Children's capacity to agree to psychological research: knowledge of risks and benefits and voluntariness

A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not be upset if the children refused. In contrast, other studies found that children were much more likely to stop their participation if the experimenter said explicitly that she would not be upset if they stopped. We suggest that experimenters should pay more attention to describing the possible risks and benefits of participation in research, and that they should also make it clearer to children that they are free to stop once they have begun.     

Social Validity of a Training and Coaching Program for Parents of Children With Autism Spectrum Disorder on a Waiting List for Early Behavioral Intervention

Due to limited public resources, many children with autism spectrum disorder and their families must wait several months, if not years, to access early behavioral intervention (EBI) services. Service providers must thus develop alternative support models to assist families placed on waiting lists. The present study assessed the social validity of one such initiative, a training and coaching program for parents whose children had been put on a waiting list for EBI services. This program consisted of group training sessions on strategies to cope with their child’s disorder based on applied behavioral analysis and on one-hour, weekly follow-up meetings to support parents’ interventions with their child over the course of 12 months. Social validity was assessed through parental satisfaction with this program and their perception of its effects on themselves, the family, the child, and parental stress. The 94 participants were generally satisfied with the program overall, although they wished for more frequent and intensive interventions. They reported that the program had positive effects on their psychological well-being, their family’s quality of life, and their child’s behavior. However, parenting stress levels were found to have increased over the 12-month period. These results demonstrate that training and individually supporting parents can be beneficial for families of children with ASD who cannot have access to early behavioral intervention immediately upon receiving a diagnosis. Importantly, however, these lower-cost, parent-focused programs cannot be considered a substitute for more intensive and children-driven services.     

Families with a Member with Mental Retardation and the Ethical Implications of Therapeutic Treatment by Marriage and Family Therapists∗

In this article, ethical issues related to the treatment of families with a member with mental retardation are discussed. The history of psychotherapeutically treating the community with mental retardation and accompanying concerns, such as dual diagnosis and diagnostic overshadowing, are discussed. Ethical considerations of the informed consent and assent process are discussed and applied to more modern areas of confidentiality, treatment goals, and individual sexuality. Marriage and family therapists are encouraged to bring clarity and balance to the process of informed consent and assent when working systemically with the population with mental retardation and their families.     

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.     

Stakeholders’ Opinions on the Implementation of Pediatric Whole Exome Sequencing: Implications for Informed Consent

Advances in whole genome and whole exome sequencing (WGS/WES) technologies have led to increased availability in clinical settings. Currently, there are few guidelines relating to the process and content of informed consent for WGS/WES, nor to which results should be returned to families. To address this gap, we conducted focus groups to assess the views of professionals, parents, and adolescents for the future implementation of WES. The discussions assessed understanding of the risks and benefits of WES, preferences for the informed consent discussion, process for return of results, and the decision-making role of the pediatric patient. Professional focus group participants included bioethicists, physicians, laboratory directors, and genetic counselors. Parent focus groups included individuals with children who could be offered sequencing due to a potential genetic cause of the child’s condition. On-line discussion groups were conducted with adolescents aged 13–17 who had a possible genetic disorder. We identified discrepancies between professionals and patient groups regarding the process and content of informed consent, preference for return of results, and the role of the child in decision-making. Professional groups were concerned with the uncertainty regarding professional obligations, changing interpretation in genomic medicine, and practical concerns of returning results over time. Parent and adolescent groups focused on patient choice and personal utility of sequencing results. Each group expressed different views on the role of the child in decision-making and return of results. These discrepancies represent potential barriers to informed consent and a challenge for genetic counselors regarding the involvement of pediatric patients in decision-making and return of results discussions.     

Self-Reported Parenting of Clinic-Referred and Non-referred Mexican American Mothers of Young Children

Behavioral parent training (BPT) interventions for child behavior problems have been based on decades of research that demonstrate links between particular parent behaviors and child externalizing problems. However, the majority of this research has been conducted with European-American (EA) families, and less is known about whether these findings can be generalized to Mexican Americans (MAs). In the current study, we investigated self-reported parenting practices that have been associated with externalizing behavior problems among EA families (harsh parenting, inconsistency, and low parental warmth), to determine if those practices can also differentiate MA mothers whose young children have clinically significant behavior problems from MA mothers whose children do not have behavior problems. Participants were 115 MA families with young children, 58 with a child with clinically significant behavior problems and 57 with a child in the normal range for such problems. Results indicated that MA mothers whose children have behavior problems self-reported significantly less warmth and consistency and more harsh parenting compared to parents whose children’s behavior was in the normal range. These findings indicate that parenting behaviors that are associated with externalizing behavior problems among EA families are associated with the same problems among MA families with young children, suggesting that parent training interventions designed to target these behaviors are also likely to be relevant to MA families with children in this age range. However, findings also indicate that parenting behaviors differ depending on acculturation level, suggesting that BPT programs must respond to variation in normative parenting practices for MA families.     

Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.     

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?     

患者拒绝签署紧急手术知情同意书的处理对策

签署手术知情同意书是医方履行告知义务,保障医患双方合法权益的一种重要手段。当患者病情需要紧急手术但患者或其家属拒绝签署手术知情同意书时,医院面临错失抢救时机和巨大的医疗风险,甚至可能因此成为被告。结合我院临床工作中的成功经验,探讨医院如何在尽可能抢救患者生命的情况下,规避相关法律风险。     

The capacity to appoint a proxy and the possibility of concurrent proxy directives

With the projected increase in the number of persons with dementia (who eventually lose their capacity to give informed consent to treatment and research), third-party decision-making will become even more common than it is today. We argue that, because there are situations in which an appointed proxy is preferred over a de facto surrogate, it is ethically important to understand the capacity of persons with dementia to delegate their decision-making authority regarding treatment and research decisions.In this paper, focusing mainly on the research consent context, we examine the idea that persons suffering from neurodegenerative disorders may retain significant abilities-including sufficient capacity for delegating one's authority for giving consent to research-even if they are not capable of giving independent consent themselves. We first propose a rationale for assessing the capacity to appoint a proxy and then describe a novel interview instrument for assessing the capacity to appoint a proxy for research consent.     

Hide-and-seek or show-and-tell? Emerging issues of informed consent

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.     

Malpractice Arising From Negligent Psychotherapy: Ethical,Legal, and Clinical Implications of Osheroff v. Chestnut Lodge

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.     

纸质与视频补充材料对手术知情同意体验的影响：以腹腔镜胆囊切除手术为例

知情同意书在医患沟通中起着间接传递信息的重要作用。以159名大学生为被试,通过操纵不同的知情同意方式,考察了纸质或视频补充信息对患者知情同意满意度、理解程度以及患者信息需求的满足程度影响。结果发现,接受纸质补充知情同意或视频补充知情同意的被试对知情同意过程的满意度、对手术信息的理解程度与知情同意信息需求的满足程度显著高于接受普通知情同意的被试。同时,纸质补充知情同意使得“治疗信息需求的满足程度”最高。这表明,纸质补充知情同意更能满足患者对治疗信息的需求。     

The Ethics of Smart Pills and Self-Acting Devices: Autonomy,Truth-Telling,and Trust at the Dawn of Digital Medicine

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.     

Child Assent and Parental Permission in Pediatric Research

Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent has been theparadigm for assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent.     

术前谈话与患者的知情同意权

告知说明义务是医师的法定义务,知情同意权是患者的法定权利,术前谈话是外科医师履行告知说明义务和手术患者实现知情同意权的共同方式。外科医师应深入理解患者的知情同意权,合理履行告知说明义务,临床实践中做到告知说明内容充分,变更手术重新告知说明,避免使用穷尽式列举,确定签字人身份合法且具有完全民事行为能力。     

Ethical Issues in Observational Family Research

Ethical issues raised by the increasing reliance on observational technology in family research are discussed. The tensions between scientific advancement and participant welfare are highlighted by delineating the process of observational research and the nature of the relationship between family scientists and the families they study. Guidelines are proposed for ethical decision making regarding potential child abuse, suicidality, informed consent, confidentiality, and debriefing.     

Further reflections on the impact of clinical writing on patients

Though it is unlikely that instituting universal guidelines will ever be possible for patient approval of the analyst's use of clinical material outside of the treatment setting, the author offers some supplementary refl ections to those already available in the literature. Broadly applied informed consent guidelines would increase the distortion that already exists in our clinical literature due to self-imposed restraints by writers. Moreover, the powerful irrational forces mobilized by consent in the dyad are not easily 'held' by traditional applicable legal categories. Metapsychological formulations of the intrapsychic and intersubjective impact of patient participation in the writing process on individual analytic dyads are needed. Notions of privacy protection, validation, dyadic co-construction, or writing-as-containment by a third as rationales for informed consent fail to encompass the transindividual and external sources of human identity and the ineradicable lack of unity in the unconscious. Nevertheless, theoretical affi nity and preferred technique may be mediating factors in positive outcomes of the consent process. Some paradigms not only accommodate more comfortably but also actively seek the intersubjective repercussions of informed consent. Asanalternativeorcomplementaryviewpoint, theauthoroffersthehypothesis that the clinical ramifi cations of either disguise or consent are not exclusively, nor even necessarily, concerned with what patients read about themselves, but what they assess or intuit-directly or indirectly through the material presented-of their analyst's unconscious strivings. To truly triangulate the clinical reporting project, it is wisest to consult the third ear of a colleague to assess the potential impact on patients on what might be being unconsciously transmitted by the analyst in the writing and the consent process     

What do Patients Prefer: Informed Consent Models for Genetic Carrier Testing

The recent increased number of conditions for which patients can undergo genetic carrier testing raises the question of how best to obtain pre-test informed consent. Clinical approaches vary from a minimalist model to a model where patients are given detailed information about all conditions to be screened for. Few data exist as to patient preferences, or how information impacts decision-making. Eight high-literacy focus groups were conducted to assess the knowledge and preferences of pregnant patients and their male partners. Most groups indicated that some balance between details and brevity was optimal, recognizing that anxiety can occur when patients are provided with too much information and that the wide range of tests offered during pregnancy often led to confusion. Critical areas for the informed consent process included (1) details about the conditions and risk of being a carrier, (2) logistics of testing, (3) next steps if the test is positive, and (4) prognosis, options and resources if the child were to be affected with a disorder. It will be useful to develop model consent programs and prospectively assess their impact on informed consent and patient satisfaction, both when positive and negative results are received.     

Informed Consent and the Requirement to Ensure Understanding

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it.