Assent to participate in healthcare research

TY - JOUR

T1 - Assent to participate in healthcare research

AU - Fisher, Helen

PY - 2013/8/1

Y1 - 2013/8/1

N2 - This article explores the issue of research in children and whether it is possible for a healthcare professional (HCP) who is directly involved in a research project to accurately gauge the child's willingness to be involved in the study. Consent for research participation requires participants to understand complex information and, when children participate in research, formal consent is obtained from their parents or legal guardian. The assent or agreement of the children should also be sought, and the only difference between consent and assent should be that assent is not legally binding. The ethical principles underpinning the requirement of assent are justice (i.e. recognising children's rights) and respect for autonomy. At the same time, the HCP should uphold the principle of beneficence (doing good) by ensuring the best interests of the children who participate in research and simultaneously furthering the interests of those children who will ultimately benefit from the research findings. As children taking part in research will not always derive direct benefit from participation, the principle of non-maleficence requires that harm must not be inflicted on the research participants. The harm principle features strongly in research ethics guidelines and in research ethics committees' assessment of research involving children. The multifaceted nature of acquiring assent makes it difficult to accurately assess the quality of a child's assent to research. This is particularly true in situations where the need to conduct research to benefit the wider community conflicts with the needs of individual participants and, in the case of children, the wishes of the parent. While HCPs can and do accurately determine the assent of children participating in healthcare research with which they are directly involved, they should be alert to potential biases or conflicting interests that may prohibit an impartial appraisal, and, if in doubt as to the validity of the assent of a child on their study, should seek impartial advice.

AB - This article explores the issue of research in children and whether it is possible for a healthcare professional (HCP) who is directly involved in a research project to accurately gauge the child's willingness to be involved in the study. Consent for research participation requires participants to understand complex information and, when children participate in research, formal consent is obtained from their parents or legal guardian. The assent or agreement of the children should also be sought, and the only difference between consent and assent should be that assent is not legally binding. The ethical principles underpinning the requirement of assent are justice (i.e. recognising children's rights) and respect for autonomy. At the same time, the HCP should uphold the principle of beneficence (doing good) by ensuring the best interests of the children who participate in research and simultaneously furthering the interests of those children who will ultimately benefit from the research findings. As children taking part in research will not always derive direct benefit from participation, the principle of non-maleficence requires that harm must not be inflicted on the research participants. The harm principle features strongly in research ethics guidelines and in research ethics committees' assessment of research involving children. The multifaceted nature of acquiring assent makes it difficult to accurately assess the quality of a child's assent to research. This is particularly true in situations where the need to conduct research to benefit the wider community conflicts with the needs of individual participants and, in the case of children, the wishes of the parent. While HCPs can and do accurately determine the assent of children participating in healthcare research with which they are directly involved, they should be alert to potential biases or conflicting interests that may prohibit an impartial appraisal, and, if in doubt as to the validity of the assent of a child on their study, should seek impartial advice.

UR - http://www.scopus.com/inward/record.url?scp=84884915586&partnerID=8YFLogxK

M3 - Article

AN - SCOPUS:84884915586

SN - 1609-3607

VL - 26

SP - 145

EP - 150

JO - Current Allergy & Clinical Immunology

JF - Current Allergy & Clinical Immunology

IS - 3

ER -