Informed Consent

Seeking informed consent from children and young people (as well as from their parent/carer) is central to an ethical, children’s rights approach to research. Informed consent signals respect for children’s dignity, their capability to express their views and their right to have these heard in matters that affect them.

Informed consent involves a number of important aspects:

  • Children must have an understanding of the research and their participation within it;
  • Consent should be an explicit agreement (typically involving the researchers(s), the child, their parents/carers and sometimes their institution / community leaders);
  • Children’s consent must be given voluntarily (and without coercion); and
  • Consent should be renegotiable, so that children can withdraw at any stage of the research process.

Below is an updated overview of the ERIC approach to informed consent in research involving children.

You can also download a pdf of the original ERIC guidance on this topic. It is available in Englishfrançaisespañol한국어Türkçe and Bahasa Indonesia.

In most research circumstances, parental (or carer) consent is required to involve children in research. Researchers should then engage with children regarding informed consent (referred to by some researchers as assent or informed assent).

Informed consent is an explicit agreement that requires participants to be informed about, and have an understanding of, the research. In essence, then, informed consent can be understood as comprising two parts: an informing part and a consenting part (Mayne, Howitt & Rennie, 2016).

Child Ethics INFORMED CONSENT
Child Ethics INFORMED CONSENT

The informing aspect reminds of the educative nature of the informed consent process. It is about providing children with enough clear and appropriate information (taking into account age, ability and context) so that they can make an informed decision about whether or not to take part. This ‘informed’ aspect is underpinned by children’s right to ‘seek, receive and impart information’ (UNCRC Article 13) (Lundy, McEvoy & Byrne, 2011; Lundy & McEvoy, 2012). Ideally, the ‘informing’ process also offers opportunities to ask questions and discuss concerns; it opens up dialogue about the research, and what participation might involve, that can continue throughout the research process (Truscott, Canosa & Graham, 2024).

Children need to be informed about a range of concepts related to the research process. Some are common to most projects, such as:

Child Ethics INFORMED CONSENT
Child Ethics INFORMED CONSENT
Child Ethics INFORMED CONSENT
Child Ethics INFORMED CONSENT

Children will also need project-specific information, such as:

  • What is this research about? (And, perhaps, why does it need to be done?)
  • What does participation involve (methods, duration…)?
  • Are there any benefits or risks related to taking part?
  • Other practical project details (such as dates, location etc.).
Child Ethics INFORMED CONSENT

Consenting to research participation is an explicit act of agreement that begins at the start of the research process. It is underpinned by children’s right to have their perspectives heard in ‘matters that affect them’ (UNCRC Article 12). Initial consent from children can involve a signature, but may also involve a fingerprint, circling an ‘emoji’, adding a sticker, or ticking an appropriate box, or another approach suited to their communication abilities and the research methods of the study. Consideration should be given to environmental and relational pressures that might influence children’s decisions regarding participation (such as in schools, in families, or in communities). Children should also be informed of their right to dissent, both initially and at any time throughout the research process. They may require support to voice their dissent and researchers need to remain attuned to body language and other non-verbal cues (Bourke & Loveridge, 2014).

It is important to remember that children’s understanding of research, and their participation within it, will evolve as a study progresses. Revisiting aspects of informed consent towards the end of a study, may be more ethical and respectful of children’s rights than relying on initial responses.

  • Children are entitled to see, receive and impart information; they have the right to know what the research is about and what it involves. Adults have a responsibility to ensure that the information makes sense to children and the research does not place them at harm (Article 13).
  • Children have the right to give their opinion about research and participation, and for adults to listen and take children’s views seriously (Article 12).
  • Children have the right to find out things and share what they think with others, by talking, drawing, writing or in any other ways, unless it harms or offends other people (Article 13).
  • Children should be aware of their rights in research. Researchers should know about these rights and help children learn about them too (Article 42).

Best practice requires that you:

  • Make sure all children are fully informed as to the purpose of the research and what their involvement will be.
  • Ensure all children participating in research have voluntarily (and without coercion) given their own consent to do so.
  • Respect children’s decision about participating in research, including their dissent or unwillingness to participate.
  • Carefully consider the strengths and limitations of obtaining parental consent.
  • Ensure that children (and others) understand that consent is negotiable and that children can withdraw at any point.
  • Design the consent process to take into account the evolving capacities of the child, situational pressures and the overall research context.
  • Consult locally to ascertain if informed consent needs to be obtained from community leaders or representatives.

Who do you need to consult prior to involving children in research?

  • Which adults, if any, do you need to meet in the family or local community in order to understand the needs and rights of the children involved?
  • Whose consent do you need for children to be in involved?
  • What information will you need to provide them with?

 

What information do children need to consent to being involved?

  • How will you find out the information children need?
  • How will you tell children about the study?
  • What procedures have been put in place to prevent children being coerced to participate?
  • What further information will children need as the study progresses to enable them to consider their continued consent, and at what stages?

 

What form will the information for children take?

  • Will you provide written information for children? If so, why?
  • If you do not provide written information, how will you convey the information? Why have you chosen this method?
  • Is there a designated person that the child (and/or parents) can go to if they have any questions or concerns (now and in the future)?

 

Do children require extra support to contribute?

  • How will you identify the special needs of individual children?
  • How will you respond to these needs?

 

How will you assess the competence of children to consent?

  • How will you ensure children understand what consent is?
  • How will you support children to understand and weigh up any risks?
  • How will you ensure that children are able to withdraw without negative consequences?
  • How will you ensure children understand that they are able to withdraw consent at any time without penalty?
  • How will you make provision for gaining children’s informed consent or allowing their dissent at different stages over long-term projects?

Informed Consent: Frequently Asked Questions

Generally, all children can indicate consent in some way, if we, as researchers, are creative and tune into their efforts to communicate. For example, babies, young children and children with communication difficulties may indicate consent or dissent primarily through body language, which needs to be identified and responded to in the moment.  

Even if children are unable to engage in conversation, researchers can provide information appropriate to children’s capabilities. This may be explained verbally, accompanied by written and visual aids and information (see FAQ below: How can researchers ensure that children are fully informed?). 

In long-term research projects, such as longitudinal studies, children will likely need to receive additional information as the project progresses, appropriate to their age and evolving capacities, in order to consent to their on-going participation. Some projects have clearly defined phases, which lend themselves to gaining children’s consent at each consecutive stage. An important aspect of this is ensuring that children are informed about, and in agreement with, the storage and use of their personal data over time, particularly in cases of secondary analyses of previously collected data.

Assent is used in some ethics documentation, particularly in North American and international biomedical guidelines (such as those reviewed by Avard et al., 2012). Some researchers advocate the use of assent, the affirmative agreement of a child, rather than consent, to make a distinction between parental / carer informed consent and as a useful concept for younger children.   

However, the use of assent is not universally recognised or supported. When used in place of consent it creates a grey area around the ‘informing’ aspect of consent and may mean researchers do not engage deeply enough in efforts to inform children. Other criticisms are that it could be used to indicate that children are ‘not refusing’ but with little consideration given to the social and situation conditions in which children are being asked (Alderson & Morrow, 2020).

Sometimes children’s comprehension and indications of consent may seem closer to a notion of assent (perhaps particularly with babies, young children, children with communication difficulties or in multi-lingual situations). However, this highlights that neither assent nor indications of consent are sufficient in ensuring ethical integrity, they must be complemented by on-going researcher reflexivity (sometimes referred to as ethical mindfulness).

Initial consent usually involves the participant providing a written signature or thumb print, but sometimes a verbal agreement is made. Flexible means of signifying initial consent are essential for children, or parents, who are not able or willing to use written methods. Signing consent forms can be problematic and/or intimidating for those who are not physically able to, and populations who are not literate or are particularly vulnerable. For example, undocumented migrants may prefer not to sign documents. In some cultural contexts written consent may be highly problematic, if written practices are different or hold other meanings, for example, related to deception, domination or abuse. This may create distress for people if they are required to sign something they do not understand well.  

In situations where children or parents do not provide written consent at the beginning of research participation it is important to have a planned process and witnesses (or means of auditing) that can verify a proper process was followed and can confirm that the child appears to have given their consent freely.

As flagged above, the ERIC approach requires that consent is an on-going process. It is also important to remember that children’s understanding of research, and their participation within it, will evolve as a study progresses. Revisiting aspects of informed consent towards the end of a study (such as at the point of reporting when participants can see what will be reported), may be more ethical and respectful of children’s rights than relying on initial responses (Jones, 2011; see also this ERIC case study by Tim Moore).

Researchers can provide information appropriate to children’s age and competencies in written/ visual form and verbally. Rather than using a formal and scientific (‘jargonistic’) form of language, researchers need to translate ideas into very simple terms to promote and enhance understanding. Creative methods of informing children are now widely used, for example, using images, photographs, video and stories (see a range of examples in the ERIC Blog Post: Supporting children to make informed decisions about research participation). The ERIC case study by Laura Benton and Julia Truscott also shares an example of a video resource to educate children about research. Increasingly, researchers are working with child / parent reference groups to co-create or, at least, to consult and pilot participant information and informed consent materials to confirm understanding and suitability (Fons-Martinez et al., 2023; Grootens et al., 2015; Martin-Kerry et al., 2019).

It is also important that children have a source of information for future reference about what they are consenting to (or that be revisited with non-verbal/ not-yet-verbal children). Information should include the research topic, the purpose of the research, what participation involves, any potential risks or benefits that the researcher is aware of (appropriate to the age and competencies of the child), the ongoing option to withdraw, and practical matters, such as where the research will take place and how long it will take. In addition, children should be informed as to what the researcher intends to do with what they learn through the research and anything children produce in the process of doing research, such as drawings, artwork and photographs. If the intention is that such products will be taken away by the researcher then this should be made explicit to the children, and issues of ownership and acknowledgement discussed and clarified in order for consent to be given.

However, ensuring that informed consent-related information is received and understood by children (and parents) can be problematic in practice, regardless of how comprehensive and encompassing it is. Mismatches in understanding are likely and can be difficult to detect (Gallagher et al., 2010; Lobato et al., 2016; Ruiz-Casares & Thompson, 2016). This is particularly heightened when the researcher/interviewer and children participating do not speak the same language. The use of interpreters presents unique challenges, with another layer of communication to be navigated in ensuring that the intended meaning of the information is conveyed and received. Simply providing information (particularly in written form) is not enough to ensure understanding; researchers need to engage with ways of ascertaining if potential participants and their parents understand. The ERIC case study by Jennifer Thompson provides an example of using photographs in a visual consent form, to facilitate informed consent in a community with relatively low levels of literacy and limited access to technology.

When using visual methods with children, such as children taking photographs, other people (including other children) may appear in the pictures. The ethical consideration of gaining informed consent in relation to the child appearing in the visual images can be challenging, particularly as it is often the child research participant taking the photo and who is then in the position of asking the child and/ or parents for consent, with the researcher unlikely to be present. This adds a further layer to the already complex task of ensuring that children and parents are fully informed and understand both the present context of the research and the future use which may be made of the photograph, for example in publications, reports and presentations. In a study by Phelan and Kinsella (2013) the following questions were used to design a process for children: “Why are you being asked to be in a picture? What will happen to you? What will happen to the pictures?” (p. 83).

The nature of power relations between adults and children means that it can be difficult to ascertain that children have a genuine choice regarding participation and that their consent is given freely (Gallagher et al., 2010). For example, in some contexts, such as educational or medical settings, children’s compliance with adult/authority requests and requirements is often compulsory. In school settings, the child’s relationships with teachers and peers are also likely to influence the consent process (Gallagher et al., 2010). They may also likely view the researcher as a school visitor and feel obliged to co-operate (Gallagher et al., 2010Hill, 2005). It may therefore be difficult for children to decline the request to participate in research and participation could verge on coercion (David, Edwards & Alldred, 2001), although recent research offers further insight into children’s agency in school contexts (Kirby, 2020; Kustatscher, 2014).

It is also important that salary and reward structures for research field staff do not unintentionally provide a perverse incentive to encourage consent from participants. For example, payment per interview for field staff, rather than salary, may provide an incentive for staff to persuade potential participants to take part in the research (WHO, 2011).

Cultural considerations, such as strong expectations regarding obedience of children to adults or collective decision-making, impact on children’s autonomy and their expressions of willingness to participate, or decline participation, in research (Clacherty & Donald, 2007; Truscott, Canosa & Graham, 2024). Children’s consent can be influenced by wanting to show respect to adult caretakers (Nyambedha, 2008), or constrained by power relations in the community (Ahsan, 2009). In addition, cultural standards and traditions may impact significantly on consent in ways that researchers from outside the community or area are unaware of, or unsure of how to respond to respectfully. For example, the ethics of hospitality are very strong in some cultures and may influence consent and research relationships, with people feeling unable to decline participation and sharing food or other items with researchers that they can ill afford (see ERIC Case studies by Sadaf Shallwani and Elsbeth Robson).

While it is critically important to provide children and parents with information and gain their informed consent in all research, particular care must be taken in biomedical and clinical studies in line with the specific risks. Some children have had their rights infringed through being subjected by business enterprises to unnecessary or inappropriate biomedical research without their or their parents ́ full and informed consent being given (United Nations Committee on the Rights of the Child, 2012). Special care must be taken in gaining consent to avoid any risks of ‘therapeutic misconception’ in which individuals do not understand that the defining purpose of clinical research is to produce generalisable knowledge, regardless of any potential benefit (WHO, 2011). This is an especially high risk in clinical research when participation may be perceived by participants and their families as an opportunity to access medical treatment, and in social and epidemiological research when it may be seen as a route to accessing services or benefits. Consent is thus influenced by raised expectations and unrealistic perceptions of beneficial outcomes. Similarly, children and parents need to be informed of and understand that results from genetic research are more likely to be less certain and may involve clinically unvalidated tests, compared to those used in clinical genetic procedures (Patenaude, Senecal & Avard, 2006).

Respect for children requires researchers to accept children’s decisions regarding participation. It requires them to actively engage with children and assist them to exercise their power and decline participation should they wish (Jackson-Hollis, 2019). Strategies can be discussed and rehearsed with children, assisting them to exercise their dissent or withdraw their participation in the research study (Ahsan, 2009), for example, with younger children, using ‘stop signs’ can be practised in a playful way before interviews (Jackson-Hollis, 2019). Even with these strategies in place it may be difficult for children to stop their participation in the face of potential or perceived adult disapproval (Bourke & Loveridge, 2014). Hence, it is important to attend to children’s visual, verbal and non-verbal cues to monitor unspoken expressions of unease or dissent (Ahsan, 2009Cree, Kay & Tisdall, 2002), recognise these points of resistance as children using the power they have to express their response to research participation, and offer sensitive avenues for children to exit or end participation with dignity.

The importance of these can have aded implications in group settings or focus group research. If consent is obtained in a group setting it may be difficult for children to indicate their dissent, due to social and power dynamics at play. For example, doing so may risk disapproval and subsequent bullying or ostracism from their peers. In addition to the strategies above, researchers may build in some informal time before activities begin to allow those who do not want to participate to leave without being noticed.

The issue of consent when engaging in participatory research or ethnography within a confined space presents added difficulties that may not exist within other forms of research. For example, when a parent or child refuses consent, but the researcher nonetheless remains in the setting conducting research with some other children present (see ERIC Case Study by Muireann Ni Raghallaigh and Robbie Gilligan). Respect for the individual child might suggest that researchers should ensure there is no note taking or other data collection techniques used that involve the dissenting child (for example, when they are interacting with the rest of the group).  The ERIC case study by Michael Gaffney discusses challenges in obtaining informed consent in ethnographic classroom- based research with children who have a disability.

Behavioural and verbal signs of dissent need to be sensitively observed and attended to by researchers. Very young children, such as babies and pre-verbal infants (Dalli & Stephenson, 2010), or those with physical disabilities, may not be able to move themselves out of situations in which they are uncomfortable. Children who are able to verbalise may not make an explicit spoken request to withdraw from research (Spriggs, 2010). As noted by Clark (2005), listening to children is an active process of communication that is not limited to the spoken word. Behavioural signs of dissent include: passivity; lack of cooperation; fussiness; silence; crying or puckering; constant looks towards the door; lack of eye contact with the researcher; and signs of boredom such as multiple yawns (Keith-Spiegel, 1983). Verbal indicators of dissent made by young children may include: ‘I want to go to the toilet’; ‘I’m tired’; ‘When will I be done?’; and responding repeatedly to direct and age appropriate questions with ‘I don’t know’ (Keith-Spiegel, 1983; see also the ERIC case study by Katrin Velten & Julia Höke). Even in one-off questionnaire-based studies children may signal dissent by not completing the survey very comprehensively, by making obviously irrelevant answers, or by not participating again if the study is repeated.

In most cultural and institutional contexts, consent from at least one adult gate-keeper (such as a parent, carer, school, community leader) is required prior to approaching children about research participation. Such requirements for adult consent reflect underlying understandings and assumptions about children, childhood, child-parent and wider community relationships.

Consequently, consent from someone in a parental role is generally a standard expectation in research involving children and researchers need to argue why it might not be necessary (or indeed could be harmful) in a particular project. Valid arguments for not gaining parental consent might include the risk of suppression of children’s information, or situations in which it is impossible or inappropriate (see following FAQs below for more detail).

It is critically important to bear in mind that parents and other adults in gate-keeping roles have an important and positive function in protecting children from potential harm. However, they can also use their power to censor young people (Masson, 2004 (see Fraser et al., 2004)) and may not always have the best interests of the child in mind. 

Adults in gate-keeping positions, especially community and institutional positions, can be hesitant about children’s direct participation in research, particularly when the children are considered especially vulnerable (such as children in care) or when the topic is considered sensitive (Canosa et al., 2022; Powell et al., 2020; Taplin et al., 2021). Consequently, parents and other adults play a significant role in restricting researchers’ capacity to include children’s views and limiting children’s participation in research (Powell et al., 2011, 2020). Researchers are advised to establish sound relationships with gate-keeping adults (Bogolub & Thomas, 2005Thomas & O’Kane, 1998). 

While the vast majority of parents care deeply and act in the interests of their children, in some instances, the assumption (usually made in gaining parental consent) that parents will always act in their children’s best interests simply may not be true, and the child’s parent may have reasons for not wanting the child to participate based on their own concerns or interests. Parents who are abusive, for example, may not consent to their child participating in research studies for fear of the child revealing the abuse and the researcher subsequently reporting it to authorities. The ERIC case study by Lucie Cluver, Franziska Meinck and Mark Boyes discusses the dilemmas faced conducting research with children affected by HIV and AIDS in South Africa in regard to obtaining informed caregiver consent when guardians were unavailable, unable or unwilling to provide this.

Passive consent procedures, in which parents are only required to let researchers know if they do not want their child to participate, can allow researchers to bypass the usual parental consent requirement, and children to participate and contribute in research. However, this is a contentious area, particularly for young children and those with decision-making impairments. The ethics of this have mostly been debated in relation to sensitive research topics, when gate-keeping is more likely to occur (Powell et al., 2012). Ethics committees tend to favour active consent, or ‘opt in’ consent procedures, even though they may have the effect of silencing children who are dependent on someone else giving consent for them to participate (Alderson, 1995).

The already complex matter of obtaining the informed consent of parents or carers is further complicated in some contexts by practical challenges. These may include difficulties identifying and locating parents or guardians, low rates of literacy, scepticism about signing documents, and concern that signing a consent form may carry risk to participants or their families in certain contexts (Abebe, 2009Clacherty & Donald, 2007Hutz & Koller, 1999).

Undertaking research involving children who are unaccompanied or orphaned also significantly complicates issues of consent. The conditions around which this occurs may include humanitarian emergencies, such as situations of civil war, conflict and peace-keeping, or natural disasters. It may also include unaccompanied children migrating to seek refuge in response to humanitarian emergencies or for other reasons. In such situations children are exceptionally vulnerable and the research may be driven by political or other imperatives which are operating under time, resource and other constraints. Therefore, in the absence of parental support and concern for their children’s welfare, it is critically important that the primary factor in deciding children’s participation in research is the best interests of the individual child and that responsible child advocates are involved in the consent process.

Usually, there are caretakers or legal guardians who, in accordance with domestic laws in force, may have similar responsibility and powers as parents. In some instances, the state may have a role regarding responsibility for children that needs to be respected. To this end, some ethical guidelines stipulate a descending order of people from whom consent should be sought or a waiver required. Guidelines prepared by the Human Sciences Research Council of South Africa (2010), Informed consent guidelines re minors (including orphans and vulnerable children (OVC)) and parental substitutes, for example, suggest the order should be: parent; guardian; foster parent (per order of Children’s Court); caregiver (per Children’s Act); or if minor is a caregiver in a child-headed household then consent should be sought from a responsible person (per s137 Children’s Act), or a trusted adult nominated by the minor, including but not limited to social worker, community worker or teacher.

There are some situations whereby it may be inappropriate or impossible to seek parental consent, for example when children have runaway or homeless (Meade & Slesnick, 2002), living on the streets (Richter, Groft & Prinsloo, 2007Vakaoti, 2009), or emancipated minors (King & Kramer, 2008).* Some researchers (and/ or young people) also argue that it is not appropriate to ask for parental consent for studies with sensitive research topics that are confidential and private to the young people participating. This applies, for example, in studies concerning sexuality (Flores et al., 2018Macapagal et al., 2016Sims & Nolan, 2021Valentine, Butler & Skelton, 2001) or drug use (Langhinrichsen-Rohling, Arata, O’Brien, Bowers & Kilbert, 2006). In such contexts, researchers have sometimes been able to argue for and ethically navigate research that does not involve parental consent. This is most likely when the research involves older children, for example young people over 15 years of age. 

*In some countries/states statutes allow minors to become legally emancipated and treated as an adult for legal purposes, for example, through marriage or based on
petition from the minor or the minor’s parents (King & Kramer, 2008).

Not disclosing information, or covert research, challenges the ethical principles of respect, justice and honesty, and considerable ethical debate exists as to whether deceit of participants can ever be fully justified.

In some research contexts, however, there may be a tension between wanting to ensure that research participants are fully informed, with consent freely given, and wishing to maximise participation in their research (Hill, 2005 (see Greene & Hogan, 2005)). This tension might arise, for example, where full disclosure of the study may place the children in the path of potential harm. Careful consideration then needs to be given as to whether it is safe to go ahead with the research at all.

There may also be some instances where not fully disclosing the focus of research will potentially increase research validity. For example, in naturalistic observations, participants’ knowledge of the specific behaviours that are being recorded (such as, altruistic behaviours – sharing toys or helping another child) may alter the behaviours that are demonstrated by the participants. Similarly, in some experiments, participants’ knowledge of the study’s purpose/ research question, experimental conditions and how the scores on outcome variables will be interpreted, may change or manipulate their responses and potentially producing a response bias, inaccurate data and reducing the benefits of the findings.

In such circumstances, researchers need carefully and reflexively consider the information they share with participants in a way that respects the dignity and rights of participating children. They may consider providing a more general overview of the topic of research, while still attending to other aspects of informed consent such as fully explaining to children the procedure of the study, the risks involved and the benefits expected, in a manner suitable for their age and competency. Researchers also need to provide age and competency appropriate answers to any questions the children have before, during and after their participation, and to provide support for any ongoing issues arising from their participation.

Reduced disclosure of a research topic is likely only justifiable where the research involves: no more than low risk to participants; potential benefits justify the limited disclosure and possible risk to trust in research and researchers; and the precise extent of limited disclosure is defined and articulated (Spriggs, 2010). Provision of debriefing procedures is of vital importance to all research, but particularly so if any deception is used. 

A significant amount of meaningful and important knowledge about children and their lives can be generated without involving children directly, for example, analysing registries and other statistical information. However, there are important ethical issues raised for researchers who access, or have privileged access to, children’s information that was provided for purposes other than research. These might be further heightened if the organization holding the records is highly specialised and easily identifiable. For example, a practitioner working in a therapeutic service for children might want to conduct research based on the children’s files, or researchers may want to use information provided by children to child helplines. This raises the question of whether it is ethical to use information, perhaps for a cause such as raising awareness about issues children face, without having asked the children who provided the information for their permission to do this. Realistically, it may not be feasible to ask a distressed child in crisis whether the service might at a later date use their case to raise awareness or influence change. One option, without having gained consent, is for researchers to try turning children’s cases into anonymous vignettes. However, the children themselves may still have the impression that their experience, disclosed in confidence, is being used to influence others or for publicity purposes.

Informed Consent: ERIC Case Studies

The following ERIC Case Studies offer insight into how others have approached informed consent processes with children and young people in different research contexts.

Keywords: informed consent, child autonomy, participant understanding, ethical participation