Children Research Paper

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The bioethics of research involving children has been, and remains, the subject of considerable debate and sometimes controversy. Codes and guidelines for ethical practice exist at national and international levels, but there remains debate on key issues among bioethicists, researchers, and clinicians. While codes for ethical research, such as the Nuremberg Code, sought to protect children from research and experimentation, there is now recognition of the potential benefits of research with children. The aim of ethics guidelines is now to protect children within research. Yet there remains division on critical issues of informed consent and children’s competence to decide whether or not they wish to participate in research or experimentation. While issues of consent and competence are essential to debates about bioethics, equally important are the ways in which methodology and method intersect with bioethics.


The bioethics of research involving children has been, and remains, the subject of considerable debate and sometimes controversy. While codes and guidelines for ethical practice exist at national and international levels, there remains division among bioethicists, researchers, and clinicians, particularly on key issues of children’s competency and consent.

This entry traces the development of thinking about bioethics and research with children, examining the development of the Nuremberg Code before focusing on the way in which children are positioned in the Declaration of Helsinki. It then turns to an examination of some of the key dimensions of bioethics and research involving children: consent, informed consent, and children’s competency to make important decisions. Finally, the entry discusses the distinction between methodology and method, highlighting its importance for ethical research with children.

While the concept of who is a child varies considerably across cultural contexts and depending on the issues at stake, the internationally agreed definition of a child is any person from birth to 18 years of age. This definition is based on the United Nations Convention on the Rights of the Child (UNCRC), adopted in 1989 and ratified by all but three countries. Article 1 of the CRC states: “a child means every human being below the age of 18 years unless under the law applicable to the child, majority is attained earlier.”

History And Development: Background Of The Issue

The first efforts to establish international guidelines for medical research were a direct response to the experiments carried out by the Nazi regime from the 1930s and throughout World War II. Children were often the victims of these experiments; for example, Josef Mengele’s inhuman experiments on children – particularly twins – are well documented. The Nuremberg Code was established in 1947, at the conclusion of the trials of several Nazi medical doctors, with the aim of protecting the human subjects from experimentation and preventing unethical practices carried out in the name of research. The first article of the Nuremberg Code identifies the consent of “the human subject” as “absolutely essential.” The first article of the code goes on to state:

The person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.

The Nuremberg Code does not specifically refer to children. The reference to “legal capacity” implies that children who are under the legally recognized age of consent should not be involved in medical experimentation. The requirement that the “research subjects” have “sufficient knowledge and comprehension” raised the question of whether children, particularly young children, have the capacity to understand the nature of research sufficiently to consent. Children’s relative lack of power raises the possibility that they might be coerced or manipulated during the research process. The Nuremberg Code responds to potential risks and harm by avoiding medical research and experimentation on children. Yet there are clearly instances when research involving children is both justifiable and ethical. This raises an ongoing ethical debate – and a very real dilemma for researchers – about the competency of children to give their consent. This is an issue that will be discussed further later in this entry.

In 1964, the World Medical Association adopted the Helsinki Declaration, which has subsequently undergone nine amendments and clarifications. Alderson (2007, p. 2274) has argued that if the Nuremberg Code can be seen as “a response to unjustifiably harmful research.. .Helsinki addresses the dangers of under-researched treatments.” Knowledge of the effects of thalidomide on fetuses was emerging in the early 1960s and fed into debates about the nature and content of the declaration. Yet, neither the devastating impact of experimental drugs on children nor debates about the bioethics of experimenting on or administering under researched drugs to children were new. In an earlier case, in Lubeck, Germany, in 1930, 76 newborn babies died after being vaccinated against tuberculosis with the newly developed BCG vaccine. The bioethics of the case were debated and scrutinized at the time, with critics of the use of the vaccine arguing that it had not been fully tested and noting that the dead babies had been treated within the public hospital system and were the children of poor families. The Lubeck case demonstrates the intersection between bioethics, socioeconomic status, and political context and is not alone in highlighting the vulnerability of some children to unethical and/or unauthorized medical experimentation. These very issues were among those debated during the development of the Helsinki Declaration.

The idea of an International Code of Medical Ethics had first been introduced by the World Medical Association in 1949 (Lederer 2004). The development of the declaration that would finally be adopted at the World Medical

Association General Assembly in Helsinki in 1964 revealed the depth of debate and the extent of disagreement over bioethics. Central to these debates was the involvement of children in medical experimentation. While some delegates argued that children as a collective group should not be involved in medical experimentation, others limited their concern to the trialing of vaccines, drugs, and medical treatment on children living in orphanages or other institutions, including institutions for children with disabilities. A contentious draft declaration, published in the British Medical Journal in 1960, stated that human experimentation should not be conducted under certain conditions, including on “children in institutions and not under the care of relatives” (Lederer 2004, p. 210). Lederer has noted that the debates about the bioethics of experimentation on children divided along national lines, with the French and British delegates arguing that institutionalized children should not be used in medical experimentation, while the Americans and Canadians argued to the contrary. Pharmaceutical companies, too, had a strong stake in the debates, given the practice of trialing a range of vaccines in children’s institutions in a number of countries.

Children in institutions were “captive” subjects for drug trials. In Australia, for example, a 2004 Senate inquiry found that a number of Australian medical research institutes had carried out medical trails of vaccines on children and babies in orphanages and other institutions until the 1970s, with results published in leading journals. At the time of the medical trials, potential public benefit and scientific knowledge was placed ahead of the rights, interests, and well-being of the children involved in the research. Children’s consent was not considered necessary at the time, nor were efforts made to seek consent from living parents. In the years immediately following the 2004 Australian Senate inquiry, in a striking example of the attitudinal shift that has taken place in relation to research ethics in the past four decades, leading research institutions and universities in Australia offered apologies to those who had been subjected to nonconsensual medical research as children. The rationale of promoting social good or scientific knowledge was no longer considered an acceptable justification for violating the rights of individual children. At the time of the drafting of the Declaration of Helsinki, however, the bioethics of research and experimentation involving children was relatively new, and principles were still emerging.

Ultimately, the 1964 Declaration of Helsinki allowed for research on children, subject to parental consent. This was a significant departure from the Nuremberg Code, which aimed to protect children from all forms of medical research and experimentation. Across the nine revisions and clarifications of the Helsinki Declaration, there are subtle but important differences in the conceptualization of consent as it relates to children. In early versions, authority was vested in the medical practitioner or researcher, with acknowledgement of the necessity of parental consent. In a significant development, the 1983 version of the declaration was amended to include the clause “when a child is to be a subject for research, that minor’s consent must be obtained.” The 2013 version states: “Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees,” but does not refer specifically to children. The question of who is “capable of giving informed consent” remains contentious.

The development of the bioethics of medical research with children, reflected in the debates around the Declaration of Helsinki, highlights several ethical issues, three of which are the focus of the remainder of this entry. First, how does the concept of informed consent relate to research with children; second, when are children competent to make decisions about involvement in research. Finally, how does bioethics interact with the principles that underpin the methodological approach taken and the methods used to gather data in research involving children?

Ethical Dimensions


As discussed above, the concept of consent has been – and remains – at the heart of debates about the bioethics of research involving children. The principle that subjects of research or experimentation must provide informed consent has been well established since the middle of the twentieth century. Yet the question of whether children can and should provide consent on their own behalf has continued to cause debate among bioethicists and researchers. While the Nuremberg Code took the position that children could not provide informed consent and therefore should not be subjected to medical or scientific research, the Helsinki Declaration allowed for research with children on the basis of consent being provided by parents and, in later versions, by children themselves.

Until the last decades of the twentieth century, bioethics prioritized parental consent. The consent of children, while sometimes sought, was not universally or consistently considered essential to ethical research. This left children vulnerable in at least three ways. First, children had little opportunity to disagree with their parents’ decision, or even to voice their objections. The requirement for parental consent is based on the legal fact that parents hold responsibility for their underage children. It is also based on an assumption that parents will necessarily act in accordance with their children’s interests and will make appropriate decisions on behalf of their child. Yet there is research to show that even when the parents’ intention is to act in their child’s interests, their position may not be the same as that of their child. It is not necessarily or always the case that a parent’s view is more reliable or better informed than that of the child. Nor is it the case that parents will always ask the same questions or raise the same concerns as their child. A child’s real concerns about involvement in or exclusion from a particular research project may be ignored if she or he is excluded from the decision-making process, given no information about the research and no opportunity to ask questions or express a view.

Second, and related, the requirement for parental consent is based on the assumption that parents will act in their child’s best interests. There are, however, scenarios when parent’s interests may conflict with that of their child. For example, if parents stand to benefit from or are offered incentives for their child’s participation, the child’s best interests may not be the priority. Moreover, in some instances, parents may be manipulated or coerced, or feel unable to refuse their child’s participation. The possibility of parents being pressured may be a particular problem when research takes place in an institutional set ting, where both parents and children have relatively little power.

The third issue arising from the requirement of parental consent is that children without parents – particularly those in orphanages or other institutions – are vulnerable to the kinds of experimentation discussed earlier in this entry. In institutional settings, consent is generally required from the individual with responsibility as the child’s legal guardian. This individual holds responsibility by virtue of their professional position and may know little about an individual child beyond information written in a file. The individual with legal responsibility need not have met the child. In such cases, it is difficult to ethically justify a position that the adult responsible is able to act in the child’s best interest. At best he or she may be able to make a generic assessment of risks and benefits.

An ethical dilemma also arises in relation to research with children who have no legal guardian. For example, children living on the street or otherwise independently of their parents, particularly in the global South, often have no adult charged with their legal responsibility. While parents or other relatives may be living, children often have no contact with them. In such cases, the concept of parental consent makes little sense. Moreover, it may be considered unethical to exclude all such children from research because no adult is able to provide consent. Many ethics committees take the position that parental consent is not required if it is shown that the child lives independently. In providing for this exemption, however, ethics committees – usually located in countries or institutions of the West – are often imagining adolescents who are close to the age of majority. The ethical dilemma becomes acute when the prospective research participants are eight or nine year olds, living independently on the streets.

Over time, an attitudinal shift has moved the child’s own consent to the center of bioethics. There is, however, considerable difference between countries, institutions, and disciplines as to whether or not children’s consent should be sought and as to how much weight it should be given. Alderson (2007) notes, for example, that in Britain far greater weight is placed on children’s consent than in the United States. In almost all cases, parental consent is still required, but children’s consent is now generally considered to be necessary in addition. Importantly, most ethics guidelines are clear that a child’s refusal to participate overrides a parent’s consent. However, in practice, parent refusal will almost always prevent children from participating in research. By means of illustration, in Australia accepted ethical practice requires consent of both parent and child, but the parent provides the first level of consent. Should parents refuse consent, researchers are not able to approach their children. On the one hand, this may provide children with protection against inappropriate pressure from researchers or others with a vested interest. On the other hand, it may result in children who wish to participate in a particular research project being excluded by default. This dilemma remains unresolved.

While ethics guidelines increasingly require children’s as well as parents’ consent, researchers are often faced with dilemmas in putting guidelines into practice. As noted above, tensions arise when the child and his parent have different views on participation in research. Two different scenarios serve to further illustrate the ethical dilemma. In the first, the parent may want a child to participate, while the child herself does not wish to. This scenario may be particularly difficult to resolve when parents believe that research may benefit the child – for example, in the case of medical research involving a child with an illness or disability – while the child considers the risks, discomfort, or potential harm to outweigh the potential benefits. In such a case, children’s competence to make a decision is likely to be doubted because it differs from that of both parents and adult professionals. As will be discussed below, however, giving precedence to the child’s consent not only raises ethical questions but directly challenges adult, and more specifically parental, authority over children. This challenge to child adult relations may be at least as difficult for a researcher (or a parent) to deal with as the ethical question of children’s competency to make decisions that differ from those of adults who are important in their lives.

In a second scenario, a child may want to participate in research, but the parent refuses. This scenario may be particularly challenging when the research subject is highly sensitive for both child and parent, for example, domestic violence or child abuse, but one on which a child wants to express his views and experiences. As noted above, in practice, this second scenario is generally overcome because parental consent is sought prior to seeking a child’s consent. Thus, if a parent refuses consent, the child is not approached. While this resolution avoids possible conflict between parent and child, which ethical research must aim to do, it does exclude some children from research that may be personally or socially important to them. Such exclusion based on adult preferences : may in itself be considered unethical if children are considered competent actors. Thus, while the idea of consent is central to ethical research with children, researchers are often faced with real-world dilemmas that are difficult to resolve.

The shift towards seeking consent from child as well as parent emerged from the late 1970s and is apparent in the 1983 revision of the Declaration of Helsinki, which requires the child’s consent in addition to that of the parent. The idea that children have the right to consent or refuse to participate in research was bolstered considerably in

1989, with the adoption by the United Nations’ General Assembly of the Convention on the Rights of the Child (UNCRC). The UNCRC reshaped the ways in which children are positioned in society, within laws, and within research. The UNCRC does not refer explicitly to research with children. It does, however, position children as the bearers of human rights, with entitlements to protection and participation. Article 12(1) states:

States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child.

This article has been widely interpreted as including research and as entitling children to decide whether or not they wish to participate in research. Arguably, the UNCRC has been more influential in the social sciences than in medicine and related fields, although it has had universal impact and is increasingly being interwoven with discussions of bioethics (Graham et al. 2013).

While the extent to which very young children are able to consent is debated, some scholars have argued that even babies are able – through body language and crying – to demonstrate unwillingness to participate. This is not to demand the termination of research with very young children who show unwillingness to participate. Rather, unwillingness on the part of the children should result in a pause in the research and reflection on the part of the researcher as to the methods being used, the environment in which the research is being conducted, and the reasons for the child’s distress. Thus, consent is a relevant ethical issue for research with all children, regardless of age.

As ideas of children’s rights within the research process have developed, there has been a shift away from the idea that children’s assent to research, alongside parental consent, is sufficient. The concept of assent, still used in some ethics guidelines, differs markedly from consent. At the most superficial level, assent may require no more than a child not actively refusing to participate. At a more meaningful, but still inadequate, level, assent may mean that children agree, but without fully understanding the nature or aims of the research (Alderson and Morrow 2011). Unlike assent, consent is based on having sufficient knowledge of the research to make an informed choice and being able to understand the information provided.

Significantly, however, some researchers and ethics guidelines use the term “assent” in relation to children because “consent” is considered to have a legal basis, and children do not have the legal right to consent. Some researchers have argued that assent need not be used in the superficial manner referred to above. Rather, they argue, ethical research practice demands that children have the necessary information to agree or refuse to participate in research, even when the concept of assent is more relevant than that of consent (see Docket et al. 2013). This raises the important point that consent or agreement is not sufficient – informed consent is essential to ethical research.

Informed Consent

The concept of informed consent can be traced to the Nuremberg Code and the requirement that prospective research participants “should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.” This crucial principle of having sufficient knowledge and comprehension has remained an essential component of consent.

Underpinning opposition to the idea that ethical research must seek consent from prospective child participants is the view that children, particularly young children, are unable to understand sufficiently the nature or subject matter of research. Thus, it is argued, the concept of consent makes little sense in relation to children. This position may recognize the importance of informed parental consent, but not informed consent from children.

The counter position argues that research which does not provide information to children in a manner that they understand is unethical. Beazley et al. (2009) have argued that researchers have a professional and ethical obligation to provide children with age-appropriate information, delivered in an age-appropriate and culturally sensitive manner that will assist them in making an informed choice about their participation in research. They contend that researchers’ obligation is grounded in both ethics guidelines and the UNCRC. Article 13 of the UNCRC entitles children to information, although it provides little detail on how information should be conveyed.

The literature around ethical research with children provides a range of examples of how information can be provided to children, including very young children (Danby and Farrell 2004; Alderson and Morrow 2011; Graham et al. 2013; Dockett et al. 2013). Two points are important here. First, written information is not always the most appropriate way of explaining research to children. Indeed, providing information only in writing to young children or to children who are illiterate or semiliterate is itself unethical practice. Second, informed consent should be an ongoing process that occurs throughout the research. Information should be reiterated and re-explained as the research progresses, with ample opportunity for children to ask questions, seek clarification, or seek additional information. As part of the process of informed consent, children should be aware that they have the right to decide, at any point, to withdraw from the research. Ennew and Boyden (1997) have argued that the principle of informed dissent – children’s right to say no or to withdraw from research – is as important in protecting children and ensuring research is ethical as the principle of informed consent.

Children’s Competency

The principle that children’s consent must be sought has become increasingly influential in bioethics. It is not, however, universally accepted. Opposition to seeking informed consent from children is generally based on the view that children, particularly younger children, are not competent to understand the complex nature of research, to make sense of information provided, or to balance potential benefits and risks.

The view that children are not competent to consent to participation in research has been increasingly challenged, as the body of empirical evidence demonstrating children’s competence has grown. Alderson’s (2007) research on children’s views of medical research and interventions, and their status within those processes, reveals that children often have higher levels of competency and understanding than assumed by adults and may be better placed to make informed decisions than adults.

Reconceptualization’s of childhood – based on both empirical and theoretical work since the late1970s – have been important in challenging the idea that children lack competency. In particular, “new” social studies of childhood have made important contributions to thinking about the ethics of research with children across a range of disciplines. Two broad epistemological positions arise from the social studies of childhood. First, children can and do exercise agency and have the competency to make choices about their lives, particularly when they are appropriately informed and supported. Second, generationally based power hierarchies shape the ways in which children are able to exercise agency and make decisions. Each of these positions has important implications for research ethics. First, an acceptance of children’s agency and competency leads to the view that children are able – and must have the right – to choose whether or not they wish to participate in research. The researcher has an ethical and professional obligation to explain the nature of the research and the likely consequences of participation in a way that is understandable to the child. Carefully designed research methods create the opportunity for children to engage meaningfully in research on complex topics. Second, recognition of the ways in which generational power shapes and constrains children’s ability to exercise agency and demonstrate competency demands methodologies and methods that overtly seek to disrupt adult-child power relations within the research process. Alderson (2007) has suggested that reluctance to take seriously children’s consent is about protecting adult power more than protecting children from research. She quotes a hospital chaplain who “said he believed that children’s competence greatly depends on adults’ competence to be supportive, generous, courageous and ‘big enough’ to respect children.” Alderson points out that taking children’s consent seriously, and recognizing their competency to make decisions, requires adults – professional researchers, clinicians, and parents – to surrender some power. Such arguments reveal the extent to which bioethics and related questions of children’s competence are embedded in social and cultural context and in social and human relations.

Methodology And Method

The major debates around bioethics and research involving children have tended to focus on whether or not children should be permitted to be involved in research and on who should make that decision. Equally important to bioethics are the ways in which research is undertaken. Consequently, research methodology and method are central to the bioethics of research with children.

The terms “methodology” and “method” are often used interchangeably. Within discussions of research ethics, however, it is valuable to recognize the important distinction between the two. Methodology can be seen as the theoretical framework, the principles, and the values that underpin the approach to research. Methodology is crucial in determining whether research is being undertaken in an ethical manner and in determining how people are positioned and treated within the research process. The language used to describe those people – “subjects,” “participants,” and “partners” – often signals the methodological approach adopted. Some researchers have identified the historical tendency for research to see people – particularly children – as the “objects” of research. Here, the priority is on “scientific methodology” and producing findings that can be defended within a particular discipline, rather than on the well-being or human rights of those involved. Such an approach may well be described as extractive and ethically unsound. Woodhead and Faulkner (2008, p. 13) identify the ethical shortcomings of research that transform the child into “a depersonalized object of systematic inquiry, their individuality evaporated into a set of measurable independent and dependent variables, and then condensed into general laws of behaviour.” Ethical research requires a methodological approach that is scientifically rigorous and robust and treats children as competent, rights-bearing individuals.

In critiquing the objectification of children through research as unethical, Woodhead and Faulkner provide as a concrete example the “Strange Situation” experiment, which aims to measure young children’s attachment to their primary caregiver. The experiment is generally carried out in a laboratory setting, where the child’s reactions and emotions can be observed and carefully recorded by researchers. During the experiment, a young child is placed “in a strange room, leaving them with a stranger, as well as entirely alone, whilst dispassionately measuring the level of their distress in terms of crying, sobbing and other expressions of panic” (Woodhead and Faulkner, 2008, p. 20). Instructions developed for the procedure call for the experiment to be stopped if a child is highly distressed and does not settle within 30 s. While this requirement limits the extent of distress that a child may experience, the ethics of such an experiment are questionable. The child is subjected to a situation that is anticipated to cause distress, the child’s crying is a clear indication of his preference to not participate, and the experiment relies on the child being subjected to deception. The principle of beneficence – that no harm is done to the individual child – would appear to be violated. When ethics are interwoven with principles of children’s human rights, such experiments must be identified as unethical. Yet, the Strange Situation Procedure continues to be used by some researchers concerned with child development and attachment, and the findings published in well-regarded journals. As human research ethics committees are now standard within universities and other research institutions in the developed world, and are increasingly so in the global South, important questions arise about the processes and guidelines that allow the approval of research that is ethically questionable. An important issue here is the ways in which disciplinary-specific appeals to scientific rigor and standard practice can overshadow ethical concerns.

Interestingly, Woodhead and Faulkner pose the question of how the ethics of an experiment similar to the Strange Situation Procedure would be assessed if the subject was an adult parent rather than a child. Woodhead and Faulkner’s scenario is as follows: at an outing to the zoo, a child – already informed by researchers of her role – slips away from her parents. Researchers are ready to observe and measure the parents’ distress as they realize their child is lost and to monitor the parent’s reaction to reunification. While the “Strange Situation” is still used to gain insight into children’s attachment, including across very different cultural settings, it is unlikely that a similar experiment that actively deceived and caused distress to an adult would be considered ethical. It is unlikely that a potential participant, child or adult, would consent to involvement if fully informed of the distress they may suffer. Interestingly, however, some parents do consent to their child’s involvement. This particular experiment raises many issues that are central to bioethics. It also demonstrates the interrelationship between ethics and methodology.

While methodology shapes the ways in which research is designed and conducted, and is thus key to ethical research, methods are also important. Methods are the “tools” used by researchers in order to engage with children and to gather data. If methodology determines the ways in which researchers think about children, it is the methods that children most directly experience. For example, children experience measurement within a controlled laboratory setting differently from participatory methods whereby children photograph social phenomena that are important to them (often described as “photovoice”). In the latter example, there is considerable opportunity for children to exercise agency within the research, to determine what is important to them, and to share with the researcher their knowledge of their social environment. In line with the intent of participatory research, the result may be empowering for the child as well as producing robust data. However, the guiding principles, more than the methods used, determine the way in which children experience research. Both measurement of children’s behavior in a controlled environment and the use of participatory methods such as photovoice may be ethical and treat children with dignity and respect, depending on the underlying methodological approach. Equally, each can be depersonalizing or extractive, if sufficient methodological attention has not been given to the ways in which researchers will interact with children. Moreover, methodology is important in ensuring that ethical principles determine the choice of methods.

Methodology and method are essential components of ethical research. The potential harm caused by research may be reduced considerably by carefully designed methodology that prioritizes the interests and well-being of the child. Carefully chosen and appropriate methods provide an additional protective layer for children who participate in research.


Undertaking research with children raises ethical issues that do not arise, or arise differently, in research with adults. Issues around informed consent and children’s competence present especially challenging ethical dilemmas. The methodology and methods used are crucial in determining whether or not research is ethical. Over the past half century, there has been an increasing recognition of the potential benefits of research involving children. This recognition sits alongside a history of unethical research that has harmed children, extracting data with little regard for each child’s human rights, welfare, or well-being. The development of an ethical framework for research with children is an attempt to maximize the benefits of research and protect against harm and abuse. While much has been achieved, many issues remain contentious and the bioethics of research with and on children remains a work in progress.

Bibliography :

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  10. Woodhead, M., & Faulkner, D. (2008). Subjects, objects or participants? Dilemmas of psychological research with children. In P. Christensen & A. James (Eds.), Research with children: Perspectives and practices (2nd ed., pp. 10–39). New York: Routledge.
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