Hugh Devlin, Victoria University of Manchester, United Kingdom
ORCID Nicoline Potgieter
This is an open-access article distributed under the terms of the
Conducting oral treatment early in the disease course, is encouraged for better health outcomes. Obtaining informed consent is an essential part of medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine. In practice, consent means different things in different contexts. Silver Diamine Fluoride (SDF) and Silver Fluoride (SF) is becoming popular and cost effective methods to manage carious lesions, however, cause black discolouration of lesions treated. Obtaining informed consent and assent is crucial for any dental treatment—and has specific relevance with SDF/ SF treatments.
The aim of this paper is to describe informed consent regulations for dental care in a selection of countries, focusing on children and patients with special health care needs. An online survey was shared with a convenience sample of dental professionals from 13 countries. The information was explored and the processes of consent were compared.
Findings suggest that there are variations in terms of informed consent for medical practice. In Tanzania, South Africa, India, Kenya, Malaysia and Brazil age is the determining factor for competence and the ability to give self-consent. In other countries, other factors are considered alongside age. For example, in Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Many countries' laws and regulations do not specify when a dentist may overrule general consent to act in the “best interest” of the patient.
It is recommended that it is clarified globally when a dentist may act in the “best interest” of the patient, and that guidance is produced to indicate what constitutes a dental emergency. The insights gathered provide insights on international practice of obtaining informed consent and to identify areas for change, to more efficient and ethical treatment for children and patients with special needs. A larger follow up study is recommended to include more or all countries.
Oral diseases pose a major health burden, affecting over 3.5 billion people globally (
In addition to dental caries, children also suffer from traumatic dental injuries, which are very common in the first ten years of life. These injuries are more common particularly in school-going children who may be involved in sports activities. These injuries may include not only laceration of chin and lips but also fractures of facial bones and teeth that require children to be taken to a dentist for further management and treatment (
Obtaining informed consent before treatment, delivered to a patient is an essential part of contemporary medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine (
Globally, persons who can provide consent varies. Typically, whether or not a patient can provide consent themselves is determined by each patient's comprehension of the treatment proposed (
The aim of this article is to describe informed consent regulations for dental care in a selection of countries, focussing on children and PSHCN. This paper's view of consent aims to provide insights on international practice of obtaining informed consent for paediatric dentistry and to identify areas for change, to more efficient and ethical treatment of children and PSHCN populations.
The cross-sectional study was conducted, in 2021/22, by means of a self-administered questionnaire, by representatives from different countries. The selection of countries was based on personal contacts and past research collaborations. The questionnaire asked each representative to provide information on the policies, guidelines and practice of informed consent and assent in the respective countries/areas. A convenience sample of 13 countries/jurisdictions across the globe were used. The data collected through the questionnaire. The principle researchers collated the data from the questionnaires and and cross-checked the data with the laws and regulations referenced. Once all data were combined, tabled and organized, all authors contributed to the discussion to bring context of the different countries' laws and regulations.
Globally, parent or legal guardian are required to give informed consent to “minors” for medical/dental treatment. Age is the main determinant of being a minor in most countries.
Summary of the legal requirements for consent and the age of self-consent for dental treatment.
| Age of giving self-consent | Exceptions to enable giving self-consent as a minor | Act/law/policy stipulating specific age for self-consent | Summary of consent allowed during an emergency situation | Assent legally required? | |
|---|---|---|---|---|---|
| Brazil ( |
>18 years | None | No 2-SEI/2017-CGSAJ/DAPES/SAS/MS, together with Children and Teenager Statute, and The Brazilian Dental Ethical Conduct (Resolution CFO—118/2012) in the article 11° |
Medical professionals are forbidden from performing any medical procedure without previous explanation and consent of the patient or his/her legal representative, except in cases of imminent threat to life |
No |
| China ( |
≥18 years | <8 years has no civil capacity and 8–17 years restricted civil capacity | Civil Code of People's Republic of China Chapter 2 and Chapter 6 |
Dentists may provide treatment with the approval by the person-in-charge of the hospital |
No |
| India ( |
>18 years | 12–18 years can consent for examination but not procedures | Majority Act, Guardian and Wards Act, and Indian Contract Act |
“Loco parentis” person in charge: example: Principle of the school. No consent needed in medical emergency/ life endangerment |
No |
| Kenya ( |
>18 years | None | Kenyan Children Act No 8 of 2001 |
Reasonable steps to obtain consent Clinician Court of law Next of kin Not necessary in emergency that could result in death or irreversible damage |
No |
| Malaysia ( |
>18 years | None | The Laws of Malaysia Act 21: Age of Majority Act 1971 and Malaysian Medical Council guideline: Consent for treatment of patients by registered medical practitioners |
Court of law “Protector” when child is in protective custody When parent or legal guardian is unavailable, Primary and secondary physician co-sign during life endangerment Dental practitioner may act for the best interest of the patient, in consultation with parents or legal guardian |
No |
| Maryland state USA ( |
>18 years | Gillick Competency |
People's Law Library of Maryland |
Minor has the same capacity as an adult |
No |
| Netherlands ( |
>16 | Gillick Competency |
Wet Geneeskundige BehandelOvereenkomst |
Dentists may act to create a non-acute situation. |
Verbally Assent |
| Nigeria ( |
≥18 years | Married woman and head of households can give consent regardless of their age. | Section 29 (4) of the 1999 Constitution of the Federal Republic of Nigeria |
Dentist to avoid death or serious harm Police Nigerian Supreme Court |
Yes |
| Pakistan ( |
None set for routine dental procedures. Self-consent is required only major surgical procedures ≥ 18 years | Gillick competence |
Majority Act, 1975 |
Physician Consultation with family members |
No |
| Singapore ( |
>21 years | Gillick competence |
No statute law, however “…p |
Doctor/dentist acting in “best interest” Some healthcare institutions may necessitate a “double clinician consent”, where a registrar-level and a consultant-level doctor/dentist will discuss and concur on a shared best-interest decision. This is not required legally, but an organisational policy. |
No |
| South Africa ( |
≥12 years | With sufficient maturity |
Children's Act No 38 of 2005 |
Court appointed Social worker Clinical manager/Superintendent of hospital |
Yes |
| Tanzania ( |
>18 years | None | The Law of the Child Act, No.21 of 2009 |
Government authorities Doctor/Dentist Police |
Yes |
| United Kingdom ( |
≥16 years | Gillick Competency |
The Children Act 1995 The Children Act 1995 (England, Wales, Scotland) |
Any adult with parental responsibility. Practitioner in the “best interest of a child” |
No |
| Vietnam ( |
>18 years | 15–18 years may perform civil transactions (this may be argued as dental treatment) | None |
Legal representative or representative appointed by court Head of medical facility Dentist/medical practitioner |
No |
Gillick Competency: is used to identify children aged under 16 who have the legal competence to consent to medical treatment. Competency is conferred if the child can demonstrate sufficient maturity and intelligence to fully understand the proposed treatment and its implications, including an understanding of the risks and any possible alternative course of action (
In other countries, there are varying exceptions and multiple factors that are taken into consideration to apply the “age-rule” for consent. In Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Gillick Competence is used to identify children aged under 16 who have the legal competence to consent to medical treatment. Competency is conferred if the child can demonstrate sufficient maturity and intelligence to fully understand the proposed treatment and its implications, including an understanding of the risks and any possible alternative course of action (
The Netherlands also have an age range (12–16 years) wherein both the parent and the child should give consent with two exceptions: (1) if not treating the child will give a serious disadvantage; (2) If the treatment is the well-considered wish of the child. In Nigeria, the social status of the child's family can influence the decision to give self-consent (
In Vietnam, for those who are from 15 to 18 years old, the civil act capacity determines the ability of the individual to provide consent. The civil act capacity of an individual is his or her capability to establish and perform civil rights and obligations. Per article 21 of the Civil Code, those who are above six years of age also have civil act capacity. However, in a similar vein to the Gillick Competency test, if the patient is incapable of “recognizing or controlling his/her acts due to mental disease or other ailments”, the court may revoke or restrict their civil act capacity (article 22 and 23). In such a case, a legal representative will give consent to medical/dental treatments on their behalf (
Like Vietnam, India applies age as a determinant of competence, however comprehension of treatment is also considered, whereby an incompetent patient is one “who is a minor” or a person of unsound mind or a patient who is unable to weigh, understand or retain the relevant information about his or her medical treatment; unable to make an informed decision because of impairment of or a disturbance in the functioning of the mind or brain: or a person who is unable to communicate the informed decision regarding medical treatment through speech, sign or language or any other mode (
When patients are not deemed capable of providing consent themselves, it is requested that a parent or legal guardian consent on their behalf. However, in some situations, one or two of the parents or guardians may refuse to provide consent for treatment. In this situation, there are different procedures in place depending on the context.
In India, “when the parents/guardian refuses their child to undergo the diagnostic procedure/treatment after a complete and comprehensive information has been provided, the parents should be informed in a discreet professional manner of consequences of refusal, failing that the physician can be held liable in the court of law. The conflict of “best interest standards” for treatment of the child vs. “rational parent standard” for the attitude of parents is matter of never ending debate” (
In Tanzania, Section 4 (2) of the Law of the Child Act insists that the best interest of a child should be the primary consideration in all actions pertaining to the child. Also Section 9 (1) of the same Act provides for the right to life, dignity, respect, leisure, liberty and health for children and parents, guardians and relatives are responsible to ensure the enjoyment of those rights. Again Section 13 (1) of the same Act prohibits degrading treatments to children, and institutions like local government authorities and police are vested with legal duties under the said Act to ensure children's safety (
In the United Kingdom, as in Singapore, another actor is brought in if the young person themselves, or the individual with parental responsibility refuses to give consent to medical treatment for the young person or child. In most countries participating in this study, the Court of Protection is brought in and can overrule the decision if it is deemed to be in the best interest of the young person or child, such as, if refusing the treatment may result in the death or permanent injury.
There are several country-specific issues related to consent that add to the complexities of securing informed consent for dental treatments.
In India, most dentists are unaware of all the necessary aspects of the consent process (
In Nigeria, an ethical dilemma dentist's face is the request to extract the maxillary central primary incisors when they erupt ahead of the lower central incisors. This is because of the widespread belief that a child who erupts the maxillary central primary incisors ahead of the lower has supernatural abilities that makes the child able to pronounce curses. Parents therefore, request dentists to remove these teeth otherwise they hide the child out of sight from guests until the lower teeth fully erupts or get “quacks” to do the extraction. The presence of natal/neonatal teeth gives similar concerns to the parents. Also, a diastema is regarded as a sign of beauty and patients sometimes visit the dentist to create an artificial diastemas (
In Singapore, healthcare decision making can be affected by the source of financing. Singapore's healthcare utilises a mixed financing system (
In Vietnam, an ethical dilemmas often arises when family members of the child disagree on an emergency treatment. Due to the Law on Medical Examination and Treatment, physicians are legally prevented from delivering care, unless the patients' family comes to a consensus (
If the Gillick Competency test is met, then the child is deemed capable of providing consent to treatment (
Beyond the country specific issues related to obtaining informed consent highlighted above, there are also cultural or religious practices that, due to their risk of harm to patients, they raise ethical concerns and have specific consent related considerations. In Pakistan, the religious beliefs can be problematic as some believe a negative medical outcome is God's Will, and as a result they would prefer to accept their child's fate and pray, rather than to provide consent for treatment (
Dentists, as professional health care providers, are required to provide care based on sound ethical principles. Ethics is defined as “the moral principles or virtues that govern the character and conduct of an individual or a group” (
The ethical principle “Autonomy” refers to “Patients have the right to determine what should be done to their bodies” (
Although all countries included in this study have governing, rules and regulations regarding consent and the age of consent, the final decision making falls to the dentist. “Regardless of the parent's request, the dentists’ primary ethical, moral and legal duty is to the child” (
Many dental practitioners would like to apply the “best interest” principle in routine practice, thereby taking control of the decision making regarding treatment of minors. However, the responses from most countries confirmed that dentists may only act in the best interest of the patient and treat the patient without formal consent if it is a life threatening situation and/or there is no legal person available to give consent. However, in Nigeria children are primarily considered the property of the State and parents are custodians of children on behalf of the State (
Although some countries' laws mention the dentists' authority to act in emergency situations, what constitutes an emergency in the dental setting is not specified or defined. Most laws only refer to “emergency” or “life threatening” situations, which leaves room for individual interpretation regarding dental conditions. Examples of dental emergencies are trauma, abscess formation (without facial swelling) or a lost filling among other. However, it is debatable if these dental conditions can be considered as “emergencies” for which dentist may overrule consent/assent or even act in the best interest of the child regardless of consent.
A limitation of this study is that it only includes 13 countries and a larger follow up study involving more or all countries should be done. The results of this pilot study can therefore not be safely generalized.
The policies and guidelines enabling children to self-consent for dental treatment varies globally. Some countries make use of a combination of age and Gillick Competency, whereas others strictly adhere to age as determining factor for competency. Obtaining assent from a child-patient is compulsory in some countries, but not specified in laws or regulations in all countries. Many countries' laws and regulations do not specify when a dentist may act in the “best interest” of the child- overruling general consent rules. Taking into consideration the aesthetic implications of SDF/SF treatments, obtaining informed consent plays a crucial role in successful management of caries with these products.
It is recommended at three areas are clarified to help dentists in providing appropriate dental care; first, when a dentist may act in the “best interest” of the child. Second, guidance what constitutes a dental emergency and third, clarity within the law with regard to overruling consent. A larger follow up study is recommended to include more or all countries around the world.
The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.
NP: Conceptualization, Data curation, Investigation, Methodology, Project administration, Writing – original draft. GB: Conceptualization, Data curation, Formal Analysis, Investigation, Methodology, Writing – original draft, Writing – review & editing. ME: Data curation, Investigation, Writing – original draft, Writing – review & editing. MF: Data curation, Investigation, Writing – original draft, Writing – review & editing. SG: Data curation, Investigation, Writing – original draft, Writing – review & editing. SG: Data curation, Investigation, Writing – original draft, Writing – review & editing. AJ: Data curation, Investigation, Writing – original draft, Writing – review & editing. AK: Data curation, Investigation, Writing – original draft, Writing – review & editing. DL: Data curation, Investigation, Writing – original draft, Writing – review & editing. PL: Data curation, Investigation, Writing – original draft, Writing – review & editing. SM: Data curation, Investigation, Writing – original draft, Writing – review & editing. RM: Data curation, Investigation, Writing – original draft, Writing – review & editing. JM: Data curation, Investigation, Writing – original draft, Writing – review & editing. MM: Data curation, Investigation, Writing – original draft, Writing – review & editing. AQ: Data curation, Writing – original draft, Writing – review & editing. NT: Data curation, Investigation, Writing – original draft, Writing – review & editing.
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