FEEDBACK ON THE HUMAN BIOMEDICAL RESEARCH BILL
Thank you for providing your feedback in this form. Your input is important to help shape the regulatory frameworks for human biomedical research and human tissue for use in research, which will be enacted in the Human
Biomedical Research Bill.
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A. Regulatory Framework for Human Biomedical Research
Is the proposed regulatory framework for human biomedical research reasonable in its requirements and controls?
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If yes, what is useful or positive about the framework?
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If no, what is not reasonable or not likely to be effective?
Please feel free to provide your overall impression of the proposed framework.
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B. Suggested Improvements to the Human Biomedical Research Framework
How can the proposed human biomedical research framework be improved to :
1) regulate human biomedical research, to safeguard the safety and welfare of human research subjects;
2) regulate the conduct of sensitive human biomedical research (“restricted research” in the consultation materials), such as research involving human eggs, human embryos or human-animal combination embryos (distinct from the risk posed to human research subjects)?
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C. Regulatory Framework for Human Tissue for Use in Research
Is the proposed regulatory framework for human tissue reasonable in its requirements and controls?
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If yes, what is useful or positive about the proposed framework?
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If no, what is not reasonable or not likely to be effective?
Please feel free to provide your overall impression of the proposed framework.
D. Suggested Improvements to the Human Tissue Framework
How can the proposed human tissue framework be improved to :
1) protect the safety and welfare of tissue donors;
2) prohibit commercial trading of human tissue effectively;
3) ensure human tissues used in biomedical research are obtained only through altruistic donations.
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E. Specific Areas
1) What is your view regarding the section on anonymisation, where a 3 rd holds the ‘key’ to identifying information (page 5 of the pictorial guide):
party a) Can the ‘key’ be held by the same organisation but by a different department from the research team? For example, within the same organisation,
Department A conducts the research while Department B holds the ‘key’. If yes, why? If no, why not? b) Should the ‘key’ be held by a different organisation? For example,
Organisation A conducts the research while Organisation B (unrelated to
Organisation A) holds the ‘key’. This option is aligned with the framework for personal data in the Personal Data Protection Act (PDPA). If yes, why? If no, why not?
2) Are the controls protecting minors and the mentally incapacitated sufficient? In particular, do you think a sufficienc y of understanding threshold for a minor’s consent is adequate, or should we apply section 5 of the Mental Capacity Act’s test for decision-making capacity (see Annex A) – that is, the ability to understand, retain, use or weigh information as part of the decision-making process and communicate a decision? Do you have further suggestions?
3) Should health information data/tissues be permanently made non-identifiable or should there be a means to reverse de-identification? Why or why not?
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4) Should the research subject be informed of clinically significant incidental findings? Should this be a rule? If yes, why? If no, why not?
5) Should we additionally prohibit non-consensual genetic testing in relation to deidentified tissue used in human biomedical research? Or, more specifically, nonconsensual whole-genome sequencing?
F. Any Other Feedback
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Annex A
Section 5 of the Mental Capacity Act
Inability to make decisions
5.
(1) For the purposes of section 4 , a person is unable to make a decision for himself if he is unable — a) to understand the information relevant to the decision; b) to retain that information; c) to use or weigh that information as part of the process of making the decision; or d) to communicate his decision (whether by talking, using sign language or any other means).
(2) A person is not to be regarded as unable to understand the information relevant to a decision if he is able to understand an explanation of it given to him in a way that is appropriate to his circumstances (using simple language, visual aids or any other means).
(3) The fact that a person is able to retain the information relevant to a decision for a short period only does not prevent him from being regarded as able to make the decision.
(4) The information relevant to a decision includes information about the reasonably foreseeable consequences of — a) deciding one way or another; or b) failing to make the decision.
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