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Participants under 18 Guidance

HSSREC Guidance on cases of ethics approval involving

participants under 18

1.         Low Risk Cases (under 16s)

Low risk cases are defined as those where the research is taking place in an institutional setting (e.g. school, young offender institution, hospital, ‘looked after’ children in local authority care).   Parental consent required.

Low-risk cases involving participants under 16 should always be ratified by the HSSREC under Chair’s action.

Departments must ensure:

  • Parental/gatekeeper consent is obtained;
  • Appropriate measures are in place for informed consent/involvement of participants where competent;
  • Investigator has been trained in dealing with non-adult participants;
  • Survey design is appropriate to the age group, and use of non-adult participants is warranted. This is particularly relevant to student projects;
  • Protocols for use of e.g. school or similar settings have been observed
  • Investigator has considered differential potential for distress/adverse effects among non-adult participants, e.g. embarrassment, non-understanding, fear of authority etc.

2.         Low Risk Cases (16-18)

Low-risk cases involving participants aged 16-18 can be handled by local procedures

Departments must ensure:

  • Written informed consent is obtained;
  • Parental/gatekeeper knowledge has been obtained. Formal consent may be required in some settings;
  • Participant information and participant consent documentation is appropriately drafted;
  • Investigator has been trained in dealing with non-adult participants;
  • Survey design is appropriate to the age group, and use of non-adult participants is warranted. This is particularly relevant to student projects;
  • Protocols for use of e.g. school or similar settings have been observed

3.         High Risk Cases

High-risk, sensitive or complex cases involving participants under 18 will require full review by HSSREC.

High risk cases are defined as those where the research is taking place in a non-institutional setting (e.g. involving children who are being home schooled, or children who are disaffected with school).   In the latter case codes of ethical practice normally suggest that parental consent would have to be sought and researchers are required to conduct interviews in an externally observable space (for example, a room with a glass window open to view from the outside) – or at home, with an appropriate adult in an adjacent room.

Departments must ensure:

  • Written informed consent is obtained;
  • Parental/gatekeeper knowledge has been obtained. Formal consent may be required in some settings;
  • Participant information and participant consent documentation is appropriately drafted;
  • Investigator has been trained in dealing with non-adult participants;
  • Survey design is appropriate to the age group, and use of non-adult participants is warranted. This is particularly relevant to student projects;

 

 Guidance for applying protocols to student projects

Departments should in the first instance determine the level of risk that a project entails. All projects involving U16 participants and all projects entailing a high degree of risk must be referred to HSSREC.

Members of the Ethics Committee must satisfy themselves of the following:

  • That use of U18 participants is vital to the project
  • That all necessary measures and sufficient training have been undertaken or will be undertaken by the researcher to ensure the safety and comfort of all participants
  • That the researcher has sufficiently considered the design of the project and of any forms/documentation to take account of the age of the participants.