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Deception of children in research
  1. Merle Spriggs1,
  2. Lynn Gillam2
  1. 1Hearing, Language & Literacy, Population Health, Murdoch Childrens Research Institute/Children's Bioethics Centre, Centre for Health & Society, School of Population Health, University of Melbourne. Melbourne, Victoria, Australia.
  2. 2Children's Bioethics Centre, Royal Children's Hospital, Centre for Health & Society, School of Population Health, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Merle Spriggs, Hearing, Language & Literacy, Population Health, Murdoch Childrens Research Institute. Parkville, VIC 3052, Australia; merle.spriggs{at}mcri.edu.au

Abstract

The aim of this article is to draw attention to an under-recognised but ethically important phenomenon involving the deception of children in research. The type of deception we are referring to is not planned deception that is part of the research design. Instead it is deception that occurs in individual cases where parents ask researchers not to reveal something about the research to their child. Our focus is children who do not have ultimate decisional authority—children around the ages of 7–14 years old who may have the cognitive capacity to understand but not to consent for themselves; children whose agreement is required but not sufficient to authorise research. We provide three illustrative scenarios for analysis. Then, we identify circumstances in which non-disclosure might be justified and set out reasons why providing information to non-competent children is ethically required. On this basis, we argue that non-planned deception requested by parents is very unlikely to be ethically acceptable. Finally, we recommend that guidelines should (a) require researchers to consider what to do if parents do not want to disclose information to a child and (b) clarify that the most ethical response is to simply not include that child in the research.

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The aim of this article is to draw attention to an under-recognised but ethically important phenomenon of deception of children in research. Our focus is on unplanned deception of children who have the cognitive capacity to understand the research, but not to consent for themselves. This would be around the ages of 7–14 years of age (although the age is less important than the developmental stage), where typically a research ethics committee (REC) might require children's assent. Assent is standardly understood as being the child's choice based on information tailored to the child's developmental stage1 The child's agreement is required but not sufficient to authorise research. The need for children's assent in addition to parent's consent is a feature of research ethics guidelines in a number of countries.2–6 Unplanned deception can occur when a REC has approved a research protocol in which children's assent is to be sought, but something happens during the conduct of the research which leads researchers to consider keeping hidden from a particular child some key information about the research. Usually the REC approves the child-friendly written information to be given to the child as part of the assent process, with simplified explanation of purpose, procedures, risks or discomforts and expected benefits. This is based on the idea of assent as engagement with the child,7 not just getting compliance.

We know that these kinds of situations can arise in paediatric research because, as part of a project investigating consent in research involving children, we asked researchers about the things they have difficulty with when conducting paediatric research.8 Among the difficulties they described were situations involving or potentially involving deception such as the following:

  • Child A is 8 years old and has cancer. Her parents do not want her to know her diagnosis and they say that no one is allowed to tell her. Now they are enrolling her in a clinical trial but to make sure she does not find out her diagnosis, they do not tell her about the trial or pass on to her written information that researchers have provided. The trial involves a new drug, extra blood tests and biopsies specifically to collect research data.

  • Child B is 11 years old. His parents want him to take part in a study about children conceived by assisted reproductive technologies but forbid the researchers to do anything to make him aware of how he was conceived. They do not want him to know that they used donor eggs and that he is not genetically related to his mother. The study involves children filling in questionnaires about their psychological well-being and family relationships.

  • Child C is 9 years old. Her parents have been asked to involve her in a study following up on the health and well-being of children diagnosed in utero with a chromosome rearrangement found by coincidence in the course of a routine prenatal test for something else like Down Syndrome. The health implications of the rearrangement are not clear but studies show various symptoms and an increased risk for abnormality which is between 5% and 10%. The research involves a questionnaire to be filled out by a parent and an educational achievement and IQ test to be completed by the child. Child C's mother believes this is important research and wants her child to be involved but she has not told her about the rearrangement. She does not want her child to feel different or stigmatised so she asks the researcher to pretend that he is doing research on normal children—just checking up on them.

These kinds of situations involving deception were unexpected and troubling for researchers who felt they had no guidance for dealing with them. In this article, we analyse the ethical issues involved, with the aim of providing some guidance.

We address two ethical questions: first, whether not disclosing information in these circumstances counts as deception and if so, whether such deception can be justified.

Throughout, we focus on situations where the non-disclosure is not part of the research design as approved by the REC and may specifically go against the approved protocol, for example, where written information specifically designed for children was part of that protocol. We do not address planned deception of children in research, which would involve a proposal to a REC that information be withheld from all children recruited for the research. Such planned deception, at least of adults, is generally regarded as sometimes ethically justifiable, especially where it is necessary for the successful conduct of the research,2 ,4 ,9 but that is not the circumstance we are dealing with here.

In order to answer the question of whether unplanned non-disclosure to children in research is ethically justified, we need to take into account two more general matters: (1) the ethics of deception in research and (2) the ethical reasons for giving information to non-competent children who are potential research subjects. This will provide the basis for deciding whether the information that has been omitted in these scenarios is ethically required, and hence whether its omission counts as unethical deception. We consider what is acceptable and what is not acceptable in terms of the type of information and the amount of information that is given to children and we suggest what the role of researchers and ethics review bodies should be in dealing with these types of scenarios.

Overall, we argue that hiding information from children in a research setting is ethically inappropriate and hard to justify. Hence, children who have not received the key information about the research should not be participants in that research, even if their parents want them to be included and are driving the non-disclosure. In short, the researcher should not include that child under conditions of non-disclosure or deception. That child should be omitted, and the researcher should simply move on to recruit other children. This is not a conclusion that the parents are doing wrong in not disclosing some piece of information to their child: that is a complex ethical judgement based on many factors that the researcher is not privy to. It is simply a claim that it would be wrong to include such a child in research, where the justifications for deception are different.

1. The ethics of deception of participants in research: what do research ethics guidelines and regulations say?

Research ethics guidelines and regulations in the UK, Australia and the USA have nothing specific to say about the deception of children but some refer to deception in a general way.2–4

The Australian National Statement on Ethical Conduct in Human Research refers to deception generally and defines it as “[w]here relevant material is withheld from research participants, and/or they are intentionally misled about procedures and/or purposes of research”.2 Deception is described as being at one end of the spectrum of limited disclosure, which ranges from “simply not fully disclosing or describing the aims or methods of observational research in public contexts, all the way to actively concealing information and planning deception of participants”.2 Limited disclosure is said to be ‘sometimes justifiable’ because in some research such as the study of human behaviour, “the aims of the research cannot be achieved if those aims and/or the research method are fully disclosed to participants”2 The guidelines on ‘limited disclosure’ state that only a human research ethics committee can review and approve research that ‘involves active concealment or planned deception’.2

US Federal Regulations do not mention ‘deception’ or limited disclosure, but the Belmont Report which remains the basis of US Human Subject Research Protection Regulations9 refers to research involving ‘incomplete disclosure’. Such research is justified only if: it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.10

It also says that: Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.10

These guidelines suggest that the three scenarios are ethically problematic, because in these scenarios the purpose of deception is not to make it possible for the research to accomplish its aims. Rather, it is to protect the child from information which the parents presumably believe would be distressing or damaging in some way. However, assenting children are ethically different from consenting adults, so we need to consider whether there might be a particular justification for non-disclosure of information to children. There is a lack of clarity in the guidance in terms of the special situation that exists with parental permission and child assent and to whom information should be provided in the context of research involving children.

2. Ethical reasons for giving information to non-competent children in research

What is the purpose of giving information to non-competent children in the research context? The assent of non-competent children does not itself provide ethical authorisation for research; that is, the role of parental informed consent. Even if we accept the standard view in research ethics that children's agreement is needed1 ,11 so they are not forced to do something against their wishes, why does the child need information in order to give assent?12–14 The following are the main reasons for telling non-competent children what the research is about and what will happen. Some reasons are to do with preventing harm (1 and 2) and some are about respect for persons (4 and 5). These two types of reasons are the ethical goals which children's assent to research is intended to serve.1 ,13 There are also practical reasons (3):

  1. In general, it is psychologically beneficial and less frightening for children to know what to expect. This is known from the clinical setting, where best practice is to explain to children what treatment they are going to have, how it will help and what it will involve.14 For example, literature from the paediatric cancer setting shows that most children who are given information about their diagnosis and prognosis have less anxiety and depression.15

  2. Telling children what is happening and why preserves the child's trust in parents and researchers. Again in relation to paediatric cancer, preserving trust is the reason most parents cite for giving information to their child.15

  3. Giving information is in the researcher's interests. The disclosure of information allows the child to cooperate. A lack of cooperation can alter the thing the researcher is trying to measure, for example, blood pressure. The researcher needs the child to put out their arm to measure their blood pressure. The child is more likely to cooperate if they know what it is about. In addition, anxiety could increase blood pressure and distort study findings if the child does not understand what is being done to them.

  4. Giving information allows the child a meaningful opportunity to say ‘no’. Without information about what they will have to do, and what the study is for (in particular, that it is not for their direct benefit), the child cannot form a view.16 The later the stage of development of the child, the more important information about the broader purposes of the research becomes.

  5. Informing children about the research they are asked to take part in demonstrates respect for them,16 and, on the contrary, deliberately not informing them about something demonstrates lack of respect.

All of these reasons together strongly suggest that it is ethically important to give information to non-competent children in the research setting. However, the question of whether non-disclosure of some information could ever be justified needs to be asked. One response is that children may be distressed or harmed in some way by being given information about research, and hence that it should not be given. After all, this is presumably the parents’ reason for wanting information withheld. However, even if we accept the parents’ judgement about the negative effects on the child of having the information, this does not provide a good justification for including the child in the research without giving them the information. It only provides a reason for not giving them the information. Rather, it suggests that the child should not be included in the research. There is no actual need to include the child in research. The child does not lose anything beneficial to him or herself by not being in the research, so there is no good reason for deception to facilitate involvement—setting aside very rare instances where there is known clinical benefit from the research intervention and it is not available outside the research context. The research context is significantly different in this regard from the clinical context, where treatment is beneficial to the child and it may be argued very strongly that it is justified to deceive a child in order to get them to cooperate or to make the experience of treatment less distressing for them. It may be objected that this same argument would apply to so-called therapeutic research, but characterising research as ‘therapeutic’ is widely challenged,17 ,18 because the purpose of clinical research is precisely to find out if the benefits of a treatment sufficiently outweigh the risks. If that is already known, then the intervention is clearly therapeutic, and should be provided for a child as therapy, not in the context of research.

A second possible reason for not disclosing all of the aims and methods of a research project is to assist with the child's understanding. For very young children, this is understandable and it is probably a common practice. Young children under the age of 6 or so have limited understanding, so carefully restricting the amount and type of information can in fact enhance their understanding within the bounds of their developmental stage. Limiting information can be ethically acceptable when promoting understanding is the reason, and would not count as deception, because the intent is to increase understanding, not decrease it. However, as the child matures and becomes able to understand more about research, in particular about its purpose, such limitation of information becomes less relevant and more ethically problematic. In the research setting, the key test of ethical acceptability is whether non-disclosure is genuinely required to assist the child to understand the situation. Unlike the clinical situation, there is no justification in terms of protecting the child from distressing information in order to get them to do something that is beneficial for them.

Discussion

Using the reasons set out above, we will now discuss the scenarios posed earlier, in order to shed light on the ethics of hiding information from children in research. Each scenario involves limiting information to children, presumably to prevent harm. We will see, however, that it is very hard to argue that limiting information is ethically defensible.

In the first scenario, Child A's diagnosis of cancer is concealed. This means that she will not know the purpose of the research, although she may be informed about research procedures. She will think the procedures are part of regular treatment. Child A's parents believe they are protecting her from harm by concealing the truth about the diagnosis and benefiting her by enrolling her in the trial (even if benefit will not result and Child A's parents are under the therapeutic misconception). However, without knowing that she has cancer and that she is in a study, Child A is denied the opportunity to say that she does not want to participate in the study (reason 4). If research interventions are different from treatment interventions, hence unfamiliar to the child, reason 1 for disclosure is also operative. She might also come to feel deceived and hurt and to lose trust in her parents and her doctors if she learns that she has undergone uncomfortable or painful procedures which are for research purposes rather than necessary for her personal benefit (reason 2). Concealing information also demonstrates a lack of respect (reason 5). In addition, the limiting of information here does not meet the test of promoting understanding. It is now common practice to explain to even very young children that they have cancer.19 The research has been planned on the basis that child participants will know their diagnosis, as this is the clinical reality.

In the second scenario as well, if Child B learns that the purpose of the research has been concealed from him he may lose trust in his parents, the researchers and medical research itself (reason 2). This case differs from the first scenario though. Child B has an opportunity to say if he does not want to take part in the research (reason 4). While not informed about the purpose of the research, he has been informed about the procedures. Child B can say no on the basis of his view of the procedures involved, but does not have a choice about taking part in research which is about assisted reproductive technologies. If he did know, he might feel embarrassed and not want to participate or alternatively, he might be very keen to participate. In not telling Child B what the research is about, the researcher demonstrates a lack of respect by not allowing him to act on his own reasons (reason 5). Again, limiting information is not being done for the purpose of promoting understanding.

The third scenario is similar to the second. Child C is given information about the achievement and IQ test but she is told that it is to check up on children rather than checking for abnormality. She can choose not to take part if she does not want to do the tests but she is not given the choice of saying that she does not want to be assessed for abnormality—something she might object to if she knew about it, even without a complete understanding of the study rationale and aims (reasons 2 and 5). The purpose of non-disclosure does not appear to be related to understanding, since there is no reason to think that Child C would be confused by an explanation of the basic purpose of the research.

Hence, non-disclosure does appear to be deceptive and not ethically justified in all three scenarios. In addition, the scenarios draw attention to another significant issue. When researchers collude with parents in leaving out information about the purpose of research or in misrepresenting the nature of the research, the matter becomes a professional issue. Information statements are intended to be understood by the child and used for the purposes of explanation. The study has been approved by the Institutional Review Board (IRB) or REC on the understanding that the information statement as presented will be used. In these scenarios, parents are effectively asking that the approved protocol is not followed. Do parents have the ethical authority to override the researcher and by extension, the IRB or REC? We suggest they do not, when there is the simple non-detrimental alternative that the child does not participate in the research.

What should the guidelines say?

A difficulty with the scenarios described is that it may not be apparent at the stage that applications undergo review that deception is involved. The type of deception we are referring to is not planned deception. It may be something that researchers are confronted with only when they are actually doing the research.

We recommend that all researchers doing research with children in this age group be asked to address the question of what they should do if parents want to limit disclosure or if researchers themselves see a need to limit disclosure to prevent harm. In this way, researchers and ethics review bodies together can make a case-by-case decision about what is appropriate. Research ethics guidelines and regulations should have some guidance about these sorts of situations in which it could ever be justified to withhold information from particular children, when the plan for the research is to disclose. It should not be left to individual IRBs or ethics committees to make up their own principles. Most importantly, guidelines should clearly state that when parents do want particular information about research disclosed to their child, the most ethically appropriate response is simply not to proceed with recruitment of that child into the research.

Conclusions

In the age group we are focusing on, limiting information could be acceptable if it is to promote understanding but not where the child does have some understanding. The reason that we give children information is so that they have a meaningful choice and as a demonstration of respect. This does not confuse assent with informed consent, but does assume that meaningful assent involves information. Withholding information or misrepresenting the nature of research is not acceptable unless there are good reasons. Those reasons must be clearly articulated and must stand up to scrutiny. We argue that parents’ desire to protect children from knowledge about their own medical condition or circumstances do not (generally) count as a good reason. Parents may legitimately make this decision in relation to the rest of the child's life, but not in relation to research. Parents do not have the authority to override the requirements of ethical research. They can say “I don't want my child to know her diagnosis or that she is in a study” but that then disqualifies their child from being in the research. The child does not miss out on anything important by not being in research. An additional benefit may be that this causes some parents to rethink the information they give or they allow their child to receive. However, maintaining ethical standards in research is the key issue.

References

Footnotes

  • Contributors Both authors participated equally in the concept, design, drafting and revision of this manuscript. The manuscript has been read and approved by both authors.

  • Funding The Alfred Felton Bequest which is managed by ANZ Trustees. Merle Spriggs was supported by the Victorian Government's Operational Infrastructure Support Program.

  • Competing interests None.

  • Ethics approval This article is focusing on one aspect of a study which involved human subjects (interviews with key informants), had ethics committee approval from the Royal Children’s Hospital human research ethics committee and the results of that study have been published—see reference 8. This article is an ethical analysis of one kind of situation identified in the larger study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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