Table 2 Summary of results after panel ratings from Rounds 1 and 2 of the policy Delphi
# | KIDS Framework statement (13) | Measurea | Round 1 (n = 10) | Round 2 (n = 12) | Validated? | ||||
|---|---|---|---|---|---|---|---|---|---|
Average | Consensus | Polarity | Average | Consensus | Polarity | ||||
1 | The best interests of children are primary | RI | 1.4 | High | None (0.488) | – | – | – | ✔ |
F | 2 | High | None (0.444) | – | – | – | |||
2 | Children should be listened to, and involved in decision-making processes related to genomic and associated clinical data sharing in developmentally appropriate ways | D | 2 | High | None (0.222) | – | – | – | ✔ |
F | 2.3 | High | None (0.233) | – | – | – | |||
3 | Parents should be informed in a transparent manner how their child’s genomic and associated clinical data will be securely managed and used | RI | 1.2 | High | None (0.177) | – | – | – | ✔ |
C | 2.1 | High | None (0.322) | – | – | – | |||
4 | In a research context, data sharing infrastructures should enable children to withdraw consent to continued sharing of their genomic and associated clinical data when possible upon reaching the age of majority | D | 1.8 | High | None (0.177) | – | – | – | ✔ |
F | 2.6 | High | None (0.488) | – | – | – | |||
5 | Parental authorization for ongoing, or future unspecified research should include the provision of information related to existing data governance | RI | 1.6 | High | None (0.711) | 1.5 | High | None (0.45) | ✔ |
D | 1.7 | High | Weak (0.9) | 1.33 | High | None (0.24) | |||
6 | Values conveyed by family, legal guardians or primary care givers should be respected when possible | RI | 1.7 | High | None (0.677) | 1.58 | High | None (0.27) | ✔ |
F | 2.6 | Low | Strong (1.155) | 2.5 | High | None (0.45) | |||
7 | Professionals involved in consent processes related to data sharing and data-intensive research have the responsibility to balance potential benefits and risks. A trained designate should be available to discuss these with parents at the time of consent | D | 1.8 | High | Weak (1.06) | 1.5 | High | None (0.45) | ✔ |
F | 2.4 | Low | None (0.5) | 2.08 | Mod | None (0.81) | |||
8 | The decision to share pediatric genomic and associated clinical data should be supported by an evaluation of realistic risks and benefits | F | 1.5 | High | None (0.5) | – | – | – | ✔ |
C | 1.7 | High | None (0.455) | – | – | – | |||
9 | Duplicative collection of genomic research data involving pediatric patients should be avoided | D | 1.5 | High | None (0.5) | – | – | – | ✔ |
F | 2.4 | High | None (0.488) | – | – | – | |||
10 | Anonymized pediatric data should be made available via publicly accessible databases | D | 2 | High | Strong (1.11) | 2.17 | Low | Strong (1.42) | |
F | 2 | High | None (0.66) | 1.92 | Mod | None (0.81) | |||
11 | Identifiable pediatric genomic and associated clinical data should be coded and made available through a controlled access process | D | 1.6 | High | Strong (1.115) | 1.75 | Mod | Strong (1.48) | |
F | 1.8 | High | Weak (0.844) | 2 | Mod | Weak (0.91) | |||
12 | Providing children and their parents the opportunity to share genomic and associated clinical data is an obligation of those who generate such data | D | 2 | High | Strong (1.11) | 1.67 | Mod | Strong (1.15) | |
F | 2.3 | Low | Strong (1.122) | 2.5 | Low | Strong (1.18) | |||
13 | Incidental (secondary) findings of clinically actionable genomic results should be made available | D | – | – | – | 1.66 | High | None (0.45) | ✔ |
F | – | – | – | 2.33 | High | None (0.7) | |||