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. (shrink)

Video ethics in educational research involving children is a recent topic that has arisen since the increase in the use of visual mediums in research (such as photovoice and video) especially with the development of new and ubiquitous internet technologies and social media. This paper emerged as an expressed concerned by a group of scholars associated with the new Video Journal of Education and Pedagogy (Brill) that was established in 2016. The paper is the result of (...) a collective writing process over a period of a few months that discusses visual studies in education and visual ethics in relation to qualitative research in education, and as it applies to children. The article also uses the newly established convention of open review, publishing the results with the paper. (shrink)

In a Norwegian study on how children aged 7-12 years cope during a period of serious illness within the family and on their quality of life at this time, several ethical questions became apparent. These were mainly concerned with the vulnerability of children during research, with their ability to make autonomous decisions, and with considerations regarding how to respect their right to confidentiality during the research process. In this article we approach these questions using our experience (...) from this previous study, discussing them within the framework of theories of ethics and relevant research ethical guidelines. Finally, we discuss our experience in the light of the overall purpose of this article: how to deal with the ethical dilemmas that may appear during research involving young children. (shrink)

Video ethics in educational research involving children is a recent topic that has arisen since the increase in the use of visual mediums in research especially with the development of new and ubiquitous internet technologies and social media. This paper emerged as an expressed concerned by a group of scholars associated with the new Video Journal of Education and Pedagogy that was established in 2016. The paper is the result of a collective writing process over a (...) period of a few months that discusses visual studies in education and visual ethics in relation to qualitative research in education, and as it applies to children. The article also uses the newly established convention of open review, publishing the results with the paper. (shrink)

This study examines the way that consent is reported for participation in school-based research involving children or young people aged from 5 to 16 years. Databases containing descriptions of research identified during systematic reviews were surveyed to determine to what extent consent is sought, and from whom, and to see whether reporting varied by study characteristics such as the age of participants, the country in which the research was carried out, research design and substantive (...) area of study. Of a total of 489 studies in school settings involving children or young people, less than a third reported seeking consent. Only one in seven sought consent from children or young people themselves. Consent was reported significantly more frequently in studies sourced from health promotion reviews, when compared to those sourced from education reviews. Codes of practice indicate that researchers should seek consent from research participants. This study demonstrates that these principles are often not reflected in practice. (shrink)

Background:The right of children to have their voice heard has been accepted by researchers, and there are increasing numbers of qualitative health studies involving children. The ethical and methodological issues of including children in research have caused worldwide concerns, and many researchers have published articles sharing their own experiences.Objectives:To systematically review and synthesise experts’ opinions and experiences about ethical and methodological issues of including children in research, as well as related solution strategies.Research (...) design:The research design was a systematic review of opinion-based evidence, based on the guidelines by Joanna Briggs Institute.Methods:A search of five computerised databases has been conducted in April 2014 and 2271 articles were found. After screening the titles, abstracts, full texts and appraising the quality, 30 articles were finally included in the review. A meta-aggregative approach was applied in the data analysis and synthesis process.Ethical considerations:Ethical approval is not needed as it is a systematic review of published literature.Results:Six themes were identified, including evaluating potential risks and benefits, gaining access, obtaining informed consent/assent, protecting confidentiality and privacy, building rapport and collecting rich data. The similarities and differences between research involving children and that involving adults were indicated.Conclusion:All potential incentives should be justified when designing the study. Further studies need to research how to evaluate individual capacity of children and how to balance protecting children’s right to participate and their interests in the research. Cultural differences related to researching children in different regions should also be studied. (shrink)

In this article, we explore the ethical issues related to the reporting of suspected abuse or neglect in research involving children. Ethical dilemmas related to reporting child maltreatment are often complex because the rights of children and their adult caregivers may conflict and determinations of abuse or neglect are socially constructed judgments that depend on particular circumstances. We argue that when reporting is legally mandated, investigators must follow the law and report their suspicions to Child Protective (...) Services. When reporting is not legally mandated, investigators still have an ethical obligation to report to help prevent additional maltreatment and allow children to obtain access to services needed to recover from abuse or neglect. We also argue that investigators should include plans and procedures in the research protocol for making reports and training research staff in recognising evidence of child abuse or neglect. Although investigators should report evidence of abuse or neglect that is discovered incidentally, they have no mandate to actively search for such evidence when it is not related to the study’s objectives. Investigators should also inform parents and children about their obligations to report suspected abuse or neglect. (shrink)

An Institute of Medicine panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards, institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.” We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents. Here, we report (...) additional results from our study and identify some of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to (...) the medical intervention as such. It has been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

Children and individuals with developmental disabilities compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from (...) class='Hi'>research by equitable participation. Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy. (shrink)

Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow (...) us to conclude that the results are valid and, in consequence, how far the vaccination plans for children are scientifically justified.The principal aim of this article is to analyse critically the process of clinical research on COVID-19 vaccines involving children, highlighting the ethical concerns that arise, including the need to stratify the results from older adolescents separately for analysis before proceeding, if further research is warranted, in descending age order. The development of COVID-19 vaccines is examined, with a special look at the participation of children throughout their clinical development, including a review of the clinical trials registered in three international databases. We also offer some additional considerations about the inclusion of minors in vaccination plans. Finally, we conclude with some recommendations, with particular emphasis on the following ethical duties: research in children should be carried out only once the relevant research in adults has previously been conducted; issues that concern children’s needs and rights should be specifically addressed; and, therefore, the highest standards of ethical and scientific quality should be met. (shrink)

Der Kinder- und Jugendgesundheitssurvey soll repräsentative, gültige Daten und Erkenntnisse zur gesundheitlichen Situation von Kindern und Jugendlichen in Deutschland als entscheidende Voraussetzung für die Bewertung und die Verbesserung von deren gesundheitlicher Lage schaffen. Forschung und insbesondere Blutentnahmen an nichteinwilligungsfähigen Personen erfordern eine profunde ethische und rechtliche Überprüfung. Der Beitrag befasst sich damit, welche medizinethischen Empfehlungen und welche rechtlichen Grundsätze in Deutschland für die Bewertung relevant sind. Nach geltendem deutschen Recht können Eltern zu Blutentnahmen bei ihren Kindern nur zustimmen, wenn diese (...) in deren individuellem gesundheitlichen Interesse liegen. Ein „gruppenspezifischer Nutzen“, wie er von Medizinethikern national und international als Voraussetzung für ethische Akzeptabilität (bei minimalem Risiko der Untersuchungen) ebenfalls für sinnvoll und wichtig angesehen wird, und der in dem geplanten Survey in jedem Falle gegeben wäre, genügt deutschen Rechtsansprüchen nicht. Im Pretest hat sich der potenzielle individuelle Nutzen der Blutentnahmen bestätigt: Viele Kinder hatten biochemisch nachweisbare Gesundheitsrisiken (z. B. verborgener Nährstoffmangel, allergische Sensibilisierung, Hinweise auf Impflücken oder langfristige Gesundheitsrisiken), die ohne Blutuntersuchung nicht feststellbar gewesen wären. Bei über 90% der Kinder waren nach schriftlicher Einwilligung der Eltern und Jugendlichen sowie informeller Zustimmung der Kinder, die in jedem einzelnen Falle berücksichtigt wurde, Blutentnahmen möglich. Nach der Befragung einer Unterstichprobe ist die Akzeptanz insgesamt gut. (shrink)

Der Kinder- und Jugendgesundheitssurvey soll repräsentative, gültige Daten und Erkenntnisse zur gesundheitlichen Situation von Kindern und Jugendlichen in Deutschland als entscheidende Voraussetzung für die Bewertung und die Verbesserung von deren gesundheitlicher Lage schaffen. Forschung und insbesondere Blutentnahmen an nichteinwilligungsfähigen Personen erfordern eine profunde ethische und rechtliche Überprüfung. Der Beitrag befasst sich damit, welche medizinethischen Empfehlungen und welche rechtlichen Grundsätze in Deutschland für die Bewertung relevant sind. Nach geltendem deutschen Recht können Eltern zu Blutentnahmen bei ihren Kindern nur zustimmen, wenn diese (...) in deren individuellem gesundheitlichen Interesse liegen. Ein „gruppenspezifischer Nutzen“, wie er von Medizinethikern national und international als Voraussetzung für ethische Akzeptabilität (bei minimalem Risiko der Untersuchungen) ebenfalls für sinnvoll und wichtig angesehen wird, und der in dem geplanten Survey in jedem Falle gegeben wäre, genügt deutschen Rechtsansprüchen nicht. Im Pretest hat sich der potenzielle individuelle Nutzen der Blutentnahmen bestätigt: Viele Kinder hatten biochemisch nachweisbare Gesundheitsrisiken (z. B. verborgener Nährstoffmangel, allergische Sensibilisierung, Hinweise auf Impflücken oder langfristige Gesundheitsrisiken), die ohne Blutuntersuchung nicht feststellbar gewesen wären. Bei über 90% der Kinder waren nach schriftlicher Einwilligung der Eltern und Jugendlichen sowie informeller Zustimmung der Kinder, die in jedem einzelnen Falle berücksichtigt wurde, Blutentnahmen möglich. Nach der Befragung einer Unterstichprobe ist die Akzeptanz insgesamt gut. (shrink)

BackgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.MethodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and (...) performed within the following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.ResultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in researchConclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV. (shrink)

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The (...) analysis indicates that recent writers misconceive how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

In this article, I explain why it is important for theologians to involve children in empirical research, and why children themselves can and should be considered as ‘theologians’. Therefore, I refer to theories in childhood studies and child theology (children as active participants and subjects), and also to contemporary trends in empirical research and practical theology (views on theology and ethnography, lived religion etc.). Counter-arguments for involving children in empirical research are discussed (...) as well. In the second step, I deal with ethical issues and discuss which aspects have to be taken into account when doing research with children. (shrink)

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. (...) No articles provided a single, comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child’s readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child’s role as a research participant. The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent. (shrink)

In the last decade, there has been an increased focus on child protection cases in the European Court of Human Rights. The heightened attention on child protection underscores the actuality of children’s rights, rendering it an interesting area for researchers in fields such as children’s rights, child protection, or international relations. All judgments from the Court are public. Research on social media data has shown that public data is not necessarily intended for the public. Moreover, in child (...) protection cases, the child is rarely a part of the case. It is the biological parents against the domestic authorities. Nevertheless, the situation the case revolves around includes the child, making the child an indirect part of the judgment. There is little research on the ethical considerations of indirectly involving children in research on court judgments. However, there is abundant research on ethical considerations in researching public data, specifically social media data. By drawing on research on ethical considerations in the use of social media data, this article delves into the ethical consequences of including children indirectly in research. The article pinpoints crucial areas that require special attention from researchers and provides insights on navigating ethical challenges effectively. (shrink)

Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam (...) is the dominant religion in these countries, and it affects people’s behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants’ primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children’s bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies. (shrink)

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the (...) legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children. (shrink)

The future health of children depends on clinical research which is an important part of medical progress. The principles of the child’s best interests standards and how it is applied in the context of research are explored. This review will show that there is a need for research involving children but there are gaps in the current legal and ethical framework which are not readily applicable to non-therapeutic research involving children. There (...) are significant challenges in trying to achieve a balance between what is socially good and the obligation to protect children who participate in research. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic (...) Testing Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of (...) the researcher to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

The Environmental Protection Agency has adopted new regulations that prevent the agency from conducting or funding intentional exposure research involving children, pregnant women, or fetuses. I argue that these regulations overprotect children, and that the EPA should revise them to conform with Subpart D of the Department Health and Human Services’ regulations governing research with humans.

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic (...) Testing Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the (...) legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children. (shrink)

Data from the 5–6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers—very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be (...) communicated to them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK. (shrink)

In clinical mental health research with children, both child and parent are essential members of the research team. The 3 R's of parent/child team membership are respect, rapport, and recognition. Respect and recognition include fair reimbursement for time, expense, and inconvenience, but the most important compensation for many families is the appreciation of the other team members for their sacrifice and cooperation. Reimbursement, although honoring the principles of justice and respect for persons, raises difficult issues about appropriate (...) amount, particularly in research involving children. The 3 R's are supported by the investigator 5 A's: attitude, adaptability, availability, attachment, and appreciation. Although the principles seem clear in the abstract, implementation encounters many practical problems. Perhaps the most difficult of these is determining the appropriate amount of compensation that avoids undue inducement but not at the expense of the 3 R's and 5 A's. (shrink)

The considerations and recommendations set out by Bhatia-Lin and colleagues (2019) for the appropriate use of social media platforms to locate and track research participants are timely and importa...

From the very beginning of civilization, children are made the subject matter of many social and clinical researches. Due to the vulnerabilities of physical frailty and mental immaturity, children’s interests and rights need to be protected from the risks associated with any kind of research. Recently, there has been increased global concern towards the involvement of children in research for the protection of their rights by the ethical research practice. It emphasizes upon the ongoing (...) nature of ethical considerations that ethical issues need to be considered throughout the research process and even the post research ethical issues are equally significant. The study explores some of the major ethical issues that arise in research involving children during and after the research in terms of the best interests of the children.Bangladesh Journal of Bioethics 2015 Vol.6 (1): 6-10. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code and is embodied in various federal human research protection regulations. In a program named "SATURN", each school in (...) the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

The aim of this paper is to investigate how children use their participation in research as a potential transformative social practice in everyday life. The concept of transformative social practice will be discussed in relation to the notion of transformation. Through empirical examples provided by Holly (12) and Oliver (11), the article argues that research processes open up possibilities for understanding ourselves (researchers and participants) in new ways. ‘Life Mapping’ - as dialogical method in research with (...) children - will be presented and reflected upon as a way for children to develop different understandings of themselves, their families, and everyday life. This emphasizes the connection between the use of child-relevant methodologies and how specific children can bring dialogues from the research process in to play in their everyday lives. Data is drawn from a qualitative study and is a part of a PhD project studying children’s everyday lives with two households as a result of parental divorce. The project involves ten children aged 8- 12 and their parents. (shrink)

The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view (...) on the body and vulnerability. It is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent. (shrink)

This paper considers the often-expressed fear that medical research may use children merely as means, and not respect them as ends in themselves – especially insofar as they are deemed less able to consent than adults. The main focus is on large-scale genetic, socio-medical and epidemiological research. The theoretical starting point of the paper is that to be treated as an end in oneself is to be regarded as – and to act as – a participant in (...) cooperative endeavours. This participatory status is certainly connected with individual authority to consent and dissent; and there is no doubt that consent plays an important role when adults participate in many research projects. However, insofar as consent is located within structures of human cooperation, the authority to consent is not a straightforward privilege. Rather, consent is bound up with responsibility for one's choices and commitment to shared terms of cooperation. Given this understanding, it is argued that consent should not be our principal concern when we involve children in research. This is not because of children's (possible) incompetence to consent as such, but rather because children are still learning how to respect and assess the cooperative terms involved in our institutional lives. Instead, our leading concern should be with the terms regulating their involvement in research. Given suitable safeguards, research is one way in which children may learn what it is to bear responsibilities and to act as an end in oneself – that is, to cooperate with others on reasonable terms and for worthy ends. (shrink)

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration (...) of Helsinki, and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health , and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration. (shrink)

Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively.

Social scientists who conduct qualitative research frequently use emotional engagement to gather information about participants’ thoughts, feelings, and behaviours in relation to a particularly research question. When the subject under investigation is related to trauma, listening to, or being exposed to personal accounts of participants’ traumatic experiences can carry a significant emotional cost for researchers. This may place them at risk of secondary trauma. In this article, I examine these issues from the context of my doctoral field (...) class='Hi'>research in South Africa, which focused on intergenerational trauma amongst descendants of victims of apartheid-era gross human rights violations. I reflect on my positionality as both an insider and outsider and feelings of guilt that emanated from my sense of being privileged and an imposter. I also reflect on the emotional turmoil brought about by my engagement with the trauma of participants and their families. I conclude by sharing the lessons I have learnt, and that have enabled me to sustain my scholarly engagement with intergenerational trauma. Ultimately, this article gives insight into, and raises awareness about, the emotional consequences of conducting trauma research. It offers practical suggestions to help researchers navigate the emotional minefield involved in conducting trauma research. (shrink)

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine (...) "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments. (shrink)