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provides options for participants to receive secondary findings or to provide contact information for
participation in future research outside the scope of HKGP. For participants who consented to receive
secondary findings, HKGP will return pathogenic/likely pathogenic variants in a well-defined list of genes
that are in line with the international practice. Thirteen genes are currently included in the analysis and the
reporting approach is age-dependent [Table 2]. While the gene list and approach will be reviewed
periodically, participants are informed of the scope and practice during the consent process and have access
to the gene list through our website.

Apart from the consent form, two versions of information booklets and 11 videos are produced to provide
detailed and step-by-step information for potential participants [Figure 3]. Since the potential participants
are from a wide age range, including adults, teenagers, and children, the entire content is presented in age-
appropriate and colloquial dialects and enriched with coloured infographics and animated cartoons to
facilitate easy understanding of informed consent.

As emphasised, public trust and confidence in genomic testing are vital of the success of any large-scale
genomic project. Background of the Project, recruitment information and consent materials can be easily
accessed via HKGP website. This also helps set the inaugural move in enhancing public literacy and
promoting awareness of genomic medicine in Hong Kong.

Three-tier informed consent process
HKGP recruits participants of all ages and different versions of consent forms are formulated to customise
their needs. Like any research involving child participants, their parent or legal guardian is involved in the
consent process and will provide written consent on the child’s behalf as a proxy. While obtaining assent is a
universal aim in both clinical and research consent, there is no single practice internationally. The concept
of assent and its application varied in different countries, ranging from the most paternalistic approach of
adhering strictly to legal provisions to the most liberal approach of respecting child/young participants’
wishes as much as possible.

A unique three-tier model of informed consent was designed and implemented in the HKGP after thorough
discussions at EAC [Table 3]. The model is adopted to delineate the consent and assent rationale to balance
the paternalistic and liberal approaches in the international arena. In Hong Kong, the legal age is 18 years
old; therefore, adult participants aged 18 or above would sign the consent form themselves. Participants
aged 16 and 17 would co-sign their consent form with parents/legal guardians. This approach aims at
recognising and maximising the autonomy and best interests of adolescents who have sufficient capacity to
understand the Project entirely. If there is any difference in opinions between the participants and their
parents/legal guardians, further discussion would be encouraged, and the participants would not be
recruited. For participants aged below 16, their consent forms would be signed by parents/legal guardians.
Verbal assent would be taken wherever possible, in accordance with the child participant’s level of
understanding. When child participants reach legal age, a formal re-consent process will be conducted.

The entire consent, pre-test counselling, and withdrawal process (if applicable) of HKGP are based on this
three-tier model, with an emphasis on open, pro-active, and respectful engagement of all participants about
their involvement in the Project in an age-appropriate, humane, and ethical manner.

Needs, challenges, and aspirations for developing the genetic counselling profession in Hong Kong
The previous section depicted the importance of informed consent and pre-test genetic counselling as the
first step of patient engagement of HKGP. The process is performed by genetic counsellors specifically hired