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Is coiste eitice a dhéanfaidh an t-athbhreithniú eitice i gcomhréir leis an dlí náisiúnta.
The ethical review shall be performed by an ethics committee in accordance with national law.
Is coiste eitice a dhéanfaidh an t-athbhreithniú eitice i gcomhréir leis an dlí náisiúnta.
The ethical review shall be performed by an ethics committee in accordance with national law.
Is coiste eitice a dhéanfaidh an t-athbhreithniú eitice i gcomhréir leis an dlí náisiúnta.
The ethical review shall be performed by an ethics committee in accordance with national law.
forléireofar “coiste eitice” de réir alt 8;
"ethics committee" shall be construed in accordance with section 8;
(c) in aghaidh coiste eitice nó aon chomhalta de,
( c ) an ethics committee or any member thereof,
Bunaítear Coiste Eitice leis an gCód Iompair.
The Code of Conduct establishes an ethical committee.
an Coiste Eitice.
the ethical committee.
AN COISTE EITICE
ETHICAL COMMITTEE
An Coiste Eitice
Ethical committee
Bunaítear Coiste Eitice leis seo.
An ethical committee is hereby established.
An Coiste Eitice
The Ethics Committee
Idirghníomhaíocht idir na Comhaltaí, an Coiste Eitice agus an Chúirt
Interaction between the Members, the Ethics Committee and the Court
An Coiste Eitice
The Ethics Committee
Idirghníomhaíocht idir na Comhaltaí, an Coiste Eitice agus an Chúirt
Interaction between the Members, the Ethics Committee and the Court
Bunaítear Coiste Eitice leis an gCód Iompair.
The Code of Conduct establishes an ethical committee.
an Coiste Eitice; agus
the ethical committee; and
Riail 33 — Coiste Eitice
Rule 33 – Ethical committee
an Coiste Eitice.
the ethical committee.
na sé lánchomhalta agus na sé chomhalta cúltaca dá bhfuil an Coiste Eitice comhdhéanta;
the six full members and six reserve members of the ethical committee,
an Coiste Eitice;
the ethical committee;
Bunaítear Coiste Eitice leis an gCód Iompair.
The Code of Conduct establishes an ethical committee.
an Coiste Eitice; agus
the ethical committee; and
Riail 33 — Coiste Eitice
Rule 33 – Ethical committee
an Coiste Eitice.
the ethical committee.
na sé lánchomhalta agus na sé chomhalta cúltaca dá bhfuil an Coiste Eitice comhdhéanta;
the six full members and six reserve members of the ethical committee,
an Coiste Eitice;
the ethical committee;
CUID II – AN COISTE EITICE
PART II – ETHICAL COMMITTEE
An Coiste Eitice
Ethical committee
Bunaítear Coiste Eitice leis seo.
An ethical committee is hereby established.
—(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.
— (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.
Gan dochar d’Airteagal 17, i gcás ina measann an Coiste Eitice go bhfuil cúis ann lena cheapadh go bhféadfadh sé go bhfuil na caighdeáin eitice atá leagtha amach sa Chód sáraithe ag comhalta, tionscnóidh an Coiste Eitice imscrúdú.
Without prejudice to Article 17, where the ethical committee considers that there is a reason to think that a member may have breached the ethical standards set in this Code, it shall open an investigation.
Gan dochar d’Airteagal 17, i gcás ina measann an Coiste Eitice go bhfuil cúis ann lena cheapadh go bhféadfadh sé go bhfuil na caighdeáin eitice atá leagtha amach sa Chód sáraithe ag comhalta, tionscnóidh an Coiste Eitice imscrúdú.
Without prejudice to Article 17, where the ethical committee considers that there is a reason to think that a member may have breached the ethical standards set in this Code, it shall open an investigation.
Bunófar Coiste Eitice agus Comhlíontacháin taobh istigh den Bhord Stiúrthóirí, ar a mbeidh an triúr stiúrthóirí is faide seirbhís a dheonaigh a bheith páirteach ann, chomh maith le cathaoirleach an Choiste Iniúchóireachta.
An Ethics and Compliance Committee shall be established within the Board of Directors, composed of the three longest-serving directors who have volunteered to participate in it, plus the Chairman of the Audit Committee.
Déanfaidh an Coiste Eitice agus Comhlíontacháin rialú ar aon choinbhleacht fhéideartha leasa chomhalta nó iar-chomhalta den Bhord Stiúrthóirí nó den Choiste Bainistíochta.
The Ethics and Compliance Committee shall rule on any potential conflict of interest of a member or former member of the Board of Directors or the Management Committee.
Is coiste eitice a dhéanfaidh an t-athbhreithniú eitice i gcomhréir le dlí an Bhallstáit lena mbaineann.
The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned.
ní dhearna coiste eitice, arna bhunú i gcomhréir leis an dlí náisiúnta, tuairim dhiúltach a eisiúint maidir leis an imscrúdú cliniciúil, atá bailí don Bhallstát sin ina iomláine faoina dhlí náisiúnta;
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
má tá tuairim dhiúltach maidir leis an modhnú substaintiúil ar an imscrúdú cliniciúil eisithe ag coiste eitice sa Bhallstát sin, atá bailí, i gcomhréir leis an dlí náisiúnta, don Bhallstát ina iomláine.
an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
níor eisigh coiste eitice, arna bhunú i gcomhréir leis an dlí náisiúnta, tuairim dhiúltach maidir leis an staidéar feidhmíochta, atá bailí don Bhallstát sin ina iomláine faoina dhlí náisiúnta;
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law;
Cuirfidh an Coiste Eitice comhairle ar an Uachtarán agus ar an mBiúró, arna iarraidh sin dó nó di, maidir le léirmhíniú agus le cur chun feidhme fhorálacha an Chóid seo.
The ethical committee shall advise the president and the bureau, upon request, on the interpretation and implementation of the provisions of this Code.
Féadfaidh an Coiste Eitice comhairle a lorg ó shaineolaithe, tar éis dul i gcomhairle leis an Uachtarán, ach amháin má tá sé nó sí i gcoinbhleacht leasa.
The ethical committee may, after consulting with the president unless he or she has a conflict of interests, seek advice from experts.
Foilseoidh an Coiste Eitice tuarascáil bhliantúil maidir lena chuid oibre agus beidh an tuarascáil sin curtha go cuí i ndíth ainm.
The ethical committee shall publish an annual report of its work, duly anonymised.
Déanfaidh an Coiste Eitice a rialacha nós imeachta féin a mholadh agus beidh na rialacha sin le glacadh ag an mBiúró.
The ethical committee shall propose its own rules of procedure, to be adopted by the bureau.
Cuirfidh an Coiste Eitice Uachtarán an Choiste ar an eolas go bhfuarthas an gearán, ach amháin i gcás ina mbeidh an tUachtarán féin ina ábhar nó ina hábhar don ghearán sin.
The ethical committee shall inform the president of the Committee of the receipt of the complaint, except where the President is him or herself the subject of the complaint.
Scrúdóidh an Coiste Eitice imthosca an tsáraithe líomhnaithe agus tabharfaidh sé éisteacht ó bhéal nó i scríbhinn don chomhalta lena mbaineann.
The ethical committee shall examine the circumstances of the alleged breach and shall hear the member concerned, either orally or in writing.
Chuige sin, scrúdóidh an Coiste Eitice aon ghníomhaíocht sheachtrach atá ann cheana nó a iarradh i bhfianaise na gcritéar ginearálta a leagtar síos in Airteagal 12(4).
To that end, the Ethics Committee shall examine any existing or requested external activity in the light of the general criteria laid down in Article 12(4).
Chuige sin, scrúdóidh an Coiste Eitice aon ghníomhaíocht sheachtrach atá ann cheana nó a iarradh i bhfianaise na gcritéar ginearálta a leagtar síos in Airteagal 12(4).
To that end, the Ethics Committee shall examine any existing or requested external activity in the light of the general criteria laid down in Article 12(4).
Cuirfidh an Coiste Eitice comhairle ar an Uachtarán agus ar an mBiúró, arna iarraidh sin dó nó di, maidir le léirmhíniú agus le cur chun feidhme fhorálacha an Chóid seo.
The ethical committee shall advise the president and the bureau, upon request, on the interpretation and implementation of the provisions of this Code.
Féadfaidh an Coiste Eitice comhairle a lorg ó shaineolaithe, tar éis dul i gcomhairle leis an Uachtarán, ach amháin má tá sé nó sí i gcoinbhleacht leasa.
The ethical committee may, after consulting with the president unless he or she has a conflict of interests, seek advice from experts.
Foilseoidh an Coiste Eitice tuarascáil bhliantúil maidir lena chuid oibre agus beidh an tuarascáil sin curtha go cuí i ndíth ainm.
The ethical committee shall publish an annual report of its work, duly anonymised.
Déanfaidh an Coiste Eitice a rialacha nós imeachta féin a mholadh agus beidh na rialacha sin le glacadh ag an mBiúró.
The ethical committee shall propose its own rules of procedure, to be adopted by the bureau.
Cuirfidh an Coiste Eitice Uachtarán an Choiste ar an eolas go bhfuarthas an gearán, ach amháin i gcás ina mbeidh an tUachtarán féin ina ábhar nó ina hábhar don ghearán sin.
The ethical committee shall inform the president of the Committee of the receipt of the complaint, except where the President is him or herself the subject of the complaint.