Table 2 Ethics checklist for genomic research involving children affected by NDDs

Research design and ethics review

 ☐ Have you considered risks and benefits for the participants (e.g. data safety, privacy, possible stigmatization or discrimination based on the research results)?

 ☐ Have you considered using a community-based participatory design for (part of) your research?

 ☐ Have you reflected on the use of terms “abnormal”, “pathogenic” etc. in the context of your research protocol?

 ☐ Do you have access to personnel trained in handling children/persons with limited cognitive abilities?

Inclusion of research participants

 ☐ Have you considered accumulation of burdens for research participants and their families that might be caused by participation in numerous research studies?

 ☐ How you will avoid diagnostic/therapeutic misconception in the process of informed consent?

 ☐ How you will explain the difference between NDD research and clinical care to potential research participants?

 ☐ Have you included in the informed consent form information on the return of individual genomic research results and incidental findings?

 ☐ How you will address children’s changing capabilities and rights as they grow and reach the age of consent? Do you plan to apply age-gradual assent? Do you plan to seek re-consent after research participants reach maturity?

 ☐ Have you considered that parents or research participants in certain situations may share limited cognitive abilities due to a heritable condition, and that, therefore, there might be need for specifically designed informed consent forms?

 ☐ What kind of materials do you plan to use to support research participants’ and their families’ understanding about research in the process of informed consent (e.g. visual aids, augmented communication systems, easy reading texts)?

Sharing of research results

 ☐ Do you plan to use community consultations (e.g. with patient organizations) for understanding the communities’ views on communication of research results?

 ☐ Will you develop a dissemination plan tailored to relevant patient communities?

 ☐ How will you protect identities of those with rare conditions in the context of open-access publishing?

 ☐ How can the research project contribute to general education within society about NDD and psychiatric conditions to reduce risk of stigma and discrimination?