Principles applicable to projects of research
20 Principles applicable to projects of research
A licence shall not be capable of authorising any research contravening the condition referred to in subsection (3).
No licensee shall carry out, or authorise or facilitate or become involved in the carrying out of, any project of research —
upon or with —
human gametes obtained in the course of an in vitro fertilisation procedure or intended for use in an artificial fertilisation procedure; or
a human egg undergoing fertilisation or a human embryo whether or not live;
or
involving any person who is a participant in an artificial fertilisation procedure,
unless general or specific approval relevant to that project has already been granted by the Council, or unless specific prior approval from the Council for that particular project of research is sought for in such manner as may be required by the Code or directions, and if the Council so requires is also sought from a specific Institutional Ethics Committee recognised by the Council, and is obtained.
Subsection (2)(a)(ii) does not apply in relation to an excess ART embryo except in relation to a use of such an embryo that is an exempt use as defined in section 53W(2).
Every licence is subject at all times to the condition that any project of research shall be carried out in accordance with the terms of, and any conditions applicable to, the approval given and not otherwise.
The Council, subject to subsection (5), may under the Code grant general approval to the carrying on by any licensee of a project of research of a kind or in relation to matters specified in the Code, but may impose conditions as to the manner in which the research is to be carried on.
The Rules or directions may make provision as to —
the requirements with which a licensee proposing to carry out any research must comply in seeking approval to the proposal, for the manner of submitting that proposal to an Institutional Ethics Committee or to the Council, and for the furnishing by the licensee of a report on that proposal from such a Committee to the Council or the CEO;
any requirement for —
counselling;
the obtaining from any person of an effective consent,
for the purposes of the research;
generally, the ethics and standards that should apply to the carrying out of projects of research by or involving licensees.
In considering whether to grant approval to a project of research, the Council shall have regard to any decision or report which may have been made by an Institutional Ethics Committee and may adopt a decision or report so made as sufficient grounds for the grant of approval by the Council.
[Section 20 amended: No. 17 of 2004 s. 14; No. 28 of 2006 s. 270(2).]
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