Notes for Participants

HKGP is a long-term research project. The Project team needs participants’ medical records at various times to enable them to continue with the genomic data analysis. Therefore, consent forms to join the Project must remain valid even in the unfortunate circumstance that participants lose the ability to make decisions on their own or pass away, so that the Project team can access the relevant participants’ medical records, including information added after the loss of decision-making abilities or death.

Should a participant lose the ability to make decisions on their own or have passed away before receiving their report, the Project team hopes to contact a designated person to inform him/her of the participant’s result.

As HKGP participant, you may choose to provide the contact information of the designated person, so that the Project team can try to contact and inform him/her about your result when necessary (including the Main Findings and Additional Findings report).

If HKGP has any updated information that may influence your decision on whether to continue participating in the Project, the Project team will notify you in time. You may then need to sign a new consent form stating that you have received this pertinent new information.

1. If you have any comments or complaints during your participation in the Project, please contact HKGI:

• Phone: (852) 2185 6700
• Email: enquiry@genomics.org.hk

This Project has been approved by multiple research ethics committees, including the Hospital Authority Central Institution Review Board, The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee, and Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster, to conduct the Project in each of the Partnering Centres (Hong Kong Children’s Hospital, Prince of Wales Hospital and Queen Mary Hospital).

2. If you have any queries about the Project, please call the genetic counsellor(s) of your affiliated Partnering Centre.

3. For any enquiries about the rights of Project participants, please contact the Institutional Review Board or research ethics committee of your affiliated Partnering Centre.

4. Collection of Personal Data

HKGI will access, use and retain participants’ personal data in accordance with the consent form for project participation. Personal data collected will be kept for seven years after the completion of HKGP. Afterwards, the personal data will be deleted.

According to the Personal Data (Privacy) Ordinance, Cap. 486, participants have the right to keep their personal data confidential, including those kept by or related to HKGP, their collection, retention, control, usage (including for analysis or comparison), transfer into or out of Hong Kong, non-disclosure, elimination and/or the right to handle or dispose of in any manner. If participants would like to access/correct any personal data held by HKGI, they can apply by contacting the genetic counsellor in respective Partnering Centre.

In addition, relevant research ethics committees and the regulatory authority(ies) can access data for verification of the research, pursuant to the relevant legal or statutory basis, as the case may be.

For any queries, please contact the Office of the Privacy Commissioner for Personal Data to ask about proper handling of personal data.

Phone: (852) 2827 2827

Fax: (852) 2877 7026

Email: communications@pcpd.org.hk

5. If you wish to apply to access your genomic data, please contact the Project team of your affiliated Partnering Centre. HKGI will process your application according to standard procedures.

6. Will joining HKGP Affect Personal Insurance?

In May 2020, the Hong Kong Federation of Insurers issued the “Best Practice on the Use of Genetic Test Results” (referred to below as the “Best Practice”). Under no circumstances will insurance companies demand any type of genetic test results related to HKGP for underwriting purposes.

For details of the “Best Practice”, please visit the Hong Kong Federation of Insurers website.

7. Genetic Discrimination in the Workplace

According to the Disability Discrimination Ordinance (DDO), Cap. 487, a disability includes one that presently exists, previously existed but no longer exists, may exist in the future, or is imputed to a person. Therefore, congenital genetic conditions and genetic predispositions are included as “disabilities” under the DDO.

An employer must have reasonable grounds and justification to require an employee to provide relevant medical reports. For example, such grounds and justification may include helping the organisation determine if the employee’s disability will preclude him/her from meeting the intrinsic requirements of his/her job, or helping the organisation consider accessible accommodations and facilities. Otherwise, it is illegal for employers, as a form of discrimination against employees, to request or require employees to submit medical information, including genetic and genomic information.

8. Compensation and treatment for injuries caused by participation in HKGP

Participating in HKGP will not expose you to extra risks, so HKGI will not provide compensation nor additional treatment.

9. Termination of Research

Currently, HKGI has no foreseeable plan to terminate the Project.

One of HKGP’s objectives is to drive research in genomic medicine and related fields. After examining the de-identified data generated by the Project, research entities may wish to invite individual participants to join additional research studies, such as clinical trials for drugs.

You can decide if the Project team may contact you in the future and ask if you are open to taking part in other research outside the scope of HKGP. This decision is voluntary and separate from your decision in joining HKGP. Whether you agree to future contact from the team will have no impact on your participation in the Project. HKGI will not transfer your contact information to other research institutions/personnel without your consent.

If you do agree to being contacted about future research studies, HKGI will use the information provided to contact you should the occasion arises. You can then decide whether to participate in further research. If you agree to this option of future contact in the consent form, but later decide to exit HKGP, you will not receive further invitation on research outside the scope of HKGP.

You can contact the Project team of your affiliated Partnering Centre if you want to withdraw from the Project. The genetic counsellor will explain to you in details. When HKGI receives your withdrawal application, an acknowledgement receipt of withdrawal will be sent to you by mail or email.

1.Sample Processing after Withdrawal

When you decide to withdraw from the Project, you may request HKGI to destroy your biological samples (such as blood samples, etc.) and the genetic materials taken from them. If you do not request your samples to be destroyed, HKGI will store your samples with those of other participants until the Project ends, and then dispose them all together.

2.Data Processing after Withdrawal

Withdrawal implies that:

• The Project team will not use your data for any additional analysis or research;
• The Project team will cease using your data for clinical diagnosis and medical care purposes; and
• Qualified research institutions and personnel will not be able to access your de-identified data.

Your genomic and personal data has to be archived for the following reasons:

• Ongoing research studies are using your de-identified data
  • Ongoing research studies refer to research studies that have started but not completed analysing your data before your withdrawal. Qualified research institutions and personnel have accessed and analysed the data via HKGI’s designated platform. To maintain scientific research integrity and consistency, they need to continue using the same set of data. Deleting your data will affect the results of these research projects. However, after your withdrawal, new research studies cannot utilise your data.

• Completed research studies have already used your de-identified data
  • The Project team must safeguard the integrity of the findings of completed research studies. Missing data will affect the credibility of the results.

• Audit purposes (for instance, to provide a record that you have once participated in the Project)
  • To meet the requirements for auditing, HKGI will access minimal information from archived data. This may include your name, date of birth, ID number, address and contact information. Only staff authorised by HKGI can access and use information from archived data. Information used for the audit will be classified as confidential. HKGI will scrutinise and record the use of such data to guard against improper usage.

What are the potential risks of joining HKGP?

1. Process of Providing Samples

• While drawing blood, you may experience bruising, mild discomfort or feeling anxious, which have been reported by a small proportion of individuals who have experienced this procedure previously.
• If it is necessary to collect buccal swab samples, the process may cause mild discomfort or anxiety, as reported by a small proportion of individuals who have experienced this procedure previously.
• If saliva samples are needed, the whole collection process is simple and safe.
• If body tissue samples are needed, the Project team will collect them only when you clinically require a surgery, or from excised tissues after you have had your surgery. Collecting tissues for HKGP will not require additional surgeries nor add risks to your treatment plan.

2. Impact of Report Results

The Project aims to help clinicians understand, diagnose, and address patients’ conditions. However, it is possible that the results from “Whole Genome Sequencing” analysis may not lead to definitive identification of the cause of illness. Even if a cause is identified, it may not immediately result in better treatment options. Therefore, some worry and anxiety may be arisen from the report results.

3. Impact on Family

Each person is unique, but your genome contains some sequences that are shared with other individuals in your bloodline, such as parents, siblings, and children. Therefore, your report results may reveal insights about your family members’ health and genetic risk factors.

Although the thought of sharing these findings might make you and/or your family members uneasy, your family members may actually want to know these results so that they can make their own informed decisions about whether to conduct further tests or follow-up. If potential risk factors are found, HKGI will notify you through the Partnering Centre. Only then will you have to decide if the Project team can disclose the results to your family.

4. Data Security

As mentioned in section three of Project Participation, HKGI will deploy all practical and feasible steps to safeguard the privacy and the security of all participants’ data. All analysis results and personal data will be processed and monitored according to international standards, to guarantee that the data is protected by rigorous confidentiality measures.

However, with rapid technological advancement, it is possible that the de-identification technology could be decoded in the future. Although the Project team will continuously update the security measures to protect participants’ privacy, they cannot eliminate the very minimal chance of a data breach or leak. In case of data breach, HKGI will follow prevailing guidelines from the Office of Privacy Commissioner for Personal Data and inform the affected participants.

If any person/organisation/company deliberately discloses your data, or intentionally identifies you from the de-identified data, HKGI will ban them from using HKGP’s data again. If the breaching actions are illegal, HKGI will report the matter to relevant law enforcement agencies.