Should protections for research with humans who cannot consent apply to research with nonhuman primates?

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent?     

Limits on risks for healthy volunteers in biomedical research

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.     

Toward a Model Informed Consent Process for BRCA1 Testing: A Qualitative Assessment of Women's Attitudes

As an initial part of a project to develop a model informed consent process for BRCA1 testing, we conducted a series of focus groups. At the groups, women initially expressed great interest in testing, but their interest diminished after learning more. If offered testing, women would most want to learn about test accuracy, practical details of testing, and management options if the result was positive. Perceived benefits of testing included gaining information leading to risk reduction, relief of uncertainty, more responsible parenting, and assisting in research. Perceived risks included the discomfort and cost of the testing process itself, and anxiety after a positive result. The risk of possible insurance discrimination was rarely mentioned spontaneously. Many women would want their providers to make recommendations, rather than be nondirective about testing. We observed that women vary greatly in their informational and counseling needs, and suggest that the informed consent process should be individualized, taking into account a woman's perception and her preferences for how testing decisions should be made.     

Number Use at Home by Children and Their Parents and Its Relationship to Early Mathematical Performance

The purpose of this research was to measure the frequency and variety of number activities occurring in the homes of pre-school and kindergarten children and to determine if there was a relationship between those activities and the children's mathematical performance. In two studies, parents were interviewed over the telephone and asked how often their child or they and their child had engaged in each of 33 number-related activities over the last week. Both studies found considerable variability in the frequency and type of number activities that children participated in at home. There was a positive correlation between the frequency of number activities that parents reported for their children and parental participation in the same activities. In addition, in study 2, parental reports of children's number activities at home were predictive of children's performance on a standardized test of early mathematical ability.     

Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health.     

Parents' consent to the post-mortem removal and retention of organs

Parents of children who died following complex heart surgery have recently discovered that organs were removed and retained in post-mortem investigations to which they consented. It has been established that many of these parents did not give informed consent to the retention of organs. The Bristol Royal Infirmary Inquiry which examined these practices drafted codes of practice to govern future post-mortem activities. It is argued that these codes of practice may be onerous to some parents, yet effectively disbar them from dissenting to their application whilst they might otherwise agree to the post-mortem removal and retention of organs for purposes of medical audit, research or training. This consequence arises from employing an over-rigorous concept of informed consent in the immediate circumstances of bereavement. That concept is discussed in detail. An alternative proposal is canvassed which improves on the status quo but does not impose a practice of consent which may be burdensome and distressing to many.     

Preschool child care and parents' use of physical discipline

Parenting practices, including the use of physical discipline, are shaped by multiple influences. Although much research focuses on how parent, child, and dyadic characteristics shape parenting practices, extra‐familial resources may also play a role. This paper focuses on how children's experiences of child care during the preschool years may affect one aspect of parenting—discipline practices. Using a rich, nationally representative data set, we explore the correlation between children's participation in centre based care, Head Start, or other non‐parental care arrangements and parents' use of physical discipline, and related phenomena, parents' experience of domestic violence and parenting stress. We conduct probit regressions of parents' use of physical discipline, and parents' experiences of domestic violence, on preschool child care experiences. For disadvantaged groups of children, who have higher risks of experiencing physical discipline and witnessing family violence, we find that Head Start participation is associated with an increase in the likelihood that parents say they never spank their children and reduction in reports of domestic violence. And, for children in two‐parent families, Head Start is associated with an increase in the likelihood that parents say they never spank their children and the likelihood that they do not say they would resort to spanking in a hypothetical situation. However, we find no evidence that non‐parental child care is associated with a lasting reduction in parenting stress. Copyright © 2005 John Wiley & Sons, Ltd.     

Black Boxing Restraints: The Need for Full Disclosure and Consent

In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families of treatment risks, we argue that physical interventions are an unvalidated treatment for aggressive and violent behavior and should be used only as a safety intervention. We focus our discussion on the informed consent issues for school aged children, adolescents, and emancipated minors and contend that if restraints are used they must pose less risk than the behavior they are trying to alleviate. We also opine that if restraints are misused by mental health or child welfare treatment settings, then their misuse may be considered a subject of a patient maltreatment, abuse, criminal or civil action. A central thesis of the article is that informed consent must be seen as an integral and dynamic process of treatment. We recommend strategies that gain parental permission and child assent, that view informed consent as a dynamic and individualized process that aids and supports the therapeutic relationship, and that stress the importance of simplicity and clarity.     

Re-evaluating the therapeutic misconception: response to Miller and Joffe

Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research.     

Évolutions législatives et enjeux éthiques liés à la prise en charge des enfants ayant un trouble de la différenciation sexuelle (DSD)

The ethical dilemma concerning the care of children with a disorder of sex development opposes patients who have benefited from undeniable medical and surgical advances over the past 30 years and patients who have suffered from initial carek, experienced as “torture” or “genital mutilation”. The latter, grouped into advocacy organization (including the International Intersex Organization), recommend that genital operation of children must be avoided until they can give their prior consent, in the name of the fundamental right to self-determination and physical integrity. This “free choice” left to the child would not take into account the opinion of the parents or that of the medical team, nor any psychological, social and societal consequences, nor the risks of late surgery. Recent legislative developments are exposed. The interest of legislating on these delicate situations affecting the most intimate is questioned, especially as they are of great complexity because of the heterogeneity of genetic causes and family situations. Medico-surgical Societies, in connection with patient associations denounce this media hold by “Intersex” activists, who are not representative of the patients having been managed more recently. They advocate to continue to understand these situations on a case-by-case basis, leaving the choice to the parents to allow the child to grow up in a gendered body.     

Wrestling with the future: should we test children for adult-onset genetic conditions?

Genetics professionals have been reluctant to test children for adult-onset conditions because they believe this would create psychosocial harm to children not counterbalanced by significant benefits. An additional concern they express is that such testing would violate the autonomy of these children as adults. Yet weighing the harms and benefits of such testing results in a draw, with no substantial harms proven. Moreover, such testing can enhance, rather than violate the adult autonomy of these children. In deciding whether to proceed with predictive testing of children, parents, mature children, and health care professionals should consider a complex of factors relevant to the particular child. The importance of these factors will vary depending on the condition at issue, the age and stage of development of the child, family dynamics, and the concerns, values, and objectives of the parents and mature child. The final decision whether to test a child for an adult-onset condition should rest with the parents and the mature child.     

Omission bias in vaccination decisions: Where’s the “omission”? Where’s the “bias”?

Several studies have reported that parents are often reluctant to vaccinate their own or other people’s children, even when the balance of health risks and benefits clearly favors vaccination. This reluctance has been interpreted as a manifestation of “omission bias”, a general tendency to prefer inactive to active options even when inaction leads to worse outcomes or greater risks. The research raises significant public health concerns as well as worries about human decision biases in general. In this paper we argue that existing research on vaccination decisions has not convincingly demonstrated any general reluctance to vaccinate nor has it made the case that such a tendency, if found, would constitute a bias. We identify several conceptual and methodological issues that, we argue, cloud interpretation of earlier studies. In a new questionnaire-based study (Experiment 1) we examined the vaccination decisions of undergraduate students (N=103) and non-student adults (N=192). In both groups a clear majority chose to vaccinate when disease and vaccination risks were balanced. Experiments 2 and 3 identify several problems associated with the measures used in earlier studies, and show how these problems could have led to the misleading appearance of majority anti-vaccination preferences. In our data, vaccination intentions appear to be less a function of generalized preferences for action or inaction than they are of the regret respondents expect to feel if vaccination or non-vaccination were to lead to a poor outcome. Regret-avoiding choices led some respondents to favor vaccination, others to oppose it. In two follow-up studies, few respondents mentioned action or inaction per se in explaining their choices. We conclude that there is no convincing evidence that a generalized “omission bias” plays any important role in vaccination decisions.     

Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research

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”. An earlier version of this paper was presented at: The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Seven Vulnerabilities in the Pediatric Research Subject

Most recent thinking about thevulnerability of research subjects uses a``subpopulation' focus. So conceived, theproblem is to work out special standards forprisoners, pregnant women, the mentally ill,children, and similar groups. In contrast, an``analytical' approach would identifycharacteristics that are criteria forvulnerability. Using these criteria, one couldsupport a judgment that certain individuals arevulnerable and identify needed accommodationsif they are to serve as research subjects.Seven such characteristics can be evident inchildren: they commonly lack the capacity tomake mature decisions; they are subject to theauthority of others; they (and their parents)may be deferential in ways that can maskunderlying dissent; their rights and interestsmay be socially undervalued; they may haveacute medical conditions requiring immediatedecisions not consistent with informed consent;they may have serious medical conditions thatcannot be effectively treated; and they (andtheir parents) may lack important sociallydistributed goods. Each of thesevulnerabilities can call for special care inthe design and implementation of researchprotocols.     

Potential Positive and Negative Consequences of Coresidence for Teen Mothers and their Children in Adult-Supervised Households

In 1996, part of the creation of TANF (Temporary Assistance for Needy Families) required minor teen parents to live in an adult-supervised household in order to receive cash assistance. This literature review discusses the positive and negative consequences of coresidence. Research has suggested that coresidence may be beneficial for the educational and financial success of teen mothers. However, there is some evidence that coresiding teen mothers have poorer parenting skills than teen mothers who do not coreside. Implications for policy implementation are discussed. Case managers should be aware of the possible risks of coresidence and weigh these risks against potential benefits. In addition, families of teen mothers, especially grandmothers, should be included in programming and interventions in order to provide positive living environments for teen mothers and their children.     

Parent–Child Roles in Decision Making About Medical Research

Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4–15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the child's cognitive development. The audiotaped interviews were transcribed and analyzed for themes related to parent and child decision-making roles. Both parents and children varied in their perceptions of decision-making roles. Child perceptions of parental influence on decision making as knowledge-based increased with cognitive development, whereas perceptions of parental influence as power-based decreased. Both children and parents commented that they would collaborate with each other when making decisions. Collaborative decision making appeared to increase with cognitive development. These findings suggest that approaches to child assent and parent permission should consider the parent–child relationship and how children and families typically make decisions. Future research is necessary to explain variation in the process of research decision making across children and families, explore the role of collaboration on children's decision-making skills, and understand developmental trajectories and mechanisms related to research decision making.     

Minors' competence to consent to abortion

In the light of legal restrictions in some states, the psychological evidence for whether adolescents are competent to give informed consent to abortion is reviewed. It would be important to know whether competence to decide on pregnancy outcome reflects maturity to be a parent; further, whether degrees of maturity can be traced throughout adolescence. Research shows that parents, not peers, are major sources of advice for minors' abortion decisions. Younger and less competent minors are more likely to consult parents than older, mature minors. There is no evidence that adolescent issues or developmental tasks influence pregnancy decisions. Decision making competence does not differ from that of adults, except as affected by the living situation of the adolescent. Decision performance does differ: minors are more likely to consider their present family's opinion, and not consider future risks, than are adults. The sparse research available on this problem provides no basis for restricting minors' decision making on the ground of competence alone.     

Sensing everyday activity: Parent perceptions and feasibility

Mobile and wearable sensors provide a unique opportunity to capture the daily activities and interactions that shape developmental trajectories, with potential to revolutionize the study of development (de Barbaro, 2019). However, developmental research employing sensors is still in its infancy, and parents’ comfort using these devices is uncertain. This exploratory report assesses parent willingness to participate in sensor studies via a nationally representative survey (N = 210) and live recruitment of a low-income, minority population for an ongoing study (N = 359). The survey allowed us to assess how protocol design influences acceptability, including various options for devices and datastream resolution, conditions of data sharing, and feedback. By contrast, our recruitment data provided insight into parents’ true willingness to participate in a sensor study, with a protocol including 72 h of continuous audio, motion, and physiological data. Our results indicate that parents are relatively conservative when considering participation in sensing studies. However, nearly 41 % of surveyed parents reported that they would be at least somewhat willing to participate in studies with audio or video recordings, 26 % were willing or extremely willing, and 14 % reported being extremely willing. These results roughly paralleled our recruitment results, where 58 % of parents indicated interest, 29 % of parents scheduled to participate, and 10 % ultimately participated. Additionally, 70 % of caregivers stated their reason for not participating in the study was due to barriers unrelated to sensing while about 25 % noted barriers due to either privacy concerns or the physical sensors themselves. Parents’ willingness to collect sensitive datastreams increased if data stayed within the household for individual use only, are shared anonymously with researchers, or if parents receive feedback from devices. Overall, our findings suggest that given the correct circumstances, mobile sensors are a feasible and promising tool for characterizing children’s daily interactions and their role in development.     

Nanotoxicology and Ethical Conditions for Informed Consent

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized.     

Cultural sex-role expectations and children's sex-role concepts

Middle-class children between the ages of 4 and 8 were interviewed about their sex-role attitudes, in order to determine the extent to which recently changing cultural mores have influenced children's sex-role concepts. The children were asked about their career goals; the careers they would choose if they were the opposite sex; the reasons why they like being a boy or girl; and their opinions regarding the appropriateness of men and women participating in 14 sex-stereotypic occupations and activities. The children's parents provided demographic information. The children expressed very nonstereotypic attitudes towards the 14 occupations and activities, compared to children in recent studies; but they chose very traditional careers for their own choices and opposite-sex career choices, and often gave stereotypic reasons for preferring their own sex. Parents' education, mothers' employment status, fathers' nontraditional careers, and the children's gender predict responses to several of the sex-role-related questions. Implications for research are discussed.