Taking Part in Research at University Hospitals Birmingham

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1 University Hospitals Birmingham NHS Foundation Trust The Trust provides free monthly health talks on a variety of medical conditions and treatments. For more information visit or call Birmingham Clinical Research Office HRSC Building College of Medical and Dental Sciences West Campus University of Birmingham, Edgbaston, Birmingham, B15 2TT Telephone: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital, Edgbaston, Birmingham, B15 2TH Telephone: Taking Part in Research at University Hospitals Birmingham Delivering the best in care GD09_49211 UHB/PI/0897 (Edition 2) Author: University Hospitals Birmingham NHS Foundation Trust Date: September 2010 Review Date: September 2012 UHB is a no smoking Trust

2 Introduction At some stage, while you are under the care of doctors and nurses at the Queen Elizabeth Hospital or Selly Oak Hospital, you may be invited to donate a tissue sample, or to take part in a research project. Before you decide, it is important that you understand what it will involve. It may be little more than completing a questionnaire or agreeing to give a small amount of extra blood, but it could involve having extra tests done or taking part in a trial of a new form of treatment. This leaflet aims to provide information about how and why research is carried out in this Trust. The purpose of clinical research is to increase our understanding of the causes of disease, to improve diagnosis and treatment or to suggest better ways of providing a health service. In order to continue to improve healthcare in years to come it is important that clinical research flourishes now. The hospitals that make up this Trust are especially well placed to help in this. The Queen Elizabeth Hospital in particular is one of the leading clinical research institutions in the country. It has a key role as a major teaching hospital; it is adjacent to the College of Medical and Dental Sciences of the University of Birmingham; and it is a regional and national centre for specialist clinical services. Research is important for the Trust. At any one time there may be several hundred research projects underway and, in collaboration with the University, the Trust has established a bank to store human tissue for research called the Human Biomaterials Resource Centre (HBRC). We believe that our involvement in research will ensure that the Trust maintains the skills and expertise to deliver the most advanced forms of clinical treatment. For example, a strong research track-record helps create an environment that attracts some of the best doctors and nurses to work in Birmingham. The fact that the University of Birmingham is next door to the Queen Elizabeth Hospital allows clinicians to work alongside scientists to speed up the transfer of laboratory research into clinical practice. All of this benefits the service that the Trust can provide to its patients. For these reasons the Trust supports and encourages your participation in research - provided you believe it is right for you. Regulations All clinical research in this Trust has to be approved by a National Research Ethics Committee which will look at the design of the study, the balance of risks and benefits to patients, and whether the study respects the dignity of the patients. Research cannot take place if the ethics committee does not approve it. In addition, the Trust Research and Development Director must approve the study on behalf of the Trust. He will take into consideration other factors as well as the decision of the ethics committee. Some types of clinical research are also subject to national and international regulations. For example clinical trials of new pharmaceutical products must be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA). Gene therapy research must be approved by the Gene Therapy Advisory Committee (GTAC). The collection, storage and release of tissue samples by the HBRC is regulated by the Human Tissue Authority. Research Funding Much of the research carried out in the Trust is supported by three main sources of funding: industry, medical research charities, and the government (either directly or indirectly, for example through the Medical Research Council). In all cases the funders will have reviewed the proposed research for the quality of the design of the study. Other research may receive no direct funding, in which case the Trust itself is responsible for checking the quality of the design of the study. 2 3

3 Clinical Trials Sponsored by Commercial Companies Strict regulations in the UK, Europe, the United States and most of the rest of the world mean that all new drugs and medical devices have to be thoroughly tested before they will be licensed for general use. Pharmaceutical companies in particular are obliged to conduct rigorous clinical trials to demonstrate the safety and effectiveness of new drugs. Because these trials primarily support the commercial interests of the company, NHS trusts, as publicly funded bodies, must seek to recover all of their costs associated with taking part in the trial. These include the costs of the treatment, other tests, and the cost of the time spent by nurses and doctors in working on the study. Specific information about each clinical trial is given on a separate information leaflet. Consent You must give explicit consent that you are willing to donate tissue to the HBRC or to participate in research. This applies even if you are only being asked to give a small additional sample of blood or to complete a questionnaire. For specific research projects and clinical trials you will usually be given an additional information sheet that explains the study and what it will involve. You can ask as many questions as you like and you will be given a contact number so that you can talk to someone and ask questions you think about later. It is important that you understand exactly what is involved and you will be given sufficient time to consider whether or not you want to take part. Although it is unlikely that the research will directly benefit you, you can benefit from the knowledge that you are personally contributing to improvements in healthcare in the future. You will be asked to sign a consent form. You do not have to take part in research or donate tissue samples and you do not have to sign the form. You can ask to have a copy of the consent form that you signed (in most cases you will be given a copy automatically). You can change your mind at any time, without giving a reason, even if you have already signed a consent form. You should contact your hospital doctor or the Research Office at the hospital (contact details at the end of this leaflet). In all cases, if you decide not to take part in the research or withdraw at a later stage, this will not affect your care or treatment in any way now or in the future. If you consent to donate tissue samples to the HBRC, this will be enduring unless you change your mind. If you do change your mind, all samples in storage will be destroyed in the way human tissues are normally destroyed by hospitals. Similarly, any information we store about you will be deleted so that it can never be used again. We will also contact any research groups using your tissue and ensure that they destroy any unused samples and associated data. If you change your mind after a long period of time, the samples may already have been used. We cannot recall samples or information from researchers if this is the case. Parents and legal guardians can give consent on behalf of their children if the child is not competent to make the decision themselves, or chooses not to. In this case it is important that the child assents wherever possible. If there is question as to the mental capacity of a patient aged 18 or over, a formal assessment should be carried out. The patient may have appointed another person to make healthcare decisions on their behalf using a Lasting Power of Attorney (LPA), or they may have a deputy appointed by the Court of Protection. If this is the case then such persons can consent on behalf of the patient, but must still act in the patient s best interests. 4 5

4 Blood and Tissue Samples If you need to undergo surgery or a clinical procedure which involves the removal of tissue or body fluids, these samples will usually be sent to the pathology laboratory to assist with diagnosis. In many cases there will be surplus material remaining after the diagnosis is complete and this would normally be disposed of. You may be asked for your permission to give some of this surplus material for a specific project, or to the HBRC where your sample(s) will be stored until release for use in other ethically and scientifically approved research projects. The pathology laboratory may also have kept some of your sample(s) from a previous surgery or procedure, and this can still be very useful for researchers. Again, we may ask permission for some of this material to become part of the HBRC or to be used in specific research projects directly. During your care in hospital you will normally give blood samples or urine in order to carry out clinical tests. Either while this is happening, or at a different time, we may ask you to allow the staff to take additional samples so that they can be used in research. There is NO increased risk to your health by donating a tissue sample which is removed as part of your routine treatment. You will only be allowing the use of samples which would be collected anyway as part of your normal care and there are no more risks of giving blood for research than there are for giving any routine blood sample. The standard Trust consent form by which you agree to treatment or surgery also asks you to agree that tissue and fluid samples removed during routine treatment can be used for generic research purposes, and this would include donation to the HBRC. Your samples will be used mainly by local researchers but may also be made available to researchers outside of Birmingham, in the UK or overseas. They may work in universities, hospitals or private/commercial companies that do medical research. Your samples may be released for genetic studies but only for research projects aimed at providing clues to the nature of disease. They may also be used to support ethically approved medical research which uses animals, but only when this is absolutely necessary and experiments cannot be performed in any other way. Animal models can be invaluable for increasing our understanding of disease and advancing treatments. Occasionally you may be asked to sign a second consent form which relates to a specific project or clinical trial. Blood and tissue samples donated for research should be regarded as a gift which means that you would not own the material and would have no legal rights over it. However, you would have the right to know how the material was used and disposed of. The HBRC will not routinely report back individual research results because the development of new clinically reliable diagnostic, prognostic or predictive tests takes many years. However, if a research project which uses your tissue generates clinically important information then your doctor, or another member of your healthcare team, will contact you. You will not receive any payment as a result of donating your tissue and the samples you have gifted will never be sold for profit. However, the HBRC may ask researchers to cover some of the cost incurred in tissue collection and storage. Access to Medical Records Information about your condition, other disease(s) and your past treatment is scientifically useful to researchers. This includes long term follow up information held, for example, by the National Cancer Registry and the Office of National Statistics. Also, the monitoring and audit of research is important to ensure that the research is being properly conducted, and to check the accuracy of the data produced. 6 7

5 We will therefore ask for consent to access your medical records at the same time you are asked for consent to take part in research. Within the HBRC your sample(s) will be given a unique code, and your identity will not be known. When your sample is released for research, personal information such as your name, address or phone number will NOT be provided. The information the researcher will be given will relate to your disease and treatment only. All information about you will remain confidential and will be stored in accordance with the UK Data Protection Act No information will ever be released to an insurance company. Continued Treatment For some research you may be given a new drug that is currently not available in the NHS. Often the cost of this drug is subsidised by the sponsor of the research during the study. At the end of the study, the subsidy is likely to come to an end and the Trust may then not be able to continue to provide the drug. If you still need treatment you may have to be prescribed a more standard form of treatment. You should ask about this before you give consent to take part in the study. If the researcher does not know if the drug will still be available at the end of the study, then you should assume that it will NOT be available. What if something goes wrong? It is most unlikely that anything will go wrong. For most clinical research studies there are no special compensation arrangements if you suffer injury as a result of taking part. You have rights if you believe your injuries are due to negligence, but you would usually have to prove this in court. The Trust is not allowed, by law, to take out insurance to cover socalled no fault compensation. For some studies, however, the organisation sponsoring the research will take out special insurance cover for no fault compensation. This is likely to be so for studies sponsored by industry and the Trust will usually require the sponsor to agree to this type of compensation. You can make a claim if you believe that you suffered injury as a result of taking part in the research but cannot prove that anyone was negligent. The researcher must be able to tell you whether or not no fault compensation is available for the study. It may alter your attitude to the balance of risks and benefits and influence your decision whether or not to take part. Further Information For specific research projects, the doctors and nurses running the study are best placed to provide you with detailed information about the study and you should speak to them if you have any questions. If for any reason you feel unable or unwilling to speak to the researchers you may contact staff in the Birmingham Clinical Research Office (the address is at the bottom of this leaflet). They are not directly involved with any of the studies carried out in the Trust and would not be able to provide detailed information about a study, but they will be able to look into concerns about the conduct of the study or pass queries on to the researchers. If you want more information about the HBRC then again, please contact the Birmingham Clinical Research Office who will pass on information or provide contact details. 8 9

6 Key Points The Trust encourages you to take part in research, but only if you believe it is appropriate for you. You do not have to take part, and your treatment will not be affected if you decide not to. You should always be asked to sign a consent form before you take part in a research study or donate samples to the HBRC. Even if you do decide to take part in the research you can change your mind at any time afterwards without having to give a reason. You should ask for a contact telephone number so that you can ring up and ask questions later. All research in the Trust must have been approved by a National Research Ethics Committee and by the Trust s Director of Research and Development