Léim ar aghaidh chuig an bpríomhábhar

Seanad Éireann díospóireacht -
Wednesday, 26 Nov 1986

Vol. 115 No. 1

Control of Clinical Trials Bill, 1986: Committee Stage (Resumed).

Government amendment No. 18:
In page 5, before section 5, to insert a new section as follows:
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 a medical practice (in the case of a registered medical practitioner) or of a dental practice (in the case of a registered dentist) and
(ii) the principal purpose of that administration is the welfare of the patient,
(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.".
Debate resumed on amendment No. 1 to amendment No. 18:
In subsection (2) (b), after "chemist" to insert "or as a registered physiotherapist".
—(Senator FitzGerald).

I would like to make a suggestion to the Minister which he might consider for Report Stage. I accept his problem in relation to the fact that there is no registration process for physiotherapists. Section 5 (1) (a) states that a person shall not conduct a clinical trial unless he is a registered medical practitioner or a registered dentist. Could the Minister insert in the section: "or a physiotherapist working with a registered medical practitioner or a registered dentist"? It would probably not apply in the area of dentistry. Is there any way in which the Minister could manoeuvre the wording so that the profession of physiotherapy would be at least mentioned in the Bill as some sort of recognition, whatever about registration?

There may be another battle being fought under the framework of this Bill, that is, the very strong desire, and one with which I have considerable sympathy, that the profession of physiotherapists should be a formally registered profession. To give statutory status to the profession, the question of definition of physiotherapist would inevitably arise. I will be meeting an ad hoc committee of various professions who are seeking professional status as a registered profession. Only then will that question come up. At the moment anybody can claim to be a physiotherapist.

On the point of registration of physiotherapists, if that were to occur in the near future, would the Minister have power to include by regulation registered physiotherapists in the section? The question arises as to whether the Minister should have a residual power to do so. It is not something that I have examined. It would be desireable if that were to occur, that the Minister would be able by regulation to extend the scope of this new section to a registered physiotherapist. I welcome the clear assurance the Minister has given that the section would not affect the practical classes involving physiotherapy students which are required for their qualifications.

I have one other question arising out of the Minister's response to Senator FitzGerald when he referred to the pharmacological effect of the preparation. That arises out of the wording of the section here. It is part of the definition of conducting a clinical trial which refers to the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect. Would the Minister clarify whether placebos are considered to have a pharmacological effect? They were discussed in some detail on Second Stage and they are an essential part of the conduct of certain clinical trials, so it would be important to know whether they were included.

I rise to support the suggestion made by Senator Robinson. Perhaps the idea of having a clause which covers the possibility of registration would be a good idea. Without that, the dangers which the Minister has identified are considerable. I wonder, if we are to have a clause which includes the registration of physiotherapists, whether we are not now into a whole new arena of the registration of paramedics in general. That would need to be looked at very carefully because, after all, we are dealing with drugs and other matters of research which could have potentially dangerous side effects and which can on occasion be lethal. While I have never advocated a very special position for my profession in these affairs, I still feel they are probably the best qualified to supervise any research which is being done.

Has the Minister made the distinction between clinical trials which are trying to push forward the frontiers of science and clinical demonstrations? We have, in fact, made that very clear but we must be careful that people are not being used for teaching purposes in what is seen as a relatively safe manner. This applies particularly to medical students, physiotherapy students, or any other students who are vulnerable to their overseers and teachers and who may be under some obligation to participate in trials as demonstrations, or at least they may feel they are under some obligation. All of these matters need to be taken into account. I certainly feel that, if we extend it to registration, we are talking not just of physiotherapists but of registration of paramedics in general.

As we know, demonstrations as such are not encompassed, although I can readily see that if one is to conduct a class properly one may want to involve certain aspects of the demonstrtion by way of training. A trial is a clearly defined entity within the framework of the Bill. We could not agree to the physiotherapists being brought in under the Bill. I share the view that there would be uproar. If they were conducting a trial, accompanied by a registered medical practitioner or under his auspices, there would be no necessity to have it because there are a whole range of people who could work with a registered GP. In the end the question boils down to, "what is a physiotherapist?" by way of statutory definition. There is none at the moment and I do not think we could contrive one in the framework of the Bill. It would require a separate piece of legislation such as registration of medical practitioners, registration of dentists and registration of the other professions.

As we know, placebos do not have a pharmacological affect. They are not prohibited by the Bill and the problem does not arise.

By and large the physiotherapists, who understandably may feel aggrieved at some of the comments I have made, do understand the situation. As Minister for Health I do not employ nor do I encourage the employment of physiotherapists by either the public or voluntary agencies unless they have undergone what we would call a recognised training and achieved a certain competence, but that is not a statutory recognition as such.

Amendment No. 1 to amendment No. 18, by leave, withdrawn.
Amendment No. 18 agreed to.
Amendment No. 19 not moved.
Section 5, agreed to.
Government amendment No. 20:
In page 5, line 37, to delete paragraph (b) and substitute the following:
"(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.".

The amendment is to provide for an explanation by the Minister of the reasons for revoking a permission. There has been some criticism about the absence of such a provision from the Bill as published and I have included there a quite specific statement that the Minister shall communicate the reason for his revocation of the permission to the person who had been granted the permission. I think that meets the criticism which has arisen.

I welcome the fact that the Minister has been prepared to come forward with an amendment requiring that where a permission to hold a clinical trial has been revoked he would have to communicate the reason for this revocation of the permission to the person who had been granted the permission. This was raised on Second Stage and it was a genuine concern.

I still have a further concern about the breadth of the second ground which allows the Minister to revoke a permission granted. Section 6 (b) reads:

for any other reason, the trial should not continue

As the Bill has been amended, the Minister has accepted that before granting a permission he would consult with the National Drugs Advisory Board. This was accepted in an amendment to section 3. It seems that the Minister is being given very unfettered discretion in relation to revocation. It would be easier to accept that there would be a power and, indeed, responsibility on the Minister's part to revoke a permission where the trial or any part of it was not being conducted in a manner in accordance with the permission. That is a necessary power and there should not be any requirement of consultation there. Under paragraph (b) all the Minister has to do is to communicate the reason, which is an important safeguard. It may be that the reason would not warrant revocation and if the Minister had an obligation to consult with the National Drugs Advisory Board the opinion they would give would be that, notwithstanding the circumstances that had come to the attention of the Minister, it did not warrant revocation of the permission.

Would it not be desirable, since the Minister accepts the requirement of consulting the National Drugs Advisory Board prior to giving the permission, that he should be prepared to consult them where he was potentially exercising a very open-ended power to revoke and where now he accepts it would be necessary to give the reason for revocation? I say this because if the permission is revoked there is no body to whom a person can appeal against that revocation. Therefore, it is important that revocation would not occur unless it was fully warranted and justified. I would have thought that the National Drugs Advisory Board would have a very crucial role to play in relation to that.

I am seeking clarification of a few points on section 6 and on the amendment. We are not told in the section or in the amendment what the procedure will be for communicating the revocation of the permission. If the Minister decides to revoke a permission, will the notification of the revocation be conveyed in writing to the person conducting the clinical trial? Must the clinical trial be discontinued immediately on receipt of the notification of the revocation, or how soon afterwards must the clinical trial be discontinued?

There are two elements in a clinical trial, first, the administration of the substances or preparations to the persons undergoing the clinical trial and, secondly, the monitoring of the effects of those substances and the investigations which would take place after the substances had been administered. If the notification from the Minister revoking permission for the clinical trial arrives after the substances have been administered but before the effects of these substances or preparations have been monitored, it would be wrong to discontinue the conduct of the monitoring at that stage. It would be most important that the monitoring of the effects of the substances which might have been administered should continue. Perhaps the Minister might clarify these points.

I support what Senator Robinson said in relation to the fact that there is no right of appeal contained in the section. Under this section the person conducting the clinical trial should have recourse to some appeal procedure or should have an appeal process of some sort available to him or her.

I welcome the Minister's amendment. This item brought the greatest criticism when the original Bill was published. The Minister says in his amendment that he "shall communicate". Does he have in mind a particular timescale within which he will communicate with the people involved in the trial, or is he obliged under the provisions of the Bill to communicate within a certain period of time regarding his intention to revoke? Section 6 (b) allows the Minister great room for manoeuvre and there has been previous criticism of that clause. Therefore, I would like the Minister to specify the other reasons.

I join the other Senators in welcoming this amendment. I spoke at length on this matter on Second Stage. It is reasonable that if a trial should not continue the reason for the revocation of the permission should be given to the person involved. The very strong criticism that was voiced when the initial Bill was introduced has been cleared to some extent by this amendment and for that reason I totally support it.

Would it be any help to suggest that section 6(b) might be reworded as follows:

That following consideration with the National Drugs Advisory Board in relation to the permission already given he believes there is a reason why the trial should not continue.

I am not opposed to considering a formulation of consultation on Report Stage in relation to this section. If, for example, the Minister of the day got information under section 10, which deals with the reporting of adverse reactions, it would be quite exceptional if he did not deal with the matter immediately. That is why we do not wish to have a time limit on it because he would perhaps ask for an immediate cessation of the trial. I would have no objection to providing something like the following: "If for any other reason following consultation with the National Drugs Advisory Board the Minister indicates the trial should not continue". I do not think we could provide for a further appeal — that would be like chasing one's own tail. I will come back to that on Report Stage.

Amendment agreed to.
Section 6, as amended, agreed to.
Amendment No. 21 not moved.
Government Amendment No. 22:
In page 5, subsection (1), lines 43 and 44, to delete "where the Minister grants permission for the proposed clinical trial to be undertaken," and substitute "where the ethics committee gives its approval in accordance with subsection (2),".
Amendment agreed to.
Amendment No. 23 not moved.

An Leas-Chathaoirleach

Amendments Nos. 25, 27 and 28 are consequential on amendment No. 24. Amendment No. 26 is related to amendments Nos. 24, 25, 27 and 28. All these amendments may be discussed together.

Government Amendment No. 24:
In page 5, subsection (2), line 45, to delete "members of the".

These amendments are to meet the objection that individual members of ethics committees could not be expert in all aspects of a proposal for a trial. Accordingly, I met the objections there and Amendments Nos. 26 and 27 are drafting amendments consequential on amendments in the previous paragraph.

I have a certain sympathy with members of ethics committees who are worried about their expertise but the evidence, and particularly the evidence given at the inquest on Niall Rush, would not give one any great confidence in the collective wisdom of ethics committees or their collective conscientiousness in doing what they are supposed to do. Some of the evidence at that inquest was quite horrifying about the laxness of the procedures involved.

I find it difficult to accept that what we have now is a committee which becomes a single body, an "it" rather than a group of individuals with individual responsibilities. There is nothing I can see in the Bill which would suggest what would be a quorum of the committee, which members of the committee would require to be present, or whether a committee could carry on in the absence of certain members. It is quite conceivable that a committee could operate consisting of one or two members without the lay members being present if the time did not suit them. This seems to me to be singularly unsatisfactory. If people are not prepared to accept the individual responsibility of doing the things which an ethics committee are supposed to do, they should not go on ethics committees.

Ethics committees are not rewards for people to show that they are eminent people in society who can be relied upon to do important jobs very well. They are extremely important jobs which should be done by people who take the job seriously and whose terms of reference, as defined by law, require them to take the job seriously. The people on one ethics committee of whose membership I am aware, which is the one quoted by the ICP in June 1986, all sound like eminently reasonable, concerned and interested people. As the Bill now stands, none of those people will have any obligation to be in attendance at meetings to discuss the proposed clinical trial and will not have any obligation to inform themselves about what is going on in a proposed clinical trial because all that will be required is that the committee as an "it" says something, does something, or carries out certain responsibilities and that could be done by one or two and no more. I would like the Minister to elaborate somewhat more on that. The representations I got by and large on this issue were not about the sensitivities of the ethics committee. They had far more to do with the manifest failures of ethics committees in the past to deal with things like frequent use of the same volunteers, the very doubtful procedures for recruitment, the question of the relative role of payment to people being induced to carry on. In those sort of basically very important areas the ethics committee not only did not meet the high level of responsibility listed in this Bill but failed at the most obvious ones.

It is astonishing, for instance, that as late as two months ago the ICP were not in a position to give me any information about the socio-economic background of the people they were having as volunteers. They could not say what proportion of the volunteers were unemployed; they could not say anything like that. If the existing ethics committees did not consider it worth their while to insist that that sort of obviously important information should be available, if they had not clarified the question of the procedures for recruitment, I do not think we should give a collective title to a committee and say that "it" may do this, that and the other thing. The least we can expect is that the individual members take their responsibility seriously. It may well be true that there are certain specific technical questions, but the vast majority of the things that are listed as responsibilities under this Bill for ethics committees are things on which a competent lay person should be able to make a reasonably satisfactory judgment.

If the Minister wants to put in a provision about a reasonable effort on the part of the members of the committee to make these judgments I will be quite happy, but to give a blanket exemption which means that all you have to do is put your name at the end of a page and the committee says it is satisfied and no individual has an individual responsibility to anything, seems likely to turn these committees into something like prison visitation committees which do a good job of giving the Department of Justice an easier ride than they otherwise would get.

As you recognise yourself, a Leas-Chathaoirligh, you need your wits about you at the moment to understand where you are with these amendments. As I understand it, although we have amended part of subsection (1) of section 7 it still contains the initial proviso that "where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting..." and so on, the Minister is still satisfying himself as to the competence of the ethics committee and then that will become the ethics committee for the particular clinical trial.

On Second Stage I put strongly to the Minister — I still want to come back to this, perhaps on the section — the reality of the present situation where ethics committees are ongoing committees; where people serve for a number of years and have a range of different experience and expertise. They are by no means all members of the medical profession, as the Minister knows, but they acquire a particular sensitivity to the issues and they would be the kind of people who would be responsible and able to examine the various matters under the headings set out in subsection (4).

I have considerable sympathy for the objection raised by Senator Ryan. At present, we have a section which requires the Minister to be satisfied with the competence of the members of the ethics committee to do the job. As the section stands the members of the committee must be satisfied under the various headings, but the Minister is now proposing to change that and to have the ethics committee in some way as a collective body but not necessarily with all of the members of it satisfied with the various criteria. There is no provision in the Bill for a quorum or for how majority decisions will be taken or any other matters and this seems to be contrary to the Minister's insistence, apparently, on having ad hoc ethics committees about whose competence he must be satisfied before they can be an ethics committee for the conduct of a clinical trial. The Minister owes the House an explanation as to why he is bringing in these amendments at this stage.

The difficulty I have had in relation to this section is that it is being represented to me very forcibly that there would be great reluctance on the part of individual persons, particularly lay persons, to serve on such committees if they had individual personal responsibility imposed on them and that was the position, as Senators are aware under the Bill as originally provided. I have consulted a number of bodies and I have taken into account the guidelines in the report on The use of Drugs in Biomedical Research by the Royal College of Physicians of Ireland of January 1986 and their particular approach. I have only taken it into account, I am not bound by it.

Regarding the manner in which the committee will subsequently conduct their business, I propose to issue guidelines in detail about the informal operations of the committees. To put all of that into the Bill would have made it a very, very big cumbersome Statute. The committee should act on a collective basis and have collective responsibility for their decisions. That is the only way in which one can get a broad cross-section of people to sit on those committees. Otherwise lay persons who have no expertise in the area may be entirely reluctant to go forward and participate on a community basis on such committees.

I support the Minister's concept of collective responsibility but I would qualify some of the matters which will be under trial. They could be so complex that there might, in fact, be no one on the ethics committee who would understand fully the implications. To put it another way, as has already been suggested many people on the ethics committee might not understand. If there is no one on the committee who can explain to the lay people the precise implications of what is involved in a clinical trial we must consider the possibility of co-opting someone for the purposes of explaining in layman's terms what is involved. After all it is very important that the people who are using their instinctive judgment about what is right and what is wrong, what is appropriate and what is not, should be fully informed. I agree with the issue raised by Senator Ryan about the number of people sitting on ethics committee. There should be some obligation to ensure that a minimum number are present while important decisions are taken.

I support the view of Senator Robb. Collective responsibility has to be the attitude and aim of an ethics committee. I have seen some of these medical protocols and certainly I support the view of Senator Robb that they are very technical and very medically worded. It requires a real medical presence on an ethics committee to fully understand them. All ethics committees should be loaded in that area; indeed, most of them I know have three or four medical and nursing people, people who have been involved in the medical profession over many years. It is also important from moral and other aspects that we should have a lay presence as well and again there is evidence that this is the case. These people are giving their time to help medical research and we should not do anything that would frighten them away from ethics committees. They are very responsible people. In the past ethics committees looked for more information from the National Drugs Advisory Board. The point made by Senator Robb, I understand it, is that at all of the ethics committee meetings the medical adviser for the company must be present — the medical investigator. He obviously explains the trial and the protocol to the whole committee. This raises the question of a national ethics committee.

The Minister might consider having a national supervisory committee who would advise and give guidelines to the various ethics committees throughout the country. Obviously we are talking about people connected with the National Drugs Advisory Board who are clearly expert and are well qualified to issue regular guidelines to ethics committees. This is something the Minister might look at. Certainly his amendment is an improvement.

I hope we are not going to be intimidated by experts. The reality is that the person who is to give the approval to go ahead with a trial will be the Minister. He will consult all sorts of important people but he will be the person who gives the permission and he will most definitely, on most occasions, not be an expert. He will have the best expert advice at his disposal. I will explain what I believe to be the real quality of an expert in a moment. It is offensive to the average lay person in the community to suggest that what the Minister can understand sufficiently well to be able to give his permission cannot be understood by the lay members who freely choose, and are under no coercion to do so, to go on an ethics committee.

The late Lieutenant-General Costello had a very definite view about experts. The real expert was the person who could explain things to an average citizen in a way that was comprehensible; the real inexpert was the person who could not, and pretended that because it was too complicated the lay person could not understand. There is nothing that cannot be explained by a true expert to an intelligent lay person in a way that enables the intelligent lay person to grasp it. That incidentally, in my view is the very essence of democracy — the idea that people are competent and qualified to understand everything to the extent of being able to make intelligent decisions about it. If they are not, we do not believe in the essential value of democracy.

The remarkable thing about democracy is that it has demonstrated consistently the capacity, by and large, of people over the last 100 or 200 years to do just that. People who are faced with difficult choices, hard and complex issues come to remarkably wise decisions. It is beyond me why lay people on an ethics committee who freely choose to be on it but who half the time, apparently, will not understand what is going on will still append their names to a report and say it is all right. There is quite legitimately a reasonable argument that perhaps there should not be a burden of proof on an individual member of a committee to show that they made a detailed study of each issue. It is reasonable to expect that there should be a requirement to take reasonable steps to understand what is going on, on each individual member of the committee. That would be a long way from this but, as it stands, we are going to have an ethics committee which could meet with one third, a half, or a quarter of the members, depending on the urgency of the situation, which could be made up of perhaps two medical people or, in the more extreme opposite case, two lay people. The Minister's assurance on guidelines is inadequate.

If we were going to talk about regulations which would prescribe the method under which the committee should meet, what should constitute a quorum, that a committee such as this should not be empowered to take decisions without the presence of at least one lay member of the committee, we are really leaving this thing wide open, not to abuse but to shortcuts when circumstances dictate. Inevitably, if we do not make it in some way a condition of membership of this committee that each individual member takes the job sufficiently seriously to understand what is going on, we will end up with active members who will have a long list of letters after their names, and honorary members who will be the lay people who will be there to give the committee a good impression in the public eye.

Therefore, I am still far from happy that this totally sweeping shift from individual responsibility to group collective responsibility is the proper way to ensure that an ethics committee take their job seriously. As I have said the evidence that came out at the inquest on Niall Rush suggested that the present ethics committee, for whatever reason, were not in a position to understand and did not take sufficient steps. The other evidence available is that they do not know the sort of socio-economic background or the methods of recruitment. Apparently they never got round to asking these things because the information was never compiled. All of these things suggest to me that we must define the responsibilities of an ethics committee and of the individual members far more closely than the amendment suggests.

I do not think I am talking at cross purposes with Senator Brendan Ryan; in fact, I would go a long way with everything he has said. I should like to tease out one or two aspects of the problem. If we have collective decision making certain numbers will be affirming, certain members may not know and certain members may be against. I would like to hear from the Minister whether the collective decision will be a majority decision, or a consensus decision, or will the committee go on discussing the matter until there is general agreement that they are for or against the proposed trial.

The essence of the whole problem is the point raised by Senator Ryan, and he could not have done better than to quote Lieutenant-General Costello because that is the right definition of an expert. Whatever way the committee is constituted and no matter how it does its work, it is vital that the people who are in it, and particularly those who would not claim to be expert, fully understand what they are doing and feel free to participate in the discussion even if they are not experts. As I have heard said at many meetings in the North in recent years, spare us from the experts. The experts are the products of a refining process, a reduction process. The layman, as he is called, the person who is the non-expert, is relating to the thing by instinct and by feeling and he knows instinctively what is right and what is wrong, but he does need information. A propos of what Senator Ryan was saying, Eric From, the philosopher, once said that the price of freedom is choice and in that sense it is the choice of the individual and not the choice of the group — but we will not get too philosophical.

I return now to a point made by Senator Fallon. He emphasised the need to consider this collectively. I was a little concerned, however, about the suggestion that the drug company expert or doctor went to no end of trouble to explain what was involved. I am quite certain there is a high level of ethics and a high standard among the vast majority of drug company doctors but, nevertheless, they are representing a commercial enterprise and the drug companies are there to make profits. If one is subjected to many different people coming with very much the same sort of drug — as the Minister will know, under many different colours, covers and names; one using a minor parameter which is different from the others — one will know the sort of pressures which these people are under, not unlike the pressures which prison doctors suffer when they are employed by the State and, according to their ethics, there should be nothing between them and the prisoner. There is a problem there, so I would be wary of taking all my advice and information from even the most highly prized expert or even the most highly paid non-expert of the medical profession representing a drug company if he is to be the sole presenter of the information which is being sought. It comes back then to a point Senator Mullooly made the last time we discussed this — the need for independence, the feeling of independence, the right to an independent attitude and the encouragement of an independent point of view and voice, so that we can blend together in this ethics committee, for the benefit of the individual be he a non-expert or expert, the right ratio and insist that there are enough members of that committee present so that, when the decision is made, we can have as much confidence as it is possible to have that it is the right decision.

A number of critical and important points have arisen in contributions by Senators. We reviewed the responsibility of individual members of committees. We reviewed it very thoroughly with the Attorney General's office and the legal advisers of the Department. It was a very difficult decision to take but our view was that we had drawn up the original section too tightly in terms of imposing individual responsibility and we felt it would be more appropriate to have a collective devolution of authority and responsibility on the committees as a whole.

Senator Fallon inquired whether the NDAB would be consulted and if they would be in a position to advise and bring forward formal proposals regarding the composition of committees. The answer, I can assure the Senator, is in the affirmative. They intend to do just that. The NDAB have a particular view, which they have conveyed, and they would regard the composition of an ethics committee as follows. A minimum composition might be as follows: that there would be two medical practitioners, neither of whom would be personally involved in the study to be conducted; one practitioner at least should be independent of the institution in which the study is being conducted or is to be conducted; one at least should be personally familiar with the conduct of clinical trials generally; and then on the paramedical side, one would have to have a nurse actively involved in patient care, involved in the composition of the committee. Certainly, the view of the NDAB is that because of monetary considerations and financial issues which inevitably arise, the cost of the trials, assessment and so on, and whether inducements are being offered, there should be a professional, non medical-person with experience in public administration or industry who would be in a position to evaluate that question. The other two people involved would be members of the lay public whose competence and general integrity would be held in regard. That is essential for such a committee. Of course, inevitably, legal questions would arise. There is a view that a person with legal competence or background, not medical legal competence, should be on the committee since litigation problems could arise. That would be a committee of about six people and would be the general minimum structure.

Would the Minister be happy with that type of broad concept of composition?

Yes. That would be the broad concept. In consultation with the NDAB there are a number of documents available. The Royal College of Physicians of Ireland have ethics committees, and they have publications relating to the composition and procedures of ethics committees, membership and the whole question and mode of working of the committees. These documents are available as are the Journals of the Royal College of Physicians of London. Together with the NDAB, we would propose to issue pretty comprehensive guidelines for the operation of those committees under the Act. We have that advantage. They do not have the advantage of having an Act and to that extent, I am slightly jaundiced about some of what is written down and what is practised in reality but, nevertheless, we will have a stronger overview.

It is a difficult question, because the Minister of the day has to be the repository of all knowledge in this area, but he will have to be satisfied one way or the other about the qualifications and the bona fides of those he will allow to take on the responsibility of technical evaluation on his behalf. He will have that confidence.

Those are the main points I wish to make. The original wording was that bit too tight and could result in a substantial number of persons refusing to serve either professionally or in a lay framework, because they would have personal responsibility as members of the committee devolved on them. I cannot really say a whole lot more. While I have said to Senator Ryan that I would broadly accept ethics committees of the kind the NDAB have listed, I want to assure him that I will not be giving blanket approval for clinical trials because I am very unhappy about general blanket approval or sloppy administration in this area. It is a very dangerous, difficult area and, therefore, each ethics committee will have to be approved by the Minister of the day. I can see him doing a great deal of midnight work on files, but he will have to accept that responsibility if we want to have that kind of work done in a publicly responsible way.

I have been talking to some companies and a number of professional medical representatives. They feel that once this Bill is enacted and the Act is there at least they will know the position with regard to litigation. There is nothing worse for a major pharmaceutical company than to come to a country and not know where they stand if problems arise. We have a very large number of such companies in Ireland. They are major companies and quite a number of them would be prepared to accept a regime because, while there are cowboys in every industry, it can be very difficult to deal with them. There are quite a large number of companies in the industry who wish to act in an ethical manner and they are very proud of the product authorisation which they get from Ireland. I know how difficult it is in some countries to get a product authorisation. I will mention France, for example, where frequently consumer authorisation is denied more for commercial reasons than for any other reason to preserve the monopoly situation of French companies. With Irish statutory backing, particularly in the European Community, it should be possible to break into such markets more effectively. While I digress to that framework, I broadly accept what Senator B. Ryan and Senator Robb have said. I share their views in that regard. I can see the NDAB having a lot of midnight work to do as well to satisfy the Minister of the day on a mutual basis.

I want to clear up a couple of things. What is the difference between the legal accountability of the members of the committee under the Bill as it is at present and under the proposed amendment? In other words, if there were a court case and there were an investigation as to whether the committee as a group fulfilled all obligations required to be fulfilled, what would be the effect on an individual member of the committee of what is proposed in the amendment and what is contained in the Bill? That is the first question.

Is the Minister referring to guidelines in the form of regulations or is he simply talking about guidelines by way of a departmental circular? Departmental circulars may have awesome capacities behind them but they have no legal standing and, therefore, the ethics committee would be perfectly free to ignore them or to say that the exigencies of the situation by way of time or some other issue prevented them from following all the guidelines. One useful solution would be to issue guidelines by way of regulations for the operation of ethics committees, in particular on what constitutes a quorum and also how they come to decisions. Is it majority decisions, two-third decisions, or consensus? I would like to have these two specific questions answered.

Regulations may be made under the Act. Certainly should I have the opportunity initially it would be my intention to lay down informal guidelines and have them instituted, operated, reviewed and if necessary bring in statutory regulations relating to the guidelines themselves. It can be done. Senators know my personal impatience about such matters. I prefer to do everything today but we have to get the informal guidelines moving first and moving well. If they prove to be impossible or if they are circumvented in any way, we can bring in statutory guidelines under the Act and they would have the full rigour of the law.

The same applies in relation to the legal responsibilities of ethics committees. The Minister of the day will have to be very careful to ensure that he has established an ethics committee prepared to accept the legal responsibility because as the Senator knows, they can be co-joined in any action against the Department of Health, the Attorney General, the People of Ireland, against the company concerned and the NDAB. It is no secret that the NDAB are very concerned about that kind of litigation. In fact, without disclosing too much before this House we have had considerable discussions with the NDAB on the question of their liability and their indemnity in relation to the work they do. This is one of the main reasons the Minister for Health rather than a board of the NDAB must take up the public indemnity.

I asked what was the difference between the position of an individual member under the Bill as published and under the amendment?

The fact that he is emphasising a collective decision would not give him an exemption because each member of the ethics committee would be cited if a trial went disastrously wrong. They would all be cited. They would not have the option of saying: "I did not agree, I was one of five or six". It is rather like the Christmas bonus.

The Minister will have his own liabilities in that area.

An Leas-Chathaoirleach

He will deal with that.

In my opinion that is not clear from the Bill. Whatever problems would have arisen about the individual's responsibility will arise again if it is made clear to the members of an ethics committee that they are personally, via the committee, going to be actionable for improperly carrying out their duties, that it is not something that would be carried by the people conducting the trial. If, as the Minister said, the committee are still capable of being co-joined as a party in a court case I am not sure the amendment makes as much difference as I thought it did. It was suggested that people may be unwilling to serve on committees if it is possible to seek damages from an ethics committee because they failed to carry out their duties — that the entire committee would be sued. It is all the more reason to ensure that the procedures by which the committee operate are clearly written down and are available and are seen to be followed.

It would be difficult for a member of a committee to do other than resign if the committee failed to follow the departmental guidelines, whereas if the departmental guidelines have statutory force at least by way of regulation, the members of the committee could insist, if necessary through the courts, that the statutory procedures for the operation of the committee should function. I can see why the Minister would be very enthusiastic about having an informal set of guidelines to see how they would work. Although he probably cannot say it as bluntly as I can, I think the Minister agrees with me. Committees in the past seem not to have overly exerted themselves in seeking information in a number of areas, at least judging from the absence of that information on the part of people conducting the trials. I wish he would say he would do this by regulation and tell the committee how they must at least conduct the outline of their affairs rather than wait and see how it works. His successors may not feel they want to get involved in what is a difficult area as the Minister I am sure knows only too well.

Amendment agreed to.
Government Amendment No. 25:
In page 6, subsection (2), line 1, to delete "each".
Amendment agreed to.
Government Amendment No. 26:
In page 6, subsection (2), lines 3 to 5, to delete "the committee consider that the proposed trial is justified and are satisfied with those circumstances, they shall give their approval" and substitute "the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval".
Amendment agreed to.
Government Amendment No. 27:
In page 6, subsection (3), line 9, to delete "they are" and substitute "it is".
Amendment agreed to.
Government Amendment No. 28:
In page 6, subsection (4), lines 12 and 13, to delete "each member of".
Amendment agreed to.
Government Amendment No. 29:
In page 6, subsection (4), between lines 22 and 23, to insert the following:
"(e) the policy of insurance to which section 9 relates".

This is a brief amendment. It will require the ethics committee to have regard to the policy of insurance proposed for the cover of participants. That is the main purpose of the amendment.

Amendment agreed to.

I move amendment No. 30:

In page 6, subsection (4) (f), line 27, after "trial", to insert "and in particular the need to ensure that each participant's medical condition is monitored in the long-term so that any long-term effects of such trials are identified".

This is an attempt to elaborate on one aspect of the statutory duties of the ethics committee, which are listed in subsection (4), paragraphs (a) to (1). It refers to paragraph (f):

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

I propose to insert:

"and in particular the need to ensure that each participant's medical condition is monitored in the long-term so that any long-term effects of such trials are identified".

This representation was made to me by a number of people. There is a matter of clinical judgement being left here, which might be fine if these people were undergoing medication. The longer term effects are both a risk and a possibility. If people are authorised to conduct trials on human beings, they ought to be obliged, at reasonable intervals, to check that there is no long term effect on people's health as a result of such trials. It was alleged at the inquest on Niall Rush that one person did 12 different trials in six months — I think it was Niall Rush himself. Therefore, if you are going to have some participants in a number of trials — both of the groups who communicated with me conceded that some people did more than one trial, that they did a number of them — there is a particular obligation to ensure that not just the immediate effects of one trial are monitored but that the long term and perhaps cumulative effects of a number of trials are also monitored.

It is important for lay people to realise there are no absolutes in science. There is only the best reliable information at the time, which may or may not be reliable, which may or may not have a degree of inherent unreliability built into it. Science cannot give absolute answers — unless you want to go back to very basic things — and medicine even less so. It can only state the balance of probability and it can assess the degree of probability. It cannot state absolute certainty. It cannot even say somebody with a particular ailment will definitely die, any more than it can say that somebody with a particular ailment who gets a particular treatment will definitely live. There are no absolutes in science and less so in medicine. Therefore, there ought to be, in some form or other, a responsibility on those who systematically conduct clinical trials to look to the long term effects, if any, on a participant's medical condition.

I will not argue about the wording of my amendment but I am interested in the Minister's views — and I hope his agreement — on the need for longer term monitoring of subjects' health and also a statutory obligation of some form on those conducting the trials to do this.

While agreeing with the sentiment Senator Brendan Ryan has just outlined, I can see enormous difficulties arising. He is quite right. You can have long term effects. Nobody knew what the long term effects of Hiroshima would be. The question is whether you will monitor people for a year, for five years, for ten years, or for life. It was fashionable in academic institutions in recent times to literally possess patients, to put a label around their neck with whatever the disease was, and to follow them up for the rest of their lives. Very often they are seen by a junior member of staff who did not relate to the consultant who had originally seen them. "ISQ NAD see in six months" was written on the chart — NAD being nothing abnormal discovered. It was routine. If a university or a hospital is doing research, very often it is done by a young person who is not in that institution for very long. How is he to follow up the object of this study? If it is an industrial pharmaceutical firm we all know that firms come and go. Capital flows in the direction best suited to it. Therefore, the people who might have carried out the research might not be in the country to carry out the follow-up. You also have the subject of the research and in a very mobile world he or she will not always reside where the research took place initially.

I take Senator Ryan's point and I feel there is a need to clarify the obligations of the people undertaking the research in relation to follow-up, but I think it would be unrealistic to see this in the very long term. You might overcome this difficulty, in part at least, if after the initial follow-up had been done over the specified period a report was sent, in the usual fashion when a person is discharged from hospital, to the family doctor of the person concerned. The family doctor should, by the nature of things, be the person who knows the medical record best. Family medicine is changing rapidly, more so perhaps in the North than in the Republic. There is a new generation of family doctors who are much more health orientated than disease orientated. The whole practice of family medicine has been redefined. It has become much more community based. There is a realisation that for a number of decades the professionals had moved away and become alienated from the clients. That relationship is being looked at and a better one is bound to come through in the next ten years or so.

While I agree with the point Senator Brendan Ryan is making — and in an ideal world I would pursue it — I think it is impractical and I have, therefore, suggested a way around it.

Would the Minister explain the consequences of the amendment? Are we actually taking on board something which we might regret? On whom is the onus to follow up the long term medical condition of the participant? A commercial company carry out a trial. The product authorisation is granted. If there were recurring symptoms, necessitating hospitalisation and further medical attention, the responsibility of the commercial company would have ceased and the State would have to pick up the tab for monitoring, hospitalisation or medical care after the trial had ceased officially. In the instance of long term monitoring, it could lead to very expensive and cumbersome treatment being paid for by the State who would have to pick up the tab for a commercial enterprise which had started the trial. For that reason I am reluctant to support the amendment. Perhaps the Minister could throw some light on it.

May I ask Senators to refer to section 7 (f) of the Bill? It is as good a formulation as we could come up with on the question raised by Senator Brendan Ryan and Senator Robb and his colleagues. The section refers to: "the extent to which the health of participants is proposed to be monitored during and after the clinical trial;" in effect the committee would have to be satisfied about the extent to which it is proposed. In that framework, it can if it wishes and it would have the professional competence to so state its inquiry. It could deal in particular with the long term effects on the health of a volunteer or a participant — whichever we might call him — and it would be quite open to it to insist that there would be long term monitoring because the purpose of some particular trials might be to induce a long term change or effect. One can readily think of medical conditions where the long term effects of a particular trial are the all-important aspects. Therefore in that framework by putting in the phrase "during and after the clinical trial" the Attorney General would hold that the understandable concern of Senator Ryan and his colleagues would be met. I want to thank Senator Robb for his observations on the matter. I would point out that not every participant will of course have a GP to whom a report may be sent. Senator Ryan has been quite scathing about the absence of a GP relationship which many participants would have. That poses a problem, but in short we do not consider the amendment as formulated to be absolutely necessary, because it is covered by 7 (f).

I am quite certain that if the present Minister was to remain in office for long enough the situation prevailing in the Republic — whereby people can exist without GPs would be rectified. I think that is a disgrace, that there can be, as the Minister has perhaps suggested, quite a number of people who would not know to whom they should go for medical care if and when they need it. I have actually written in here my suggestion for overcoming the difficulties just by adding the words "and that a discharge report be sent in the usual way to the subject's family doctor advocating appropriate follow-up when this is deemed or where this is deemed necessary". The fact that the issue of the family medical service has been highlighted has been worthwhile in itself regardless of or as well as drawing attention to the need for follow-up and trying to keep follow-up in its perspective.

The Minister has underlined one of the fundamental problems of this whole business, that the type of people who do not have GPs should not be involved in these tests in the first place. The reality is that if we did not have somewhere between 50,000 and 250,000 people unemployed the two major clinics in this country would be desperately short of volunteers. It is very difficult for them to persuade people who are not stuck. Let us not pretend that it is all to do with unemployed people having free time or leisure time which they are happy to put at the disposal of the future of humanity. It is nothing like that at all. The reason why unemployed people in large numbers are prepared to undergo these trials, the reason why unemployed people are prepared, — in the case of Niall Rush, to do six trials during the nine months before his death — is that money is on the table for doing them. One simple solution would be to specify and require that a person's GP be contacted and if a GP was not available to say "right you do not have a regular GP". The excuse would be that these are healthy people who have never been to a GP. I think that by the time somebody is a full adult they will have been to a general practitioner. If they have not been, the risk of taking on a person who does not have a GP is so much greater than the inconvenience to a group conducting a trial of having to find somebody else. The evidence at the inquest on Niall Rush was that all sorts of short cuts were taken. Half a dozen recent volunteers testified and gave very similar evidence, which is a long way from the high flown phrases of the people who run those clinics. Consequently, I accept and I am happy to accept that the implication of paragraph 7 (f) as stated by the Minister does contain at least the possibility of long term monitoring. I am not happy that we could have a position that people could be tested who did not have a full medical history to be presented to the potential conductor of the trial from a GP. It gets us back to things we will discuss again about where do volunteers come from and how do we deal with them. I am not prepared at this stage to push the amendment to a vote because I do not think it is necessarily the most fundamental amendment and I would like to sit back and think about it and perhaps introduce a somewhat similar one at a later stage. However, I do not want to terminate the discussion before Senator Robb has spoken.

I think one of the matters that might be taken up by the Minister in his guidelines is that before a person embarks on a trial it should be known who their family doctor is (a) for the very simple matter that you have easy access to medical records if such exist, and (b) so that after a clinical trial a family doctor can be informed that it has taken place and as I have suggested that any further appropriate follow-up beyond the length of the trial and the natural follow-up which should take place after the trial, could be looked after by him or her.

I would briefly say that I think the suggestion made by Senator Robb and indeed by implication by Senator Ryan's colleagues that such a provision should be incorporated into the informal guidelines, I can certainly assure Senators that I would be quite prepared to incorporate it, I do not think it would be constitutional or possible to have as a pre-condition that anybody going on a clinical trial would have a named general practitioner.

Certainly what Senator Ryan is suggesting is laudable indeed. Again the practical reality, and indeed I know many of the young men and young people who take part in these trials is that they would not have a GP. Remember this before you go on a trial the two most important criteria — this is what the Bill is all about — are to ensure that you have health specimens and informed consent. They are the two principal things. I believe firmly that these requirements should be part and parcel of every trial that, you should have a healthy specimen of a young man over 18 and so on. Again we must remember that at the start of a trial, at the conclusion of a trial and many times during a trial the participant is medically examined. I would love to think that every one of these participants had a GP and that reports and so on would be followed up. Knowing many of the participants as I do I have to say they have not seen a doctor for ten or 12 years. To make that in any way obligatory would seriously impede trials. I understand Senator Brendan Ryan's real concern in this area but it will not work because it is not practical.

Amendment, by leave, withdrawn.

I move amendment No. 31:

In page 6, subsection (4), lines 31 to 33, to delete paragraph (h) and substitute the following paragraph:—

"(h) details of the method by which participants are to be recruited."

This is an amendment of a very different kind. I put it in this form because I have a later amendment coming up which refers to payments. I am suggesting that paragraph (h) which refers to "details of any proposed inducements or rewards, whether monetary or otherwise to be made for becoming or being a participant..." be deleted and a simple paragraph substituted on the details of the methods by which participants are to be recruited.

There is a disturbing and devastating body of information which suggests that people were paid in Dublin to visit hostels to recruit homeless people to do trials. That is utterly and completely unacceptable to me. I have a strong suspicion that it would probably be unacceptable to the Minister. Given that this was one of the areas of concern about this whole business that has been talked about over and over again, it is important that there is a reference to the methods by which participants are recruited as distinct from the criteria under which they are recruited.

The methods of recruitment ought to be a matter statutorily laid down for the concern of the ethics committee. It is a matter of fundamental ethics that people should not be paid to travel around hostels and night shelters in Dublin inducing people to undergo clincial tests. In many cases the people being recruited have very little information about the tests. There was the extraordinary case where a parish priest in Dublin who was on his pastoral duties in a night shelter was approached by an individual and asked would he do a set of trials in which he could make easy money. He discovered that the individual who had approached him would be paid for each volunteer who turned up having been recruited by himself. These facts were denied for a long time by the people who run these trials but when the evidence accumulated the position shifted somewhat.

Therefore I regard it as fundamental that the details of the procedure and the methods by which participants are recruited must be studied by the ethics committee on every occasion on which they propose to do or to supervise a clinical test. Anything less will leave a gap in an area which has been documented beyond any doubt to be one of the real areas of public concern. I put down this amendment so that the ethics committee shall have regard to details of the methods by which participants are to be recruited in order to eliminate what has become a most scandalous exploitation.

I want to reinforce what Senator Ryan has said by reading from a letter which I got with a cheque dated 1977 which has yet to be cashed. The letter states: "Also we confirm that for every ten completed patient record cards received by us between now and 31 March 1978 a further payment of £15 will be made to you." I do not think I need say much more by way of emphasising the point Senator Ryan made.

I support both Senator Ryan's and Senator Robb's case for this amendment. There is an element of racketeering going on and Senator Ryan's amendment brings more clearly into the common person's perception the reality of what is happening on the ground rather than any other confused way there might be of putting it in the Bill. I warmly support Senator Ryan's amendment.

I do not oppose Senator Ryan's amendment. It should be part and parcel of the ethics committee's function to discuss this aspect and to issue guidelines.

As we know, the ethics committee must examine the qualifications and competence of each person conducting the trial. They must be satisfied as to the nature and extent of the medical examination participants undergo as volunteers in the trial. They have to examine the details of any proposed inducements, rewards or payments made to persons for conducting the trial. There are many criteria laid down in section 7(4). I could meet the wishes of the Senators in that regard and try to marry in the amendment proposed by Senator Ryan if it were to read — I have to talk in a very open way because the parliamentary draftsman will fashion the wording in the appropriate way — as follows: "...the criteria to be used for the selection of participants including the method by which participants are to be recruited". I would not have any objection to that. The parliamentary draftsman and the Attorney General have already assured me that the criteria to be used for the selection of participants is encompassed by that phrase. I wish to accommodate the views of Senators as far as possible. If it would clarify the section even further, I would be prepared to add on that phrase subject to appropriate drafting on Report Stage.

Amendment, by leave, withdrawn.

I move amendment No. 32:

In page 6, subsection (4), between lines 43 and 44, to insert a new paragraph as follows:—

"(m) the socio-economic background of each participant and the need to ensure that the lower socio-economic group are not over-represented at such trials."

This amendment in many ways follows on from my previous amendment. It also follows from the astonishing experience I had of discovering that the ICP had no records as to the socio-economic background of the people being tested. They admitted that a great number of the participants in their trials were at least "partially unemployed". Apart from grounds of social policy I would have thought that on medical grounds alone the socio-economic background, the nutritional background and the housing background of each participant would be important.

This is important and this is why I deliberately worded the amendment: "the socio-economic background of each participant and the need to ensure that the lower socio-economic group are not over-represented at such trials". If there is any evidence of an overly high representation of lower socio-economic groups in an area where there is a risk that the majority of society are not prepared to take one has to cry halt and cry exploitation. It is difficult to envisage any reason other than the attraction of material inducement which could arguably result in a disproportionate representation of lower socio-economic groups at such trials. I cannot see any reason other than that. If the reason is that they are being attracted by rates of payment or other kinds of inducements, that is wrong. It is wrong because it adds yet another level of burden and abuse to an already excessively abused group — the lower socio-economic groups. It is extremely important that it should be an obligation to keep this sort of information and to ensure that there is reasonable representation of all sections of society.

This may sound a bit unrealistic but if it is the affluent and those of conspicuous consumption who demand that various drugs be made available to heal them of the consequences of excessive and conspicuous consumption it seems a bit much that those who will never be able to afford that excessive and conspicuous consumption should have to pay the medical price of discovering the drugs to pay for other people's excesses. That is putting it in slightly extreme language. Nevertheless basic fact is that up to now these groups did not even bother to collect this sort of information. We should make it obligatory and also ensure that there should not be excessive representation of the lower socio-economic groups in these trials.

While agreeing with the general thrust of what Senator Ryan said what needs to be emphasised is not so much that over-representation but the exploitation. I would have preferred if the amendment had read that the socio-economic background of each participant and the need to ensure that the lower socio-economic group are not exploited as would be indicated by such as their over representation. The reference to exploitation is important.

I do not like using emotive language.

I do not think the language is emotive. It does not necessarily follow that over representation is exploitation. This is where I would take issue with you although I agree that it is an indication.

I can assure Senator Ryan that I have tortured myself, tortured the Attorney General and his parliamentary draftsmen with the sentiment expressed in the proposed amendment. It is not simply possible in legal terminology, or indeed in a legal concept, to put the formulation as such into the Bill. As we well know the structures of socio-economic backgrounds in Ireland are in many ways disintegrated. They are subject now to an enormous variation of influences, such as money, social attitudes, education and other pressures. Therefore, to lay down a specific criterion of that nature in the Bill is simply not possible. I will certainly insist in the guidelines on the taking of general epidemiological data relating to all volunteers. That data will be subjected to very subjective assessment and a person who ostensibly comes from the top socio-economic background can be enormously vulnerable in terms of trials. Therefore, to say that the lower socio-economic groups should not be over-represented frequently begs questions in relation to other groups.

In terms of the difficulties we have had, I will quote from the informal guidelines of January 1986 of the Royal College of Physicians of Ireland. I am quoting from these guidelines more for the information of Senators rather than to pass judgment on it at this stage. The college state:

Healthy volunteers are important contributors to medical research. Unfortunately, at present, they are often vulnerable individuals (unemployed, low paid workers and students) who are primarily participating for financial reward. Drug abusers may present a special problem. We feel that efforts should be made to widen the volunteer pool. Ethics Committees should be informed of all proposed payments to volunteers and should be satisfied that they are reasonable and are not so large as to induce subjects to take risks primarily for a reward. Advertisements seeking volunteers should be seen and approved by the Ethics Committee. If healthy volunteers are to be recruited in another institution, e.g., students, staff, then a responsible officer of that institution should be informed and general approval sought in case participation could adversely affect work performance whether through drugs, action or absence from work.

They go on to deal with many other aspects. There is even the problem where a child may be sent forward with agreement of the parent, the parent being in a low socio-economic group and participating in a particular trial. The college are quite specific in relation to this. They state:

Children should not be the subject of research that might equally well be carried out on adults. Children should in no circumstances be the subjects of research holding no potential benefit for them.

I would have a problem with this because I would then have to consider the question of, for example, mentally handicapped persons and what proportion of mentally handicapped persons could or could not be included in research. The current correct guideline is that they should never be the subject of research that might equally well be carried out on adults in full possession of their intellectual faculties, but they are clearly the only subjects available with the particular mental disease or disability, with the agreement of the immediate family. One then has to go down through the other criteria. It is a very difficult area.

In short, the terms used by the Senator are not precise legal terms. I hope to see the epidemiological background built up and then see the ethics committees on an informal and regulatory basis given definite guidelines. I do not think it is possible to put it into the Bill as such.

Is the amendment withdrawn?

Not quite, but you will be glad to hear I am moving in that direction. The Minister has made a very good case. I never felt I was in competition with the parliamentary draftsman when it came to drafting amendments on Committee Stage. Therefore, I never worry if the drafting of an amendment of mine is inadequate. If I can persuade the Minister in question to accept the principle involved I am perfectly happy to let the Minister go ahead and persuade the parliamentary draftsman to draft the appropriate amendment. Having witnessed and having had to understand some of the creations of the parliamentary draftsman I was never too overwhelmingly intimidated either.

Nevertheless, I hope the Minister will refer specifically to the issue of excessive representation of unemployed people in the pool of participants in clinical trials in his guidelines. I am not at all clear from what he said that he shares my view that there is something very suspect in this. I keep wondering what countries like Switzerland and Sweden which have thriving pharmaceutical industries and very low to minuscule unemployment do in relation to clinical trials. Switzerland has virtually no unemployment. Do they actually export their trials to other countries like ours where there are large numbers of unemployed people available, or do they have a different method of recruiting volunteers? It intrigues me how some of the countries who have the most prominent developing pharmaceutical industries can carry out clinical tests if they have no unemployed people because the argument is that if it were not for unemployed people nobody would volunteer.

It has been suggested to me that there are other groups who participate in a big way. I hesitate to mention them because I would only get myself into a row peripheral to the issue. I would like the Minister to clarify that the guidelines will advert to the need to be particularly careful that unemployed people, hostel dwellers etc. are not seen to be excessively overly represented among participants in trials.

I would like, in setting out the informal guidelines, to bring many factors to the attention of the ethical committees, for example, many drugs which are entirely related to the conditions of women. There are many very vulnerable women who are not unemployed and not necessarily in the lower socio-economic group who may wish to participate in such trials for multiple reasons. These women need protection. Many criteria have to be taken into account in directing ethics committees to have a fair and reasonable sample — I detest the use of the word — of volunteer participants. That will have to be examined in great detail.

As I indicated, it is not possible to put it in the Bill in a formal ratio basis. There are 12 specific areas of regard inserted into the Bill and the general view is that one could not refine it down much further by absorbing the point made by the Senator. I totally share his view that if there is exploitation of persons in the lower socio-economic group to induce them on a financial basis to participate in trials which might in any way injure their health, that is reprehensible and would be totally opposed. I would not give a cent to any trial going ahead on that basis. Each trial has to be examined in a particular way. For example, there are trials specifically for the elderly. Inevitably one might have 25 pensioners between the ages of 68 and 75 years on a relatively low income. For such a trial one would only have that cohort of people. One cannot put that into a Bill. Similarly as frequently happens one may have 40 people who suffer from multiple sclerosis and by virtue of enormous disability their income may be very low. They may be all on DPMA. After a long analysis in an effort to conduct a trial relative to that condition the persons may agree to undergo the trial. It is impossible to encompass that within a statutory framework but it is possible to do so in the context of the criteria for ethics committee setting out on that road. If necessary one can do it by formal regulation. There are hundreds and hundreds of trials in the country, many more than people are aware of and as such the Bill will set a framework. I certainly share the sentiments of the Senator and wish I could encompass them in the Bill but it is not legally possible at this stage.

Amendment, by leave, withdrawn.
Government amendment No. 33:
In page 6, lines 44 to 47, to delete subsection (5) and substitute the following:
"(5) The composition of the ethics committee may at any time be changed with the approval of the Minister.".

This amendment is designed to remove the concern that, in the Bill as published, the applicant for permission appeared to have the liberty to alter the ethics committee the composition of which is normally a matter for decision by the institution where the trial is taking place. That meets a concern of Members of the House that we might have left a loophole in the Bill. We have closed it.

Amendment agreed to.
Section 7, as amended, agreed to.

Acting Chairman

Amendments Nos. 34, 36, 42 and 43 are related and may be discussed together.

I move amendment No. 34:

In page 7, subsection (3) (a), line 8, after "is" to insert "not of a low I.Q. and is clearly".

Briefly, this is just another criterion. I would like to be assured that people bordering on the mentally retarded or who have an extremely low IQ would not and could not be accepted for a trial. I know every effort is made to explain in great detail in simple English what a trial involves but, nonetheless, in the knowledge that consent is so important in a trial and that it be given freely and openly, there might be some people going through these trials with a very low IQ or bordering on mental retardation. The Minister may say this is covered in the guidelines but I am simply highlighting the fact that such people should not be included in trials.

I have examined in detail the proposed amendment and I do not consider it to be necessary because section 8 (3) is very specific. It states:

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.

If these two fundamental criteria are not adhered to the consent will not be valid. That section is not going to be messed around with by anybody in the organisation or by obtaining consent from persons who would be directly involved.

Amendment, by leave, withdrawn.

I move amendment No. 35:

In page 7, subsection (3), between lines 11 and 12, to insert a new paragraph as follows:—

"(c) a reasonable period of time has elapsed between the person being informed of the nature of the trial and his participation in the trial."

This is in addition to two quite stringent sounding conditions for consent. It is a suggestion that a period of time should elapse between the person being informed of the nature of the trial and his participation in the trial. In other words, people should have time to reflect on what they are actually undertaking.

The Institute of Clinical Pharmacology in their document state — though evidence would suggest that this is not always followed — in their paragraph on informed consent:

A comprehensive verbal explanation of the study is given by the examining physician. Following this, the volunteer is given a typed study information-consent form to consider at home.

That is what one of the groups conducting clinical trials at present asserts is done but a fair amount of the evidence supplied to me shows that that is not what they do: that is what they assert is done. Therefore, all I am suggesting in this amendment is that we should make it clear that people who are informed about the nature of a trial ought to feel free to withdraw that consent and, in order to feel free to withdraw that consent, they should be able to take some time. I did not want to make it too specific and talk about overnight or something like that, but there ought to be a reasonable time period allowed within which people can reflect on the information given to them, can read and think about it and perhaps seek advice from somebody else if they are unhappy about it. We are not talking about confident, articulate people; we are talking at the very best about a random selection of our society and people ought to be in a position to think about things like that and perhaps discuss it with their spouses or with their families if they are so concerned.

Therefore, it would not be an unreasonable requirement to suggest that a reasonable period of time should elapse between the time people are informed of the nature of the trial and their participation in the trial in order to allow any second thoughts they might have or qualms they might have to surface. This is not something into which people should be rushed quickly; it is something over which they should have as much control and feel as much control as possible. Therefore, I move the amendment that a reasonable period of time should elapse between the time a person is informed and the time they participate in the trial.

Section 8 (5) is quite adequate and perhaps in many ways stronger than the time gap suggested by Senator Ryan. Section 8 (5) says:

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.

I would have great difficulty in specifying a reasonable period of time. I can sense and understand what Senator Ryan is proposing, that from the time of signing a consent there should be a gap of some period before the trial would commence. I can see the point the Senator is making but, on the other hand, one does not want to be too — I cannot get the correct phrase; I suppose in some ways it could be paternalistic. If the trial is due to commence the following week the person is entirely free to withdraw his consent an hour or even ten minutes after signing the form. He can withdraw his consent at any time. If one says that a trial cannot commence for a period of one week or for a period of 20 days and so on, there could be objections from people.

Equally, there is the problem that some trials relate to people with particular conditions. They may have a terminal cancerous condition and it may be a matter of last resort. Admittedly, it is not a trial; it is clinical treatment, but the person might agree or, in the case of matters relating to fertility where only at specific times would it be possible in relation to women for trials to be undertaken or in areas of pregnancy at specific times, say, in relation to vitamin supplements and so on, one might be imposing a condition on people which would enable the trial to be frustrated to a degree. That is a difficulty. If the Senator would care to suggest a reasonable period, I could consider it on Report Stage but at the moment my inclination would be to consider the amendment not to be entirely necessary in view of section 8 (5). Perhaps the Senator might want to suggest some period and I will be guided by the House but, as of now, I would have some reluctance in setting out the whole thing in such a rigorous fremework that people might say they are not free. Some people would take the trial, for example, during the period of annual leave and they would have to sign a consent prior to that period. It is a very difficult one and I would be interested in the Senator's further reaction.

I have a lot of sympathy with Senator Ryan's amendment in that I made the same suggestion on Second Stage. I also suggested that each participant should be given at least 24 hours to consider the consent form before giving his consent. Does the Minister intend to prescribe by regulation the format of the consent form and, if so, will he ensure that printed on the consent form will be the condition that the participant may withdraw his consent at any time and that no contractual liability shall be incurred by such person from such withdrawal? In the section as it is before us here, we are told that every person shall before giving his consent in accordance with this section be made aware of certain matters. There are four matters of which the participant would be made aware under that section, but there is no obligation to make him aware of the fact that he may at any time withdraw his consent or the consent he has given in accordance with this section.

As a member of the medical profession who would be to a large degree involved in these trials, I would like to endorse everything Senator Mullooly has said. It is a very important safeguard.

I would like to endorse what Senator Mullooly has said. A lot would hinge on the aspect of being made aware and by whom the participant was being made aware and for that reason, as Senator Mullooly has said, the form of application and participation should certainly show in a very clear way the option that the participant might have of withdrawing at any given time from the trial. It was mentioned earlier in the afternoon that the GP of a participant might not always be aware of a participant's involvement in a trial. If there was some tie-up and if the participant should have sanction or approval from his GP incorporated in the actual consent form, it might be a help in so far as one could further ensure the safety of the participant in that case.

It is important to remember that exploitation does not presuppose that the exploiter has sat back and decided that he is going to exploit people. Exploitation can happen by accident; it can happen because of the preoccupation of the exploiter with other areas of his or her work. It is not a question of sitting back and deciding: "I am going to find these vulnerable people because they are handy people to get in". It can happen just as easily by default as it can by any action. It is still exploitation whether the person knows or feels he or she is being exploited — taking short cuts with people's health and safety.

The Minister invited me to nominate a period. I was going to say a minimum of six hours should elapse so that people would have time to detach themselves from where they got this information and to reflect about it. Let me say that subsection (5) does not really bear on this. Subsection (5) deals with the right to withdraw his consent at any time. I am not talking about a person's right to withdraw his consent; I am talking about providing him with an environment in which he can think about the consent free from the particular atmosphere and free from any sense of being under pressure.

I have never undergone a clinical trial. Having read what I have about the whole business I suspect I never will, but I know people feel pressurised by the environment; they feel pressurised by an excess of documentation; they feel pressurised by all sorts of things and we should leave it to people to decide about these things. If the Minister is worried about some very specific circumstances where you cannot really specify a time lapse between the consent and the trial — it is possible to talk about specific extreme circumstances or something like that in the case of the whole area of fertility and the female cycle — it seems to me far more a matter of a clinic planning its tests properly than having to deal with them in a hurry once the participants become available.

I suggest a minimum of six hours should elapse between people being informed and their participating in the trial. I do not mind — six hours, 12 hours, 24 hours. I would probaby prefer 24 hours but the people with whom the Minister has had to deal are probably inclined to take a shorter period. I do not mind but I do think a person who is prepared to take this sort of risk — and there is a risk involved at various levels — should be allowed time to reflect. As I said, the ICP say — though the evidence at my disposal is in direct contradiction of that — that the person takes home the written documentation to study it. The volunteer — and they make no exception — is given a consent form to consider at home. If the ICP tells us that all their volunteers — and they make no exception — take home a written consent form to study, I do not see why we should not hold them to their promise and write it into the legislation that what they claim to be the practice becomes their legal obligation and therefore, I suggest, six, 12, 24 hours. I would take any of the three of them but a minimum of six. Below that, you get involved in trivialities.

We have had a concerned and interesting discussion on this issue. I can assure Senators that I will consider the situation on Report Stage. I have an open mind on the amount of time. I do not want to give a formal assurance to the House that I will put in an amendment because in relation to trial arrangements, I do not want to — so to speak — legally put my foot in it at this stage, but I can see considerable merit in the arguments. Senator Ryan has said six hours, maybe 24 hours, and it might well be that on consultation, we may be advised to go further. I will consult Senators on an informal basis before Report Stage and I will come back with the views I will obtain. I appreciate the point made. I cannot give a formal assurance on it at this stage.

Amendment, by leave, withdrawn.

Amendment No. 36 has been already discussed with amendment No. 34, as amendments Nos. 34, 36, 42 and 43 are related.

I was not aware that amendment No. 36 was being discussed with amendment No. 34. Does that mean I am precluded from discussing amendment Nos. 36 and 42? I would be interested in the Minister's views on amendments Nos. 36, 43 and 44. Amendments Nos. 43 and 44 relate particularly to the giving of consent by a person other than the person undergoing the trial. If I had looked at them in time or had the ruling in time, perhaps I would have quibbled with it, because they relate to something quite different which is somebody giving permission for a trial to be conducted on a third party.

The position was stated.

I realise that, a Chathaoirligh, and you have been extremely helpful in this whole debate which is extremely important although that does not make it any less complicated. If I can say on No. 36 it is simply an attempt by myself to make it perfectly clear that the final accountability for ensuring that people consent freely rests with the person who conducts the trial. That is all it is about. It simply says that the person conducting the clinical trial shall satisfy himself that the person consenting to participate in a clinical trial is capable of comprehending the nature, significance and scope of his consent and, where any doubt arises, the person shall not be allowed to participate in a clinical trial. Simply, I am suggesting that in all cases where there is a doubt about the capacity of the individual to freely consent the benefit of the doubt should be in the negative and the person should not be allowed to participate in the trial. As regards amendments Nos. 43 and 44, I must beg your indulgence, because it is very difficult——

Amendment No. 44 is separate.

The trouble is that amendment No. 43 relates to a position where it is proposed to conduct a clinical trial on any person suffering from an illness and in subsection (6) (b) where the person is incapable of comprehending it is difficult to talk about a person giving consent for himself and a person giving consent on behalf of a third party — it is difficult for me to discuss them together because they are very different things.

I announced that the four amendments may be discussed together. In fact, they were not. The Members of the House decided they would discuss amendment No. 34. The others were not discussed, therefore. Perhaps they decided not to do it that way.

Does Senator Ryan want to hear the Minister on amendments Nos. 36, 42 and 43?

I do not know how we can talk about amendments Nos. 36 and 43 together because they are about different things. Amendment No. 43, unless I am misreading it, is about a situation where somebody other than the person who is being subjected — if I can use the phrase — to the trial is giving consent. Therefore, it is a separate issue.

We will allow a separate discussion on amendment No. 43, when we come to it.

I can see the point made by the Senator regarding amendment No. 36 but I think there is a danger that we may, so to speak, gild the lily so much that the Bill could run into difficulties. As I have already indicated in relation to the sentiment expressed, I do not consider it necessary because, again, section 8, is quite specific and states that the consent shall not be valid unless the person giving it is capable of comprehending the nature, significance and scope of his consent. I think, by and large, that satisfies the rigours we demand of the Bill itself. Indeed, I will leave it at that because I think that the Senator is not anxious to discuss amendment No. 43 at this stage.

Amendment No. 36 not moved.
Government amendment No. 37:
In page 7, subsection (4), between lines 20 and 21, to insert the following:
"(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,".

This amendment is considered desirable because proposed participants should be informed beforehand whether or not the trial will include the use of placebos. It will also help to allay concern that the Bill precludes the use of placebos, which is not the case. In this connection the amendment will be helpful.

Amendment agreed to.
Amendment No. 38 not moved.

Amendments Nos. 39 and 40 are related and may be discussed together.

I move amendment No. 39:

In page 7, between lines 25 and 26, to insert the following subsection:

"(5) Every person shall, before giving his consent under this section, fully disclose all drugs and medication taken by him within the previous six months."

Many people want to get in on trials for obvious reasons of which we are all aware — financial gain. That being so, it is imperative from their own point of view that they disclose at all times that they have been on medication or that they have been on drugs in the preceding six months. This would be a welcome development if it could be implemented. It would be important for the people carrying out the trial and more important for the people participating in it as it will have obvious effects for them if the full facts are not disclosed. This awareness should be there and the participants should be asked specific questions regarding medication and drugs which they may have taken over the previous six months.

With regard to amendment No. 40 it is important that participants advise when and where they have had their last trial. Senator Ryan referred to a case of a person having 12 trials in six months. This is wrong. Anything we can do in the Bill to alleviate or to amend that should be done.

I recall coming from Athlone to Dublin one morning 12 months ago. I gave a lift to a young gentleman I did not know. He explained to me that he had come off a trial in Elan Chemical Centre and he was on his way to a trial in ICP in Dublin. I do not know if ICP would be able to pick up the fact that he had just come off a trial in Athlone, whether they would ask this question; I would like to think they would. This young man was saving hard to buy a car and he wanted as much money as he could get and as a result he was going from one place to another on these trials. This is wrong and it has to be stopped. It has happened in cases that I am aware of; I cannot say how widespread it is. Every effort should be made to ensure that there is a significant period of time before participants go from one trial to another. I do not know what the appropriate medical period should be. There should be a three to four months interval between one trial and another. Every effort should be made to ensure that those two amendments are implemented. They are for the benefit of the participants and this is what the Bill is all about.

There may be difficulties in enforcing these two amendments.

Progress reported; Committee to sit again.