PART 2 | 3. This Part applies to all tissue banks. |
| Notification by tissue bank |
4.—(1) For the purposes of section 34(2) of the Act, the notification required to be submitted by a tissue bank must be in the applicable form set out at the relevant website and must contain all of the following information:| (a) | the name of the tissue bank and the address, telephone number and email address at which that tissue bank may be contacted; | | (b) | any other information that is required or specified in the form set out at that website. |
| (2) A tissue bank that has not started any tissue banking activity before 1 November 2019 must submit the notification required by section 34(2) of the Act no later than 30 days before the start of its first tissue banking activity. |
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| Notification of tissue banking activity started before 1 November 2019 |
5.—(1) A tissue bank that has started any tissue banking activity before 1 November 2019 must submit a notification required by section 34(2) of the Act to the Director‑General in the applicable form set out at the relevant website no later than 1 December 2019.(2) The tissue bank must ensure that the notification mentioned in paragraph (1) must contain all of the following information:| (a) | the name of the tissue bank and the address, telephone number and email address at which that tissue bank may be contacted; | | (b) | any other information that is required or specified in the form set out at the relevant website. |
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(3) A tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both; or | | (b) | in any other case, to a fine not exceeding $10,000. |
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| Principal person in charge designated by tissue bank |
6.—(1) Subject to paragraph (2), the principal person in charge designated by the tissue bank under section 35(2)(b) of the Act must be an individual who —| (a) | is ordinarily resident in Singapore; | | (b) | is in the direct employment of, or acting for or by arrangement with, the tissue bank; | | (c) | is principally responsible for the management and conduct of any type of business or tissue banking activities in Singapore of the tissue bank; | | (d) | has the authority to ensure that the tissue bank complies with the Act and these Regulations; and | | (e) | is suitably qualified to perform the duties of a principal person in charge. |
| (2) In addition to paragraph (1), in the case of a tissue bank to whom Part 3 applies, the principal person in charge designated must be a medical practitioner. |
| (3) The principal person in charge designated must at all reasonable times be contactable by the Director‑General for the purposes of the duties and functions of the tissue bank under the Act and these Regulations. |
(4) The tissue bank must notify the Director‑General in the applicable form set out at the relevant website of all the following information:| (a) | the name and designation of the principal person in charge designated; | | (b) | the address, telephone number and email address at which that person may be contacted; | | (c) | any other information relating to that person that is required or specified in that form. |
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(5) A tissue bank who or which contravenes paragraph (4) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both; or | | (b) | in any other case, to a fine not exceeding $10,000. |
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| Change of information and particulars |
7.—(1) Every tissue bank must notify the Director‑General in the applicable form set out at the relevant website of any change to the information and particulars notified under regulation 4, 5 or 6 no later than 30 days after the date the tissue bank or the principal person in charge designated first becomes aware of the change, whichever is the earlier.(2) A tissue bank who or which contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both; or | | (b) | in any other case, to a fine not exceeding $10,000. |
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| Declaration of compliance |
8.—(1) For the purposes of section 36(1) of the Act, the declaration of compliance that a tissue bank is required to submit to the Director‑General under that section for all tissue banking activities conducted under the supervision and control of the tissue bank must be made in the form set out in the First Schedule by the principal person in charge designated.| (2) The Director‑General may modify or amend the form mentioned in paragraph (1) for the purpose of facilitating the submission of that form. |
| (3) The declaration of compliance must be made in writing and submitted to the Director‑General at any time between 1 March and 18 April (both dates inclusive) of every year. |
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| Notification under section 35(3)(a) of Act |
9.—(1) For the purposes of section 35(3)(a) of the Act, a tissue bank must ensure that all relevant information (except for the information specified in paragraph (3)) required under that provision in relation to tissue banking activity conducted under the supervision and control of that tissue bank is —| (a) | recorded; and | | (b) | submitted to the Director‑General as soon as possible and in any event not later than 7 days after the tissue bank or the principal person in charge designated first becomes aware of the information, whichever is the earlier. |
| (2) The relevant information mentioned in paragraph (1) must be submitted to the Director‑General in the applicable form set out at the relevant website. |
(3) For the purposes of section 35(3)(a) of the Act, a tissue bank must ensure that relevant information relating to contraventions in relation to tissue banking activity conducted under the supervision and control of that tissue bank and that did not cause harm to and had no potential to cause harm to any tissue donor, is recorded and submitted to the Director‑General —| (a) | at the same time the declaration of compliance is submitted in accordance with regulation 8(3); and | | (b) | on an annual basis aggregating the information in the applicable form set out at the relevant website. |
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| Notification of serious adverse event |
10.—(1) A person conducting any tissue banking activity carried on or conducted under the supervision and control of a tissue bank must immediately report to that tissue bank any serious adverse event which is associated with that tissue banking activity.| (2) As soon as possible after making the report mentioned in paragraph (1), the person mentioned in that paragraph must submit to the tissue bank a detailed written report with all relevant information. |
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| Notification by tissue bank of serious adverse event |
11.—(1) For the purposes of section 35(3)(b) of the Act, a tissue bank must notify the Director‑General of any serious adverse event which is associated with any tissue banking activity carried on or conducted under its supervision and control.(2) Where the serious adverse event results in death or is life‑threatening, the tissue bank must ensure that ––| (a) | all relevant information about the serious adverse event is recorded; | | (b) | the recorded information on the serious adverse event is submitted to the Director‑General as soon as possible and in any event not later than 7 days after the tissue bank or the principal person in charge designated first becomes aware of the event, whichever is the earlier; and | | (c) | any additional relevant information about the serious adverse event is recorded and submitted to the Director‑General within 8 days after the record is made. |
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(3) Where the serious adverse event does not result in death and is not life‑threatening, the tissue bank must ensure that all relevant information about that event is —| (a) | recorded; and | | (b) | submitted to the Director‑General as soon as possible and in any event not later than 15 days after the tissue bank or the principal person in charge designated first becomes aware of that event, whichever is the earlier. |
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| (4) The notification of the serious adverse event must be submitted to the Director‑General in the applicable form set out at the relevant website. |
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| Notification of untoward occurrence arising from removal of tissue under section 35(3)(c) of Act |
12.—(1) A person conducting any tissue banking activity carried on or conducted under the supervision and control of a tissue bank must immediately report to that tissue bank any untoward occurrence which is associated with that tissue banking activity.| (2) As soon as possible after making the report mentioned in paragraph (1), the person mentioned in that paragraph must submit to the tissue bank a detailed written report with all relevant information. |
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| Notification by tissue bank of untoward occurrence arising from removal of tissue under section 35(3)(c) of Act |
13.—(1) For the purposes of section 35(3)(c) of the Act, a tissue bank must notify the Director‑General of any untoward occurrence which is associated with any tissue banking activity carried on or conducted under its supervision and control.(2) Where the untoward occurrence results in death or is life‑threatening, the tissue bank must ensure that —| (a) | all relevant information about the untoward occurrence is recorded; | | (b) | the recorded information on the untoward occurrence is submitted to the Director‑General as soon as possible and in any event not later than 7 days after the tissue bank or the principal person in charge designated first becomes aware of the occurrence, whichever is the earlier; and | | (c) | any additional relevant information about the untoward occurrence is recorded and submitted to the Director‑General within 8 days after the record is made. |
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(3) Where the untoward occurrence does not result in death and is not life‑threatening, the tissue bank must ensure that all relevant information about that event is —| (a) | recorded; and | | (b) | submitted to the Director‑General as soon as possible and in any event not later than 15 days after the tissue bank or the principal person in charge designated first becomes aware of that event, whichever is the earlier. |
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| (4) A notification of an untoward occurrence must be submitted to the Director‑General in the applicable form set out at the relevant website. |
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| Notification of cessation of tissue bank’s operations |
14.—(1) A tissue bank must notify the Director‑General of its intention to cease operating as a tissue bank as soon as possible and in any event not less than 30 days before the cessation of operation or any shorter period that the Director‑General may allow in any particular case.(2) The tissue bank must ensure that the notification required under paragraph (1) is accompanied by —| (a) | a plan for the manner of disposal of the human tissues held by or in the possession of the tissue bank and information related to those tissues; | | (b) | where the plan mentioned in sub‑paragraph (a) involves the transfer of any human tissue or information related to the tissue to another tissue bank (called in this regulation the receiving bank) —| (i) | the name, address and contact particulars of the receiving bank; and | | (ii) | documentary evidence provided by the receiving bank (such as but not limited to a letter of undertaking) to the effect that the receiving bank will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor; |
| | (c) | the date of the cessation of operation of the tissue bank and the reason for the cessation; and | | (d) | any other information that the Director‑General may in any particular case require. |
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| (3) The notification and the information mentioned in paragraphs (1) and (2) must be submitted to the Director‑General in the applicable form set out at the relevant website. |
(4) A tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both; or | | (b) | in any other case, to a fine not exceeding $10,000. |
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| Requirements before tissue is removed, supplied or exported |
15.—(1) Before any tissue which is individually‑identifiable may be removed from the supervision and control of, or supplied by, a tissue bank to any person for use in research carried out by that person in circumstances other than in paragraph (4), the tissue bank must ensure that —| (a) | an institutional review board has approved or exempted from review the proposed research that the tissue would be used for; and | | (b) | there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor. |
(2) Before any non‑identifiable tissue may be removed from the supervision and control of or supplied by a tissue bank to any person for use in research carried out by that person, the tissue bank must ensure that —| (a) | either an institutional review board has approved or exempted from review the proposed research that the tissue would be used for or the tissue bank is satisfied that there is scientific merit for the proposed research; and | | (b) | there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor. |
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| (3) Paragraph (2) does not apply where the non‑identifiable tissue under a tissue bank’s supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore for use in research. |
(4) Before any individually‑identifiable tissue under a tissue bank’s supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore, the tissue bank must ensure that —| (a) | appropriate consent has been obtained from the donor for the export or removal, as the case may be; and | | (b) | there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor. |
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| Protection of confidentiality of donor’s information |
16.—(1) Every tissue bank must establish a system comprising reasonable measures necessary to protect the confidentiality of information relating to the donor of each tissue under the supervision and control of the tissue bank and to maintain the donor’s privacy.(2) A tissue bank who or which contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both; or | | (b) | in any other case, to a fine not exceeding $10,000. |
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| Tracking of consent and integrity of records |
17. Every tissue bank must establish a system to ensure —| (a) | that every donor’s consent in relation to each tissue under the supervision and control of the tissue bank is accurately tracked; and | | (b) | the integrity of records of the consent and other information relating to the donor. |
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| Safety and welfare of donors |
18.—(1) Every tissue bank, who or which is involved in the removal of tissue from tissue donors for use in research, must establish a system to ensure the safety and welfare of the tissue donors.(2) The tissue bank must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the tissue donors:| (a) | the qualifications of and training to be received by the personnel involved in the removal of tissue; | | (b) | the measures to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any tissue; | | (c) | the management of quality control and maintenance of instruments and equipment used for the removal of tissue. |
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(3) A tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —| (a) | in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or | | (b) | in any other case, to a fine not exceeding $20,000. |
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| Policy on incidental findings |
19. Every tissue bank must —| (a) | formulate a policy on whether or not the tissue donor should be re‑identified and informed in the case of an incidental finding in relation to a tissue; and | | (b) | inform all donors and recipients of every tissue received by the tissue bank on or after 1 November 2019 —| (i) | of the details of the policy mentioned in paragraph (a); and | | (ii) | if the policy provides for the donor to be re‑identified and informed in the case of an incidental finding, whether the donor has expressed a wish to be re‑identified and informed. |
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