Table 1

Summary of selected major guidelines on ethical conduct of research in children

GuidelineCore principlesConsiderations for adapting to low-resource, low-literary and minority language settings
World Medical Association, Declaration of Helsinki7
  • If a research subject is not capable of giving informed consent, it should be sought from a legally authorised representative.

  • When the subject can give assent to decisions about participation in research, assent should be sought in addition to consent. Dissent should be respected.

  • Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

  • Consent should be given preferably in writing, if not the non-written consent must be formally documented and witnessed.

Council for International Organizations of Medical Sciences3
  • Obtain permission from a parent or a legally authorised representative of the child.

  • Obtain assent from the child or adolescent according to his or her capacity and after having been provided with information tailored to the child’s or adolescent’s level of maturity.

  • Consult with and engage communities in the informed consent process.

  • Obtain a signed form as evidence of informed consent, justify any exceptions to this general rule and seek approval of the research ethics committee.

Standards for Research (StaR) in Child Health4
  • Obtain consent and assent when age appropriate.

  • Provide age-appropriate, clear, concise and ongoing information for parents and children.

  • Provide clear justification to involve a particular population and equitable sharing of benefits and risks.

  • Community consultation can be helpful but does not replace the need for individual consent.

  • Strengthen composition and expertise of local ethics committees.

National Bioethics Advisory Commission, Ethical and Policy Issues in International Research8
  • Develop culturally appropriate ways to disclose information that is necessary for adherence to the ethical standard of informed consent.

  • Develop procedures to ensure that participants understand the information provided in the consent process.

  • Respect local requirements of asking permission from community representatives for approaching potential participants, but respect the requirement of individual informed consent.

  • Ethics review committees can waive the requirements of written and signed consent in accordance with local cultural norms.

European Council and European Parliament Guidelines9
  • Consent should be sought from parents or legal representatives.

  • Information should be provided to the minor according to its capacity of understanding.

  • The explicit wish of a minor who is capable of forming an opinion and assessing information to refuse participation should be considered.

  • The individual or legal representative has to give written consent. If the individual is unable to write, oral consent may be given in the presence of at least one witness, as provided for in national legislation.