Ethics considerations for the trial
| Ethical consideration | Proposed response |
| Student withdrawal from study | A student will be withdrawn from the study if parents/guardians actively choose to opt out of the study. This may be communicated either directly to the research team, or parents can also communicate this via the teacher. If communicated via the classroom teacher, the research team will follow-up with the parent to confirm. In both instances, the parent will be asked to complete the opt-out form to confirm withdrawal from the study. This form will be provided to all parents at study commencement, and a copy will also be made available on request at any time point during the study. Parents will be able to withdraw their child at any point in the study and a reason for withdrawal is not a requirement of opting out. |
| Unforeseen adverse event reporting | We do not anticipate any serious adverse events to occur during this project. Parents, teachers and schools will be able to contact members of the research team at any stage during the study if they have any concerns. Contact details for the research team will be clearly listed on all study materials as well as on the study’s website. Any events will also be included in the project’s logbook. Where necessary, concerns will also be communicated to the Human Research Ethics Committee (HREC) at the Royal Children’s Hospital and the New South Wales (NSW) Department of Education to ensure they are appropriately addressed. |
| Project record retention | All project materials will be stored on the password-protected electronic database or in locked cabinets until the youngest participant is 25 years old, for example, 2039. After that time, hard copy materials will be destroyed by shredding, and any password-protected electronic archives will be permanently deleted. |
| Confidentiality | Participant confidentiality is strictly held in trust by the participating investigators, research staff, and the sponsoring institution and their agents, and is extended to cover school, teacher, student and parent information relating to the project. The project protocol, documentation, data and all other information generated will be held in strict confidence. No information concerning the project, or the data will be released to any unauthorised third party, without prior written approval of the sponsoring institution. The HRECs of the sponsoring institution may inspect all documents and records required to be maintained by the Investigator. All evaluation forms, reports and other records that leave the site will be identified only by the child participant ID number to maintain subject confidentiality. |
| Protocol modification | This project will be conducted in compliance with the current version of the protocol. Any change to the protocol document or informed consent form that affects the scientific intent, project design, participant safety, or may affect a participant’s willingness to continue participation in the project is considered an amendment, and therefore will be written and filed as an amendment to this protocol and/or informed consent form. |
| Protocol deviations | All protocol deviations must be recorded in the child record on the secure database by the research project manager. Deviations must also be reported to the CIs. Protocol deviations will be assessed for significance by the chief investigators. Those deviations deemed to have a potential impact on the integrity of the project results, participant safety or the ethical acceptability of the trial will be reported to the HREC during the project from 2016 to 2018. |