Here, I focus on American safety net programs, many of which are (...) joint operations between federal administrative agencies and state governments. In this context, a central mode of bureaucratic policy innovation comes in the form of administrative waivers, whereby a federal administrative agency waives some statutory requirement that is otherwise binding on state administrators. For example, the Centers for Medicare and Medicaid Services recently granted waivers to allow several states to impose various “personal responsibility” requirements on Medicaid beneficiaries. Faced with a choice between legislative inactivity and policy innovation through waivers, many scholars and policymakers of both parties have tended to favor waivers. The appeal of waivers as a path around legislative gridlock is compelling. However, I argue that this view has neglected the federal structure of American safety net programs, and does not account for the state politics of implementation. Moreover, scholars have not focused on the severe information problems that federal agencies face when issuing waivers; a permissive waiver regime exacerbates these problems. Focusing on Medicaid implementation, I highlight the risks of waivers for American safety net programs. Before concluding, I discuss possible reforms to administrative procedures, and offer a case study of litigation surrounding one recent waiver application. The case study illustrates many of the theoretical arguments, and further demonstrates the failure of judicial review; it indicates how review might be adjusted to promote more effective use of waivers and diminish their perils. (shrink)

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent (...) published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay (...) while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. (shrink)

BackgroundWith the enactment of Bill C-7 in Canada in March 2021, people who are eligible for medical assistance in dying (MAiD), whose death is reasonably foreseeable and are at risk of losing decision-making capacity, may enter into a written agreement with their healthcare provider to waive the final consent requirement at the time of provision. This study explored healthcare providers’ perspectives on honouring eligible patients’ request for MAiD in the absence of a contemporaneous consent following their loss of decision-making capacity. (...) MethodA critical qualitative methodology, using a feminist ethics theoretical lens with its focus on power and relationality, was used to examine how socio-political and environmental contexts influenced healthcare providers' moral agency and perspectives. Semi-structured interviews were conducted with 30 healthcare providers (13 physicians, six nurse practitioners, nine nurses and two social workers) from across Canada who provide MAiD-related care.ResultsThemes identified include; (1) balancing personal values and professional responsibilities, (2) anticipating strengths and limitations of the proposed waiver of final consent amendment, (3) experiencing ethical influences on decisions to enter into written agreements with eligible patients, (4) recognizing barriers to the enactment of MAiD in the absence of a contemporaneous consent and (5) navigating the potential for increased risks and burden.DiscussionTo our knowledge, this is the first study in Canada to explore healthcare providers’ perspectives on waiving the final consent for MAiD using a written agreement. Most participants supported expanding eligible people’s access to MAiD following loss of capacity, as they believed it would improve the patients’ comfort and minimize suffering. However, the lack of patients’ input at the time of provision and related ethical and legal challenges may impact healthcare providers’ moral agency and reduce some patients’ access to MAiD. Providers indicated they would enter into written agreements to waive final consent for MAiD on a case-by-case basis. This study highlights the importance of organizational, legal and professional support, adequate resources, clear policies and guidelines for the safety and wellbeing of healthcare providers and to ensure equitable access to MAiD. (shrink)

Judges wield enormous power in modern society and it is not surprising that scholars have long been interested in how judges think. The purpose of this article is to examine how US judges reason on language issues. To understand how courts decide on comprehension of constitutional rights by speakers with Limited English Proficiency (LEP), I analyzed 460 judicial opinions on appeals from LEP speakers, issued between 2000 and 2020. Two findings merit particular attention. Firstly, the analysis revealed that in 36% (...) of the interrogations, LEP speakers were advised of their rights only in English. This means that two decades after the Executive Order 13166 (2000) _Improving Access to Services for Persons with Limited English Proficiency_, law enforcement still doesn’t have adequate resources to advise LEP speakers of their constitutional rights in their primary languages. Secondly, the analysis revealed that some courts treat second language proficiency as an all-or-none phenomenon. This approach results in linguistic discrimination against LEP speakers who cannot comprehend legal language but are denied the services of an interpreter because they can answer basic questions in English. I end the discusson with recommendations for best practices in delivery of constitutional rights. (shrink)

There are few moral principles less controversial than “don’t touch people’s private parts without consent.” Though the principle doesn’t make explicit that there are exceptions, there clearly are some. Parents must wipe their infants. If an unconscious patient is admitted to the emergency room with a profusely bleeding laceration on their genitals, a doctor must give them stitches. The researchers who proposed the study in question, which would look for a connection between burn patients’ microbiomes and their clinical outcomes, presumably (...) believed they had identified an additional exception to the aforementioned principle. I argue that they did not. Rather, because of their tremendous inherent risks, we ought only to perform intimate procedures on those who can’t consent when the procedure is for their own good. -/- Intimate violations have been overlooked in both philosophy and medicine. Because of this, we have lacked an adequate conceptual framework for identifying certain kinds of harms research can inflict. When we understand these special risks, we see that the IRB was right to deny a waiver of consent. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

The slavery contract is not a rights violation since the right not to be enslaved and the right not to give out a benefit are waivable and the conjunction of their voluntary waiver is not itself a rights violation. The case for the contract being pejoratively exploitative is not clear. Hence given the general presumption in favor of liberty of contract, such a transaction ought to be permitted. The contract is also not invalid on the grounds that the wrongdoer’s (...) consent to it necessarily reflects involuntariness or irrationality or on the grounds that it is logically impossible for the wrongdoer to satisfy the contract. Allowing such contracts may not have desirable consequences, but for the liberal this by itself is not a sufficient reason against allowing them. One case where the slavery contract might be relevant is where a victim’s agent or the state agrees to waive its claim to harsh punishment in return for the offender agreeing to be enslaved. (shrink)

The slavery contract is not a rights violation since the right not to be enslaved and the right not to give out a benefit are waivable and the conjunction of their voluntary waiver is not itself a rights violation. The case for the contract being pejoratively exploitative is not clear. Hence given the general presumption in favor of liberty of contract, such a transaction ought to be permitted. The contract is also not invalid on the grounds that the wrongdoer’s (...) consent to it necessarily reflects involuntariness or irrationality or on the grounds that it is logically impossible for the wrongdoer to satisfy the contract. Allowing such contracts may not have desirable consequences, but for the liberal this by itself is not a sufficient reason against allowing them. One case where the slavery contract might be relevant is where a victim’s agent or the state agrees to waive its claim to harsh punishment in return for the offender agreeing to be enslaved. (shrink)

BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...) a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method’s increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have (...) implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected. (shrink)

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept that (...) in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials. (shrink)

The Securities and Exchange Commission requires the disclosure of changes to or waivers of corporate codes of ethics. Because the nature of amendments or waivers can vary, we expect the text of Item 5.05 to include different topics within different filings. We examine the population of these disclosures in Item 5.05 8-K filings from 2004 to 2020. While previous studies utilized small samples (fewer than 50 observations) to examine limited aspects of these filings, we use the population of these filings (...) from 2004 to 2020 (2121 8-K filings) to elucidate the nature and details of the disclosures. We assess whether Latent Dirichlet Allocation—a computational linguistics technique—can help discern the underlying topics represented in filings. While the Securities and Exchange Commission identifies two topics—amendments and waivers—the Latent Dirichlet Allocation analysis reveals four topics (three related to amendments): (1) code updates and clarifications; (2) combining codes of conduct for all officers and employees, or splitting codes to include a code directly applicable to senior financial officers; (3) codes of ethics waivers; and (4) substantive code changes. The overall trend is for fewer 8-Ks to be filed in recent years, with updates and clarifications becoming the predominant filing type. Our results further indicate that Item 5.05s related to updates and clarifications, and those related to combined or split codes, use fewer words and are more easily readable than those disclosing waivers or material code changes. Although we find no significant price reaction to Item 5.05 8-K filings, we find significant trading volume and volatility reactions, suggesting that these disclosures could give rise to differences in opinion among investors, which is consistent with the US Senate's assertion that these disclosures are of interest to investors. (shrink)

Abstract:This essay criticizes recent trends in disability policy as restrictive of individual liberty and informed by too narrow a definition of what constitutes human flourishing. I defend the value of intentional community settings as one legitimate residential option for people with intellectual and developmental disabilities. Recent federal regulations (HCBS Final Rule) define intentional communities or disability-specific housing as presumptively institutional in nature, misunderstanding the positive, noninstitutional features of intentional, integrated communities created by and for people with developmental disabilities. In addition, (...) current disability policy, despite its stated concern for the autonomy of people with intellectual and developmental disabilities, limits individual liberty by strictly defining the types of settings eligible for Medicaid waiver funding, expressly excluding agricultural communities, disability-specific residential settings, and intentional communities. A robust commitment to the autonomy of people receiving Medicaid waiver services would allow them to choose to direct their program dollars, recognizing that some individuals may choose a life in intentional community or with others facing similar challenges to themselves over an illusory “integration” into a wider society that remains too often unwelcoming and difficult to navigate. (shrink)

Criminal defendants in many countries are faced with a dilemma: If they waive their right to trial and plead guilty, they typically receive charge or sentence reductions in exchange for having done so. If they exercise their right to trial and are found guilty, they often receive stiffer sanctions than if they had pled guilty. I characterize the former as ‘waiver rewards’ and the latter as ‘non-waiver penalties.’ After clarifying the two and considering the relation between them, I (...) briefly explicate the grounds for a moral right to trial. I then assess the defensibility of such rewards and penalties. In addition to considering whether waiver rewards and non-waiver penalties serve the aims of legal punishment, I address the three main arguments for permitting them. The first suggests that defendants willing to plead display more remorse for their crimes and thus are deserving of lighter sentences. The second defends waiver rewards and non-waiver penalties in cases where prosecutors are alleged to know that defendants are guilty but face problems establishing their guilt at trial. The third holds that guilty defendants who are willing to plead conserve scarce state resources and should be rewarded for it, whereas those unwilling to plead squander such resources and should be penalized accordingly. I contend that none of these arguments provides persuasive grounds for waiver rewards or non-waiver penalties, even on the assumption that we can distinguish those defendants who should waive their right to trial from those who should not. This conclusion presents a fundamental challenge to contemporary plea bargaining practices. (shrink)

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs (...) where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies. (shrink)

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

This paper gives an ethical argument for temporarily waiving intellectual property protections for COVID-19 vaccines. It examines two proposals under discussion at the World Trade Organization : the India/South Africa proposal and the WTO Director General proposal. Section I explains the background leading up to the WTO debate. Section II rebuts ethical arguments for retaining current IP protections, which appeal to benefiting society by spurring innovation and protecting rightful ownership. It sets forth positive ethical arguments for a temporary waiver (...) that appeal to standing in solidarity and holding companies accountable. After examining built-in exceptions to existing agreements and finding them inadequate, the paper replies to objections to a temporary waiver and concludes, in section III, that the ethical argument for temporarily waiving IP protection for COVID-19 vaccines is strong. There are no data in this work. (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the (...) class='Hi'>waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

I develop a contractualist theory of just intelligence collection based on the collective moral responsibility to deliver security to a community and use the theory to justify certain kinds of signals interception. I also consider the rights of various intelligence targets like intelligence officers, service personnel, government employees, militants, and family members of all of these groups in order to consider how targets' waivers or forfeitures might create the moral space for just surveillance. Even people who are not doing anything (...) prejudicial to other states' security can be modeled as ceding rights against diagnostic collection--light touch collection limited to ascertaining if someone is likely an intelligence threat--as part of their duty to support just foreign institutions. Foreign intelligence officers could not perform the same job potential targets can reasonably demand their intelligence agencies perform on their behalf without this ceding of rights. More invasive forms of collection can only be justified if officers can reasonably model their citizens consenting to being the target of the same sort of collection by adversary states. (shrink)

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment (...) of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver. (shrink)

This article outlines and compares current and proposed global institutional mechanisms to increase equitable access to COVID-19 vaccines, focusing on their institutional and operational complementarities and overlaps. It specifically considers the World Health Organization's (WHO’s) COVAX (COVID-19 Vaccines Global Access) model as part of the Access to COVID-19 Tools Accelerator (ACT-A) initiative, the WHO’s COVID-19 Technology Access Pool (C-TAP) initiative, the proposed TRIPS (Trade-Related Aspects of Intellectual Property Agreement) intellectual property waiver and other proposed WHO and World Trade Organization (...) technology transfer proposals. We argue that while various individual mechanisms each have their specific individual merits—and in some cases weaknesses—overall, many of these current and proposed mechanisms could be highly complementary if used together to deliver equitable global access to vaccines. Nonetheless, we also argue that there are risks posed by the proliferation of proposals in this context, including the potential to disperse stakeholder attention or to delay decisive action. Therefore, we argue that there is now a clear need for concerted global multilateral action to recognise the complementarities of specific models and to provide a pathway for collaboration in attaining global equitable access to vaccines. The institutional infrastructure or proposals to achieve this amply exist at this point in time—but much greater cooperation from industry and clear, decisive and coordinated action from states and international organisations are urgently needed. (shrink)