ETHICS & DATA
Consistent with guidelines from the National Bioethics Committee of Icelandic, the participants in the proposed sample as well as their parents will be approached to provide informed written consent prior to being enrolled in the study. The data collection will be conducted in accordance with the Privacy and Data Protection Authority in Iceland by and under the direction of the Icelandic Centre for Social Research and Analysis.
ACCESS TO THE DATA
Only the PI and one Icelandic CI will have access to the linkage between the national ID code (kennitala) and a unique study ID code constructed by the research team. We envision that the research team, including the original aforementioned team plus potentially other researchers that will join the group later, as well as Ph.D. students and post-docs will have access to the final data analysis file on a computerized format.
Data will be kept on closed computer files where the only information about participants will be a unique study ID code not linkable to their national id-code (kennitala). The linkage between the national id-code and the unique study ID will only be known to the PI and one other Icelandic CI. This information will be kept in a single and separate file in a private computer not accessible to anyone else.
The main ethical issues involved are the following
Data will be stored using personalized study id codes but these will be derived from the Icelandic national id codes (kennitala). We will ensure that the connection between the study id code and the national id-code will only be known to the PI and one CI and not used in any of the data analysis files.
The saliva sampling may be uncomfortable to some participants. We have demonstrated the possibility of opting out from this component of the study if desired (see attached Letter of informed consent).
A few of the questions in the questionnaire may be uncomfortable to some participants. As before we will ensure that those may be skipped if desired. This is outlined in the introductory text to the study in the letter of informed consent.
The nature of the registry data may be sensitive to some participants. We have also outlined clearly in the introduction to the study in the letter of informed consent that this part may be skipped if desired. We also ensure that this study material, as well as all other data that will be collected, will never be stored or reported with personalized information that is recognizable to others.