Country: US
Discipline: Bioethics
Summary:
An important chapter about children’s competence – the most useful and the most comprehensive treatment of children’s competence in the bioethics literature. The chapter is about minors’ competence to decide about their medical treatment or care rather than competence to participate in research but ‘[m]uch of the analysis’ could be applied to research even though as the author’s note, ‘research raises some distinct issues of its own’ that are not addressed in the book (p.217). The chapter focuses on conceptual issues and includes empirical data e.g. developmental evidence into the analysis where appropriate. The purpose is to ‘ascertain whether the general policy presumption of minors’ incompetence for health care decision making is sound, or whether it ought to be revised’.
The chapter discusses values at stake in competence decisions:
- The child’s well-being
- The child’s self-determination
- The parents’ interest in making decisions concerning their children.
Buchanan and Brock also make a distinction between children’s competence and children’s decisional authority and claim this is an ‘important and inadequately appreciated difference’. Competence together with an informed and voluntary decision does not ‘fully settle the issue of the child’s right to decide’ (pp.234-5). They critique appeals to the ‘family’s interest’ or ‘familial objectives’ and claim it is far more conducive to clear thinking to talk in terms of ‘the legitimate interests of other
individuals within the family’. They conclude with a section on ‘implications for medical practice and legal policy regarding children’s competence’. This includes discussion of emancipated minors and mature minors.
Children are sometimes compared with previously competent adults. Brock and Buchanan question the usefulness of this comparison in the context of determining decisional authority and parent’s interest in making important decisions about their children’s welfare (pp.233-4).
Country: USA
Discipline: Psychology
Summary:
This is an influential, much cited article. It takes into consideration person factors, situation factors including role constraints and consent-seeker factors. There is also a section on assessment and promotion of competent decision making and of voluntary decision making.
Country: Australia
Discipline: Education, ethics, social sciences
Summary:
Provides a good overview of issues in social science research.
Good sections on deception in research, research connected with child abuse and research involving different cultural groups.
Also has advice on putting in ethics applications to ethics committees.
Country: UK
Discipline: Health care law
Summary:
This is an excellent chapter containing a synopsis (a detailed synopsis) of the important issues. It contains an interesting section on the acceptability of risk which highlights the difference between the UK and the US approaches to risk. It also has an interesting discussion on the ‘more rigorous approach’ to consent in research and the ‘different function’ of consent in the research and the treatment contexts (pp.176-177). The chapter includes discussion of the Gillick case (pp.177-178) and ‘proxy consent and its limits’ (pp.179-180). In light of a view that ‘parental consent can only be given in the best interests of their children’, some justification is offered for research participation that could come into the category of research that is ‘not against’ the child’s interests (pp.179-180). Montgomery makes the point that ‘[t]he Gillick decision established that parents were given powers and rights in order to protect the interests of their children rather than to protect a conception of parental rights or family privacy that demanded that society did not interfere’ (p.179).
Country: USA
Discipline: Psychology
Summary:
Written as part of a working group on ethical issues in social and behavioural research with minors. Offers a developmental perspective on research risk and emphasises that children’s vulnerability in research does not simply decline linearly with age.
Country: USA
Discipline: Bioethicist / Clinician
Summary:
Discusses the tendency to conflate assent with consent and discusses the difference between assent and consent – the difference in moral weight. Argues that self-determination or respect for autonomy is not the appropriate model for understanding informed consent in the paediatric setting - the appropriate model is respect for persons or protection (or beneficence or best interests). Also considers the goals of assent. Also, some discussion of altruism.
Country: USA
Discipline: Bioethics / Pediatrics
Summary:
An interesting historical background section. An informative section on the ‘assent requirement’ – discusses Gaylin’s example of trying to teach a child to be altruistic. A short section on payments for research participation. Gives some defense of Willowbrook while acknowledging that it remains controversial.
Country: USA
Discipline: Bioethicist
Summary:
Interesting synopsis of the debate between Paul Ramsey and Richard McCormick. Explains where the idea of levels of risk originated and refers to McCormick’s view that the justification for proxy consent is based on what the child “ought” to want rather than what the child “would” want.
Country: USA
Discipline: Bioethics
Summary:
Relates specifically to US regulations but nevertheless a useful and interesting article. Summarizes the debate about whether phase I trials offer direct benefit. She argues that ‘Phase I trials do not offer the prospect of direct benefit and classifying them as if they do fails to acknowledge the moral relevance of the researchers' intent.’ Ross proposes a ‘new research category that incorporates the concept of "secondary direct benefit" to ‘avoid the need for national review’ i.e. for [USA] Phase I oncology trials.
Country: USA
Discipline: Bieothics / Medicine
Summary:
Very useful article on assent.Argues that assent lacks a legal function. There is no need to insist on a signature. Requiring a signature can distract from the important goal of engaging the child and risks being superfluous.
Country: Australia
Discipline: Medicine / Paediatrics / Psychology / Public Health
Summary:
This is a useful review article dealing with the importance of clinical trials in children, the benefits and the risks of trial participation and why so few children are involved in trials. It contains an interesting discussion of recruitment and looks at doctor factors, parent factors, child factors and trial factors. For doctors, barriers to recruiting children include concerns such as ‘difficulty with ethics requirements and informed consent’.
In a section on participation in paediatric oncology trials, the authors argue that there is ‘almost a fusion between clinical research and clinical practice’ because of widespread participation. Treatment regimens can be adjusted and outcomes improved in each subsequent trial.
The article also contains a useful overview of international public policy in relation to medical research in children covering the US Pediatric rule and exclusivity provisions etc. It does not get bogged down in the detail of the regulations as US writers tend to. This article also emphasises the weaknesses of the US system of review.
Country: New Zealand
Discipline: Law
Summary:
This article offers a useful and fresh perspective not tied to US or Australian guidelines/regulations.
It starts with an example of a controversial, ‘non-therapeutic’ study involving children / babies in which the physiological causes of SIDS was being investigated. Refers later in the article to a survey conducted with the parents who enrolled their babies and those who declined.
This article addresses 3 ‘fundamental issues’:
- Should children be involved in health research?
- Do parents have the right to consent to children’s participation and under what conditions?
- The child’s right to consent or refuse participation.
Peart claims that international guidelines have been vague, incomplete and inconsistent. The section on risk contains a commentary on UK guidelines about ‘permissible risk’. Looks at the question of ‘what is the justification for proxy consent?’ The justification that applies in medical treatment i.e. the best interests of the child ‘cannot apply in the context of most research’. Another justification: ‘proxy consent is justified if participation is not clearly against the child’s interests’. Refers to various reports and Conventions. Discusses the European Convention on Human Rights and Biomedicine and claims that ‘for those states that are not a party to this Convention, such as New Zealand, the legal status of proxy consent remains somewhat uncertain’ (p.432).
In terms of ‘children’s right to consent to their participation in health research’, the author puts forward an argument for applying Gillick which was decided in the context of medical treatment to the research context (p.437).
Looks at ‘parents’ motivation in granting consent’ and refers to the SIDS study again.
Summarizes results of survey i.e. most enrolled their babies ‘to benefit medical science and to prevent SIDS’. Most understood the purpose of the study. Inconvenience was the main reason for declining. 29.3% refused because of
concerns about the safety of their children.
Concludes that:
- both therapeutic research and non-therapeutic research is necessary.
- A ‘general risk formulation’ is ‘best avoided’.
- A distinction to be made between a child’s lack of competence and the child’s ‘minority status’.
Country: USA
Discipline: Neuropsychiatry, law, psychology
Summary:
This chapter contains an interesting discussion about the involvement of state wards in research and the special protection for wards (pp.181-2) in the context of US regulations. Permission is required not only from a ward’s guardian but also form an advocate ‘not associated in any way … with the research, the investigator(s), or the guardian organization.’ Under the heading of ‘independent consent by minors’ there is a comparison of the right to treatment without parental permission with the right to participate in research without parental permission. It is argued that ‘it is unlikely that the right of independent access to psychotherapy implies a corollary right to consent independently to research related to child mental disorders’.
Questions related to decisional authority and competency to consent are illustrated with reference to empirical studies. There are discussions about the ‘socialising effect of research participation’, longitudinal studies (p.184), and the reasons parents give permission for their children to participate in research (pp.184-5). There is also an interesting discussion with examples of children’s ‘tacit expression of a decision to withdraw from research’ (p.186).
Country: USA
Discipline: Bioethicist
Summary:
Includes useful sections on:
- Justifying children's involvement in research - in terms of medical benefit to the child, non-medical benefit to the child and benefit to others. Assesses arguments (including Ramsey 1970) about the ethical obligation of children to participate in research.
- Parents' interests in making decisions concerning their children
- Procedures for determining acceptable levels of risk for children
Country: USA
Discipline: hematology/Oncology, Bieothics, Pediatrics.
Summary:
See entry in assent / dissent section.
Country: Australia
Discipline: Law / Psychology
Summary:
This article is an invited commentary relating to an earlier article published in Child Abuse & Neglect. It deals primarily with consent and confidentiality issues. First, it highlights the importance to research in taking account of and not censoring the expression of children's views. Next, the foucs of discussion is children's reports on their experience of violence for a New Zealand national survey of children's experiences of violence at home and at school.
Cashmore analyses the "passive" or "opt out" form of consent used in the New Zealand study. The requirement for parental consent to research in sensitive areas can have the effect of censoring the expression of children's views and for this reason, letters were posted to each home with a stamped addressed envelope for parents to return the form if they did not want their child to take part. Cashmore, raises the point that "it is not clear in this study, as in most, to what extent chidlren feel able to refuse or to withdraw once they have engaged in the research process."' This is a relevant concern especially as the questionnaire was administered in "test-like conditions"
The paper also considers promises of confidentiality in the context of ethical and mandatory reporting obligations to report any harm or risk to children that is revealed during research participation. There is discussion on various opinions and practices including the collection of anonymous or blinded information which is sometimes used "as a means of avoiding reporting obligations."
The paper also looks at attemps to obtain access to research data by the courts. It discusses an unreported decision by the Family Court of Australia, T v L (2001) which indicates that promises of condifentialty to children may be protected from subpoena in subsequent legal proceeding. (See details of this case in this bibliography under 'cases' - Patrick Parkinson's "Research and promises of confidentiality to children".)
 | Bannister E. and Daly K. (2006). Walking a fine line: Negotiating dual roles in a study with adolescent girls, In Leadbeater, B., Banister, E., Benoit, C., Jansson, M., Marshall, A. and Riecken T. Ethical issues in community-based research with children and youth. Toronto: University of Toronto Press. pp. 157- |
Country: Canada
Discipline: Nursing
Summary:
This is a really good chapter about research involving focus groups with young people. Key ethical issues covered in the disucssion include: researcher's dual roles in relation to participants; research practitioners's divided loyalties between research and professional employment; the difference between research goals and therapeutic goals e.g. participants mistakenly assuming that the researcher is a therapist or a friend; and, issues of confidentiality. The discussion includes ways to deal with these issues. This chapter is also a good source of further relevant references.
| Yuile, A., Pepler, D., Craig, W. and Connolly J. (2006). The ethics of peeking behind the fence: Issues related to studying children's aggression and victimization , In Leadbeater, B., Banister, E., Benoit, C., Jansson, M., Marshall, A. and Riecken T. (2006). Ethical issues in community-based research with children and youth. Tonront: University of Toronto Press. |
Country: Canada.
Discipline: Psychology
Summary:
This is a really good chapter which includes a discussion on obtaining parental consent, maintaining confidentiality and parental requests to see their child's responses in the context of longitudinal research. There is an interesting discussion of naturalistic observations of children using remote microphones and video cameras to peek into children's social worlds. It also deals with dilemmas such as when to intervene when agressive behaviour is observed and whether researchers have the authority to intervene. Suggestions on how to doeal with these kinds of situations are included.
Country: USA
Discipline: Law / Pediatrics / Medical Ethics
Summary:
This is a great article about the inclusion of terminally ill children in clinical research. According to the authors, this is a topic that has received limited ethical and legal scrutiny. The focus is on phase I studies and the authors claim that 'we need to establish the extent to which it is ever appropriate for children to participate' given that the extent to which there is any benefit in participation is 'incidental, or indeed conincidental, to its central purpose'. The aim of a Phase I study is to 'determine the maximum dose at which [a] drug can safely be tolerated' rather than to treat or cure the participant.' (pp.305-6). This article contains an interesting discussion of what may be deemed a 'benefit' and what is meant by a 'response rate' in Phase I trials. The authors question whether the assessment of benefits and risks leave out questions about the quality of life for children enrolled in Phase I studies: 'Did the clinical trial enhance or impede the individual's dying process? Did enrollment in a clinical tiral limit eligibility for or receipt of palliative and hospice care?' There is also a discussion of the therapeutic misconception in relation to Phase I studies which cites empirical research findings such as: consent forms 'frequently use language that connotes treatment rather than research'; and many oncologists and pediatricians themselves share the therapeutic misconception (p.309-310).
The authors point out that whilce there may be 'psychic' benefit in taking part in a Phase I trial, 'most patients who consent to participate in Phase I research do so not for the "psychic" benefit, but because they mistakenly believe they will experience an actual benefit.'
The article concludes with what is needed for truly informed consent for Phase I studies, strategies for physicians to meet their fiduciary duty to patients e.g. for ensuring a committment to the child's welfare and concedes that, in the end, 'we may have to accept that participation in Phase I studies embodies our hopes - no matter how unrealistic - and our fears of the premature death of our children and simply outweighs our rationality (p.317).