Page 20 - Read Online

Page 14 Chu et al. J Transl Genet Genom 2022;6:290-303 https://dx.doi.org/10.20517/jtgg.2022.02

possible. The findings were highly valued and shaped the current structure of the informed consent and
patient recruitment process, publicity, and public engagement strategies of the Project.

For genomic medicine to be widely adopted, there is also a need for public engagement in the areas of
science and medicine to improve genomic literacy and foster public support. The Project provides a good
opportunity to enhance the public’s understanding of the benefits and limitations of genomic medicine and
genome sequencing on healthcare decisions, as well as relevant ethical and privacy standards. To
complement and promote the launch of HKGP, a dedicated project website with user-friendly information,
videos, and publications on genomic medicine are developed to draw public’s interest in genomics and
enhance genomic literacy (Available from: https://hkgp.org/en/). With the governance of its
Communications and Education Committee [Figure 1], HKGI will continue to do pulse checks on all public
engagement and awareness strategies adopted by the Project.

Other than project marketing and promotion strategies to manage public opinions, high-level of
transparency, clear, and continuous communication between healthcare professionals and patients is a
crucial pillar of building public trust and credibility . One major priority in the implementation of HKGP
[23]
is the design of a patient-focused and ethical consent protocol. A truly thorough “informed consent”
practice for complicated WGS testing must be done in a thorough, colloquial, non-directional, and humane
manner.

The thorough process in developing a patient-focused consent protocol
In the era of genomic sequencing, the models of consent have stretched the traditional approaches as a vast
amount of genetic information can be obtained from a single test. The expanded scope of testing puts
pressure on the width and depth of pre-test discussion on several emerging areas, including but not limited
to genomic data handling and privacy, uncertain results, unexpected or secondary findings and the
associated psychosocial and familial impact. There is still a lack of consensus in the genetic community
about the standard constitution of informed consent in genomic settings owing to its complexity.

During the design process of HKGP consent protocol, consent protocols of other large-scale genomic
projects such as the 100,000 Genomes Project, the latest consent policy and consent clauses for genomic
research from the Global Alliance for Genomics and Health (GA4GH) were referenced, with the
understanding that these frameworks have considered the opinions of the professionals and public [24-27] . To
address the specific project details of HKGP, the Ethics Advisory Committee (EAC) [Figure 1] of HKGI
advises on ethical issues in relation to the design and implementation, including the endorsement of the
consent protocol of HKGP. The formation of EAC comprises external experts and professionals from
diverse backgrounds to offer crucial perspectives on relevant ethical decisions, including bioethicists,
lawyers, patient group representatives, and clinical geneticists. Opinions from the participating local bodies,
including the Equal Opportunities Commission, Privacy Commission for Personal Data, and legal advisers,
are gathered in addition to comments from the EAC to ensure concerns from other stakeholders are well-
addressed before the submission to the Institutional Review Boards (IRB).

One of the challenges of achieving informed consent for genomic sequencing is often related to the
[28]
subjective and poorly defined line of adequate information and comprehension . With an aim to meet the
specific needs of individuals and facilitate the consent process, the consent materials of HKGP adopted a
colloquial and well-organised presentation according to carefully designed sequences and levels of detail.
The consent form seeks broad consent for using participants’ donated samples, collecting clinical
information for genetic analysis, and sharing de-identified data for approved research studies. It also