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Clinical Trials - Consent forms |
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6.10.03 Immunotherapy With Heat Shock Enhanced Autologous Tumour Lysate, Alpha-Interferon And Granulocyte-Macrophage Colony Stimulating Factor In Patients With Malignant Mesothelioma
Chief Investigator: Professor Bruce WS Robinson, University Department of Medicine, Queen Elizabeth II Medical Centre, Monash Avenue, Nedlands, Perth, Western Australia.
Associate Investigators: Dr Alex Powell, Department of Medical Oncology, Queen Elizabeth II Medical Centre, Monash Avenue, Nedlands, Perth; Clinical Professor Bill Musk, Respiratory Physician, Sir Charles Gairdner Hospital, Monash Ave, Nedlands, Perth, WA; Dr Michelle Murphy, University Department of Medicine, Queen Elizabeth Medical Centre, Monash Avenue, Nedlands, Perth, WA
1. I, the undersigned, . Hereby consent to my involvement in the research project Immunotherapy with heat shock enhanced autologous tumour lysate, alpha-interferon and granulocyte-macrophage colony stimulating factor in patients with malignant mesothelioma. I acknowledge that the nature, purpose and possible effects of the project so far have been fully explained to my satisfaction and that my consent is given voluntarily. I have read the Plain Language Statement attached to this Consent Form and fully understand the contents herein. 2. The details of the procedures have been explained to me. I have been given clear information about the proposed study and time to consider whether I wish to participate in this study. 3. I understand that I may have to have an operation called a thoracoscopy or have a lump removed from under my skin to obtain cancer cells to manufacture the vaccine. The details and risks involved with these operations have been explained to me and I have had the opportunity to read the information sheet regarding what is involved. 4. Although I understand that the purpose of this research project is to improve the quality of medical care, it has also been explained to me that my involvement is not likely to be of benefit to me. 5. I have been given the opportunity to have a member of my family or a friend present while the project was explained to me. 6. I am informed that no information regarding my medical history will be divulged beyond the researchers involved. Results of investigations involving me may be published provided my name or other identifying information is not used. 7. I understand that my involvement in the project will not affect my relationship with my medical advisers in their management of my health. I also understand that I am free to withdraw from the study at any stage. 8. I understand that participation in this study does not prejudice any right to compensation that I may have under statute or common law.
.. ./ / Name of Patient Signature of Patient Date
.. ./ / Name of Witness Signature of Witness Date
.. ./ / Name of Investigator Signature of Investigator Date
The Sir Charles Gairdner Hospital Research Institutional Ethics Committee has given ethics approval for the conduct of this project. I understand that I am free to contact the Secretary of this Ethics Committee (08 9346 2999) if I have any concerns. All study participants will be provided with a copy of the Patient Information Sheet and Consent Form for their personal records.
Detailed
protocol with references For more information contact: jolghazi@cyllene.uwa.edu.au
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