Clinical Vaccine Trials Report: Statements. 15th November, 2000 Minister for Education and Science (Mr. Martin): The report of the chief medical officer of the Department of Health and Children into certain clinical trials involving residents of children's homes was laid before both Houses last week. The three clinical trials - all of them involving vaccines - happened in the 1960s and 1970s. Questions of ethical propriety, consent and responsibility have been raised. These children were in the care of the State and it is important to establish if the State fulfilled its obligations to them. The report does not and could not provide answers to all the questions raised and it cannot be the end of our interrogation of this issue. I will provide Senators with some background information on the three trials. Trial No. 1, published in 1962, examined what would happen if four vaccines, diphtheria, whooping cough, tetanus and polio, were combined in one. At the time, the standard approach was to administer tetanus vaccine and polio vaccine separately at different times and at different injection sites. Trial No. 2, published in 1971, was to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts. If it did, serious consequences could ensue, particularly for pregnant women. Trial No. 3 was carried out during 1973, but not published. It compared the propensity of a commercially available DPT vaccine to produce adverse reactions as against the capacity of a modified vaccine to produce the same reactions. The modified vaccine had fewer organisms per dose. Concern about this matter first surfaced almost a decade ago when raised by former residents of children's homes where the vaccination trials appear to have been conducted. The then Minister for Health first answered questions in the Dáil on this matter in 1991. In 1993, there was correspondence between the then Minister and a former resident in a Dublin children's home. In 1997, my predecessor as Minister, Deputy Cowen, promised the Dáil that he would have inquiries made into the matter following which he would consider what was the most appropriate action to take. The Minister asked Dr. James Kiely, chief medical officer of the Department, to make the promised inquiries. From the moment I became Minister for Health and Children, I have been aware of this issue. I have met a representative of past residents of a number of children's homes who believe they might have been involved in these trials. Even though there does not seem to have been any negative medical outcome for any of these children, the story has made many of them extremely anxious. I arranged with the chief executive officers of the relevant boards, the Eastern Regional Health Authority and the Southern Health Board, that where supporting documentary evidence is available, former residents can be informed immediately whether they were part of any of these three trials. For former residents of the homes in Dublin area, the Eastern Regional Health Authority's customer service telephone number is 1800 520 520 and for former residents of Bessboro in Cork the relevant Southern Health Board's telephone number is 021 486 1260. In addition, I have ensured a counselling service for any former resident of a children's home involved in such trials, which is also available from the relevant health boards. Before submitting his report to me, Dr. Kiely sent draft copies to anybody named in it who might be affected by its publication. That afforded them the opportunity to comment on the contents. All those comments were considered fully. On the face of it, the trials appear to have had no medically negative consequences for any of the children involved. In some cases, the vaccine used was somewhat weaker than the alternative, but when this emerged, booster doses were given to many of the children involved. We have no evidence that any child contracted a serious illness as a result of the trails. In view of the fact that the report makes no suggestion that any child was directly harmed by these trials and that two of them were published in prestigious medical publications, it might be expected that, as Minister for Health and Children, I should now be saying that this is the end of the story, but I want to make it clear that is not what I am saying. The chief medical officer's report is a good report, but it is incomplete. It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights. The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials. While we must remember that the trials were not recent, this lack of documentation is at best puzzling. It is certainly unsatisfactory and it is my hope that perhaps the publication of this report will help us to fill in the missing bits in the jigsaw by stimulating memories or helping to locate lost files. I have read and reread this report. I have discussed it with the chief medical officer in detail. In spite of the information gaps and the indications that no child was medically harmed, each reading made me more sure that his work must regarded as the beginning and not the end of the matter. When a child comes into the care of the State, the State must fight fiercely for all of that child's rights, rights such as bodily integrity. The State does not have the right to view children in care as lesser citizens. Their bodily integrity is a basic human right, which can never be watered down or infringed. When we consider vaccination trials, the issue of consent is involved immediately. I am not satisfied that the chief medical officer has been able to find solid, informed consent on the record, given by the people who were entitled to give it. Let me put this in context, the history of drug trials includes some ghastly case studies where the rights of individuals were grievously ignored. The vaccine trials covered in this report are in a different league, a different country and a different time. In addressing them, we must be careful of the reputations of the highly regarded professionals involved. We must remember that, in many cases, we are looking at marginal degrees of difference in the vaccines administered, not at experimental, unproven or dangerous medications. We must take into account that the protocols of 30 years ago are not necessarily the protocols applied today. The key issue, that of consent, cannot be fudged because it is fundamental. Children in care have the same rights as other children. The vindication of those rights is the constant responsibility of the State. We need to find out if we cared for the children the way we, as a nation, should have cared for them. If we did not, we need to find out why the failure happened and we need to apply what we learn to the future. That is our responsibility, as legislators, to the general good. As Minister for Health and Children, my responsibility goes further. It goes to the individual children involved and it means I must ask questions this report cannot answer. For instance, if one group of children was given the more experimental vaccine, why did the children in care get that one? What rationale led to the decision that children not in the State's care got the regular vaccine while children in care got the variant? Was the end result from each trial for the public good or for the commercial advantage of a manufacturer? Why were some medications given to children who were outside the age group and which of these medications were known to be effective? Above all, why are the records of some of the trial so woefully inadequate at almost every point? All those questions must be asked irrespective of the overall intent of the trials and the indications that no child suffered medically as a result. Not only must they be asked but they must be asked in a context which offers the competence to carry out investigative and therapeutic trawls. For that reason this report has been sent to Justice Laffoy so that the Commission to Inquire into Child Abuse may consider it as part of its wide-ranging investigation. This decision is based on the rights of those involved, who are entitled to a thorough, wide-ranging and public investigation of the ethical issues involved. The Laffoy Commission offers a comprehensive vehicle for dealing expeditiously and rigorously with the totality of the issues. Contrary to what some people have alleged, this would include an examination of the role of my Department in the matter. The commission's terms of reference are broad and it has the full gamut of powers and personnel needed, an experienced secretariat, a strong panel of experts with the requisite qualifications and an investigative and legal infrastructure. That combination offers an unrivalled capacity for ruthless thoroughness and appropriate speed. Much of what the Laffoy Commission has been investigating runs parallel to this, so the search methods for documents going back to the 1950s is already in place. There is a clear synergy between investigating this matter and the other matters being addressed by the Laffoy Commission. The full gamut of powers at its disposal means that we do not have to reinvent the wheel, the instrument for comprehensive investigation exists. In that context, arising from exchanges in the Dáil yesterday on the Order of Business we sought further clarification in terms of the legal situation from the Attorney General and we will be tabling a motion sometime next week regarding referral of the report to the Joint Committee on Health and Children for its consideration. We have a motion on the Dáil Order Paper referring the report to that committee for its consideration but we will have full clarity on that tomorrow morning. Not only does that instrument for investigation exist but there is provision for compellability and it has the capacity to provide for confidentiality for witnesses. This route is the ultimate guarantee against a cover-up or whitewash. Justice Laffoy has indicated her willingness and competence to take this on. I am grateful to her and My Department will of course co-operate fully with her. We believe that entering this process makes a clear and unambiguous statement to those involved in the trials: "We do not know whether your rights were protected all those years ago, we just do not know, but we believe it is important for you and for the wider society to move heaven and earth to find out and we want to do it in a forum which has the power to investigate, to compel witnesses and to publish its findings without fear or favour to ensure compensation is made if that is required." I recognise the keen interest of Members in the report and that is why it is going before the Joint Committee on Health and Children for its consideration. A desperately simple question comes out of this report. Reading it one finds oneself wondering out loud, who was minding the rights of the child? We do not know the full answer to that but we can answer the second question as to who is now endeavouring to mind the rights of those who were participants in the trials. Through the information and counselling services arranged with the health boards, publication of this report and its proper referral to the Laffoy Commission, it is clear that we are determined to vindicate the rights of the adults who participated in these trials as children.

Ms Keogh: I welcome this debate. What disturbs me is that, welcome though this report is, it seems to have been sat upon in the Department for two years. I am not criticising the Minister too much, as he is relatively new to this portfolio, but we have known that the report was complete since early 1999. We should recognise the distress of those who were children in the orphanages and homes where these trials were carried out. This delay leads to even more distress. When one considers that the first we heard of this matter was in The Sunday Tribune of 28 October 1990, it has taken a long time to reach this stage. I am glad we now have the opportunity to debate the matter in the open, but it is incredible to be reminded of how long ago this came to public knowledge. I was reading that edition of The Sunday Tribune report when preparing for this debate and one pithy remark in it struck me forcefully when the Minister mentioned children's rights. The article mentioned the fact that trials took place, and Dr. Patrick Meenan is quoted as saying: In those days there was almost a tradition of doing testing in orphanages. You went to where the material was, to put it crudely. At least we have now gone beyond that, a fact he also recognised. As the Minister may know, I have personal knowledge of two of the homes involved. The Cottage Home for Little Children and Mrs. Smylie's Home, or the Bird's Nest, are both in Dún Laoghaire. I acknowledge the pain and distress of those who were children in those homes, some of whom are friends of mine. The Minister will be aware that Councillor Victor Boyhan has been very involved in this matter, having been in the Bird's Nest home. In relation to Mrs. Smylie's Home, while the chief medical officer indicated he was aware a trial was taking place, he stated that he believed that the children in this home were being given the standard vaccines and were being used for comparison with other children being given the vaccines prepared for the trial elsewhere. In the case of the Cottage Home, the chairman of the committee of management stated that he was satisfied that at no time were trials carried out on children in this home and that only standard vaccines in routine use were administered to these children. He subsequently clarified his statement saying that it was based on information supplied to the home by Dr. Webb and Professor Hillery and was not arrived at by reference to any independent source. The documentation provided by Wellcome shows that the vaccines prepared for the trial were administered to the children in these two homes in the context of a clinical trial. The report says it is unclear whether effective consent was obtained in relation to the participation of children in these two homes in the trial. It is strange how these matters hit one locally. In my constituency there are particular concerns about the report and what happened to those children in the 1960s and 1970s. As we know, the report deals with three sets of vaccine trials which were carried out at that time. The first trial was of 58 infants in five children's homes and it compared polio vaccination given separately to the three in one - diphtheria, tetanus and whooping cough - and the quadruple vaccine where all four were given together. The second trial involved 69 children in children's homes in Dublin and 23 children living at home who were given the same vaccine for rubella. The third trial was of 53 children in mother and baby and children's homes in Dublin. There were five of those and 65 children were given different sets of vaccines - those children were at home. As I said, the children's institutions administered the modified three in one vaccine, while the children at home got the usual vaccine available through the Eastern Health Board. I have been told that the board instigated the third trial in 1973 because of objections to the three in one vaccines in use at the time. As we know, the Department of Health at the time, through the agency of the National Drugs Advisory Board, did not object to any of the trials going ahead. That must raise questions about the role of the Department of Health and Children, a matter raised by Deputy Gay Mitchell. He stated that an expert group was set up in 1977 by the Minister for Health to examine people who, it was claimed, at the time had been permanently damaged by whooping cough vaccination in the 1960s and 1970s. That group found that in 16 of the 93 cases presented to it there was a reasonable probability that the vaccine was responsible. An ex gratia payment was offered to each of the 16 to the sum of £16,000 and 15 of them took the payment. In 1992 the Supreme Court found in favour of the 16th person, Mr. Kenneth Best. According to the research seen by Deputy Mitchell, the vaccine was administered to at least 243 children in 1968 and 1969. The clinical vaccine trials were obviously taking place in the homes during the same period. The Deputy, not unreasonably, makes the connection between the suspicion about the bad batch of whooping cough vaccination and the reaction to it by so many children throughout the country and the trial tests subsequently carried out on children. He asks questions about the role of the Department of Health and Children and its agencies in this regard. That is one of the many questions which must be answered as a result of this report. The report is unsatisfactory because, as the Minister said, it raises as many questions as it answers. That is unfortunate. In terms of getting at the truth about what happened, the option preferred by the adults who were the children in question in these homes was to have an independent tribunal of inquiry. Having been persuaded by the Minister they now accept that the report should be sent to the Laffoy Commission on Child Abuse. The people in question wanted a tribunal of inquiry to investigate this matter because it would be able to deal specifically and solely with drug trials. Their main concern was that their case would be appended to the work being carried out by the Laffoy Commission. I do not wish, in any sense, to take away from Ms Justice Laffoy and the work she is doing. However, people must understand the fears of people who have already experienced delay. In the estimation of these individuals, this matter has been ongoing since 1990. As Members know, the Laffoy Commission to Inquire into Child Abuse covers physical and sexual abuse without distinction. However, there is a belief that the matter in question is a separate and distinct case. One can understand people's concerns in that regard and I would query the timeframe it is intended to impose in relation to this matter. Notwithstanding the fact that it is proposed that the report be referred to the Laffoy Commission, the Minister stated that it would also be referred to the Joint Committee on Health and Children for its consideration. I await the proposals he will produce tomorrow on foot of the recommendation of the Attorney General. My colleagues certainly believe that the joint committee should be empowered to investigate this matter, particularly in terms of the role played by the Department of Health and Children in authorising or approving vaccine tests on children in institutions and any other questions which might arise. The Minister is aware of and sensitive to the need to listen to those people who have been affected. As he stated, we do not believe they were affected physically by what happened in the 1960s and 1970s but there is no doubt that they were psychologically affected. We must learn from the other investigations that took place and listen to the stories told by victims of abuse. It is important that we know what questions they want to have answered before the Laffoy Commission commences its work. The people to whom I refer want to see the terms of reference which will apply; they want to ask questions about the relationship between the Department of Health, University College Dublin and the Eastern Health Board; they need to know if there is a register of all the children who were involved; and they are intent on discovering whether the Minister has all the information he requires. They also want to be informed about the help and support that has been given to the children affected by these trials in the 1960s and 1970s. The Minister stated that these people can contact an 1850 number. That number should be advertised in the national press. I accept that the number of those involved is not huge, but there is a need to reach out to all of them. The Minister also referred to counselling services. If we want to give support to the people involved, we should make it as easy as possible for them to access that support. We should not make life more difficult for them. It is at the time when people feel vulnerable and hurt that we must reach out to them. They must not be obliged to make requests for help. The people involved feel they suffered, and we must offer them our support, not wait for them to beseech us for help. Another crucial issue for the people to whom I refer is the information that will be made available to them. For example, will their personal files or medical files be made available to them? If not, will their medical files be made available to their family doctors? I do not believe that is an unreasonable request. These are the types of questions which must be answered because it is vitally important that we learn lessons from this matter and ensure that the necessary safeguards are put in place. There must be a speedy response to the demands of everyone involved. Answers must be given to questions the report failed to answer. The Minister alluded to those questions earlier but there is no harm in reiterating them. Why were the children in care exposed to the more experimental vaccine? What was the rationale behind this? Were the trials held for the public good or for the commercial advantage of the manufacturer? The fact that some of the medication was given to children outside the age group at which the vaccines were known to be effective raises serious questions. Why are the records not full and complete? The Minister identified these questions as those which require answers but he must also listen and ensure that the terms of reference cover all aspects of the fears and concerns of those who see themselves as victims. We must remember that the report states that, theoretically, vaccines did not leave children open to adverse effects and there is no evidence that any occurred. However, the inadequacy of records must come under extra scrutiny because of that statement. There is no doubt, as the report points out, that there are breaches of the Nuremberg code of 1947 and the Declaration of Helsinki of 1964 in relation to consent. There are other questions that need to be asked, specifically in respect of the role of the Department of Health and Children and those of its agencies to which I referred. The fact that the Department decided who should investigate this matter was challenged by many of those involved. I ask the Minister to confirm that the fact that the Laffoy Commission is investigating this report will not inhibit the Oireachtas Joint Committee on Health and Children in its deliberations. In that context, it must be borne in mind that the Minister is due to come before the Lower House to outline the advice he has received. When all things are considered, it is important that we vindicate the rights of children. We must ensure that the Laffoy Commission is given appropriate terms of reference. We must also ensure there is a speedy resolution to any investigation so that those affected will be guaranteed that their rights will be vindicated. Dr. Fitzpatrick: I welcome the Minister and compliment him on his excellent contribution which was open, forthright, honest and courageous. If the follow-through is on a par with his speech, we will get to the bottom of this matter in a quick and efficient way. Whether any Minister, doctor or other individual can address everyone's fears or deal with the trauma which has resulted from those fears is another day's work. I wish to highlight a number of points which struck me during the Minister's contribution. The trials in question were conducted in an era when the culture of authoritarianism was rampant throughout Ireland. Anyone who lived during that period will know that our society has changed completely. There is a danger of using the standards of today to judge the standards of yesterday. According to the research seen by Deputy Mitchell, the vaccine was administered to at least 243 children in 1968 and 1969. The clinical vaccine trials were obviously taking place in the homes during the same period. The Deputy, not unreasonably, makes the connection between the suspicion about the bad batch of whooping cough vaccination and the reaction to it by so many children throughout the country and the trial tests subsequently carried out on children. He asks questions about the role of the Department of Health and Children and its agencies in this regard. That is one of the many questions which must be answered as a result of this report. The report is unsatisfactory because, as the Minister said, it raises as many questions as it answers. That is unfortunate. In terms of getting at the truth about what happened, the option preferred by the adults who were the children in question in these homes was to have an independent tribunal of inquiry. Having been persuaded by the Minister they now accept that the report should be sent to the Laffoy Commission on Child Abuse. The people in question wanted a tribunal of inquiry to investigate this matter because it would be able to deal specifically and solely with drug trials. Their main concern was that their case would be appended to the work being carried out by the Laffoy Commission. I do not wish, in any sense, to take away from Ms Justice Laffoy and the work she is doing. However, people must understand the fears of people who have already experienced delay. In the estimation of these individuals, this matter has been ongoing since 1990. As Members know, the Laffoy Commission to Inquire into Child Abuse covers physical and sexual abuse without distinction. However, there is a belief that the matter in question is a separate and distinct case. One can understand people's concerns in that regard and I would query the timeframe it is intended to impose in relation to this matter. Notwithstanding the fact that it is proposed that the report be referred to the Laffoy Commission, the Minister stated that it would also be referred to the Joint Committee on Health and Children for its consideration. I await the proposals he will produce tomorrow on foot of the recommendation of the Attorney General. My colleagues certainly believe that the joint committee should be empowered to investigate this matter, particularly in terms of the role played by the Department of Health and Children in authorising or approving vaccine tests on children in institutions and any other questions which might arise. The Minister is aware of and sensitive to the need to listen to those people who have been affected. As he stated, we do not believe they were affected physically by what happened in the 1960s and 1970s but there is no doubt that they were psychologically affected. We must learn from the other investigations that took place and listen to the stories told by victims of abuse. It is important that we know what questions they want to have answered before the Laffoy Commission commences its work. The people to whom I refer want to see the terms of reference which will apply; they want to ask questions about the relationship between the Department of Health, University College Dublin and the Eastern Health Board; they need to know if there is a register of all the children who were involved; and they are intent on discovering whether the Minister has all the information he requires. They also want to be informed about the help and support that has been given to the children affected by these trials in the 1960s and 1970s. The Minister stated that these people can contact an 1850 number. That number should be advertised in the national press. I accept that the number of those involved is not huge, but there is a need to reach out to all of them. The Minister also referred to counselling services. If we want to give support to the people involved, we should make it as easy as possible for them to access that support. We should not make life more difficult for them. It is at the time when people feel vulnerable and hurt that we must reach out to them. They must not be obliged to make requests for help. The people involved feel they suffered, and we must offer them our support, not wait for them to beseech us for help. Another crucial issue for the people to whom I refer is the information that will be made available to them. For example, will their personal files or medical files be made available to them? If not, will their medical files be made available to their family doctors? I do not believe that is an unreasonable request. These are the types of questions which must be answered because it is vitally important that we learn lessons from this matter and ensure that the necessary safeguards are put in place. There must be a speedy response to the demands of everyone involved. Answers must be given to questions the report failed to answer. The Minister alluded to those questions earlier but there is no harm in reiterating them. Why were the children in care exposed to the more experimental vaccine? What was the rationale behind this? Were the trials held for the public good or for the commercial advantage of the manufacturer? The fact that some of the medication was given to children outside the age group at which the vaccines were known to be effective raises serious questions. Why are the records not full and complete? The Minister identified these questions as those which require answers but he must also listen and ensure that the terms of reference cover all aspects of the fears and concerns of those who see themselves as victims. We must remember that the report states that, theoretically, vaccines did not leave children open to adverse effects and there is no evidence that any occurred. However, the inadequacy of records must come under extra scrutiny because of that statement. There is no doubt, as the report points out, that there are breaches of the Nuremberg code of 1947 and the Declaration of Helsinki of 1964 in relation to consent. There are other questions that need to be asked, specifically in respect of the role of the Department of Health and Children and those of its agencies to which I referred. The fact that the Department decided who should investigate this matter was challenged by many of those involved. I ask the Minister to confirm that the fact that the Laffoy Commission is investigating this report will not inhibit the Oireachtas Joint Committee on Health and Children in its deliberations. In that context, it must be borne in mind that the Minister is due to come before the Lower House to outline the advice he has received. When all things are considered, it is important that we vindicate the rights of children. We must ensure that the Laffoy Commission is given appropriate terms of reference. We must also ensure there is a speedy resolution to any investigation so that those affected will be guaranteed that their rights will be vindicated. Dr. Fitzpatrick: I welcome the Minister and compliment him on his excellent contribution which was open, forthright, honest and courageous. If the follow-through is on a par with his speech, we will get to the bottom of this matter in a quick and efficient way. Whether any Minister, doctor or other individual can address everyone's fears or deal with the trauma which has resulted from those fears is another day's work. I wish to highlight a number of points which struck me during the Minister's contribution. The trials in question were conducted in an era when the culture of authoritarianism was rampant throughout Ireland. Anyone who lived during that period will know that our society has changed completely. There is a danger of using the standards of today to judge the standards of yesterday. Dr. Irene Hillery and Professor Patrick Meenan are two of the most important people to have ever been involved in virology and microbiology. It is important to remember that Professor Meenan was a barrister as well as a doctor. It is extraordinarily difficult to think that they would do anything which was outside what they considered to be proper and legal at the time. I cannot comment on how the Department of Health should have defended the rights of the children in care. However, given that Professor Meenan was the holder of a licence under the Therapeutic Substances Act, 1932, he would have been extremely careful about the importation of vaccines. I do not think anyone has queried this point. The Department must have examined whatever work they were doing because a trial was turned down in 1962. The reasons were not given in the report. The Department must have known trials were taking place and it could hardly have thought they were being carried out at UCD. The Minister stated in the Dáil that the Department did not know whether it was legal for people to carry out trials outside UCD. It would be impossible for people to carry out such trials in UCD. The Department must have had a certain involvement in this. It is important to stress that no one involved on the medical side of these trials gained monetarily. The third person I know who was mentioned in the report is Dr. Pearl Dunleavy, who was the assistant chief medical officer of the Eastern Health Board at the time. Her sole concern in getting the third trial under way was to try to avoid local reactions in small children so that their arms would not be sore. She was concerned that mothers refrained from bringing their children for second and third uptakes of the vaccination because of sore arms. This is a look back exercise and it is important for us to recall Ireland 50 years ago. Communicable diseases accounted for 25% of deaths at that time. These disease included diphtheria, influenza, polio, measles and whooping cough. Improved socio-economic conditions and the development of new drugs were important but the immunisation programmes were also extremely important. Immunisation against diphtheria, whooping cough and tetanus was introduced in 1952/53 and against polio in 1957 following a terrible epidemic. The number of cases of these diseases rapidly declined to a fraction of pre-immunisation levels. We had become complacent about the seriousness of these conditions until there was a measles epidemic this year. It is important to recall the two deaths from measles in 2000. I do not know if there were deaths in any other European country. Hundreds of thousands of children die throughout the world from measles. These are serious conditions and the trials were not conducted in regard to something trivial. The focus nowadays has rightly shifted to vaccine safety but these trials were designed to ascertain a good antibody result with a minimum of adverse affects. Two of the vaccine trials were entirely benevolent. They sought to try to find out if one could reduce the number of injections given to children. The triple vaccine was normally injected in one arm of the child and the polio vaccine in the other. The report refers to other trials carried out in Canada at the same time and I am aware that the Medical Research Council was carrying out similar trials in Cardiff and Bristol which are not mentioned in the report. An English company did not descend on Ireland to try to experiment on children. Similar trials were taking place in England to try to establish whether the antibody result would be as good if a quadruple vaccine, one injection only, was given to the child in one arm rather than two injections, which meant two sore arms instead of one. That trial discovered that the antibody result from both types of injection was not satisfactory and booster doses had to be given subsequently. The trial was of value to the children and to society in general. The trial on the other vaccine for DPT was conducted at the instigation of Dr. Pearl Dunleavy because of sore arms. She wanted to establish if the weaker variant could produce as good an antibody result without sore arms which children had developed. This could be described as an experimental vaccine but it certainly was benevolent. The children in the homes were given the weaker vaccine because they could be better observed. That was not done as a diminution of the rights of the children. The trial on German measles or rubella was of extraordinary importance. This vaccination was introduced in Ireland in 1971. German measles causes a 50% increase in the rate of spontaneous abortion in women who contract the disease in the first three months of pregnancy. If the pregnancies continue, 70% of babies will suffer from congenital rubella syndrome and will be born with permanent disabilities such as blindness, deafness, brain damage and/or heart defects. Before rubella vaccinations one in 1,000 children in Ireland was born with congenital rubella syndrome. This trial was conducted to establish whether the vaccine could be given intranasally to avoid having to inject the children. It was successful, but internationally it was found easier for doctors and nurses to vaccinate children with an injection than to give it intranasally. That method of administration never caught on but it could hardly be described as doing down the children. I totally understand the frustration of those who were in homes and the difficulties they have in obtaining their medical histories and other information to which they are entitled, but I hope they will not want our already weak vaccination programme worsened by anything that might come out of this investigation. Sometimes attempts are made to link conditions of unknown etiology with vaccination but no one has made suggestions that this has happened in this case. Why did the Minister refer to these adults as "survivors" in his contribution in the Dáil? It was an odd word to use and he did not use it in his contribution today. Mr. Martin: All the people who survived from institutions adopted the term "survivor". They prefer that term. Ms Keogh: It sums up the way they feel. Dr. Henry: I am glad the Minister clarified that because it appeared as if they were survivors of the trial. Mr. Martin: That was never the intention. It is the broader term used for children who were in State orphanages and institutions. Dr. Henry: The children involved are wondering about their inclusion in these trials. There were no ethics committees in those days, although there should have been. There was no legislation covering clinical trials until 1987. The Medical Council's guidelines and the Helsinki Declaration on human rights were followed by Irish doctors. Two of the trials, as the Minister said, were published in prestigious journals and that would not have happened if anything unethical was done. Deputy McGennis stated in the Dáil that the rights of single mothers and their children were ill-considered by society in the 1960s. As the president of Cherish, the organisation established for single mothers by single mothers in the 1960s, I recall how little account was taken of its views. I am also sorry Cherish was not thanked in the report because it would have been nice if its co-operation had been acknowledged. The doctor who vaccinated these children had to have had received consent from someone to go into those homes. She was not attached to the homes. I do not know if the medical practitioners whom she says gave consent for her to do so were entitled to give such consent but someone had to say she could enter the homes. She did not break down the door. She was not a local general practitioner or public health doctor who could have been involved in routine vaccinations. Her presence must have been known to people. I have read the Department's guidelines on childhood immunisation carefully and it is essential that the uptake of vaccinations is improved. I am sure all Ministers would support the Minister's policy on this. Mr. Madden of the Southern Health Board in his 1997 report on the trial which took place in Bessboro stated: The trial was a modification of an existing schedule. No new drugs were on trial, therefore, it was not experimental. Infants would have received vaccination as part of the routine immunisation schedule. All vaccines were approved. No serious reactions were recorded. The study was carried out in accordance with the then ethical guidelines. Consent of the medical officers, and in Bessboro's case according to the home authorities, with the knowledge of the mothers was given.   Professor Hillery has said in a public statement that she will go anywhere to answer any questions. While sympathising with the people involved in the trial who have been frustrated for so long in getting information, I hope people will take account of the Minister's words that the professional reputation of those involved is also important.