Using a picture book to gain assent in research with young children

There has been a shift in perspective from viewing children as adults-in-the-making to individual agents, possessing the right and the competence to meaningfully participate in research. Many researchers are striving to obtain informed assent from young children prior to their participation in research. Methodological concerns have been presented which differ from traditional consent for adults, many related to language and process issues. In light of these, an assent protocol utilising a picture book that included photographs of young children engaged in research activities was developed to help capture children's interest and aid in their understanding of the research project. Children in two separate studies were presented with the book and demonstrated their understanding through engaging in meaningful discussion about the research process, assenting, and dissenting to participate. Important process considerations are discussed, along with the appropriateness of using a picture book to gather informed assent from young children.     

Asking the tough questions: a guide to ethical practices in interviewing young children

This paper discusses challenging features of interviewing young children for a range of purposes. Research with young children is discussed as well as other forms of interviewing by practitioners in a range of fields. Processes in establishing the interview purpose include defining some ground rules for the young client, managing the physical setting for the interview and examining the complex nature of confidentiality and consent in interviewing young children. In terms of interviewing style, the emphasis is on encouraging the young child's free narrative within an ethical context using a range of empathic response cues to promote this. Age-appropriate projective techniques, including art work and the use of dolls and puppets, are examined for their value in managing interviews and research with young children although cautions are expressed about interpreting findings from these.     

Conducting research with young children: some ethical considerations

The recent foundation of a ‘Young Children's Perspectives’ special interest group in the European Early Childhood Education Research Association (EECERA) reflects a general move in social research towards the respectful and inclusive involvement of children in the research process. However, established education research guidelines often provide no more than a loose ethical framework, appearing to focus on avoiding poor ethical conduct rather than proposing ways forward for making children's participation in research a positive experience. This short paper draws on my own experiences of conducting ESRC‐funded ethnographic video case studies on the ways four three‐year‐old children express their understandings at home and in a preschool playgroup during their first year of early years education. The paper reflects on the processes of negotiating initial and ongoing consent, problematises the notion of ‘informed’ consent in exploratory research with young children, and considers questions of anonymity when collecting and reporting on visual data. The paper proposes that by adopting a flexible, reflective stance, early years researchers can learn much from children, not only about their perspectives, but also about how to include young children in the research process.     

Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.     

Ethics in public health research: protecting human subjects: the role of community advisory boards

Increasingly, researchers grapple with meaningful efforts to involve communities in research, recognizing that communities are distinct from individuals. We also struggle to ensure that individual participants in research are fully protected.Community advisory boards (CABs) offer an opportunity to adopt a relationships paradigm that enables researchers to anticipate and address the context in which communities understand risks and benefits, and individuals give consent. CABs provide a mechanism for community consultation that contributes to protecting communities and fostering meaningful research. Furthermore, CABs can help us to re-create informed consent as a process. It is critical that we conduct research to understand the role of CABs in the informed consent process.     

Asking the tough questions: a guide to ethical practices in interviewing young children

This paper discusses challenging features of interviewing young children for a range of purposes. Research with young children is discussed as well as other forms of interviewing by practitioners in a range of fields. Processes in establishing the interview purpose include defining some ground rules for the young client, managing the physical setting for the interview and examining the complex nature of confidentiality and consent in interviewing young children. In terms of interviewing style, the emphasis is on encouraging the young child's free narrative within an ethical context using a range of empathic response cues to promote this. Age‐appropriate projective techniques, including art work and the use of dolls and puppets, are examined for their value in managing interviews and research with young children although cautions are expressed about interpreting findings from these.     

Exporting ethics: a narrative about narrative research in South India

The article notes some problems with the prepositional discourse of research ethics that is dominant in the West, and joins the call for an ethics-in-context approach in the human sciences. Using detailed examples from my fieldwork in South India to develop a narrative about ethical conflicts, I explore the problematics of informed consent, confidentiality and other concepts central to research ethics in the USA. The article underscores the inherent and practical risks associated with ethical universalism - applying 'universal' moral principles that have been constructed (that is, derived) in one cultural context and exporting them, without modifications, to another. The personal narrative includes my emotions in the field; they do moral work. The article draws theoretically from Bakhtin, Rabinow and feminist scholars of the Indian diaspora.     

Having,loving, and being: children's narrated well-being in Finnish day care centres

The aim of this study is to answer the following question: what do children tell about their well-being in Finnish day care centres? The theoretical and methodological framework of this study is based on a narrative approach. The research material was collected by participating in the everyday life of three groups of children and listening to their narratives. The research material, consisting of observations and tape-recorded conversations, is reflected in a model of well-being developed by a Finnish sociologist, Erik Allardt. This model consists of three dimensions: having, loving, and being. With the intention of understanding children's well-being, the meanings of having, loving, and being are explored. Instead of arguing for one objective truth, this study offers diverse narratives, conveying both positive and negative experiences of children's well-being. The most positive experiences deal with inspiring and enabling material environment, responsive adults, good friends, and opportunities for meaningful activities. Darker shades permeate the narratives characterised by unyielding institutional structures, children's separateness from adults, the exclusion from peer relationships, and not being respected as a subject. This study demonstrates both potentials and limitations involved in narrative methodology when exploring young children's experienced well-being.     

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.     

Beyond informed consent

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.     

Swimming with Seals: The Developmental Role of Initiation Rituals in Work with Adolescents

This paper uses the story of one young man's coming of age to consider the natural process of initiation as a model for intentional work with youth. The paper proposes a conscious and meaningful rites-of-passage approach to helping children and youth (particularly troubled and troubling or out-of-control youth) by assisting them in a successful passage to adulthood.     

Empty ethics: the problem with informed consent

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centering on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from its clinical and social setting. By flashing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current 'empty ethics' model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials.     

Trust and informed consent: insights from community members on the Kenyan coast

Trust is an important theme running through the literature on the ethics of biomedical research, but it is rarely given centre stage. In this paper, we present data gathered from a study aimed at exploring community views regarding the informed consent processes carried out by a large research centre on the Kenyan Coast. The findings point to the centrality of trust and elements of mistrust in general community views, in parents' (mis)understanding of studies they consent their children to be involved in, in refusals and concerns, and in community members' views about whether informed consent is a relevant and practical model to follow. Tentative ideas on how trust and a healthy mistrust might be balanced highlight the importance of strengthening communication surrounding basic health care as well as research, and of fostering 'an inner generated ethic of service'. The latter is particularly fundamental, but cannot be built and regulated through the laws, policies and guidelines that currently govern biomedical research practice.     

'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.     

Ethical considerations for research involving boys diagnosed with attention-deficit/hyperactivity disorder

The ‘new sociology of childhood’ has activated a growing interest in children as social actors and their level of involvement in activities that affect their lives. In the field of research, debate is underway regarding the consent processes and methodological activities that support child participation. This paper highlights methodological and ethical considerations that emerged while engaging in research with young boys (aged 9–11 years old) with a formal diagnosis of attention-deficit/hyperactivity disorder (ADHD). Key issues include recruitment, informed consent, and participatory activities for data production. Sociocultural theories of childhood and disability are applied to reflect on the power and privilege operating through the research process. Engaging in research that involves children with disabilities, in which discourses of risk, stigma, and protection are elevated, problematizes the researcher–researched relationship and expands considerations of what constitutes ethical practice and ‘valuable data’.     

Motivating Donors to Genetic Research? Anthropological Reasons to Rethink the Role of Informed Consent

In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors’ motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research.     

A consumer perspective on informed consent and third-party issues.

Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely.     

Health literacy, self-efficacy, and patients' assessment of medical disclosure and consent documentation

Informed consent documents are designed to convey the risks of medical procedures to patients, yet they are often difficult to understand; this is especially true for individuals with limited health literacy. An important opportunity for advancing knowledge about health literacy and informed consent involves examining the theoretical pathways that help to explain how health literacy relates to information processing when patients read consent forms. In this study, we proposed and tested a model that positioned self-efficacy as a mediator of the association between health literacy and patients' comprehension and assessment of informed consent documentation. Findings from structured interviews with patients (n?=?254) indicated that lower health literacy predicted lower self-efficacy, which predicted feeling less well informed and less prepared, being more confused about the procedure and its hazards, and wanting more information about risks. Incorporating awareness of self-efficacy into disclosure documents and consent conversations may be a useful means of prompting patients to ask questions that can help them make informed decisions about care.     

The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.     

Therapeutic Misconception: Hope,Trust and Misconception in Paediatric Research

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.