Seligman Swartzman Gillis Sandman Joffe Yachad Lederman Fleishman

Transcript of Speech by Charles Gillis given on Saturday 26 November 2005 in Paisley Town Hall Review of the Renfrew/Paisley Study by Charles Gillis The first thing that comes into my mind when remembering the beginnings of Midspan was sitting across a first class railway carriage from Lord Muirsheil who, as well as being Secretary of State for Scotland, was the first chairman of the King Edward Memorial Trust. I'm not sure I knew this at the time, but what has impressed itself on my memory, was the succession of people coming up to him in the corridor and going away with either a smile or the reverse - There was an atmosphere of power! I was first introduced to him at a meeting of the workers Victor has just mentioned which took place in Eastwood House in 1970. I was struck by how much he knew about the detail of Midspan and how he managed to speak to us in such a challenging and engaging way. He obviously had the activities of the Trust at heart, particularly their insistence, that whatever we did, it had to be relevant to tuberculosis so that from the earliest time we knew Victor was right to try and extend the screening process for tuberculosis into the non communicable diseases - particularly chest and heart disease. We greatly benefited too from the activities of Sir John Crofton of the Chest, Heart and Stroke Association and Mrs Douglas Johnston of the Red Cross who managed to recruit people and funds for our work of attempting to seek evidence from Scotland to add to the emerging studies of chest and heart disease coming from Michigan, Minneapolis, New Jersey and London where Victor worked with Donald Reid and Geoffrey Rose, pioneers of what Victor expressed in his teaching and research as `the population as a patient` - a phrase which helped many, including me, to study how public health research really works. What I'm saying is that from the first we had personal contact with people who either collected, distributed public funds or provided volunteers for research here in the west of Scotland. That gave us an ethical imperative to try to do it as right as possible. At that time there was none of the cumbersome machinery that has created in the name of trust so many hoops current researchers now have to jump through in the name of protecting the public. Each of us here knows that trust is a construct which matters only in the mind of the researcher and of the population or patient being studied, and is not easily won. Is there really a process which can define it? Even so a glance at any newspaper tells us how much the medical and scientific professions have lost in trust from the time we began Midspan that I feel it is appropriate for me in the name of thanking the King Edward Memorial Trust and the participants of Midspan on this celebratory occasion to demonstrate that what we did all these years ago actually conforms to current ethical standards of research practice. It is important to do so for there are no past Midspan participants. All Midspan participants are immortal - to us, the research team. We will follow you and yours for ever! Like me, you may have enjoyed reading the Ladies No1 Detective Agency by Alexander McCall Smith-which he wrote in his spare time as professor of law and medical ethics at Edinburgh. He also wrote a textbook of how the law currently relates to medical ethics. He wrote (lest you think this is an exercise in self-indulgence) that`...ethical discourse is concerned with the search for justification of our actions` That means obtaining the approval of an appropriate body. Who better than those here today who are broadly representative of society here in Renfrew/Paisley and the medical and scientific professions. Our only problem is that we are not independent. By coming here you have demonstrated your interest in what our studies have achieved and that fulfils one of the most important ethical obligations to tell you as clearly as possible what Midspan has achieved for the people of Renfrew and Paisley and the broad scientific community. Even that important drawback is overcome by the fact that most of what we have to tell you is published in peer- reviewed journals with independent editorial boards. I now feel I can ask whether Midspan could have received permission to go ahead if it was starting now. Ethical approval is what the National Health Service require of researchers to protect the public by insisting they present evidence of respecting patients;doing good and giving everyone eligible an opportunity of taking part. This is done by asking questions about broad areas of the proposed research. The first question- Who is doing it? At the beginning it was simply Victor, an established chest physician and university senior lecturer, and me, who as a very junior lecturer had helped him with his studies on the Island of Tiree and in his studies of occupation and health - e.g., we worked in many of the factories here in Renfrew and Paisley, the Singer sewing factory where they had a swear-box for the Executives-the minimum fine for more than a four letter word was a shilling -that's how long ago it was! However such a team with suitable support would have been acceptable. We then ask how much is the study to cost, who is sponsoring it and exactly how much is being paid to whom? This is where Victor really exercised magic! Together with Mr Wood they would go into the chemistry of research and health service financing and here I would like to add my thanks and acknowledgement of George Forwell`s vital contribution for persuading the then Scottish Office that Midspan was worthy to receive funding as a project which would benefit Scotland as a whole. I think that was the first real recognition Midspan achieved. We would also be reassured that the King Edward Memorial Fund for Tuberculosis and the Chest, Heart and Stroke Association each insisted on peer-review. The Health Boards of Greater Glasgow and Argyll and Clyde were up front supporters of the study. George Forwell was here yesterday and John Bryden is here to day and its a pleasure to acknowledge them. So the ethics committee would have been happy with our sponsorship and funding. The next series of questions relate to the size of the population to be studied and raises many statistical issues. Or put simply was Paisley /Renfrew big enough i.e. contain enough people aged 45-64, to obtain a result? Most of our critics asked that question at the outset. We now know that Renfrew /Paisley is the third largest study of its kind in the world and the only one of its time to study women and to be set in a location which even today houses so many of the seriously socio-economically disadvantaged. When we started Victor and I did not suspect how important that socio-economic gradient was to be en route to delivering findings that would help the public health. Many at the time dismissed Midspan or gave it only scant acknowledgement including the first Professor of Epidemiology and Preventive Medicine, Tom Anderson, who felt that management was the key to achieving good public health. He may have been right - we certainly have more management now! One little known and probably best forgotten area of research was Renfrew/Paisley`s adventure into space. In the early 1990`s NASA was in severe funding difficulty. They thought they might get more resources if they somehow could demonstrate the importance of space exploration to health and so decided to hold a conference to bring space scientists together with a few medical researchers. Victor invited me to come to Washington and I was put in a room with a lot of seriously bright scientists whose observations led them to conclude that the hole in the ozone layer was getting bigger. Their conversation was something I had never heard before - it was similar to hearing a foreign language, but at some point I tentatively asked how they knew what their measurements might mean to those of us here on earth. This was treated as a revelation and that resulted in my being invited to meetings to discuss how to find out. We came up with proposals to have an earth orbiting satellite include Paisley/ Renfrew and Tecumseh Michigan because Tecumseh Michigan had a similar study population to Renfrew/ Paisley in its or their orbit- I understand that even now a satellite may be orbiting round us but I don't know if it is switched on! That project was a failure not just on my part but perhaps also on the part of the funding authorities concerned who were not willing to consider long term funding of so slender an hypothesis. Informed Consent..... The reason I mention this at all is that the project involved giving the detail of everything we knew about the Renfrew/Paisley population to our colleagues in the USA (anonymously of course). At the time the only people who could make that decision were the Midspan steering committee. The key question they would have had to consider was whether the consent given was informed. Victor and I will be forever grateful to Dr Mike Heasman of the Information Division of the Common Services Agency for Scotland for getting their legal department to write the sentence which, when signed by the Midspan participant, is sufficient to imply informed consent. The essentials of informed consent mean that it is obtained as Onora O'Neill, Principal of Newnham College, Cambridge put it in her Reith lectures `without coercion and without deception.` I can say that the two people, Evelyn Lapsley and Margaret Mossman, who obtained informed consent for the 10,000 people Victor and I studied, were meticulous in taking the time to ensure to the best of their considerable ability that it was obtained. We have found the wording we used on informed consent to hold to this day when applications concerning the Renfrew /Paisley cohort came up for ethical review at the Multi Centre Research Ethics Committee for Scotland which I chaired till recently. I have to admit that it was a balm to my conscience, when fortune brought me into contact with cancer as a career and I realised that I would no longer be working with Victor, that I seized the chance of continuing to be involved with Midspan. I took over the West of Scotland Cancer Registry -a data base thought to contain the names of everybody with cancer in the west of Scotland. It was a logical thought to try to link the names of everyone with cancer to the Midspan data set because we could then know the characteristics of those screened in Paisley/Renfrew and the other places Victor and I had worked and see what relation this had with cancer. In those far off days the names in the cancer registry were written on white cards. Those of Midspan came in on yellow cards. When a white met a yellow we thought we had a match - it was our first attempt at a very sophisticated game called record linkage upon which so much of the Midspan results are based and which would not have succeeded but for the technical wizardry and statistical mastery of David Hole and John Clarke. So was Midspan ethical by today's standards? I feel sure it is because it was carried out by honest people. The research design was adequate and we foresaw the problems of informed consent . Some of the hypotheses may have seemed somewhat general but we conformed exactly to the fundamentals of the King Edward Fund for Tuberculosis by seeing how far the screening mechanism of which Victor was such a virtuoso could be extended to the diseases which had replaced tuberculosis, namely coronary heart disease and cancer. If there is any doubt about that Graham Watt will tell you what was found by the many researchers have contributed to Midspan and the findings which when implemented locally and nationally could do much to improve the public health. https://www.gla.ac.uk/media/Media_140901_smxx.pdf