Guidelines

Consent requirements for research involving minors

If your research involves taking consent from a Minor (a person who is below 21 years of age and who has never been married), appropriate consent must be obtained from both the Minor AND at least one adult parent or guardian of the Minor.

In avoidance of any doubt, parental/guardian consent should be obtained for all research projects involving Minors (21yo below; not married). Where possible, this parental/guardian consent should be taken in the same hardcopy Informed Consent Form (ICF) together with the participant’s consent. If not, a separate hardcopy parental consent form may be obtained.

  • To facilitate projects in the Social, Behavioural and Educational Research (SBER) domain that are of less than minimal risk (for e.g. online surveys without any sensitive topics or any physical contact) where there is no likelihood of harm, NTU IRB will accept taking parental/guardian consent via "online consent".
    • ​"Online consent" could be in the form of emails or web forms seeking parent's/guardian's consent to their child's/ward's participation in a less than minimal risk study.
    • Names,emails and relationship of parent/guardian should be provided by the Minor(participant) in the usual ICF, and invitations for parental/guardian consent should state that their contact details had been obtained from their child/ward.
    • The Participant Information Sheet and study details (via a website or email) should be provided to the parents/guardians for their review.
    • Details required from parents/guardians in the online parental consent should include: (1) Name, (2) Email and Telephone number for verification purposes, (3) Relationship to participant, (4) Name of participant.

  • Projects in the Biomedical and Endurance & Human Performance domains are required to obtain parental/guardian consent via the usual hardcopy ICF, and in compliance with HBRA requirements. These include the below table.​ 


​Condition
​Additional Requirement
Minors with sufficient understanding and intelligence to understand the proposed research.
Both the minor and at least one adult parent/guardian to give consent.
Minors without sufficient understanding and intelligence to understand the proposed research
​1) At least one adult parent/guardian to give consent.

2) Research of comparable effectiveness cannot be carried out without the participation of this class of persons

3) Tissue removal: primary purpose must be for treatment.

Minors who lack mental capacity (e.g. Down syndrome)


Under HBRA, NTU-IRB can waive this requirement to obtain the appropriate consent of at least one adult parent or guardian for the participation of a Minor if the board is satisfied that -

  1. the research involves no more than minimal risk to the research subjects; and
  2. the waiver of parental consent will not adversely affect the rights and welfare of the research subjects;and
  3. the research may not practicably be carried out unless there is such a waiver, and  

    the research proposal —


  • is designed for conditions or for a research subject population for which parental (or guardian) consent is not a reasonable requirement to protect the research subjects(such as neglected or abused minors), and an appropriate mechanism for protecting the minors is substituted; or
  • is of such a private and sensitive nature that it is not reasonable to require permission, (such as adolescents in studies concerning treatment of sexually transmitted diseases); or
  • is within the description of such circumstances as may be prescribed.