India: National Ethical Guidelines For Biomedical Research Involving Children: ICMR

In October 2017, the first National Ethical Guidelines for Biomedical Research Involving Children has been published by the division of publication and information on behalf of the Secretary, Department of Health Research (DHR) & Director General (DG), Indian Council of Medical Research (ICMR), New Delhi.

Moreover, the latest version of "National Ethical Guidelines for Biomedical Research involving Human Participants, 2017" also has a section pertaining to research involving children. However, a need was felt to develop more comprehensive guidelines which pertain to the specifics of ethics in biomedical research involving children. Therefore, this endeavor was undertaken under the aegis of ICMR Advance Center for Newborn Health Research at All India Institute of Medical Sciences, New Delhi for the development of this guideline.

This Guideline will lead to advances in medical care which can potentially improve the health and quality of life of children and also counter the below listed queries and concerns-

Why biomedical research is necessary for children?

Here are some of the reasons, which support necessities of biomedical research in children:

  • There are some diseases which only affect children, and have no adult counterparts. Therefore, it is necessary to carry out research in children to advance the knowledge of these diseases. For example, hyaline membrane disease, birth asphyxia, neonatal hyperbilirubinemia, extrahepatic biliary atresia, infantile spasms, infantile tremor syndrome, Kawasaki disease, etc.
  • The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs much more rapidly as compared to adults.
  • The adverse effects of many drugs may also be different in children as compared to adults. For instance, Tetracycline causes teeth discoloration in young children and Aspirin use is associated with Reye's syndrome in children.
  • Age appropriate delivery vehicles and formulations (such as syrups) are needed for accurate, safe and palatable administration of medicines to infants and children.
  • The pathophysiology of many disorders is dependent on a child's growth, development and adaptive plasticity.
  • Research in children is also one of the ways to understand some adult diseases that are thought to have their origins in early life.

What are the challenges of biomedical research involving children?

Some challenges of biomedical research involving children:

  • Diseases in children may be rare, and there may not be sufficient numbers of affected patients to answer the research questions.
  • Difficult to find funding for research in children as the market for pediatric drugs and treatments is quite small compared to the adult ones.
  • The ethical concerns and obtaining informed consent of research involving children.
  • The familial and socio-cultural concerns are higher than individual patients while planning the research in children.
  • Research procedures and settings need to consider children's physical, cognitive, and emotional development.

What are the general guidelines for research involving children?

The following guidelines should be followed when conducting research in children:

  • Research proposals should be scientifically sound.
  • The equation between the potential benefit and the risk or potential harm should be at least as favorable for the proposed research procedure as for the alternatives available to the children.
  • There should be benefit to children in general and, in most cases, to the individual child subject.
  • The need for the study should be justified by a thorough review of literature.
  • The research should be conducted by a team of investigators who have the requisite expertise. One or more members of the team should be a paediatrician and/or have prior experience of conducting research involving children.
  • Research involving children should take into consideration the unique physiology, anatomy, psychology, pharmacology, social situation and special needs of children and their families.
  • Research involving children must be conducted in a child-friendly environment, as far as possible.
  • In general, drugs should be tested for safety, pharmacokinetics, and at least initial indications of efficacy in adults should be established before they are tested in children. It may often be appropriate to defer paediatric testing until adult testing has reached Phase III or beyond, when substantial data is available on the safety and efficacy of a drug in adults. However, there may be situations where studies involving children would be needed without prior adult studies, for example, Surfactant use in premature babies with respiratory distress syndrome.

How the consent or assent is obtained in research involving children?

The parental/ Legally Acceptable/ Authorized Representative (LARs) permission for the child's participation in the research is termed as 'consent', whereas the child's agreement to participate is termed as 'assent'. The consent or assent obtained by and/or behalf of children are -

  • Informed consent by parents/LAR: In research involving children, the traditional method of informed consent where decisions about research participation are made by those with the legal and intellectual capacity to make such choices for themselves, as children usually lack this capacity.
  • Informed consent by illiterate parents/LAR: When a participant is willing to participate but not willing to sign or give thumb impression or cannot do so, then verbal/oral consent may be taken on approval of the EC, in the presence of an impartial witness who should sign and date the document. This can be documented through audio or video recording of the participant, the PI and the impartial witness, all of whom should be captured in the frame.

Children assents:

  • For children less than 7 years of age, parental consent is sufficient.
  • For children between 7 (84 months and above) and 11 years of age, oral assent must be obtained in the presence of parent/LAR.
  • For children between 12 and 18 years of age, written assent must be obtained. If a child becomes 13 years old during the course of the study, then written assent must be obtained in addition to parent/LAR consent.
  • The process of re-consent/re-assent: In some cases, fresh or re-consent may need to be taken in case of new information becomes available which necessitates amendments in protocol, long term or study follow up extension, participants attain 18 year of age, treatment or protocol modalities etc.

What is Compensation in research involving children?

Compensation is two types:

  • Compensation for participation: The compensation is reimbursement of reasonable expenses incurred by child or caregivers to participate in research (for example, travel, wage loss). Children involved in research may also receive free medical services. The Ethics Committees have to ensure that payments do not act as inducements. Protocols should clearly mention the details about the type, level, and timing of payments to participants. The details should also be included in the informed consent form.
  • Compensation for Accidental Injury: Children are entitled to financial compensation and/or other assistance for any temporary or permanent impairment or disability resulting from participation in research. In the case of death, their parents are entitled to compensation.

What are special situations in research involving children?

There are various situations in research involving children where designing a research protocol needs consideration of ethics committee and subject expert committees such as -

  • Research in neonates
  • Research in HIV-positive children
  • Vaccine studies in children
  • Ethical issues in genetic research
  • Research involving children in an emergency situation
  • School-based research
  • Internet /Telephone-based research in children
  • Community-based Research in Children
  • Research involving adolescents (12-18 years)30.

NOTE- This document covers the ethical and legal issues that researchers need to consider when carrying out biomedical research in neonates and children. The aim is to set out general principles that can be applied in most situations rather than to cover every possible situation. These guidelines need to be used in conjunction with the current National Ethical Guidelines for Biomedical Research involving Human Participants, Indian Council of Medical Research (ICMR) Government of India and are meant for use by researchers, ethics committees and other involved stakeholders.

Footnote

30. http://www.icmr.nic.in/guidelines/National_Ethical_Guidelines_for_BioMedical_Research_Involving_Children.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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