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 36 

ETHICAL CONSIDERATIONS IN RESEARCH WITH CHILDREN 

 

Shahanaz Chowdhury  

Assistant Professor, Department of Community Medicine,  

Bangladesh University of Health Science, Dhaka, Bangladesh 

Email: jesmin_70@yahoo.com 

 

 

ABSTRACT: Ethical concerns and medical advances unique to children and adolescents make pediatric research an 

evolving endeavor. The current regulations for clinical research are based on a combination of ethical thought and 

history, some of it being very tragic. This article presents the ethical and historical underpinnings of these regulations, 

including elaborative discussion on ethical standards in research. In addition, the article highlights that every effort 

should be made to actively involve children as participants in the research process and care must be taken to protect 

the rights of all children, as well as specific groups of children, in research activity.  

 

key words: rights of all children, regulations for clinical research, ethical standards in research and pediatric 

research. 

 

HISTORICAL BACKGROUND: The historical origin of current ethical principles for conducting research with children 

arises from the Nuremberg Trials, which took place after the Second World War, the Code, which emerged from 

these is called Nuremberg Code  . The code sets out statements of certain moral, ethical and legal principles relating 

to research involving human subjects.  “Taken literally, research on children would be prohibited. Requires the 

voluntary consent of the subject “as absolutely essential” Later, the emergence of the Declaration of Helsinki in 1964, 

most recently amended in 1989 and 1996, now includes and examination of the issues of children as research 

subjects relation to informed consent
1
.
 
 

The ethics of research with children is a balance. On the one hand, the focus is on ways of preventing and reducing 

harms in research and ensuring adequate protection of children and young people. On the other hand, there is 

concern about the risks and harms of silencing and excluding children from research about their views, experiences 

and participation. 

There are, however, ongoing debates in the academic literature about the ethics of social research with children, 

related to different disciplinary perspectives (for example, developmental psychology and the sociology of childhood) 

and in relation to the differences between children and adults in research. The ethics principles that apply to research 

with adults – such as that of ensuring freely given fully informed consent, and the right to withdraw from research 

participation – apply equally to children, but there are four additional provisos specific to research involving children: 

i. children’s competencies, perceptions and frameworks of reference, which may differ according to factors 

including – but not only – their age, may differ from those of adults; 

ii. children’s potential vulnerability to exploitation in interaction with adults, and adults’ specific responsibilities 

towards children; 

mailto:jesmin_70@yahoo.com


Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

 37 

iii. the differential power relationships between adult researcher and child participant; and 

iv. the role of adult gatekeepers in mediating access to children, with concomitant ethical implications in relation 

to informed consent
2
. 

 

INTRODUCTION: ‘Ethics’ can be defined as 'set of moral principles and rules of conduct'. Ethics in research, as one 

author has put it, relates to 'the application of a system of moral principles to prevent harming or wrong doing  others, 

to promote the good, to be respectful, and to be fair'
3 

Ethics is a core consideration to most research. This is 

especially true for research that involves children where there will have to be a balance between the researcher's 

aims and the protection of any participants. Involving children in research can enhance the scope and findings of a 

study. The United Nations Convention on the Rights of the Child is often used as a basis for the need to actively 

involve children in research, especially when that research may be used to inform and influence policy makers: 

“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. There are some key concepts that should be considered by all researchers who hope to 

include children in their research, namely: obtaining informed consent; managing the risk of further harm to the child; 

and, managing what happens to the information given by participants
4
. More recently, pediatric research has come to 

be seen as a moral imperative
5
.  

 

METHODS:  This is a review article done during the participation in the educational activity of National Institutes of 

Health Bethesda, Maryland held by Bangladesh Bioethics Society through video conferencing on September 25, 

2013 through November 11, 2013. The search was confined to Google search and pubmed published articles. 

 

ETHICAL STANDARDS IN RESEARCH
6
 

 Research ethics are a set of principles about how researchers and research organizations should conduct 

themselves when dealing with research participants, other researchers and colleagues, the users of their research 

and society in general. Particularly relevant to the social sciences are ethics associated with projects involving human 

participants, including conducting surveys, focus groups and the use of secondary data. 

 

Principle 1. Non-harmful procedures: The investigator should use no research procedure that may harm the child 

either physically or psychologically. The investigator is also obligated at all times to use the least stressful research 

procedure whenever possible. Psychological harm in particular instances may be difficult to define; nevertheless, its 

definition and means for reducing or eliminating it remain the responsibility of the investigator. When the investigator 

is in doubt about the possible harmful effects of the research procedures, consultation should be sought from others. 

When harm seems inevitable, the investigator is obligated to find other means of obtaining the information or to 

abandon the research. Instances may, nevertheless, rise in which exposing the child to stressful conditions may be 

necessary if direct diagnostic or therapeutic benefits to the child are associated with the research. In such instances 

careful deliberation by an Institutional Review Board should be sought. 

 



Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

 38 

Principle 2. Informed consent: Before seeking consent or assent from the child, the investigator should inform the 

child of all features of the research that may affect his or her willingness to participate and should answer the child's 

questions in terms appropriate to the child's comprehension. The investigator should respect the child's freedom to 

choose to participate in the research or not by giving the child the opportunity to give or not give assent to 

participation as well as to choose to discontinue participation at any time. Assent means that the child shows some 

form of agreement to participate without necessarily comprehending the full significance of the research necessary to 

give informed consent. Investigators working with infants should take special effort to explain the research 

procedures to the parents and be especially sensitive to any indicators of discomfort in the infant. In spite of the 

paramount importance of obtaining consent, instances can arise in which consent or any kind of contact with the 

participant would make the research impossible to carry out. Non-intrusive field research is a common example. 

Conceivably, such research can be carried out ethically if it is conducted in public places, participants' anonymity is 

totally protected, and there are no foreseeable negative consequences to the participant. However, judgments on 

whether such research is ethical in particular circumstances should be made in consultation with an Institutional 

Review Board. 

 

Principle 3. Parental consent: The informed consent of parents, legal guardians or those who act in loco parentis 

(e.g., teachers, superintendents of institutions) similarly should be obtained, preferably in writing. Informed consent 

requires that parents or other responsible adults be informed of all the features of the research that may affect their 

willingness to allow the child to participate. This information should include the profession and institution affiliation of 

the investigator. Not only should the right of the responsible adults to refuse consent be respected, but also they 

should be informed that they may refuse to participate without incurring any penalty to them or to the child. 

Principle 4. Additional consent: The informed consent of any persons, such as schoolteachers for example, whose 

interaction with the child is the subject of the study should also be obtained. As with the child and parents or 

guardians informed consent requires that the persons interacting with the child during the study be informed of all 

features of the research which may affect their willingness to participate. All questions posed by such persons should 

be answered and the persons should be free to choose to participate or not, and to discontinue participation at any 

time. 

 

Principle 5. Incentives: Incentives to participate in a research project must be fair and must not unduly exceed the 

range of incentives that the child normally experiences. Whatever incentives are used, the investigator should always 

keep in mind that the greater the possible effects of the investigation on the child, the greater is the obligation to 

protect the child's welfare and freedom. 

 

Principle 6. Deception: Although full disclosure of information during the procedure of obtaining consent is the 

ethical ideal, a particular study may necessitate withholding certain information or deception. Whenever withholding 

information or deception is judged to be essential to the conduct of the study, the investigator should satisfy research 

colleagues that such judgment is correct. If withholding information or deception is practiced, and there is reason to 

believe that the research participants will be negatively affected by it, adequate measures should be taken after the 

study to ensure the participant's understanding of the reasons for the deception. Investigators whose research is 

dependent upon deception should make an effort to employ deception methods that have no known negative effects 

on the child or the child's family. 



Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

 39 

 

Principle 7. Anonymity: To gain access to institutional records, the investigator should obtain permission from 

responsible authorities in charge of records. Anonymity of the information should be preserved and no information 

used other than that for which permission was obtained. It is the investigator's responsibility to ensure that 

responsible authorities do, in fact, have the confidence of the participant and that they bear some degree of 

responsibility in giving such permission. In complying with requirements for data sharing, researchers need to 

carefully consider whether they have provided data which, if combined, risks violating participant anonymity. 

 

Principle 8. Mutual responsibilities: From the beginning of each research investigation, there should be clear 

agreement between the investigator and the parents, guardians or those who act in loco parentis, and the child, when 

appropriate, that defines the responsibilities of each. The investigator has the obligation to honor all promises and 

commitments of the agreement. 

 

Principle 9: Jeopardy: When, in the course of research, information comes to the investigator's attention that may 

jeopardize the child's well-being, the investigator has a responsibility to discuss the information with the parents or 

guardians and with those expert in the field in order that they may arrange the necessary assistance for the child. 

Researchers need to be aware that they may obtain findings suggesting that a child's health and well-being might be 

in jeopardy, that these findings may include false positives, and they should be knowledgeable about current human 

subjects procedures and regulations for informing families of incidental findings. 

 

Principle 10. Unforeseen consequences: When research procedures result in undesirable consequences for the 

participant that were previously unforeseen, the investigator should immediately employ appropriate measures to 

correct these consequences, and should redesign the procedures if they are to be included in subsequent studies. 

 

Principle 11. Confidentiality: The investigator should keep in confidence all information obtained about research 

participants. The participants' identity should be concealed in written and verbal reports of the results, as well as in 

informal discussion with students and colleagues. When a possibility exists that others may gain access to such 

information, this possibility, together with the plans for protecting confidentiality, should be explained to the 

participants as part of the procedure of obtaining informed consent. 

 

Principle 12. Misconception: Immediately after the data are collected, the investigator should clarify for the research 

participant any misconceptions that may have arisen. The investigator also recognizes a duty to report general 

findings to participants in terms appropriate to their understanding. Where scientific or humane values justify 

withholding information, every effort should be made so that withholding the information has no damaging 

consequences for the participant. 

 

Principle 13. Reporting results: Because the investigator's words may carry unintended weight with parents and 

children, caution should be exercised in reporting results, making evaluative statements, or giving advice. In some 

kinds of investigation the giving of advice is ethical if this forms an intrinsic part of the research, is agreed with the 

participant and has been subject to ethics review in advance. In other circumstances, however, a researcher may 

obtain evidence suggesting the existence of psychological or physical problems of which a participant may appear to 



Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

 40 

be unaware. In such a case, the investigator has a responsibility to discuss this with the participant if the investigator 

believes that by not doing so the participant’s future wellbeing may be endangered. Where there is an identified risk 

of such evidence emerging it is good practice to prepare a protocol in advance and establish an appropriate referral 

route. If, in the normal course of psychological research, or as a result of problems detected as above, a participant 

asks for advice about educational, personality, behavioural or health issues, caution should be exercised. If the issue 

is serious and the investigator is not competent to offer assistance, the appropriate source of professional advice 

should be recommended.
7
 

 

Principle 14. Implications of findings: Investigators should be mindful of the social, political and human 

implications of their research and should be especially careful in the presentation of findings from the research. This 

principle, however, in no way denies investigators the right to pursue any area of research or the right to observe 

proper standards of scientific reporting. 

 

Principle 15. Scientific misconduct: Misconduct is defined as the fabrication or falsification of data, plagiarism, 

misrepresentation, or other practices that seriously deviate from those that are commonly accepted within the 

scientific community for proposing, conducting, analyzing, or reporting research. It does not include unintentional 

errors or honest differences in interpretation of data. The Society shall provide vigorous leadership in the pursuit of 

scientific investigation that is based on the integrity of the investigator and the honesty of research and will not 

tolerate the presence of scientific misconduct among its members. It shall be the responsibility of the voting members 

of Governing Council to reach a decision about the possible expulsion of members found guilty of scientific 

misconduct. 

 

Principle 16. Personal misconduct: Personal misconduct that results in a criminal conviction of a felony may be 

sufficient grounds for a member's expulsion from the Society. The relevance of the crime to the purposes of the 

Society should be considered by the Governing Council in reaching a decision about the matter. It shall be the 

responsibility of the voting members of Governing Council to reach a decision about the possible expulsion of 

members found guilty of personal misconduct.  

  

 DIFFERENT RESEARCH METHODS: There are three main kinds of research that can involve children or child 

protection issues. 

 Asking children about their feelings, opinions and experiences. This can be done either in face to face 

interviews with children or by questionnaire. Data can also be gathered by asking parents about their 

children's experiences. 

 Observing children's behavior. Using monitored experiments or activities or observing children in an 

uncontrolled environment to see how they react during specific situations. 

 Analyzing information contained in files about children (for example, social care case records, serious case 

reviews, schools records)
 4

. 

 

CONCLUSION: In recognition of the benefits of pediatric research, research ethics has evolved from position of 

excluding children to one of cautious advocacy-acknowledging the critical role of pediatric research, but accompanied 



Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

 41 

by careful consideration of the scientific context, evaluation of risks and benefits, and protection to participants. Many 

countries have adopted regulations or guidelines to protect children in research. Typically, this requires a careful 

analysis of the risk associated with c\each intervention and/or procedure, and evaluation of potential benefits, 

provisions for child assent, and ensuring adequate parent/guardian permission. The regulatory agencies overseeing 

pediatric research need to make a careful ethical assessment weighing sometimes complex trade-offs s as to protect 

children’s  welfare and prevent undue risk of harm while generating scientifically valuable information to answer 

important questions concerning the health and welfare of children
8
.  

 

Research with, and for, children (defined in Ireland as people below the age of 18) is necessary and beneficial, but 

particular ethical concerns arise in relation to children’s involvement in research and these must be addressed. Basic 

ethical principles apply to all research and these include a commitment to the well-being, protection and safety of 

participants; a duty to respect the rights and wishes of those involved; a responsibility to conduct high-quality 

scientific research; and a commitment to disseminate and communicate the results to stakeholders. In addition to 

core ethical principles, research with children requires that legal and policy commitments in relation to children, 

especially national and international child protection policies and guidelines, are adhered to and that a child-centred, 

inclusive approach to research is adopted. Parental/guardian consent is required for a child to participate in research, 

but good practice also requires the child’s agreement or assent. Confidentiality is key to research practice, but a 

limitation exists in child-related research if a child protection issue arises and this restriction in relation to 

confidentiality must be explained when obtaining consent. To ensure child protection, research with children should 

be carried out in accordance with Children First: National Guidance for the Protection and Welfare of Children and 

research organizations should have a child protection policy in place, as well as a designated liaison person or 

member of staff responsible for the implementation of this policy. Every effort should be made to actively involve 

children as participants in the research process and care must be taken to protect the rights of all children, as well as 

specific groups of children, in research activity
9
. 

 

References:  

1. Anne Greig and Jane Tylo. Doing Research with children (Sage Publication) 1999 p.148. 

2. Research with children. http://www.ethicsguidebook.ac.uk/Research-with-children-105. (access 

date:12/11/13) 

3. Sieber, J. 'The ethics and politics of sensitive research' in Renzetti C & Lee R M (eds) Researching sensitive 

topics, London: Sage.14.1993.  

4. Conducting safe and ethical research with children 

http://www.nspcc.org.uk/Inform/research/briefings/ethical-research-factsheet_wda97712.html  (access 

date:12/11/13) 

5. Shaddy RE, Denne SC (2010) Clinical report--Guidelines for the ethical conduct ofstudies to evaluate 

drugsin pediatric populations. Pediatrics 125 (4):850-860.doi:peds.2010-0082 [pii] 10.1542/peds.2010-0082. 

(access date:12/11/13)  

6. Ethical Standards in Research. http://www.srcd.org/about-us/ethical-standards-research. (access 

date:12/11/13) 

7. Code of Human Research Ethics. 

http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf 



Bangladesh Journal of Bioethics 2014; 5(1):36-42 

 

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8. Ethical considerations in conducting pediatric research. 

http://www.fda.gov/downloads/AdvisoryCommittees/Committees Meeting 

Materials/PediatricAdvisoryCommittee/UCM254315.pdf. (access date:12/11/13) 

9. Guidance for developing ethical research projects involving children 

http://www.dcya.gov.ie/documents/Publications/Ethics_Guidance.pdf. (access date:12/11/13) 


	ETHICAL STANDARDS IN RESEARCH6
	 DIFFERENT RESEARCH METHODS: There are three main kinds of research that can involve children or child protection issues.




