We will resume on Senator FitzGerald's amendment to amendment No. 13. The discussion also includes amendment No. 17 in the name of Senator B. Ryan. Is there anyone withdrawing the amendment?
Control of Clinical Trials Bill, 1986: Committee Stage (Resumed).
Government Amendment No. 13:
In page 5, before section 4, to insert a new section as follows:
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 apply to the Minister for an amendment thereof and the Minister may, after consultation with the National Drugs Advisory Board, agree to the amendment of the permission.
(2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon until.—
(a) in the case of a proposed clinical trial, the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 7 (2),
(b) in the case of a clinical trial which has been approved by the ethics committee to which it relates, that ethics committee has given its approval to the amendment.".
Debate resumed on amendment No. 1 to amendment No. 13:
In subsection (1), after "Minister may" to insert "shall respond within three weeks".
— (Mr. FitzGerald.)
I think there were two aspects when we were discussing it earlier. There was support on both sides of the House for the idea of incorporating a time limit where an application was made to amend. I understood the Minister to say that is acceptable and that on Report Stage a time limit will be introduced. That is very welcome. Senator B. Ryan raised in the context of his amendment No. 17 his concern, which I share, for those who are possibly already involved in a clinical trial which has commenced and which for one reason or another the person who has applied to carry this out wishes to amend, then makes application to amend. Our concern is whether those who are involved or who are enlisted to become involved and who have consented to a clinical trial under certain understood assumptions will be safeguarded in that they will know the nature of the proposed amendment, the consequences for them, the guineapigs, that they will know precisely what the implications will be for them.
This matter was touched on by the Minister of State but I think it warrants a very clear response from the Minister. Although the Minister will not act upon an application to amend until in the case of a proposed clinical trial the ethics committee for the proposed trial has given its approval in accordance with section 7 (2), our specific concern on that was whether that would clearly require the ethics committee to ensure that the person or body carrying out the clinical trial had returned to anybody either participating or likely to participate in it for a new consent, a consent de novo to the amended nature of the proposed trial. I hope the Minister will be able to clarify some of these points.
I have just arrived and I presume we are dealing with an amendment in my name amongst other things relating to section 4——
We are dealing with an amendment in Senator B. Ryan's name, the Minister's amendment and your amendment.
I was talking earlier about the period of time that should elapse relating to an amendment of a permission which is sought. What is in the amendment relates to the introduction of something that is not in the Bill. I am talking of the question of a response within three weeks. I am prepared to have the period of three weeks adjusted to some extent. I seemed to gather from the Minister of State earlier that he was thinking of a period relatively similar to the 12 week period that exists in the original application to the Minister and in turn from the Minister to the National Drugs Advisory Board. When we are dealing with an amendment it must be possible to come up with a decision somewhat shorter than the original period of three months. If one looks at the earlier instance, in the area of planning appeals, the local authority have to respond within a two month period and An Bord Pleanála can go on looking at it ad nauseam. In some instances it goes on for years. In this case there will be an urgency to get ahead with a clinical trial, or a clinician may be waiting to advance something that is of importance in a hospital. It should not be more than half the period at the very most that exists in relation to the original application. Perhaps a period of one month might be suitable.
I will examine the suggestion made by the Senator. We had in mind having the same time limit as on a permissions consideration, namely, 12 weeks. It is difficult to be precise because one can think of many exigencies which can develop which may require a full 12 weeks of consideration particularly when applications come in over summer periods and so on. One can run easily into July or August and a meeting may not be held until September. I will look at it on Report Stage. If we could reach agreement, I am not hung up on 12 weeks, if we want to bring it back. I do not want to spancel the applicants unduly and, above all, I do not want the application to finish up threatening to go to court in order to get an immediate decision in a very tight framework. I will look at it. I will consult informally before Report Stage.
Senator Ryan's amendment would very explicitly oblige the Minister of the day to ensure that the consent provisions of section 8 have been complied with before he agrees to an amendment of a provision. However, the ethics committee, not the Minister for Health are given responsibility in section 7 (4) (d) for ensuring that valid consent has been given. It would be somewhat illogical to make the Minister responsible only for ensuring that consent had regard to the amendment of a proposal. In any event, the detailed considerations involved in assessing the validity of a consent in any individual case are not entirely appropriate to the Minister per se. For that reason I am still of the view that amendment No. 16 is inappropriate. I will leave it at that.
While the Bill outlines the responsibilities of the ethics committee it does not purport to be an exhaustive list of the matters they must have regard to. The nature of the ethics committee's responsibilities, generally speaking, can hardly be in doubt within the framework of this Bill. Such detail as requiring the committee to ensure the information to a participant is updated on an immediate basis can be dealt with administratively rather than within the framework of a full amendment here.
I am still somewhat perplexed as to why in the Government amendment subsection (2) (a) refers to section 7 (2) of the Bill only and does not include section 7 (4). If the Minister could explain that to me, I might be a lot more at ease about the whole thing. Section 7 (4) of the Bill refers to a list of the matters to which the ethics committee must have regard "without prejudice to the generality of subsection (2)." It would make it perfectly clear that an ethics committee was required on each occasion where there was an amendment to a trial proposed, that they had to ensure that the participants in the trial were fully briefed on what was being done, and had once again freely consented to participate. It depends on how you look at this issue, whether you regard what I am talking about as important. You could look as it as an administrative detail suitable for being dealt with by administrative practice if you have the perspective of the clinics and, indeed, perhaps of the State as a large body. If you do consider the type of people who in the past have been "subjected"— and I use the word advisedly — to these trials in the matter of their consent and their capacity to comprehend that consent, the information which was provided to them has been a matter of considerable concern. Perhaps the Minister can explain to me why he does not simply add it on in accordance with section 7 (2) and 7 (4) and make it perfectly clear that the ethics committee are expected to do in the case of an amendment to a clinical trial, that which they are expected to do in the case of the original trial itself.
I think the general section is reasonably drafted. The important aspect of it is that, before an ethics committee start out on their work in detail, they must consider what is stated in the Bill:..."shall each consider the justification for conducting the proposed trial". That is a fundamental precondition. The circumstances under which it is proposed to conduct trials, despite the elaboration in subsection (4), are an all encompassing obligation. The committee, having considered that, shall give their approval to the conducting of the proposed trial. The person who is arranging for the conducting of the proposed trial shall communicate such approval to the Minister in writing. We could elaborate on section 7 (4) but we would go into a great deal of excessive detail, in my view. There are data and criteria laid down. I do not propose to go over them because they are self explanatory in many ways and I would have difficulty in knowing how to elaborate on further criteria. If all the consent criteria had to be gone through first and then reverted back, one would never get the work to be done off the ground.
I am a bit perturbed because I appear to have heard the Minister suggest that perhaps where a clinical trial is to be amended we might not have to get the consent of the participants to the amendment. I have later amendments to section 7 (4). I am not interested in that. I am interested in knowing why there is not specific reference to subsection (4) in the Minister's amendment. Does he think the reference to subsection (2) obligates the ethics committee to do all the things that are referred to in subsection (4), or is it that he has the view that in certain circumstances they might not have to do all the things that are referred to in subsection (4) for some amendments to trials? Perhaps I misunderstood him. I formed the definite impression that the Minister thought that, under some circumstances, it might not be necessary to inform participants and get their free consent if a trial was to be amended and, if that is the case, I would be extremely unhappy.
In support of Senator Ryan there is an important point at issue here. The House should know, in a new section relating to procedure for amendment of an application for clinical trial, whether it is going to be necessary to get the consent of those who are participating in the trial for the amendment. If you look at section 8, it is quite clear that it is intended to provide very considerable safeguards to participants in clinical trials:
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.
The person must be capable of comprehending the nature and significance and scope of the consent and the person must know the objectives of the trial, the manner in which the substance or preparation is to be administered etc.
There is to be an amendment of all of that, is the person going to have similar rights? It is as simple as that. Will people have the protection of the safeguards in section 8? We are entitled to know that. We are not entitled to hazard a guess as to what the possible meaning of the section may be. If that is not absolutely clear now, the consequence is that there must be an amendment to bring about the result that a person who is an ongoing participant in a clinical trial or about to be a participant, who has consented to a clinical trial cannot suddenly find that they consented to process A and suddenly, because there has been an amendment granted, it is not process A that they are undergoing but process A with added complications they knew nothing about. It is absolutely crucial that we clarify this point.
In the event of there being a material change in the trial I would find it extraordinary that an ethics committee would consider they were discharging their functions if they did not acquaint the participant of the implications of that amendment. That is the fundamental role of an ethics committee.
There must obviously be a responsibility on the committee to let the participant know the implications of an amendment if the amendment is a change in the conditions of the trial and if it is of such a nature that it automatically affects the prospect of a consent being given or being withheld. I am at a loss to know how one can elaborate further on this section bearing in mind the follow through of section 8 on the role of an ethics committee. I have no preconceptions about the section but I have difficulty in seeing how the particular amendment can be fitted in.
It is quite simple. All the Minister needs to do in his own amendment is this — and I would be quite happy if he would agree to do it on Report Stage. Subsection (2) (a) on page 4 of the list of amendments should read:
in the case of a proposed clinical trial, the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 7(2) and 7(4).
That would satisfy me. It would then be perfectly clear under subsection (4) (d) of the terms of reference of the ethics committee that the procedures proposed for compliance with section 8 would have to have been investigated. Therefore, we would have what I want carried out. I simply believe that it ought to be made perfectly clear. It should not be a matter for an ethics committee to decide whether the change is sufficiently large for the individual participating in it to be consulted or informed. That should be a matter for the individual involved. It is not for me to decide whether another person needs to be informed because the change is large or small.
An Leas-Chathaoirleach
There is a vote in the other House and I am quite sure the Minister will want to go.
If I may dispose of it just briefly. I can see the point being made by the Senator. I have some difficulty in inserting an appropriate drafting point. I am quite prepared to examine it on Report Stage. If I can accommodate that development I will willingly do so. There are always the difficulties of how does one assume than an applicant can comprehend the technicalties of a clinical trial. That is a dossier that would have to be presented to him. I have no objection to that being presented to him. I have no objection to the rigours being imposed on the applicant to so oblige it to be done but I have to do that within a legislative framework. I will certainly examine the points being made on Report Stage, that is, the two further amendments, one within 12 weeks or less and the one the Senator has suggested. On that basis I will be prepared to discuss it with the Senator, Senator Robinson and other Senators with a view to accommodating that view.
May I make a suggestion?
Yes.
It may be that the appropriate amendment would be to section 8 so that it should read:
A person shall not be a participant in a clinical trial or be deemed to have consented to an amendment.
That would actually be more secure than an amendment incorporating subsection (4) of section 7.
A vote is about to take place in the other House. We have had a good innings on this. It would be unfair to the Minister and the Senators who are at this very technical level of the Bill to go further into it later tonight. It would be appropriate to report progress on it and come back to this point next Wednesday.
An Leas-Chathaoirleach
Would it help if the amendment to the amendment was withdrawn?
What does the Minister feel about reassembling?
There is an Adjournment matter and I must come back for that.
An Leas-Chathaoirleach
I have to make sure the Minister does not miss his vote. Could we have a decision now please?
I propose the adjournment of this debate until next Wednesday.
An Leas-Chathaoirleach
Is that agreed?
Senators
Agreed.
An Leas-Chathaoirleach
Is the amendment to the amendment withdrawn?
Amendment No. 1 to the amendment No. 13, by leave, withdrawn.
Amendment No. 13 agreed to.
SECTION 4.
Amendments Nos. 14 to 17, inclusive, not moved.
An Leas-Chathaoirleach
Do we adjourn the matter until next week?
Yes.
Progress reported; Committee to sit again.