Clause 26

An authorised officer may, at any time and without warrant, enter, inspect and search any premises or conveyance, and the facilities in the premises or conveyance, that are being used, or that the authorised officer has reasonable cause to believe are being used, for the conduct of any human biomedical research or tissue banking activity, for the purpose of —

investigating whether any provision of this Act has been or is being contravened;

investigating any complaint or matter in respect of which the Chief Executive may take action under section 42;

assessing whether the practices and procedures of a research institution, a researcher or an institutional review board in relation to any human biomedical research are in compliance with this Act, the regulations made under this Act and any applicable code issued under section 40; and

assessing whether the practices and procedures of a tissue bank in relation to any tissue banking activity are in compliance with this Act, the regulations made under this Act and any applicable code issued under section 40.

For the purposes of subsection (1), an authorised officer may —

inspect and make copies of or take extracts from, or require the occupier or any person having the management or control of, the premises or conveyance to provide copies of or extracts from, any book, document, record or electronic material;

inspect and make copies of or take extracts from, or require the occupier or any person having the management or control of, the premises or conveyance to provide copies of or extracts from, any medical record of any person who has been or who is being treated or examined at the premises or conveyance, even though the prior consent of such person has not been obtained;

inspect any apparatus, appliance, equipment or instrument used or found in the premises or conveyance;

inspect any test or procedure relating to any human biomedical research that has been or is being conducted in the premises or conveyance;

inspect, test, examine, remove and detain any biological material or organism or any product of human biomedical research found in the premises or conveyance;

inspect, test, examine and remove any container, article and other thing that the authorised officer reasonably believes to contain or to have contained any biological material or organism or any product of human biomedical research that has been or is being conducted in the premises or conveyance;

make a still or moving image or recording of the premises or conveyance and any individual, activity or thing in or on the premises or conveyance;

take into or onto the premises or conveyance any equipment and material that the authorised officer requires for the purpose of exercising any power under this Act in relation to the premises or conveyance; and

operate electronic equipment in or on the premises or conveyance.

The power under subsection (2)(i) to operate electronic equipment in or on any premises or conveyance includes the power —

to use a disk, tape or other storage device that is in or on the premises or conveyance and can be used with the equipment or in association with the equipment;

to operate electronic equipment in or on the premises or conveyance to put the relevant data in documentary form and remove the documents so produced from the premises or conveyance; and

to operate electronic equipment in or on the premises or conveyance to transfer the relevant data to a disk, tape or other storage device that —

is brought to the premises or conveyance for the exercise of the power; or

is in or on the premises or conveyance and the use of which for that purpose has been agreed in writing by the occupier or any person having the management or control of, the premises or conveyance,and to remove the disk, tape or other storage device from those premises or that conveyance.

In the exercise of the powers and duties under this section, an authorised officer may be accompanied and assisted by an individual appointed by the Chief Executive under section 4(6) for the purposes of facilitating the exercise of such powers and duties.

An authorised officer may seize from any premises or conveyance —

any biological material or organism or any product of human biomedical research; or

any book, document, record, apparatus, appliance, equipment or instrument,which the authorised officer reasonably believes to be the subject matter of an offence under this Act or a contravention of or non‑compliance with a provision under this Act, or to be connected with the commission of such an offence, contravention or non‑compliance.

Where any thing has been seized under subsection (5) —

the authorised officer who seized the thing must give written notice of the seizure to the person from whom it was seized, if the name and address of that person are known;

the thing may be kept or stored in the premises or conveyance where it was seized or may, at the authorised officer’s direction, be removed to any other place to be kept or stored; and

the authorised officer may —

mark, seal or label the thing in such manner as the officer thinks fit for the purpose of indicating that it is under detention; and

lock or seal the whole or part of the premises, place or conveyance in which the thing is being detained.

Any person who, without the authorised officer’s permission —

interferes or tampers with, removes or otherwise disposes of the thing;

alters, counterfeits, defaces, destroys, erases or removes any mark, seal or label placed by the authorised officer under subsection (6)(c)(i); or

opens, breaks or otherwise tampers with the lock or seal placed by the authorised officer on the whole or part of any premises, place or conveyance under subsection (6)(c)(ii),shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.

Any individual who is present in any premises or conveyance mentioned in subsection (1) must render all necessary assistance and cooperation to the authorised officer as are necessary for an entry, inspection, investigation or otherwise for the exercise of his or her powers under this Act in relation to those premises or conveyance.

An authorised officer may —

require any person —

to provide any information within his or her knowledge; or

to produce any thing within his or her possession for inspection by the authorised officer and make copies of, or to provide the authorised officer with copies of, the thing;

examine orally any person supposed to be acquainted with the facts and circumstances of any serious adverse event, contravention or suspected contravention, or related safety issues with respect to any matter under this Act, and must —

reduce to writing any statement made by the person so examined;

read the statement over to the person so examined; and

require the person so examined to sign the statement, after correction, if any; and

require, by written order, the attendance before the authorised officer of any person, being within the limits of Singapore, who, from information given or otherwise, appears to be acquainted with the facts and circumstances of matters under this Act, and that person must attend as so required.

The power under subsection (9)(a) to require a person to provide any information or thing includes the power —

to require that person, or any individual who is or was an officer or employee of the person, to provide an explanation of the information or thing;

if the information or thing is not provided, to require that person to state, to the best of the knowledge and belief of that person, where it is;

if the information or thing is recorded otherwise than in legible form, to require the information or thing to be made available to the authorised officer in legible form; and

if the information or thing is stored in a computer or other electronic device, and the person or individual is reasonably suspected to have knowledge of or access to any username, password or other authentication information required to gain access to the information or thing, to require the person or individual to provide assistance (including but not limited to providing any username, password or other authentication information) to gain access to the computer or electronic device and the information or thing in the computer or electronic device.

A person examined under this section must state truly the facts and circumstances with which the person is acquainted, except only that the person need not say anything that might expose the person to a criminal charge, penalty or forfeiture.

An authorised officer is entitled without payment to keep any information or thing, or any copy of or extract from any information or thing, provided to the authorised officer under subsection (9)(a).

In this section, “thing” includes any book, document, record, electronic material or article.Powers of auxiliary authorised officers45A.—

An auxiliary authorised officer may, during normal business hours, enter and inspect any premises or conveyance, and the facilities in the premises or conveyance, that are being used, or that the auxiliary authorised officer has reasonable cause to believe are being used, for the conduct of any human biomedical research or tissue banking activity, for the purpose of —

determining any person’s compliance with this Act;

investigating any complaint or matter in respect of which the Chief Executive may take action under section 42;

assessing whether the practices and procedures of a research institution, a researcher or an institutional review board in relation to any human biomedical research are in compliance with this Act, the regulations made under this Act and any applicable code issued under section 40; and

assessing whether the practices and procedures of a tissue bank in relation to any tissue banking activity are in compliance with this Act, the regulations made under this Act and any applicable code issued under section 40.

For the purposes of subsection (1), an auxiliary authorised officer may —

inspect and make copies of or take extracts from, or require the occupier or any person having the management or control of, the premises or conveyance to provide copies of or extracts from, any book, document, record or electronic material, but not any book, document, record or electronic material that is a medical record;

inspect any apparatus, appliance, equipment or instrument used or found in the premises or conveyance;

inspect any test or procedure relating to any human biomedical research that has been or is being conducted in the premises or conveyance;

inspect any biological material or organism or any product of human biomedical research found in the premises or conveyance;

inspect any container, article and other thing that the auxiliary authorised officer reasonably believes to contain or to have contained any biological material or organism or any product of human biomedical research that has been or is being conducted in the premises or conveyance;

make a still or moving image or recording of the premises or conveyance and any individual, activity or thing in or on the premises or conveyance;

take into or onto the premises or conveyance any equipment and material that the auxiliary authorised officer requires for the purpose of exercising any power under this Act in relation to the premises or conveyance; and

operate electronic equipment in or on the premises or conveyance.

The power under subsection (2)(h) to operate electronic equipment in or on any premises or conveyance includes the power —

to use a disk, tape or other storage device that is in or on the premises or conveyance and can be used with the equipment or in association with the equipment;

to operate electronic equipment in or on the premises or conveyance to put the relevant data (but not any data that is a medical record) in documentary form and remove the documents so produced from the premises or conveyance; and

to operate electronic equipment in or on the premises or conveyance to transfer the relevant data (but not any data that is a medical record) to a disk, tape or other storage device that —

is brought to the premises or conveyance for the exercise of the power; or

is in or on the premises or conveyance and the use of which for that purpose has been agreed in writing by the occupier or any person having the management or control of, the premises or conveyance,and to remove the disk, tape or other storage device from those premises or that conveyance.

In the exercise of the powers and duties under this section, an auxiliary authorised officer may be accompanied and assisted by an individual appointed by the Chief Executive under section 4(6) for the purposes of facilitating the exercise of such powers and duties.

Any individual who is present at any premises or conveyance mentioned in subsection (1) must render all necessary assistance and cooperation to an auxiliary authorised officer as are necessary for an entry or inspection or otherwise for the exercise of his or her powers under this Act in relation to those premises or that conveyance.

An auxiliary authorised officer, may by written notice, require any person to provide, within a reasonable period or at the time or frequency, and in the form or manner, specified in the notice, any information or thing for a purpose mentioned in subsection (1)(a) to (d).

An auxiliary authorised officer is entitled without payment to keep any information or thing, or any copy of or extract from any information or thing, provided to the auxiliary authorised officer under subsection (6).

In this section, “thing” includes any book, document, record, electronic material or article.Offence of obstructing, etc., authorised officer or auxiliary authorised officer in exercise of powers, etc.45B.—

A person who —

refuses to give access to, or obstructs, hinders, impedes or delays, an authorised officer or auxiliary authorised officer in the exercise of any power under this Part;

without reasonable excuse, does not comply with any order or requirement under section 45(2)(a) or (b) or (9) or 45A(2)(a) or (6), or with section 45(8) or 45A(5); or

refuses to be examined under section 45(9)(b) or does not attend before an authorised officer as required under section 45(9)(c),shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.

For the purposes of subsection (1)(b), it is a reasonable excuse for a person to refuse or fail to provide any information, provide a copy of or extract from any book, document, record, electronic material, or produce any thing or answer any question if doing so might tend to incriminate that person.”.