CONTROL OF CLINICAL TRIALS ACT, 1987

AN ACT TO PROVIDE FOR CONTROL OVER THE ADMINISTRATION OF ONE OR MORE SUBSTANCES OR PREPARATIONS TO PERSONS FOR THE PURPOSE OF ASCERTAINING THE EFFECTS (INCLUDING KINETIC EFFECTS) OF THE ADMINISTRATION OF SUCH SUBSTANCES OR PREPARATIONS ON THOSE PERSONS WHERE SUCH ADMINISTRATION MAY HAVE A PHARMACOLOGICAL OR HARMFUL EFFECT, TO PROVIDE FOR ETHICS COMMITTEES IN RELATION TO THE FOREGOING AND TO PROVIDE FOR OTHER MATTERS CONNECTED WITH THE MATTERS AFORESAID. [22nd December, 1987]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

1 Interpretation.

1.—(1) In this Act except where the context otherwise requires—

“administered”, in relation to substances and preparations, means the administration either directly or indirectly to a person of one or more substances or preparations by introduction into the body (whether orally, by injection or in any other way) or by external application (whether by direct contact with the body or not) and a reference to the administration to a person of one or more substances or preparations shall be construed accordingly;

“clinical trial” shall be construed in accordance with section 6; “conduct a clinical trial” has the same meaning as it has in section 6; “ethics committee” shall be construed in accordance with section 8;

“the Minister” means the Minister for Health;

“participant”, in relation to a clinical trial, means a person to whom one or more substances or preparations are administered in the course of the clinical trial;

“registered dentist” means a person registered in the Register of Dentists established under the Dentists Act, 1985;

“registered medical practitioner” means a person registered in the General Register of Medical Practitioners established under the Medical Practitioners Act, 1978.

• (2) In this Act, a reference to a section is to a section of this Act and a reference to a subsection or paragraph is to the subsection or paragraph of the provision in which the reference occurs, unless it is indicated that a reference to some other enactment or provision, as may be appropriate, is intended.

2 Restriction on application of Act, etc.

2.—(1) (a) The provisions of this Act shall not apply in respect of any clinical trial which is being conducted at the commencement of this Act.

• (b) Where any arrangements to undertake or to conduct a clinical trial were or were being made before the commencement of this Act and where paragraph (a) does not apply, then such arrangements shall, for the purpose of an application under section 3, be treated as if they had not been made otherwise than in accordance with that section.

• (2) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial and there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984), then the provisions of sections 3 to 11 shall not apply where—

• (a) the National Drugs Advisory Board—

• (i) have been notified in writing of the proposal, and

• (ii) are satisfied with the composition of a committee appointed to consider the justification for conducting the proposed clinical trial and the circumstances under which the proposed trial is to be conducted, and

• (iii) have received such information, evidence, documents, samples or other materials that they may have, not later than 4 weeks after being so notified, requested in relation to the proposed clinical trial,

and

• (b) the conditions under which the product authorisation was granted are complied with in respect of the substance or preparation concerned.

• (3) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial, and

• (a) there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, and

• (b) the purpose of the clinical trial is to determine the effect of a new use for the substance or preparation concerned,

then the provisions of sections 3 to 6 and sections 8 to 11 shall not apply where—

• (i) the National Drugs Advisory Board have been notified in writing of the proposal and have, not later than 6 weeks after being so notified, made a recommendation to the Minister on the proposal, and

• (ii) the Minister has granted permission for the proposed trial to be undertaken, and

• (iii) in respect of the substance or preparation concerned, the conditions relating to dosage form contained in the product authorisation so granted are complied with when the clinical trial is being conducted and the dosage administered in each case does not exceed that specified in the said authorisation.

3 Application to undertake clinical trial.

3.—(1) A person who proposes to arrange for the conducting of a clinical trial shall apply to the Minister for permission to make such arrangements before the trial is undertaken and every application for such permission shall be accompanied by—

• (a) the name, address and description of the applicant,

• (b) sufficient information to enable a scientific evaluation to be made of the proposed clinical trial and of the substance or preparation which it is proposed to administer in the course of that trial,

• (c) the identity (which includes the qualifications of each member) of the ethics committee,

• (d) the name, address and qualifications of each person who would conduct the clinical trial,

• (e) the criteria to be used for the recruitment and the selection of participants,

• (f) details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant,

• (g) such further information, evidence, documents, samples and other materials as may be necessary to indicate the nature of the trial, and

• (h) the appropriate fee (if any) specified by the Minister by virtue of section 16.

• (2) Where an application has been made in accordance with subsection (1) the Minister may, at any time before he makes a decision for the purpose of section 4 and whether or not he has approved of the proposed ethics committee, request such further information, evidence, documents, samples and other materials as may in his opinion assist him in making such a decision.

• (3) An application under this section may be made at any time after the passing of this Act, but any application made before the day appointed by the Minister under section 19 (2) shall, for the purpose of subsection (1), be treated as if it had been made on that day.

• (4) In this section “arrange for the conducting of a clinical trial” does not include any measures taken for the purpose of an application under this section.

4 Grant of, or refusal to grant, permission to undertake clinical trial.

4.—(1) Where in relation to a proposal to arrange for the conducting of a clinical trial—

• (a) an application has been made in accordance with section 3 (1), and

• (b) any request made under section 3 (2) has been complied with,

then, the Minister, after consultation with the National Drugs Advisory Board, shall, not later than 12 weeks after the application has been so made or such request has been so complied with (whichever is the later)—

• (i) grant permission for the proposed clinical trial to be undertaken in accordance with the application, or

• (ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or

• (iii) refuse to grant permission for the proposed clinical trial to be undertaken.

• (2)
• (a) Where under subsection (1) the Minister grants permission for a proposed clinical trial to be undertaken (with or without modifications or conditions), then the trial shall not be conducted until the ethics committee for the trial has given its approval in accordance with section 8 (2).

• (b) Where under subsection (1) the Minister refuses to grant permission for the proposed clinical trial to be undertaken, then the Minister shall, when so refusing, inform the applicant of the grounds for such refusal.

5 Amendment of permission to undertake clinical trial.

5.—(1) Where, in relation to a subsisting permission granted by the Minister under section 4 (whether or not previously amended by virtue of this section), it is proposed to do, or refrain from doing, any act in relation to the proposed clinical trial or the clinical trial (as the case may be) otherwise than in accordance with the permission, then the person who applied for the permission shall make an application to the Minister for an amendment thereof and the Minister shall, after consultation with the National Drugs Advisory Board and not later than 6 weeks after the application for the amendment was so made, either agree or not agree to the amendment of the permission.

• (2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon—

• (a) in the case of a proposed clinical trial, until the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 8 (2),

• (b) in the case of a clinical trial which has been approved by the ethics committee—

• (i) until the committee has given its approval to the amendment, and

• (ii) in respect of each person to whom one or more substances or preparations are to be administered, until the person who has given or gives his consent in accordance with section 9 has been made aware of such matters (if any) as the committee considers he should be made aware of having regard to the amendment.

6 Conducting of clinical trial.

6.—(1) A person shall not conduct a clinical trial unless—

• (a) he is a registered medical practitioner or a registered dentist,

• (b) there is a subsisting permission granted by the Minister under section 4 in respect of the trial, and

• (c) the provisions of section 4 (2) (a) or 5 (2) (a), as the case may be, have been complied with.

• (2) In this section—

“conduct a clinical trial” means the conducting of a systematic investigation or series of investigations for the purpose of ascertaining the effects (including kinetic effects) of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect, but does not include the conducting of such a systematic investigation or series of investigations as aforesaid—

• (a) where

• (i) the administration of one or more substances or preparations, as the case may be, is on a patient in the ordinary course of medical practice (in the case of a registered medical practitioner) or of dental practice (in the case of a registered dentist) and

• (ii) the principal purpose of that administration is the welfare of the patient,

or

• (b) where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or as a registered dentist or as a registered pharmaceutical chemist and where it is to be administered as part of such a course of training, or

• (c) for the purpose of examining the nutritional effect of the substance or preparation concerned where that substance or preparation is a normal dietary constituent;

“registered pharmaceutical chemist” means a person registered in the Register of Pharmaceutical Chemists for Ireland maintained under the Pharmacy Acts, 1875 to 1977.

7 Revocation of permission to undertake clinical trial.

7.—The Minister may, at any time and after consultation with the National Drugs Advisory Board, revoke a permission granted under this Act to undertake a clinical trial if he is of the opinion that—

• (a) the trial or any part thereof is being conducted in a manner which is not in accordance with the permission, or

• (b) for any other reason, the trial should not continue, and he shall communicate the reason for his revocation of the permission to the person who had been granted the permission.

8 Ethics committees.

8.—(1) Where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting the proposed clinical trial and the circumstances under which it is to be conducted, he shall give his approval of the proposed committee, which shall thereupon become the ethics committee for the proposed clinical trial and, where the ethics committee gives its approval in accordance with subsection (2), for the clinical trial.

• (2) The ethics committee for a proposed clinical trial shall consider the justification for conducting the proposed trial and the circumstances under which it is proposed to be conducted and, where the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval to the conducting of the proposed trial and the person who is arranging for the conducting of the proposed trial shall communicate such approval to the Minister in writing.

• (3) For the purposes of subsection (2), the ethics committee shall not consider the proposed clinical trial justified unless it is satisfied that the risks to be incurred by participants would be commensurate with the objectives of the trial.

• (4) Without prejudice to the generality of subsection (2), the ethics committee for a proposed clinical trial shall, in considering the circumstances under which the proposed trial is to be conducted, have regard to the following matters:

• (a) the objectives of the proposed trial and its planning and organisational structure;

• (b) the qualifications and competence of each person who would conduct the clinical trial and, where appropriate, the resources available to him;

• (c) the criteria to be used for the recruitment and the selection of participants;

• (d) the procedures proposed for compliance with section 9;

• (e) the extent and nature of the medical examination that persons selected as participants are to undergo before participating in the clinical trial;

• (f) the extent to which the health of participants is proposed to be monitored during and after the clinical trial;

• (g) whether or not the persons selected as participants are to undergo independent medical examination before, during or after the clinical trial;

• (h) details of the proposed method or methods by which participants are to be recruited;

• (i) details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant;

• (j) any payments, whether monetary or otherwise, to be made to a person for conducting the clinical trial or any part of the trial;

• (k) the criteria to be used to ensure that the identity of each participant remains confidential;

• (l) any payments, whether monetary or otherwise, to be made to any person for facilities used for the purposes of the clinical trial;

• (m) such other matters as may be prescribed by regulations made by the Minister under this Act.

• (5) The composition of the ethics committee may at any time be changed with the approval of the Minister.

9 Participants in clinical trial.

9.—(1) A person shall not be a participant in a clinical trial unless a consent to such participation has been given in accordance with this section.

• (2) Subject to subsection (7), a consent to participation in a clinical trial shall not be valid unless given in writing and signed by the person who is to be the participant in the trial.

• (3) Any consent given for the purposes of this section shall not be valid unless—

• (a) the person so consenting is capable of comprehending the nature, significance and scope of his consent, and

• (b) it is obtained by or on behalf of the person conducting the clinical trial.

• (4) The person conducting the clinical trial shall ensure that every person shall, before giving his consent in accordance with this section, be made aware of the following matters—

• (a) the objectives of the trial,

• (b) the manner in which the substance or preparation is to be administered,

• (c) the risks and any discomfort involved in, and the possible side-effects of, the trial,

• (d) whether or not a pharmacologically inactive substance or preparation is to be administered to some persons in respect of each of whom a consent has been given to being a participant in the trial in accordance with this section,

• (e) such other matters (if any) as may be—

• (i) prescribed by regulations made by the Minister under this Act, or

• (ii) specified in the permission granted by the Minister under section 4.

• (5) Unless otherwise provided for by virtue of the permission granted by the Minister under section 4 or of any amendment to that permission agreed to by him under section 5, a clinical trial shall not be conducted on any person within the period of 6 days after the day on which the provisions of section 9 (4) have been complied with in respect of such person.

• (6) Any person who has given his consent in accordance with this section may withdraw it at any time and no contractual liability shall be incurred by such person from such withdrawal.

• (7) Where it is proposed to conduct a clinical trial on any person suffering from an illness, the remedy for or alleviation of which constitutes an objective of the trial, the following provisions shall apply:

• (a) where such a person is capable of comprehending the nature, significance and scope of a consent to be given for the purposes of this section but is physically unable to give such consent in accordance with subsection (2), his consent clearly given in any other manner shall be sufficient where it is so given, in the presence of two witnesses present at the same time, to a registered medical practitioner who is treating him for that illness and where the consent is expressed in writing and is attested by the signatures of both witnesses;

• (b) where such a person is incapable of comprehending the nature, significance and scope of a consent to be given for the purposes of this section, that person may be a participant in a clinical trial only if a written and signed consent is given for such a participation by a person or persons, independent of the person who applied to undertake or is conducting the trial, who in the opinion of the ethics committee is or are competent to give a decision on such a participation:

Provided that a clinical trial to which this subsection relates may be conducted only if the substance or preparation under trial is to be administered for the purpose of saving the life of such a person, restoring his health, alleviating his condition or relieving his suffering.

• (8) No person shall offer or cause to be offered to a person for becoming or being a participant in a clinical trial any inducement or reward (whether monetary or otherwise) unless provided for by the permission to undertake the clinical trial.

10 Security for compensation.

10.—(1) A person shall not—

• (a) conduct a clinical trial, or

• (b) administer any substance or preparation for the purpose of a clinical trial,

unless such person establishes to the satisfaction of the ethics committee that he can provide sufficient security to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial.

• (2) It shall be a good defence for a person prosecuted for contravening subsection (1) to show that he reasonably believed that the provisions of that subsection had been complied with.

11 Information on clinical trials and reports.

11.—(1) Every person who conducts a clinical trial shall—

• (a) in respect of any place under his control which the Minister reasonably believes is being or has been used in connection with the trial, permit any person, duly authorised by the Minister, to inspect such place for the purpose of determining whether or not the permission to undertake the trial is being or was complied with,

• (b) comply with any request for information in relation to the progress of the trial which the Minister or any person duly authorised by him may from time to time request, and

• (c) upon becoming aware of or suspecting any adverse reaction affecting a participant as a consequence of the trial being conducted, forthwith report that fact to the Minister.

• (2) Every person, other than the person conducting the trial, who administers a substance or preparation for the purpose of a clinical trial shall, upon becoming aware of or suspecting any adverse reaction as a consequence of the substance or preparation being administered, forthwith report that fact to the person conducting the trial.

12 Incorrect or misleading information, etc.

12.—(1) No person shall provide or cause to be provided to another person any information, evidence, documents, samples or other materials—

• (a) for the purpose of an application to undertake a clinical trial, or

• (b) in relation to a clinical trial,

which are incorrect or misleading.

• (2) It shall be a good defence for a person prosecuted for contravening subsection (1) to show that he reasonably believed that the information, evidence, documents, samples or other materials to which the prosecution relates were correct and not misleading.

13 Offences.

13.—(1) (a) Subject to paragraph (b), any person who contravenes (by act or omission) any provision of this Act or any regulation under this Act or of any permission to which this Act relates shall be guilty of an offence under this section.

• (b) It shall be a good defence to a prosecution for an offence under this section relating to the administration by a person of one or more substances or preparations to show that the substances or preparations were administered for the purpose of providing emergency medical or dental treatment.

• (2)
• (a) Subject to paragraph (b), where an offence under subsection (1) is committed by a body corporate, every person who at the time of the commission of the offence was a director, manager, secretary or other officer of the body corporate shall, as well as the body corporate, be guilty of an offence under this section and shall be liable to be proceeded against and punished accordingly.

• (b) It shall be a good defence to a prosecution for an offence under paragraph (a) for a person to show that the offence was committed without his knowledge and that he exercised all due diligence to prevent the commission of the offence as he ought to have exercised, having regard to the nature of his position as director, manager, secretary or other officer and to all the circumstances.

• (3) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act, 1851, summary proceedings for an offence under this section may be instituted within 12 months from the date of the offence.

14 Onus of proof of pharmacological or harmful effect.

14.—Where, in a prosecution for an offence under section 13, it is alleged in respect of one or more substances or preparations that they have been or were intended to be administered to persons for the purpose of a clinical trial, it shall be presumed, until the contrary is shown by the person charged, that they may have a pharmacological or harmful effect if so administered.

15 Penalties.

15.—A person guilty of an offence under section 13 shall be liable—

• (a) on summary conviction, to a fine not exceeding £1,000 or, at the discretion of the court, to imprisonment for a term not exceeding 12 months, or to both, or

• (b) on conviction on indictment, to a fine not exceeding £10,000 or, at the discretion of the court, to imprisonment for a term not exceeding 3 years, or to both.

16 Fees.

16.—(1) The Minister may, with the consent of the Minister for Finance, specify—

• (a) the scale of fees payable in respect of notifications or applications made under this Act, and

• (b) such charges as he considers appropriate in relation to any matter connected with a notification or an application made or a permission granted under this Act.

• (2) All fees and charges under this Act shall be taken and collected in such manner as the Minister for Finance may from time to time direct and shall be paid into, or disposed of for the benefit of, the Exchequer in accordance with the directions of the Minister for Finance.

• (3) The Public Offices Fees Act, 1879, shall not apply in respect of fees payable pursuant to this Act.

17 Regulations.

17.—(1) The Minister may make such regulations as appear to him to be necessary or expedient to implement the provisions of this Act.

• (2) Any regulation made by the Minister under this Act may contain such incidental or consequential provisions as appear to the Minister to be necessary or expedient for the purpose of implementing the provisions of this Act.

• (3) Every regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House has sat after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder.

18 Expenses.

18.—The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Finance, be paid out of moneys provided by the Oireachtas.

19 Short title and commencement.

19.—(1) This Act may be cited as the Control of Clinical Trials Act, 1987.

• (2) This Act, other than sections 16 to 18 and this section and so much of sections 1 to 15 as are necessary to give effect to section 3 (3), shall come into operation on such day as the Minister shall by order appoint.