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Number 28 of 1987
CONTROL OF CLINICAL TRIALS ACT, 1987
ARRANGEMENT OF SECTIONS
Section | |
Grant of, or refusal to grant, permission to undertake clinical trial. | |
Acts Referred to | |
1985, No. 9 | |
1978, No. 4 | |
Petty Sessions (Ireland) Act, 1851 | 1851, c. 93 |
Pharmacy Acts, 1875 to 1977 | |
Public Offices Fees Act, 1879 | 1879, c. 58 |
Number 28 of 1987
CONTROL OF CLINICAL TRIALS ACT, 1987
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Uimhir 28 de 1987
AN tACHT UM RIALÚ TRIALACHA CLINICIÚLA, 1987
RIAR NA nALT
Alt | |
1. | |
2. | |
3. | |
4. | Cead a dheonú, nó a dhiúltú, chun triail chliniciúil a dhéanamh. |
5. | |
6. | |
7. | Cúlghairm a dhéanamh ar chead chun triail chliniciúil a dhéanamh. |
8. | |
9. | |
10. | |
11. | |
12. | |
13. | |
14. | Dualgas cruthúnais maidir le héifeacht chógaseolaíoch nó dhochrach. |
15. | |
16. | |
17. | |
18. | |
19. |
Na hAchtanna dá dTagraítear | |
Petty Sessions (Ireland) Act, 1851 | 1851, c. 93 |
Na hAchtanna Cógaisíochta, 1875 go 1977 | |
Public Offices Fees Act, 1879 | 1879, c. 58 |
Uimhir 28 de 1987
AN tACHT UM RIALÚ TRIALACHA CLINICIÚLA, 1987
[An tiontú oifigiúil]
Léiriú.
1.—(1) San Acht seo ach amháin mar a n-éilíonn an comhthéacs a mhalairt—
ciallaíonn “tabhairt”, i ndáil le substaintí agus ullmhóidí, substaint nó ullmhóid amháin nó níos mó a thabhairt do dhuine, go díreach nó go neamhdhíreach, trína gcur isteach sa chorp (cibé acu tríd an mbéal, trí instealladh nó ar aon slí eile) nó trína n-úsáid go seachtrach (cibé acu a thagann nó nach dtagann siad i dteagmháil go díreach leis an gcorp) agus is dá réir sin a fhorléireofar tagairt do shubstaint nó ullmhóid amháin nó níos mó a thabhairt do dhuine;
forléireofar “triail chliniciúil” de réir alt 6;
tá le “triail chliniciúil a sheoladh” an bhrí chéanna atá leis in alt 6;
forléireofar “coiste eitice” de réir alt 8;
ciallaíonn “an tAire” an tAire Sláinte;
ciallaíonn “rannpháirtí”, i ndáil le triail chliniciúil, duine dá dtugtar substaint nó ullmhóid amháin nó níos mó i gcúrsa na trialach cliniciúla;
ciallaíonn “fiaclóir cláraithe” duine atá cláraithe i gClár na bhFiaclóirí a bunaíodh faoi Acht na bhFiaclóirí, 1985;
ciallaíonn “lia-chleachtóir cláraithe” duine atá cláraithe i gClár Ginearálta na Lia-Chleachtóirí a bunaíodh faoi Acht na Lia-Chleachtóirí, 1978.
(2) San Acht seo, aon tagairt d'alt is tagairt í d'alt den Acht seo agus aon tagairt d'fho-alt nó do mhír is tagairt í don fho-alt nó don mhír den fhoráil ina bhfuil an tagairt, mura léirítear gur tagairt d'achtachán nó d'fhoráil éigin eile, de réir mar is cuí, atá beartaithe.
Srian le feidhmiú an Achta, etc.
2.—(1) (a) Ní bheidh feidhm ag forálacha an Achta seo i ndáil le haon triail chliniciúil atá á seoladh ag tosach feidhme an Achta seo.
(b) I gcás go raibh aon chomhshocruithe chun triail chliniciúil a dhéanamh nó a sheoladh, déanta nó á ndéanamh roimh thosach feidhme an Achta seo agus i gcás nach mbeidh feidhm ag mír (a), ansin, chun críche iarratais faoi alt 3, déileálfar leis na comhshocruithe sin ionann is dá mba nach ar shlí seachas de réir an ailt sin a rinneadh iad.
(2) I gcás go mbeartaíonn duine comhshocrú a dhéanamh chun triail chliniciúil a sheoladh nó go mbeartaíonn sé triail chliniciúil a sheoladh agus go bhfuil údarú táirge, arna dheonú faoi na Rialacháin um Ullmhóidí Leighis (Ceadúnú, Fógraíocht agus Díol), 1984 (I.R. Uimh. 210 de 1984), i bhfeidhm maidir leis an tsubstaint nó leis an ullmhóid lena mbaineann, ansin ní bheidh feidhm ag forálacha ailt 3 go 11 i gcás—
(a) go mbeidh an Bord Comhairleach Náisiúnta Druganna—
(i) tar éis fógra i scríbhinn a fháil faoina bhfuil beartaithe, agus
(ii) sásta le comhdhéanamh coiste a bheidh ceaptha chun a bhreithniú ar cheart an triail chliniciúil bheartaithe a sheoladh agus chun breithniú a dhéanamh ar na dálaí faoina seolfar an triail bheartaithe, agus
(iii) tar éis cibé faisnéis, fianaise, doiciméid, samplaí nó ábhair eile a fháil a bheidh iarrtha acu, tráth nach déanaí ná 4 seachtaine tar éis dóibh fógra a fháil amhlaidh, i ndáil leis an triail chliniciúil bheartaithe,
agus
(b) go mbeidh na coinníollacha faoinar deonaíodh an t-údarú táirge comhlíonta maidir leis an tsubstaint nó leis an ullmhóid lena mbaineann.
(3) I gcás go mbeartaíonn duine comhshocrú a dhéanamh chun triail chliniciúil a sheoladh nó go mbeartaíonn sé triail chliniciúil a sheoladh, agus
(a) go mbeidh údarú táirge, arna dheonú faoi na Rialacháin um Ullmhóidí Leighis (Ceadúnú, Fógraíocht agus Díol), 1984, i bhfeidhm maidir leis an tsubstaint nó leis an ullmhóid lena mbaineann, agus
(b) gurb é is cuspóir don triail chliniciúil an éifeacht a bheadh le húsáid nua don tsubstaint nó don ullmhóid lena mbaineann a chinneadh,
ansin ní bheidh feidhm ag forálacha ailt 3 go 6 ná ag ailt 8 go 11 i gcás—
(i) go mbeidh fógra i scríbhinn faoina bhfuil beartaithe faighte ag an mBord Comhairleach Náisiúnta Druganna agus go mbeidh, tráth nach déanaí ná 6 seachtaine tar éis dóibh an fógra sin a fháil, moladh déanta acu don Aire maidir lena bhfuil beartaithe, agus
(ii) go mbeidh cead tugtha ag an Aire chun an triail bheartaithe a dhéanamh, agus
(iii) maidir leis an tsubstaint nó leis an ullmhóid lena mbaineann, go gcomhlíonfar, an tráth a bheidh an triail chliniciúil á seoladh, na coinníollacha i ndáil le foirm dáileoige atá san údarú táirge a bheidh deonaithe amhlaidh agus nach mó i ngach cás an dáileog a thugtar ná an dáileog atá sonraithe san údarú sin.
Iarratas chun triail chliniciúil a dhéanamh.
3.—(1) Aon duine a bheartaíonn comhshocrú a dhéanamh chun triail chliniciúil a sheoladh, déanfaidh sé iarratas chun an Aire ar chead chun na comhshocruithe sin a dhéanamh sula ndéanfar an triail agus beidh na nithe seo a leanas ag gabháil le gach iarratas ar chead den sórt sin—
(a) ainm, seoladh agus tuairisc an iarratasóra,
(b) leordhóthain faisnéise le gur féidir measúnú eolaíoch a dhéanamh ar an triail chliniciúil bheartaithe agus ar an tsubstaint nó ar an ullmhóid a bheartaítear a thabhairt i gcúrsa na trialach sin,
(c) céannacht an choiste eitice (lena n-áirítear cáilíochtaí gach comhalta),
(d) ainm, seoladh agus cáilíochtaí gach duine a sheolfadh an triail chliniciúil,
(e) na critéir a úsáidfear chun rannpháirtithe a earcú agus a roghnú,
(f) mionsonraí maidir le haon aslaigh nó luachanna saothair, cibé acu in airgead nó ar shlí eile, a bheartaítear a thabhairt do dhuine as é do theacht chun bheith, nó as é a bheith, ina rannpháirtí,
(g) cibé faisnéis, fianaise, doiciméid, samplaí agus ábhair eile, de bhreis air sin, is gá chun an cineál trialach a bheidh ann a léiriú, agus
(h) an táille iomchuí (más ann) a bheidh sonraithe ag an Aire de bhua alt 16.
(2) I gcás iarratas a bheith déanta de réir fho-alt (1) féadfaidh an tAire, tráth ar bith sula ndéanfaidh sé cinneadh chun críche alt 4 agus bíodh nó ná bíodh an coiste eitice beartaithe formheasta aige, cibé faisnéis, fianaise, doiciméid agus samplaí breise, agus cibé ábhair bhreise eile, a iarraidh a d'fhéadfadh, ina thuairim féin, cabhrú leis chun an cinneadh sin a dhéanamh.
(3) Féadfar iarratas faoin alt seo a dhéanamh tráth ar bith tar éis dháta rite an Achta seo, ach aon iarratas a bheidh déanta roimh an lá a bheidh ceaptha ag an Aire faoi alt 19 (2) déileálfar leis, chun críche fho-alt (1), amhail is dá mba ar an lá sin a rinneadh é.
(4) San alt seo ní fholaíonn “comhshocrú a dhéanamh chun triail chliniciúil a sheoladh” aon bhearta a dhéanfar chun críche iarratais faoin alt seo.
Cead a dheonú, nó a dhiúltú, chun triail chliniciúil a dhéanamh.
4.—(1) Más rud é, i ndáil le beartú comhshocrú a dhéanamh chun triail chliniciúil a sheoladh—
(a) go mbeidh iarratas déanta de réir alt 3 (1), agus
(b) go mbeidh aon iarraidh a rinneadh faoi alt 3 (2), comhlíonta,
ansin, tar éis dó dul i gcomhairle leis an mBord Comhairleach Náisiúnta Druganna, déanfaidh an tAire, tráth nach déanaí ná 12 sheachtain tar éis an t-iarratas a bheith déanta amhlaidh nó an iarraidh sin a bheith comhlíonta amhlaidh (cibé acu is déanaí)—
(i) cead a thabhairt chun an triail chliniciúil bheartaithe a dhéanamh de réir an iarratais, nó
(ii) cead a thabhairt chun an triail chliniciúil bheartaithe a dhéanamh de réir an iarratais ach sin faoi réir cibé modhnuithe nó coinníollacha a shonróidh sé, nó
(iii) diúltú cead a thabhairt chun an triail chliniciúil bheartaithe a dhéanamh.
(2) (a) Más rud é, faoi fho-alt (1), go dtabharfaidh an tAire cead chun triail chliniciúil bheartaithe a dhéanamh (fara nó d'éagmais modhnuithe nó coinníollacha), ansin ní sheolfar an triail go dtí go mbeidh an coiste eitice don triail tar éis a fhormheas a thabhairt de réir alt 8 (2).
(b) Más rud é, faoi fho-alt (1), go ndiúltóidh an tAire cead a thabhairt chun an triail chliniciúil bheartaithe a dhéanamh, ansin cuirfidh an tAire in iúl don iarratasóir, nuair a bheidh sé ag diúltú amhlaidh, cad iad forais an diúltaithe sin.
Leasú ar chead chun triail chliniciúil a dhéanamh.
5.—(1) Más rud é, i ndáil le cead a bheidh ar marthain agus a bheidh tugtha ag an Aire faoi alt 4 (bíodh nó ná bíodh sé leasaithe cheana féin de bhua an ailt seo), go mbeartaítear aon ní a dhéanamh, nó staonadh ó aon ní a dhéanamh, i ndáil leis an triail chliniciúil bheartaithe nó an triail chliniciúil (de réir mar a bheidh) ar shlí seachas de réir an cheada, ansin déanfaidh an duine a chuir isteach ar an gcead iarratas chun an Aire go leasófaí é agus tar éis don Aire dul i gcomhairle leis an mBord Comhairleach Náisiúnta Druganna agus tráth nach déanaí ná 6 seachtaine tar éis don iarratas ar leasú a bheith déanta, aontóidh sé nó ní aontóidh sé leis an leasú ar an gcead.
(2) Más rud é faoi fho-alt (1), go n-aontóidh an tAire le leasú, ní ghníomhófar dá réir—
(a) maidir le triail chliniciúil bheartaithe, go dtí go mbeidh an coiste eitice don triail bheartaithe tar éis a fhormheas a thabhairt don triail bheartaithe (arna leasú amhlaidh) de réir alt 8 (2),
(b) maidir le triail chliniciúil a bheidh formheasta ag an gcoiste eitice—
(i) go dtí go mbeidh an coiste tar éis a fhormheas don leasú a thabhairt, agus
(ii) i gcás gach duine a mbeidh substaint nó ullmhóid amháin nó níos mó le tabhairt dó, go dtí go gcuirfear ar a iúl don duine a thug nó a thugann a thoiliú de réir alt 9 cibé nithe (más ann) is dóigh leis an gcoiste is cóir a chur ar a iúl dó ag féachaint don leasú.
Triail chliniciúil a sheoladh.
6.—(1) Ní sheolfaidh duine triail chliniciúil mura rud é—
(a) gur lia-chleachtóir cláraithe nó fiaclóir cláraithe é,
(b) go bhfuil cead, a bheidh tugtha ag an Aire faoi alt 4, ar marthain maidir leis an triail, agus
(c) go mbeidh forálacha alt 4 (2) (a) nó 5 (2) (a), de réir mar a bheidh, comhlíonta.
(2) San alt seo—
ciallaíonn “triail chliniciúil a sheoladh” imscrúdú rianúil, nó sraith d'imscrúduithe rianúla, a sheoladh chun a fháil amach cé na héifeachtaí (lena n-áirítear éifeachtaí cinéiteacha) ar dhaoine a ghabhann le substaint nó ullmhóid amháin nó níos mó a thabhairt dóibh i gcás go bhféadfadh éifeacht chógaseolaíoch nó dhochrach a bheith ag gabháil leis an tabhairt sin, ach ní fholaíonn sé imscrúdú rianúil, nó sraith d'imscrúduithe rianúla, den sórt sin a sheoladh mar a dúradh—
(a) i gcás
(i) gur d'othar i ngnáthchúrsa cleachtais liachta (i gcás liachleachtóra chláraithe) nó cleachtais déidliachta (i gcás fiaclóra chláraithe) a thugtar substaint nó ullmhóid amháin nó níos mó, de réir mar a bheidh, agus
(ii) gurb é an príomhchuspóir atá leis an tabhairt sin leas an othair,
nó
(b) i gcás go mbeidh an tsubstaint nó an ullmhóid lena mbaineann le tabhairt do dhaoine atá ag dul faoi chúrsa oiliúna as a dtiocfaidh cáilíocht a thabharfaidh teideal don duine sin a bheith cláraithe mar lia-chleachtóir cláraithe nó mar fhiaclóir cláraithe nó mar phoitigéir cógaisíochta cláraithe agus i gcás go mbeidh an tsubstaint nó an ullmhóid sin le tabhairt mar chuid de chúrsa oiliúna den sórt sin, nó
(c) chun scrúdú a dhéanamh ar éifeacht bheathaitheach na substainte nó na hullmhóide lena mbaineann i gcás gur cuid de ghnáth-aiste bia an tsubstaint nó an ullmhóid sin;
ciallaíonn “poitigéir cógaisíochta cláraithe” duine atá cláraithe i gClár na bPoitigéirí Cógaisíochta d'Éirinn atá á chothabháil faoi na hAchtanna Cógaisíochta, 1875 go 1977.
Cúlghairm a dhéanamh ar chead chun triail chliniciúil a dhéanamh.
7.—Féadfaidh an tAire, tráth ar bith agus tar éis dul i gcomhairle leis an mBord Comhairleach Náisiúnta Druganna, cúlghairm a dhéanamh ar chead a bheidh tugtha faoin Acht seo chun triail chliniciúil a dhéanamh más é a thuairim—
(a) go bhfuil an triail nó aon chuid den triail á seoladh ar mhodh nach bhfuil i gcomhréir leis an gcead, nó
(b) ar chúis ar bith eile, nach cóir dul ar aghaidh leis an triail,
agus cuirfidh sé chuig an duine dár tugadh an cead scéala i dtaobh na cúise atá aige leis an gcead a chúlghairm.
Coistí eitice.
8.—(1) Más rud é gur deimhin leis an Aire, maidir le coiste eitice beartaithe do thriail chliniciúil, go bhfuil an coiste sin inniúil chun a bhreithniú ar cheart an triail chliniciúil bheartaithe a sheoladh agus chun breithniú a dhéanamh ar na dálaí faoina seolfar í, formheasfaidh sé an coiste beartaithe agus air sin tiocfaidh an coiste sin chun bheith ina choiste eitice don triail chliniciúil bheartaithe agus, i gcás go dtabharfaidh an coiste eitice a fhormheas de réir fho-alt (2), don triail chliniciúil.
(2) Breithneoidh an coiste eitice do thriail chliniciúil bheartaithe ar cheart an triail bheartaithe a sheoladh agus na dálaí faoina mbeartaítear í a sheoladh agus, i gcás gur dóigh leis an gcoiste gur cheart an triail bheartaithe a sheoladh agus go mbeidh sé sásta leis na dálaí sin, formheasfaidh sé seoladh na trialach beartaithe agus déanfaidh an duine a bheidh ag déanamh comhshocruithe do sheoladh na trialach beartaithe an formheas sin a chur in iúl i scríbhinn don Aire.
(3) Chun críocha fho-alt (2), ní bhreithneoidh an coiste eitice gur cheart an triail chliniciúil bheartaithe a dhéanamh mura deimhin leis go mbeadh na priacail ina rachaidh rannpháirtithe ar comhréir le cuspóirí na trialach.
(4) Gan dochar do ghinearáltacht fho-alt (2), beidh aird ar na nithe seo a leanas ag an gcoiste eitice do thriail chliniciúil bheartaithe le linn dó breithniú a dhéanamh ar na dálaí faoina seolfar an triail bheartaithe:
(a) cuspóirí na trialach beartaithe agus pleanáil agus eagrú na trialach sin;
(b) cáilíochtaí agus inniúlacht gach duine a sheolfadh an triail chliniciúil agus, más cuí, na hacmhainní atá ar fáil dó;
(c) na critéir a úsáidfear chun rannpháirtithe a earcú agus a roghnú;
(d) na nósanna imeachta a bheartaítear a úsáid d'fhonn alt 9 a chomhlíonadh;
(e) réim agus cineál an scrúdaithe liachta faoina rachaidh daoine a roghnófar mar rannpháirtithe sula nglacfaidh siad páirt sa triail chliniciúil;
(f) a mhéid a bheartaítear faireachán a dhéanamh ar shláinte rannpháirtithe le linn na trialach cliniciúla agus dá héis;
(g) cibé acu a rachaidh nó nach rachaidh na daoine a roghnófar mar rannpháirtithe faoi scrúdú liachta neamhspleách roimh an triail chliniciúil, lena linn nó dá héis;
(h) mionsonraí maidir leis an modh nó na modhanna a bheartaítear a úsáid chun rannpháirtithe a earcú;
(i) mionsonraí maidir le haon aslaigh nó luachanna saothair, cibé acu in airgead nó ar shlí eile, a bheartaítear a thabhairt do dhuine as é do theacht chun bheith, nó as é a bheith, ina rannpháirtí;
(j) aon íocaíochtaí, cibé acu in airgead nó ar shlí eile, a thabharfar do dhuine as an triail chliniciúil, nó aon chuid den triail, a sheoladh;
(k) na critéir a úsáidfear chun a chinntiú go bhfanfaidh céannacht gach rannpháirtí faoi rún;
(l) aon íocaíochtaí, cibé acu in airgead nó ar shlí eile, a thabharfar d'aon duine as saoráidí a úsáidfear chun críocha na trialach cliniciúla;
(m) cibé nithe eile a bheidh forordaithe le rialacháin arna ndéanamh ag an Aire faoin Acht seo.
(5) Féadfar comhdhéanamh an choiste eitice a athrú tráth ar bith le formheas an Aire.
Rannpháirtithe i dtriail chliniciúil.
9.—(1) Ní bheidh duine ina rannpháirtí i dtriail chliniciúil mura mbeidh toiliú leis an rannpháirteachas sin tugtha de réir an ailt seo.
(2) Faoi réir fho-alt (7), ní bailí do thoiliú le rannpháirteachas i dtriail chliniciúil mura mbeidh sé tugtha i scríbhinn agus sínithe ag an duine atá le bheith ina rannpháirtí sa triail.
(3) Ní bailí d'aon toiliú a thugtar chun críocha an ailt seo mura rud é—
(a) go bhfuil an duine a thugann a thoiliú amhlaidh in ann an cineál toilithe atá á thabhairt aige, agus ciall agus réim an toilithe sin, a thuiscint, agus
(b) gurb é an duine a bheidh ag seoladh na trialach cliniciúla a fhaigheann é, nó go bhfaightear thar a cheann é.
(4) Cinnteoidh an duine a bheidh ag seoladh na trialach cliniciúla go gcuirfear na nithe seo a leanas ar a iúl do gach duine sula dtabharfaidh an duine sin a thoiliú de réir an ailt seo, eadhon—
(a) cuspóirí na trialach,
(b) an modh ina dtabharfar an tsubstaint nó an ullmhóid dó,
(c) na priacail agus aon mhíchompord a bheidh ag gabháil leis an triail, agus aon seachthorthaí a d'fhéadfadh a bheith uirthi,
(d) cibé acu atá nó nach bhfuil substaint nó ullmhóid, atá neamhghníomhach ó thaobh na cógaseolaíochta de, le tabhairt do dhaoine áirithe a mbeidh toiliú le bheith ina rannpháirtí sa triail tugtha i leith gach duine acu de réir an ailt seo,
(e) cibé nithe eile (más ann) a bheidh—
(i) forordaithe le rialacháin arna ndéanamh ag an Aire faoin Acht seo, nó
(ii) sonraithe sa chead arna thabhairt ag an Aire faoi alt 4.
(5) Mura bhforálfar dá mhalairt de bhua an cheada a bheidh tugtha ag an Aire faoi alt 4 nó de bhua aon leasaithe ar an gcead sin lena mbeidh aontaithe aige faoi alt 5, ní sheolfar triail chliniciúil ar aon duine laistigh den tréimhse 6 lá tar éis an lae ar ar comhlíonadh forálacha alt 9 (4) maidir leis an duine sin.
(6) Féadfaidh aon duine a mbeidh a thoiliú tugtha aige de réir an ailt seo an toiliú sin a tharraingt siar tráth ar bith agus ní thabhóidh an duine sin aon dliteanas conarthach de bharr na tarraingte siar sin.
(7) I gcás go mbeartaítear triail chliniciúil a sheoladh ar aon duine a bhfuil breoiteacht air, agus go bhfuil ar chuspóirí na trialach teacht ar leigheas nó maolú ar an mbreoiteacht sin, beidh feidhm ag na forálacha seo a leanas:
(a) i gcás go bhfuil an duine sin in ann cineál, ciall agus réim an toilithe atá le tabhairt chun críocha an ailt seo a thuiscint ach nach bhfuil ar a chumas, go fisiciúil, an toiliú sin a thabhairt de réir fho-alt (2), is leor toiliú uaidh arna thabhairt go soiléir ar aon chaoi eile má thugtar amhlaidh é, i bhfianaise dhá fhinné a bheidh i láthair an tráth céanna, do lia-chleachtóir cláraithe a bheidh ag cur cóireála air don bhreoiteacht sin agus má scríobhtar amach an toiliú sin agus má fhianaítear é le sínithe an dá fhinné;
(b) i gcás nach bhfuil an duine sin in ann cineál, ciall agus réim an toilithe atá le tabhairt chun críocha an ailt seo a thuiscint, ní cead an duine sin a bheith rannpháirteach i dtriail chliniciúil ach amháin má thugtar toiliú i scríbhinn, agus é sínithe, leis an rannpháirteachas sin ó dhuine nó ó dhaoine, atá neamhspleách ar an duine a rinne iarratas chun an triail a dhéanamh nó atá ag seoladh na trialach, ar duine nó daoine iad atá, i dtuairim an choiste eitice, inniúil ar chinneadh a dhéanamh maidir leis an rannpháirteachas sin:
Ar choinníoll nach bhféadfar triail chliniciúil lena mbaineann an fo-alt seo a sheoladh ach amháin sa chás go bhfuil an tsubstaint nó an ullmhóid atá faoi thriail le tabhairt don duine d'fhonn an duine sin a shábháil ón mbás, d'fhonn a shláinte a thabhairt ar ais dó, d'fhonn a bhreoiteacht a mhaolú nó d'fhonn faoiseamh óna phian a thabhairt dó.
(8) Ní cead d'aon duine aon aslach nó luach saothair (cibé acu in airgead nó ar shlí eile) a thairiscint do dhuine, nó a chur faoi deara é a thairiscint do dhuine, as é do theacht chun bheith, nó as é a bheith, rannpháirteach i dtriail chliniciúil mura mbeidh foráil chuige sin déanta sa chead chun an triail chliniciúil a dhéanamh.
Urrús i leith cúitimh.
10.—(1) Ní cead do dhuine—
(a) triail chliniciúil a sheoladh, nó
(b) aon substaint nó ullmhóid a thabhairt chun críche trialach cliniciúla,
mura suífidh an duine sin chun sástacht an choiste eitice gur féidir leis leordhóthain urrúis a thabhairt chun a chinntiú go mbeidh cistí leordhóthaineacha ar fáil chun cúiteamh cuí a sholáthar do gach rannpháirtí a fhulaingeoidh díobháil nó caillteanas de bharr na trialach.
(2) Is cosaint mhaith do dhuine a ionchúiseofar mar gheall ar shárú ar fho-alt (1) a shuíomh gur chreid sé le réasún go raibh forálacha an fho-ailt sin comhlíonta.
Faisnéis i dtaobh trialacha cliniciúla agus tuairiscí.
11.—(1) Gach duine a sheolfaidh triail chliniciúil—
(a) déanfaidh sé, maidir le haon áit atá faoina urláimh a gcreideann an tAire le réasún go bhfuil nó go raibh sí á húsáid i ndáil leis an triail, cead a thabhairt d'aon duine, a bheidh údaraithe go cuí ag an Aire, an áit sin a iniúchadh d'fhonn a chinneadh cé acu atáthar nó nach bhfuiltear ag déanamh de réir an cheada chun an triail a dhéanamh, nó cé acu a rinneadh nó nach ndearnadh de réir an cheada sin,
(b) déanfaidh sé de réir aon iarrata ar fhaisnéis i ndáil le dul chun cinn na trialach, is faisnéis a iarrfaidh an tAire, nó aon duine a bheidh údaraithe go cuí aige, ó am go ham, agus
(c) déanfaidh sé, a luaithe a fhaigheann sé amach nó a bhíonn drochamhras air go bhfuil droch-imoibriú ag baint do rannpháirtí de thoradh na trialach atá á seoladh, é sin a thuairisciú láithreach don Aire.
(2) Gach duine, seachas an duine a bheidh ag seoladh na trialach, a thabharfaidh substaint nó ullmhóid chun críche trialach cliniciúla déanfaidh sé, a luaithe a fhaigheann sé amach nó a bhíonn drochamhras air go bhfuil aon droch-imoibriú mar thoradh ar an tsubstaint nó ar an ullmhóid atá á tabhairt, an méid sin a thuairisciú láithreach don duine a bheidh ag seoladh na trialach.
Faisnéis mhíchruinn nó mhíthreorach, etc.
12.—(1) Ní thabharfaidh aon duine do dhuine eile, ná ní chuirfidh sé faoi deara go dtabharfar do dhuine eile, aon fhaisnéis, fianaise, doiciméid, samplaí nó ábhair eile—
(a) chun críche iarratais chun triail chliniciúil a dhéanamh, nó
(b) i ndáil le triail chliniciúil,
atá míchruinn nó míthreorach.
(2) Is cosaint mhaith do dhuine a ionchúiseofar mar gheall ar shárú ar fho-alt (1) a shuíomh gur chreid sé le réasún go raibh an fhaisnéis, an fhianaise, na doiciméid, na samplaí nó na hábhair eile, lena mbaineann an t-ionchúiseamh, cruinn agus nach raibh siad míthreorach.
Cionta.
13.—(1) (a) Faoi réir mhír (b), aon duine a sháróidh (trí ghníomh nó neamhghníomh) aon fhoráil den Acht seo nó d'aon rialachán faoin Acht seo nó d'aon chead lena mbaineann an tAcht seo, beidh sé ciontach i gcion faoin alt seo.
(b) Is cosaint mhaith é i gcoinne ionchúisimh mar gheall ar chion faoin alt seo, a bhaineann le duine do thabhairt substainte nó ullmhóide amháin nó níos mó, a shuíomh gur tugadh na substaintí nó na hullmhóidí ar mhaithe le cóireáil liachta nó déidliachta éigeandála a chur ar fáil.
(2) (a) Faoi réir mhír (b), i gcás cion faoi fho-alt (1) a bheith déanta ag comhlacht corpraithe, gach duine a bhí, an tráth a ndearnadh an cion, ina stiúrthóir, ina bhainisteoir nó ina rúnaí ar an gcomhlacht corpraithe, nó ina oifigeach eile don chomhlacht corpraithe, beidh seisean, chomh maith leis an gcomhlacht corpraithe, ciontach i gcion faoin alt seo agus dlífear imeachtaí a thionscnamh ina choinne agus é a phionósú dá réir.
(b) Is cosaint mhaith do dhuine, i gcoinne ionchúisimh mar gheall ar chion faoi mhír (a), a shuíomh go ndearnadh an cion i ngan fhios dó agus go ndearna sé gach dícheall a ba chóir dó a dhéanamh chun nach ndéanfaí an cion, ag féachaint dá phost mar stiúrthóir, mar bhainisteoir, mar rúnaí nó mar oifigeach eile agus ag féachaint do na himthosca go léir.
(3) D'ainneoin alt 10 (4) den Petty Sessions (Ireland) Act, 1851, féadfar imeachtaí achoimre mar gheall ar chion faoin alt seo a thionscnamh laistigh de 12 mhí ó dháta an chiona.
Dualgas cruthúnais maidir le héifeacht chógaseolaíoch nó dhochrach.
14.—Más rud é, in ionchúiseamh mar gheall ar chion faoi alt 13, go líomhnaítear maidir le substaint nó ullmhóid amháin nó níos mó gur tugadh iad, nó gur beartaíodh iad a thabhairt, do dhaoine chun críche trialach cliniciúla, toimhdeofar, go dtí go suífidh an duine a bheidh á chúiseamh a mhalairt, go bhféadfadh éifeacht chógaseolaíoch nó dhochrach a bheith ag gabháil leo dá dtabharfaí amhlaidh iad.
Pionóis.
15.—Aon duine a bheidh ciontach i gcion faoi alt 13 dlífear—
(a) ar é a chiontú go hachomair, fíneáil nach mó ná £1,000 nó, de rogha na cúirte, príosúnacht ar feadh téarma nach faide ná 12 mhí, nó iad araon, a chur air, nó
(b) ar é a chiontú ar díotáil nach mó ná £10,000 nó, de rogha na cúirte, príosúnacht ar feadh téarma nach faide ná 3 bliana, nó iad araon, a chur air.
Táillí.
16.—(1) Féadfaidh an tAire, le toiliú an Aire Airgeadais—
(a) an scála táillí is iníoctha maidir le fógraí nó iarratais faoin Acht seo a shonrú, agus
(b) cibé muirir is cuí leis a shonrú i ndáil le haon ní a bhaineann le fógra nó iarratas a dhéantar faoin Acht seo nó le cead a thugtar faoin Acht seo.
(2) Déanfar na táillí agus na muirir go léir faoin Acht seo a ghlacadh agus a bhailiú ar cibé modh a ordóidh an tAire Airgeadais ó am go ham agus íocfar isteach sa Státchiste iad nó cuirfear chun tairbhe don Státchiste iad de réir orduithe an Aire Airgeadais.
(3) Ní bheidh feidhm ag an Public Offices Fees Act, 1879, maidir le táillí is iníoctha de bhun an Achta seo.
Rialacháin.
17.—(1) Féadfaidh an tAire cibé rialacháin a dhéanamh is dóigh leis is gá nó is fóirsteanach chun forálacha an Achta seo a chur i bhfeidhm.
(2) Aon rialachán arna dhéanamh ag an Aire faoin Acht seo féadfar cibé forálacha teagmhasacha nó iarmhartacha a bheith ann is dóigh leis an Aire is gá nó is fóirsteanach chun forálacha an Achta seo a chur i bhfeidhm.
(3) Gach rialachán a dhéanfaidh an tAire faoin Acht seo leagfar é faoi bhráid gach Tí den Oireachtas a luaithe is féidir tar éis a dhéanta agus má dhéanann ceachtar Teach acu sin, laistigh den 21 lá a shuífidh an Teach sin tar éis an rialachán a leagan faoina bhráid, rún a rith ag neamhniú an rialacháin, beidh an rialachán ar neamhní dá réir sin, ach sin gan dochar do bhailíocht aon ní a rinneadh roimhe sin faoin rialachán.
Caiteachais.
18.—Na caiteachais a thabhóidh an tAire ag riaradh an Acht seo íocfar iad, a mhéid a cheadóidh an tAire Airgeadais, as airgead a sholáthróidh an tOireachtas.
Gearrtheideal agus tosach feidhme.
19.—(1) Féadfar an tAcht um Rialú Trialacha Cliniciúla, 1987, a ghairm den Acht seo.
(2) Tiocfaidh an tAcht seo, cé is moite d'ailt 16 go 18 agus an t-alt seo agus cibé d'ailt 1 go 15 is gá chun éifeacht a thabhairt d'alt 3 (3), i ngníomh ar cibé lá a cheapfaidh an tAire le hordú.