Human Biomedical Research Regulations 2017

For the purposes of section 23(1)(a) of the Act, the notification by the research institution must be submitted to the Director‑General in the applicable form set out at the relevant website and must contain all of the following information:

A research institution, that has not commenced any research before 1 November 2017, must submit the notification required by section 23(1)(a) of the Act, no later than 30 days before the commencement of its first human biomedical research.

A research institution that has started any research before 1 November 2017 must submit a notification to the Director‑General in the applicable form set out at the relevant website no later than 1 December 2017.

The notification mentioned in paragraph (1) must contain all of the following information:

A research institution who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —

The principal person in charge designated by the research institution under section 23(2)(b) of the Act must be an individual (however described by name) who —

The principal person in charge must at all reasonable times be contactable by the Director‑General for the purposes of the duties and functions of the research institution under the Act and these Regulations.

The research institution must notify the Director‑General in the applicable form set out at the relevant website of the name and designation of the principal person in charge, the address, telephone number and email address at which that person may be contacted and any other information relating to that person that is required or specified in that form.

A research institution who or which contravenes paragraph (3) shall be guilty of an offence and shall be liable on conviction —

Every research institution 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 3, 4 or 5 no later than 30 days after the date the institution or the principal person in charge designated by the institution first becomes aware of the change, whichever is the earlier.

A research institution who or which contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction —

For the purposes of section 24(1) of the Act, the declaration of compliance that a research institution is required to submit to the Director‑General under that section for all research conducted under the supervision and control of the research institution must be made by the principal person in charge designated by the institution in the form specified in the First Schedule.

The Director‑General may modify or amend the form mentioned in paragraph (1) for the purpose of facilitating the submission of that form.

The declaration of compliance must be made in writing and submitted to the Director‑General on a date between 1 March and 18 April (both dates inclusive) of every year.

For the purposes of section 23(3)(a) of the Act, a research institution must ensure that all relevant information (except for the information specified in paragraph (3)) required under that paragraph in relation to human biomedical research conducted under the supervision and control of that research institution is —

The notification of the relevant information mentioned in paragraph (1) must be made in the applicable form set out at the relevant website and submitted to the Director‑General.

For the purposes of section 23(3)(a) of the Act, a research institution must ensure that relevant information relating to contraventions in relation to human biomedical research conducted under the supervision and control of that research institution and that did not cause harm to and had no potential to cause harm to any research subject is recorded and submitted to the Director‑General —

A researcher conducting research must immediately report to his or her research institution any serious adverse event —

As soon as possible after making the report mentioned in paragraph (1), the researcher must submit to the research institution a detailed written report on the serious adverse event.

Where the relevant institutional review board requires any serious adverse event to be reported to the board, the person required by the board to do so must make the report to the board in accordance with the board’s requirements.

For the purposes of section 23(3)(b) of the Act and subject to paragraph (5), a research institution conducting research must ensure that paragraphs (2), (3) and (4) are complied with in relation to any unexpected serious adverse event (called in this regulation the unexpected event) —

Where the unexpected event results in death or is life‑threatening, the research institution must ensure that —

Where the unexpected event does not result in death and is not life-threatening, the research institution must ensure that all relevant information about the unexpected event is —

The notification of the unexpected event must be made in the applicable form set out at the relevant website and submitted to the Director‑General.

A research institution is exempted from compliance with paragraphs (1), (2) and (3) where the institution is, with respect to substantially the same event, required to report and has reported —

A research institution must notify the Director‑General of its intention to cease operating as a research institution 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.

The research institution must ensure that the notification required under paragraph (1) is accompanied by —

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.

A research institution who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —

Every research institution must establish a system to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any human biological material used in transplantational human biomedical research conducted under the supervision and control of that research institution.

The research institution must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the human biological material used in transplantational human biomedical research conducted under the supervision and control of the research institution that is or may be contaminated or infected in any other way:

A research institution who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —

Every research institution that is involved in the removal of human biological material from research subjects for use in research, must establish a system to ensure the safety and welfare of the research subjects.

The research institution must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the research subjects:

A research institution who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —

A research institution must appoint in writing an institutional review board in accordance with this Part.

Every institutional review board must comprise at least 5 individuals, of whom —

A research institution must not appoint or re‑appoint an individual as a member of the institutional review board unless that individual has furnished to the research institution a declaration that he or she is not disqualified under the Act or these Regulations from acting as a member.

The research institution may appoint one or more secretaries to the institutional review board who need not be a member.

The Director‑General may, on a written application by the research institution, waive any requirement mentioned in paragraph (2)(a) in respect of any particular chairperson.

For the purposes of paragraph (2), an individual is treated as external in relation to a research institution if the individual is not a researcher of, not employed by and not in a commercial relationship with the research institution.

Every individual appointed as a member of an institutional review board —

The Director‑General may, on a written application by the research institution, waive any requirement mentioned in paragraph (1) in respect of any particular person.

Every member of an institutional review board holds office for a term (not exceeding 5 years) determined by the research institution and will be eligible for re-appointment.

Any member of an institutional review board may resign from his or her appointment at any time by giving written notice to the chairperson of the board.

Every research institution must notify the Director‑General of every institutional review board appointed and of all the following information in respect of each board no later than 30 days after the date of appointment of the board:

Every research institution must notify the Director‑General in the applicable form set out at the relevant website no later than 30 days after the occurrence of any change in the chairperson of an institutional review board which it had appointed.

Any person who contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.

For the purposes of section 18(2)(c) of the Act, an individual is disqualified from being a member of an institutional review board if —

The Director‑General may make a disqualification order mentioned in section 18(2)(d) of the Act disqualifying any individual from being a member of every institutional review board if the Director‑General is satisfied that the individual —

The Director‑General must publish every disqualification order made under paragraph (2) or a list of names and other particulars of the individuals disqualified at the relevant website or in any other manner that the Director‑General may determine.

The Director‑General must take reasonable steps to ensure that the individual disqualified, the institutional review board of whom that individual was a member and the research institution that appointed the institutional review board are informed in writing of the disqualification order.

To avoid doubt, any individual who is aggrieved by an order of the Director‑General under paragraph (2) may appeal to the Minister under section 54 of the Act.

An individual who is the subject of a disqualification order may apply to the Director‑General for the order to be revoked.

On receipt of an application under paragraph (1), the Director‑General may, after considering all relevant circumstances, revoke the disqualification order where the basis on which it was made no longer applies, subject to any terms and conditions that the Director‑General thinks fit to impose.

In determining the terms and conditions to be imposed under paragraph (2), the Director‑General must have regard to —

No application to revoke a disqualification order under paragraph (1) can be made —

The Director‑General must publish every revocation of the disqualification order made under paragraph (2) or a list of names and other particulars of the individuals whose disqualification have been revoked, at the relevant website or in any other manner that the Director‑General may determine.

The quorum at all meetings of an institutional review board is 5 members, of whom —

No business may be transacted at any meeting unless a quorum is present.

A meeting of an institutional review board may be held —

A member of an institutional review board participating in a meeting as permitted under paragraph (3)(b)(i) is taken to be present at the meeting.

The fact that a meeting of an institutional review board was held as permitted under paragraph (3)(b)(i) must be recorded in writing in the minutes or other record of the meeting.

The chairperson of an institutional review board must preside at meetings of the board, and if the chairperson is absent from any meeting or part of a meeting, the member (who need not be a medical practitioner) appointed by the chairperson will preside at that meeting or part of the meeting.

A decision at a meeting of the institutional review board is adopted by a simple majority of the members present and voting and to avoid doubt, in the case of an equality of votes, the research proposal is deemed to have been rejected.

For the purposes of the institutional review board’s proceedings, papers (including declarations, disclosures and proposals to be circulated before the meeting and decisions after the meeting) may be circulated among members or delivered to the secretary of the board by hand or facsimile or electronic transmission of the information in the papers concerned.

Subject to the provisions of the Act and this Part, each institutional review board may regulate its own processes and procedures.

For the purposes of paragraph (1), an individual is treated as external in relation to a research institution if the individual is not a researcher of, not employed by and not in a commercial relationship with the research institution.

For the purposes of section 19(1) of the Act, a member of an institutional review board must declare to the board in writing, the nature and extent of all conflicts of interest or potential conflicts of interest in relation to a matter under consideration by the board arising from —

Where the institutional review board is satisfied that the member (called in this regulation a conflicted member) is unable to carry out his or her duties properly and effectively because of any conflict of interests or potential conflict of interests mentioned in section 19 of the Act or this regulation in relation to a matter under consideration by the board, the conflicted member —

Despite paragraph (2), a conflicted member may, with the permission of the institutional review board, provide any information that the board requires, but must not vote on any decision with respect to that matter.

A declaration under paragraph (1), and the decision of the institutional review board in regard to the participation of the conflicted member in the discussions and decisions of the board under paragraphs (2) and (3), must be recorded in the minutes of the meeting of the board.

For the purposes of paragraph (1), a member of an institutional review board is not regarded as being in a position of conflict of interests by reason only that the member is an employee of the research institution which appointed the board.

The chairperson of an institutional review board or a member authorised under section 17(2) of the Act (called in this regulation the authorised member) may, pursuant to section 17(2)(b) of the Act, decide that a research proposal or a class of research proposals may be reviewed through an expedited process if the proposal or class of proposals involves no more than minimal risk to the research subjects.

For the purposes of section 17(2) of the Act, the following criteria may be considered by the chairperson of the institutional review board or the authorised member for expedited review:

To avoid doubt, no proposal for restricted human biomedical research may be reviewed through an expedited process.

The institutional review board must ensure that the operational procedures on the expedited review of research proposals must be clearly documented including but not limited to the authorisation of a member to carry out the duties of the chairperson pursuant to section 17(2) of the Act and the method of reporting and ratification of decisions to the board.

The chairperson of an institutional review board or the authorised member must inform all the members of all research proposals that have been reviewed through an expedited process.

Subject to paragraph (2), the chairperson of an institutional review board or a member authorised under section 17(2) of the Act (called in this regulation the authorised member) may, pursuant to section 17(2)(a) of the Act, exempt a research proposal from review by the board if the chairperson or authorised member is satisfied that the proposal involves less than minimal risk to the research subjects.

To avoid doubt, no proposal for restricted human biomedical research may be exempted from review.

A researcher must submit to the chairperson of the institutional review board or the authorised member every application for exemption from review of a research proposal for determination by the chairperson or the authorised member.

The chairperson of an institutional review board or the authorised member must inform all the members of all research proposals that have been exempted from review.

The institutional review board must ensure that the operational procedures on the exemption of research proposals from review by the board mentioned in paragraph (1) must be clearly documented including but not limited to the authorisation of a member to carry out the duties of the chairperson pursuant to section 17(2) of the Act and the method of reporting and ratification of decisions to the board.

Every chairperson of an institutional review board must ensure that all documentation and correspondence of a board in areas other than the review of the research proposal, such as the assessment of the qualifications of a researcher, must be dated, filed and archived according to standard written procedures for the board.

Every chairperson of an institutional review board must ensure that all correspondence and other communications in relation to the review of the research proposal and other proceedings of the board, must be fully documented in writing.

Without limiting paragraphs (1) and (2), every chairperson of an institutional review board must ensure that all of the following documents, information and particulars be recorded and documented:

For the purposes of section 6(d) of the Act, any appropriate consent must be taken in the presence of a witness —

To avoid doubt, the witness may be a member of the team carrying out the research of which the individual giving the consent is a research subject.

The witness must take reasonable steps to ascertain —

Every notification, form, document, declaration or other information that is required to be submitted to the Director‑General under these Regulations must —

The Director‑General may modify or amend a form mentioned in paragraph (1) in order to facilitate the submission of that form.

The fees specified in the Second Schedule are payable by the research institution in respect of the matters set out in that Schedule.

A fee specified in the Second Schedule must be paid when the notification or declaration (as the case may be) is submitted to the Director‑General.

The Director‑General may, in any particular case, waive or refund the whole or any part of any fee payable or paid under paragraph (1).