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.     

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.     

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.     

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.     

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.     

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.     

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.     

Assent and Dissent: Ethical Considerations in Research With Toddlers

In accordance with ethical principles and standards, researchers conducting studies with children are expected to seek assent and respect their dissent from participation. Little attention has been given to assent and dissent in research with toddlers, who have limited cognitive and emotional capabilities. We discuss research with toddlers in the context of assent and dissent and propose guidelines to ensure that research with toddlers still adheres to ethical principles. These guidelines include designing engaging studies, monitoring refusal and distress, and partnering with parents. Research with toddlers requires flexibility and creativity to respect toddlers in the context of their developmental capabilities.     

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.     

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.     

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.     

Ethical Issues and Guidelines for Conducting Data Analysis in Psychological Research

Psychologists are directed by ethical guidelines in most areas of their practice. However, there are very few guidelines for conducting data analysis in research. The aim of this article is to address the need for more extensive ethical guidelines for researchers who are post–data collection and beginning their data analyses. Improper data analysis is an ethical issue because it can result in publishing false or misleading conclusions. This article includes a review of ethical implications of improper data analysis and potential causes of unethical practices. In addition, current guidelines in psychology and other areas (e.g., American Psychological Association and American Statistical Association Ethics Codes) were used to inspire a list of recommendations for ethical conduct in data analysis that is appropriate for researchers in psychology.     

Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

Intervention research with youths at elevated risk for suicidal behavior and suicide—a vulnerable and high risk population—presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated in the context of pertinent laws and regulatory requirements, and guidelines are suggested for their practical resolution. These are illustrated with case examples from NIMH‐funded intervention trials. Through the sharing of such methodological information, intervention researchers can support each other in conducting ethical research in a manner that does not unduly compromise scientific rigor.     

Rights to privacy in research: adolescents versus parents

Conducting research on adolescents raises a number of ethical issues not often confronted in research on younger children. In part, these differences are due to the fact that although assent is usually not an issue, given cognitive and social competencies, the life situations and behavior of youth make it more difficult to balance rights and privacy of the adolescents. In this article, the three ethical principles of beneficence, justice, and respect for persons are discussed in terms of their application to the study of adolescents. Then, seven vignettes are presented to illustrate how these principles apply to real-life situations. How to balance the rights of adolescents and their parents is discussed, using adolescent girls and their parents for illustrative purposes.     

Commentary on "Family dynamics and children in medical research.

Gordon and Bonkovsky describe a disturbing case of research involving minors in their article "Family Dynamics and Children in Medical Research." As presented in the case, there is little doubt that the assent obtained from the children was inadequate for the proposed research and that the institutional review board (IRB) failed to assess sufficiently the risk-benefit ratio of the research to the child-subjects.     

"Psychotherapy" versus "treatment"

Presents a comment on "Psychological treatments" by D. H. Barlow. Barlow proposed that we distinguish between the terms "treatment" and "psychotherapy." The author believes that not only is the distinction unnecessary, but that its implications could have negative consequences for the field of clinical psychology. It is the proposed distinguishing feature that treatments are "specifically tailored to the pathological process that is causing the impairment and distress" that is most problematic. Clinical psychology does not need a distinction that further exacerbates the split between researchers and practitioners.     

Nonrelativist Ethical Standards for Goal Setting in Psychotherapy

A number of authors have commented on the topic of mandated reporting in cases of suspected child maltreatment and the application of this requirement to researchers. Most of these commentaries focus on the interpretation of current legal standards and offer opinions for or against the imposition of mandated reporting laws on research activities. Authors on both sides of the issue offer ethical arguments, although a direct comparison and analysis of these opposing arguments is rare. This article critically examines the ethical arguments made by authors on both sides of the debate. The conclusion is reached that researchers should be mandated reporters of child maltreatment because the current arguments do not justify their exclusion from current ethical and legal standards. The author makes recommendations for the ethically responsible conduct of research in regard to this topic and legal implications are discussed.     

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.     

Nanoethics in a Nanolab: Ethics via Participation

A participant–observer who is both informed and interested in ethical issues, and is embedded within a nanotechnology research and development facility may be able to influence the ethical awareness of researchers in nanotechnology, and tease out the societal implications of the work being conducted. Two inter-disciplinary methods were employed: (1) regular involvement in the technical and scientific research at the facility by the participant–observer, and (2) repeated interactions and discussions between the participant–observer and the scientists. As a result of this qualitative approach, an ethics questionnaire was developed and tested. This questionnaire has been incorporated into the admissions procedures for researchers as they commence use of the nanotech facility. The questionnaire highlights the importance of ethical issues in nanotechnology research and draws researchers into an engagement with possible ethical consequences and with future societal implications of their work.