Guidelines for informed consent in biomedical research involving paediatric populations as research participants

To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.     

Consent for emergency medical services for children and adolescents

Pediatric patients frequently seek medical treatment in the emergency department (ED) unaccompanied by a legal guardian. Current state and federal laws and medical ethics recommendations support the ED treatment of minors with an identified emergency medical condition, regardless of consent issues. Financial reimbursement should not limit the minor patient's access to emergency medical care or result in a breach of patient confidentiality. Every clinic, office practice, and ED should develop policies and guidelines regarding consent for the treatment of minors. The physician should document all discussions of consent and attempt to seek consent for treatment from the family or legal guardian and assent from the pediatric patient. Appropriate medical care for the pediatric patient with an urgent or emergent condition should never be withheld or delayed because of problems with obtaining consent. This statement has been endorsed by the American College of Surgeons, the Society of Pediatric Nurses, the Society of Critical Care Medicine, the American College of Emergency Physicians, the Emergency Nurses Association, and the National Association of EMS Physicians.     

Atención a menores con progenitores en conflicto en materia de información y consentimiento relativos a la salud de los hijos. Protocolo asistencial en el contexto de la legislación vigente

Among the main social and legislative changes as regards family matters that have taken place in Spain in the last few years, are included: (i) the gradual increase in legal disputes between parents, and (ii) the introduction of Law 26/2015 on Child Protection, which modified Law 41/2002 on the Freedom of the Patient. These searched for a balance between the rights of minors and the powers of the parents, particularly when the former had not reached 16 years or had sufficient maturity or, having reached it, the decision puts their life or health at severe risk. Likewise, it has led to a jurisprudence that determines that, for any minor, there are particularly sensitive, “special” or “important” health care actions, such as psychotherapy or surgical treatments, which require, with exceptions, the consent of both parents for it to be carried out. All this, however, subject to the discretion of the doctor responsible, who must always look after the best interests of the minor. For this reason, healthcare for minors, occasionally, lead to complex conflicts as regards information and consent by the parents, particularly when they do not agree. A review is presented on the current legislative framework and the main legal concepts that regulate the healthcare of minors as regards information and consent relative to health, as well a healthcare protocol for the care of minors in situations of conflict between parents, developed in the Gregorio Marañón Hospital of Madrid, and endorsed by the Official Medical Collegiate of Madrid.     

Consent for emergency medical services for children and adolescents

Parental consent generally is required for the medical evaluation and treatment of minor children. However, children and adolescents might require evaluation of and treatment for emergency medical conditions in situations in which a parent or legal guardian is not available to provide consent or conditions under which an adolescent patient might possess the legal authority to provide consent. In general, a medical screening examination and any medical care necessary and likely to prevent imminent and significant harm to the pediatric patient with an emergency medical condition should not be withheld or delayed because of problems obtaining consent. The purpose of this policy statement is to provide guidance in those situations in which parental consent is not readily available, in which parental consent is not necessary, or in which parental refusal of consent places a child at risk of significant harm.     

Praktyczne aspekty postępowania lekarza w razie braku zgody opiekunów prawnych na udzielenie świadczenia zdrowotnego

A legal guardian's consent is needed to give a medical benefit to a juvenile patient. In some measure this consent substitutes the juvenile's consent. Such rule has the usage towards juveniles till they reach 16. After reaching this age both legal guardian and juvenile consent is required. In this subject in the progress of diagnostic-therapeutic treatment many problems may be found, for instance those concerning a definition of the way of the doctor's behavior when parents do not give consent for suggested medical treatment. In some situations the juvenile is allowed to make an objection by himself. There are also many cases when the matter has to be solved by the guardianship court. But when a delay could cause life threat or severe health disorder – is the doctor allowed to perform a treatment without the court's consent? This article is an attempt to solve such legal intricacies concerning treatment of the juvenile.     

Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)

Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used.Members of the Ethics Working Group of the CESP are: Timothy L. Chambers (UK), Francis P. Crawley (Belgium), Denis Gill (Ireland), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz, Chairman (Austria), Maria de Lourdes Levy (Portugal), Staffan Mjönes (Sweden), Andreas Constantopoulos (Greece), Armido Rubino (Italy), Pieter J. J. Sauer (Netherlands), Martti Siimes (Finland), Michael Weindling (UK) and Maximilian Zach (Austria).Approved by the CESP, May 4th, 2002     

Neonatal research: the parental perspective

OBJECTIVES: To investigate the recollections of parents consenting for their infants to be research subjects and determine their views about the need for consent. SUBJECTS: Parents of 154 sick newborn infants enrolled in a randomised trial in the early neonatal period. All parents had given written consent and received printed information. METHODS: A questionnaire and accompanying letter was sent to the parental home 18 months later. Non-responders were sent a further questionnaire and letter. RESULTS: Response rate was 64% (99/154). Some respondents (12%) did not remember being asked to consent to their baby joining a study, and a further 6% were unsure. Most of the respondents (79%) were happy, 13% neutral, and 8% unhappy with their decision to give consent. None felt heavy pressure to agree. Entering the trial caused 24% of respondents to feel more anxious, 56% neutral, and 20% less anxious about their baby. Most of the respondents (83%) would be unhappy to forgo the consent process for trials passed by the institutional ethics committee. CONCLUSIONS: A significant proportion of parents who give written consent for a trial in the early neonatal period do not later remember having done so. Parents who have had experience of neonatal research would be unhappy for their baby to be enrolled in a study that had ethics committee approval without their consent being obtained.     

Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)

A child has the full right of protection of his/her life by provision of optional medical care. There is a need in paediatrics for better evidence based practice founded on quality research into efficacy and safety of childrens medications. To protect the best interests of the child one must balance the ethical demand to do clinical studies with the necessity to avoid doing harm. To achieve this end good clinical practice in paediatric research demands that studies comply with the Declaration of Helsinki, ICH topic E11, EU Directives and other relevant international guidelines. Evident differences in physiology, pharmacology, pharmacokinetics and pharmacodynamics between children of differing ages and between children and adults demand properly constructed and conducted studies that respect the special somatic, emotional and mental needs of children. To justify any research project one must balance the benefit/risk ratio, provide experienced, competent personnel and infracture, obtain adequate informed consent/assent, and have the study evaluated and approved by an ethics committee containing expertise on the rights and needs of children.Members of the CESP Working Group are: Timothy L. Chambers (UK), Francis P. Cawley (Belgium), Denis Gill (Ireland), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz (Austria), Staffan Mjones (Sweden), Pieter J. J. Sauer (The Netherlands), Martti Siimes (Finland).     

Research information for minors: Suitable formats and readability. A systematic review

As children age, their capacity to consent or dissent to research participation increases. Numerous regulations and guidelines require that children should receive information ‘according to their capacity of understanding’. In order to gain more insight in the quality of patient information forms for minors, a systematic literature search was performed. Two aspects of quality will be analysed in this paper: the effect of format on understanding and the readability of text in the documents. A systematic search was executed in PubMed, Embase and PsycINFO. Seventeen papers on format were included. Interventions testing information formats indicate that improvement is possible, but outcome measurement varied per study and no apparently successful intervention was repeated. Only three readability papers were found, all indicating a readability gap between patient information forms and children's actual reading level. The results indicate an urgent need for further research on how to adequately inform minors about clinical trials.     

Comparison of German and American law concerning clinical trials

In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial. In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial. In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written. The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards. The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.     

Le soin contraint de l’enfant et de l’adolescent dans un cadre judiciaire

This article describes the legal framework in which medical treatment can be ordered for a minor without his/her consent, by a judge for children. The decision process includes the search for parental and children cooperation and the article insists on the importance of social services support. Juvenile justice and child protection proceedings are both addressed, the French judge for children having jurisdiction on both. The article also questions the sense of judicially imposed medical care.     

Legal basis of consent for health care and vaccination for adolescents

State law is generally the controlling authority for whether parental consent is required or minors may consent for their own health care, including vaccination. At the federal level, no vaccination consent law exists; however, federal law requires that vaccine information statements be given to the parent or another person who is qualified under state law to consent to vaccination of a minor. All states allow minors to consent for their own health care in some circumstances on the basis of either (1) their status (eg, age, emancipation, marriage) or (2) the kind of health care services they are seeking (eg, family planning services, treatment of sexually transmitted disease). In each state, a specific analysis of laws will be required to determine the circumstances under which a minor can consent for vaccination.     

Termination of life support after severe child abuse: the role of a guardian ad litem

Discontinuation of life-sustaining interventions often raises ethical concerns. In cases of severe child abuse with poor prognosis for recovery, accused parents may have a conflict of interest regarding medical decision-making for their child, because the outcome of such decisions may impact legal charges filed against them. The recently issued American Academy of Pediatrics guidelines for addressing such cases recommended the appointment of a guardian ad litem for medical decision-making. We present the case of an 8-month-old infant who was abused severely by her father, resulting in a persistent vegetative state. We describe our experience with appointing a guardian ad litem and the ethical issues involved.     

Exploration for physicians of the mature minor doctrine

The "mature minor doctrine" is the common-law rule that allows an adolescent who is mature to give consent for medical care. Ethical decisions regarding consent and confidentiality should be distinguished from legal requirements. Recent court decisions have altered the law, especially in regard to consent for refusal of life-sustaining treatment. There are statutory exceptions to the rule of parental consent regarding emergency care, sexually transmitted diseases, drug treatment, mental health care, pregnancy, contraception, and emancipation. A detailed analysis of the mature minor exception is presented, utilizing court case vignettes. There is minimal legal risk in allowing adolescents older than 14 years of age to give consent for treatments entailing small degrees of risk, when they can make adultlike decisions and demonstrate signs of maturity.     

Parler de sa propre voix : être acteur de sa maladie à l’enfance et l’adolescence

The issue of consent to care is central today when dealing with issues related to medical ethics. It concerns respect for the autonomy of the person, which is at the heart of the Patient Rights Act of 2002, which requires the medical profession to obtain the patient's consent before administering treatment. This obligation is nevertheless problematic when it comes to children or adolescents who are under the responsibility of their legal guardians. Can we allow ourselves to do without their consent on the pretext that we are not obliged by law? This is a crucial ethical issue, mainly in the area of psychiatry where the relationship between the therapist and the patient is crucial. Should we consider that a patient, because he is a child or a teenager suffering from psychiatric disorders, does not have to give his opinion? Or should we help them to look for a way to make their voices heard so that they become an actor of their illness and its treatment?     

Treating minors without their parents

Minors frequently present to the ED for treatment without their legal guardians. In most such situations, it is best to contact the parents to obtain consent for treatment and to inform them about their child's problem. However, in some emergency situations or problems involving adolescent health, it may be impractical or damaging to contact the parents. In these situations, the law is sufficiently vague to protect the well-meaning physician who gives care to consenting minors for their own benefit. Of course, if problems result from the care which is rendered, the usual malpractice law will apply, and the physician will try to demonstrate that his treatment fit into one of the legal exceptions to the general rule.     

Legal and medico-legal issues in adolescent medicine. A critical review of the present regulation and legislation

During the last years the Italian Government has taken many different initiatives to protect the adolescents rights to benefit from physical, psychical and social well-being. In particular, various projects concerning the promotion and the support of the school, the family, sport, mass-media, judicial and medical infrastructures, have been organised, promoted and financed. However, it is not always possible to assure a real safeguarding of teenagers rights; this especially happens because the problem concerning the autonomous capacity of minors to consent (or non consent) to the medical treatment is much debated. However, many contradictions still persist about the effective duration of the pediatric age. All the same, it must be noted that the Legislator apparently realised that not only the physical, psychological and social maturity proceed by steps, but also the legal capacity.     

Institutional ethics committees. Committee on Bioethics

In hospitals throughout the United States, institutional ethics committees (IECs) have become a standard vehicle for the education of health professionals about biomedical ethics, for the drafting and review of hospital policy, and for clinical ethics case consultation. In addition, there is increasing interest in a role for the IEC in organizational ethics. Recommendations are made about the membership and structure of an IEC, and guidelines are provided for those serving on an ethics committee.     

Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors

BACKGROUND: Granulocyte colony stimulating factor (G-CSF) is used for collection of hematopoietic cells in most adult and a smaller but significant percentage of pediatric normal donor harvests. Short and long-term risks of G-CSF administration and leukopheresis are not well understood in the pediatric population. PROCEDURE: Literature review including observations from the IBMTR, NMDP, EBMT, German Donor Registry, and the authors' work. RESULTS: G-CSF causes temporary discomfort in a minority of younger donors. Rare serious side effects of G-CSF have yet to be reported in children. To date, an increase in hematological malignancies after short-term G-CSF use has not been detected in adult donors and no cases have been reported in children. Reported complications of leukopheresis in children are rare and minor, but donors <20 kg may be exposed to allogeneic blood products. Pediatric aged donors vary widely in their ability to assent or consent to the risks of a donation procedure. There are key regulations and ethical imperitives, which must be addressed in deciding which donation procedures are appropriate for minors. CONCLUSIONS: While short term administration of G-CSF and leukopheresis appear to be safe and effective procedures when used to assist in collection of a hematopoietic cell graft from a normal pediatric donor, institutions adding or substituting one or both of these procedures for standard marrow donation must decide whether the donor should be considered a research subject, and if so, whether the new procedures are a minor increase over minimal risk. Because these procedures are being performed on and off study at many pediatric centers, a comprehensive study addressing donor safety could help clarify risks of rare adverse events.