Take Away Their Hammer: Logical and Ethical Problems in Range and Cotton's "Reports of Assent and Permission in Research With Children: Illustrations and Suggestions"

Range and Cotton (1995) showed that many of the articles reviewed in their study did not include a line specifying institutional review board-approved procurement of informed parental permission and child assent for child research. Range and Cotton stated that the absence of the line suggests a lack of sensitivity to permission/assent issues, implied that many authors of the articles did not obtain permission/assent, and said those who did but did not report it were camouflaging those who did not. In this article, the logic of these points is refuted, the ethics of the Range and Cotton study are questioned, and its potential divisiveness is lamented.     

Five points and a lament about Range and Cotton's "Reports of assent and permission in research with children: illustrations and suggestions

This comment responds to an article by Range and Cotton (1995) on reporting of parental permission and child assent procedures in published articles for 4 psychology journals. Issue is taken with the assumptions, methodology, interpretations, and implications of listing researchers in the Range and Cotton article. There is no evidence researchers failed in their ethical obligations or that children were put at risk. Reporting permission/assent in publications is not an ethical requirement. Listing researchers as "failing" to do something not part of an ethical code is lamentable. Too many unfortunate implications and problems can be derived from Range and Cotton's analysis and conclusions.     

Five Points and a Lament About Range and Cotton's "Reports of Assent and Permission in Research With Children: Illustrations and Suggestions"

This comment responds to an article by Range and Cotton (1995) on reporting of parental permission and child assent procedures in published articles for 4 psychology journals. Issue is taken with the assumptions, methodology, interpretations, and implications of listing researchers in the Range and Cotton article. There is no evidence researchers failed in their ethical obligations or that children were put at risk. Reporting permission/assent in publications is not an ethical requirement. Listing researchers as "failing" to do something not part of an ethical code is lamentable. Too many unfortunate implications and problems can be derived from Range and Cotton's analysis and conclusions.     

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.     

Protection of children's rights to self-determination in research

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.     

Assent and permission rejoinder

We share Roberts and Buckloh's (this issue) concern about issues of assent and permission in research with children and agree that our research cannot conclude legitimately that (a) researchers failed to obtain permission/assent, (b) children were put at risk, or (c) failure to report permission/assent procedures was, in any way, unethical. We never made these conclusions. Rather, we argue that publishing assent and permission would enhance compliance with ethical standards, sensitize researchers and readers to its importance, and shift publishing priorities in an appropriate direction.     

Ethical problems in research on risky behaviors and risky populations

The articles by Brooks-Gunn, Fisher, Hoagwood, Liss and Scott-Jones (all in this issue) present a panoply of real-world ethical issues in conducting scientific research on risky behaviors of children, adolescents, and their parents, particularly those from vulnerable populations. The universal, ethical principles of beneficence, justice, and respect for others are always applicable, but they do not resolve issues of child assent, parental consent, legal reporting requirements for illegal behaviors, and the special problems of studying risky behaviors in risky populations. Taken as a group, the articles raise some of the most interesting ethical problems that arise in developmental research. My discussion elaborates some issues and fails to resolve others. I hold the view that both science and ethics can be served by thoughtfully designed and implemented research on important social issues, but that the studies themselves cannot simultaneously solve the many societal problems of participants and be scientifically credible.     

Ethical Research in Delirium: Arguments for Including Decisionally Incapacitated Subjects

Here we describe how more important findings were obtained in a delirium study by using an informal assessment of mental capacity, and, in those who lacked capacity, obtaining consent later when or if capacity returned or a proxy was found. From a total of 233 patients 23 patients lacked capacity as judged by our informal capacity judgment and 210 did not. Of those who lacked capacity, 13 agreed to enter in the study. Six of them regained capacity later. When these 13 participants were excluded from analysis, significant findings were no longer evident. These results show that by the inclusion of subjects who lacked capacity the results of analyses of the condition from whish they suffer are altered. We suggest that this approach to the study of delirium is more ethical than the usual system of strict exclusion of people who lack capacity to give consent and for whom assent is not available.     

"I saw it with my own ears": the effects of peer conversations on preschoolers' reports of nonexperienced events

The study was designed to explore the effects of naturally occurring peer interactions and repeated suggestive interviews on preschoolers' (N=96, Meanage=54 months) memories for a personally experienced event, namely a staged archaeological dig. During the dig, one third of the children witnessed two "target" activities. A second third of the children were the classmates of those in the first group, but did not witness the target activities. The remaining children were not the classmates of those who witnessed the target activities, nor did they witness the target activities themselves, and thus served to provide a baseline against which to assess the effects of peer contact. Following the dig, the children were interviewed in either a neutral or suggestive manner on three occasions. Results from a fourth interview by a new examiner revealed that the combination of suggestive interviews and peer exposure led to claims of witnessing the target activities by the classmate group that were comparable to the children who actually did witness these activities. Further, assent rates to misleading questions employing peer pressure and false claims of actually seeing versus merely hearing about the target activities were elevated following opportunities to discuss these activities with peers.     

Writing about patients III: Comparisons of attitudes and practices of analysts residing outside and within the USA

When analysts write about patients, they find themselves in a position of conflict. Their first loyalty is to their patients and maintaining confidentiality. However, they are also committed to advancing scientific knowledge in the psychoanalytic field. The attitudes and practices of 36 analysts residing outside the USA, who published articles using clinical material from their patients, are reported. Their attitudes and practices are compared with those of 30 author-analysts residing within the USA, who had been previously interviewed. Among the 66 analysts, geographic region was not a basis for distinguishing differences in attitudes or practices. Slightly more than twice as many analysts use only disguised material as regularly ask permission of their patients to write about them. The decision to use only disguise is somewhat more frequent for analysts who reside outside the USA than for those living within it. Analysts around the world are increasingly concerned about the accessibility of published material. More analysts have come to believe that it is necessary to ask permission before publishing material. Some analysts also believe that the request itself, and the patients reading written material about themselves, focus issues that are central to patients' characters and confl icts that can then be explored analytically.     

A comparison of children who receive and who do not receive permission to participate in research

In a study examining children's social competence in elementary school settings, the authors had the opportunity to compare children who received parental permission to participate to children who did not receive permission. Results indicated that children who were not involved in the study were more likely to be viewed by teachers as having unsatisfactory relationships with peers than children who were in the study. The present results suggest that investigators begin reporting the number of children who do not participate in a given study and begin examining whether minors who receive parental permission differ on important dimensions from minors who do not receive such permission. Ethical considerations of the present study are discussed.     

Sexual Health Research Among Youth Representing Minority Populations: To Waive or Not to Waive Parental Consent

Human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) significantly burden youth 13–24 years of age in the United States. Directly engaging youth in sexual health research is a public health priority and urgently needed to develop targeted, youth-friendly, and culturally relevant HIV/STI prevention interventions. Controversies arise, however, regarding informed assent and consent, parental permission or consent, and the definition of “child”/“minor” as it relates to medical, legal, and ethical issues. In this article, we describe challenges in the human subjects review processes that were undertaken before beginning an HIV/STI prevention research project with sexually active youth in an urban setting. These findings provide important contextual information to facilitate youth sexual health research and care, and Institutional Review Board approval processes with fewer delays.     

Knowledge and causal attributions for mental disorders in HIV-positive children and adolescents: results from rural and urban Uganda

Increasing availability of antiretroviral treatment (ART) has led HIV to be considered a chronic disease, shifting attention to focus on quality of life including mental wellbeing. We investigated knowledge and causal attributions for mental disorders in HIV-positive children and adolescents in rural and urban Uganda. This qualitative study was nested in an epidemiological mental health study among HIV-positive children and adolescents aged 5–17 years in rural and urban Uganda. In-depth interviews were conducted with caregivers of HIV-positive children (5–11 years) and adolescents (12–17 years) in HIV care. Interviews were audio recorded with permission from participants and written consent and assent sought before study procedures. Thirty eight participants (19 caregivers, 19 children/adolescents) were interviewed. Age range of caregivers was 28–69 years; majority were female (17). Caregivers had little knowledge on mental disorders ;only 3 related the vignette to a mental problem and attributed it to: improper upbringing, violence, poverty and bereavement. Five adolescents identified vignettes as portraying mental disorders caused by: ill-health of parents, bereavement, child abuse, discrimination, HIV and poverty. Caregivers are not knowledgeable about behavioural and emotional challenges in HIV-positive children/adolescents. Mental health literacy programmes at HIV care clinics are essential to enhance treatment-seeking for mental health.     

Deception research involving children: ethical practices and paradoxes

This commentary draws on the thoughtful contemplation and innovative procedures described in the special section articles as well as current professional codes and federal regulations to highlight ethical practices and paradoxes of deception research involving children. The discussion is organized around 4 key decision points for the conduct of responsible deception research involving children: (a) evaluating the scientific validity and social value of deception research within the context of alternative methodologies, (b) avoiding and minimizing experimental risk, (c) the use of child assent procedures as questionable ethical safeguards, and (d) debriefing as both remedy and risk.     

A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest.     

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.     

Obstacles to research in residential juvenile justice facilities: recommendations for researchers

Federal, state, and local initiatives to improve the treatment and outcomes for young people in the juvenile justice system prompt the need for additional research. Despite the call for empirical data, researchers encounter numerous obstacles when initiating and conducting studies in detention and post-adjudication facilities. These obstacles are often only briefly mentioned in publications, but they can interfere with researchers' desires and abilities to conduct studies in these settings. This paper reviews legal, ethical, and methodological challenges to successfully conducting research in detention and residential post-adjudication placements, including selecting and accessing appropriate facilities, obtaining institutional review board approval, seeking parental permission and youth assent, reporting child abuse and neglect, responding to participants' threats to harm self or others, working effectively with facilities, juvenile justice system-related attrition, and the dissemination of research findings. Recommendations are presented to help investigators anticipate obstacles when designing and executing research protocols to prevent interference and to encourage ethical responses and successful study completion.     

Toward a further understanding of assent

Arranging assent opportunities is an increasingly common strategy for involving clients in therapeutic decisions within behavior analysis. Recent behavior-analytic articles have helped create a basic behavioral definition and conceptualization of assent, but much more guidance is needed for practitioners and researchers interested in embedding assent into their practices. The purpose of this article is to advance the conceptualization and understanding of assent and assent practices by refining previous definitions and conceptualizations of assent and providing six essential considerations for embedding assent into practice. The six considerations consist of determining the applicability and feasibility of assent, assessing assent-related skills, arranging assent procedures and teaching assent-related skills, arranging fair choices, selecting opportunities to assess assent, and informally assessing assent. Following the discussion of the considerations for assent practices, we issue a call for specific topics of research on assent.     

Reducing disruptive behavior through consultation

A university laboratory school counselor was consulted by a fourth grade teacher in order to resolve disruptive classroom behaviors of one student who did not stay seated and frequently spoke without permission. A behavioral approach in the classroom enabled the counselor to help. The teacher was instructed to pay attention to the child only when he remained seated or raised his hand for recognition. The student's behavior improved substantially. This study illustrates how the counselor can be effective as a consultant.