COLLECTION AND BANKING OF BIOLOGICAL SAMPLES AND COLLECTION OF CLINICAL DATA FROM PERSONS WITH BLOOD DISORDERS

Transcription

1 Childhood Cancer Blood Research Program BioBanking Initiative Information and Consent Form Blood Disorders COLLECTION AND BANKING OF BIOLOGICAL SAMPLES AND COLLECTION OF CLINICAL DATA FROM PERSONS WITH BLOOD DISORDERS Principal Investigator: Dr Suzanne Vercauteren UBC Department of Pathology and Laboratory Medicine Children s & Women s Health Centre of BC Physicians Division of Hematology/Oncology/BMT, Children s & Women s Health Centre of BC Dr. Jeffrey Davis, MD, FRCPC Dr. Chris Fryer, MD, FRCPC Dr. Juliette Hukin, MD, FRCPC Dr. Sheila Pritchard, MD, FRCPC Dr. David Dix, MD, FRCPC Dr. Rebecca Deyell, MD, FRCPC Dr. Rod Rassekh, MD, FRCPC Dr. Paul Rogers, MD, FRCPC Dr. Kirk Schultz, MD, FRCPC Dr. Caron Strahlendorf, MD,FRCPC Dr. John Wu, MD, FRCPC Dr. Jacob Rozmus, MD, FRCPC Dr Jessica Halparin, MD, FRCPC Research Scientists, Childhood Cancer and Blood Research, Child & Family Research Institute Dr. Catherine Pallen, PhD Dr. Sandra Dunn, PhD Dr. James Lim, PhD Dr. Chris Maxwell, PhD Dr. Gregor Reid, PhD BioBank Coordinator: Tamsin Tarling, MSc. (604) ext 6423 Emergency Telephone Number: (604) hours/day, 7 days a week Toll Free Number (BC only): For both numbers listed above, inform the Operator that you wish to speak to the Hem/Onc/BMT Physician On-Call Introduction Doctors at Children s and Women s Health Centre of BC (C&W) and scientists at the Child and Family Research Institute (CFRI) have created a research group called the Childhood Cancer and Blood Research group (CCBR). This group wants to create a bank (or library) of samples for use in research to better understand how to correct diseases of the blood. The CCBR BioBank is governed by the ethical standards overseen by the UBC / C&W Research Ethics Board (REB) as well as the Executive Committee for Management and Operations (ECMO) of the CCBR Biobank. These two groups ensure that all children donating samples to the Biobank are protected as research participants by the applicable standards that govern the operation of BioBanks. It is important that you understand that if you sign this Page 1 of 9

2 consent form, you are consenting to the banking of your samples for future research projects, which as of now, are undefined. You/your child are being invited to take part in this initiative because you/your child has or is suspected to have a blood disorder. This consent form is to help you/your child decide if you/your child want to participate in the CCBR BioBank initiative. The Principal Investigator and BioBank Coordinator will be happy to answer all your questions. From this point forward when we use you and your in this consent form, we mean you or your child. Your participation is voluntary Your participation is entirely voluntary. Before deciding, it is important for you to understand what the BioBank involves. This consent form will tell you about the banking of samples, why the banking is being done, and what will happen to these samples, in addition to the possible benefits, risks and discomforts to you. If you decide to participate, you will be asked to sign this form. If you do decide to participate, you are still free to withdraw at any time and without giving any reasons. If you do not wish to participate, you do not have to provide any reason for your decision not to participate nor will you lose the benefit of medical care to which you are entitled or are presently receiving. Please take time to read the following information carefully and to discuss it with your family, friends and doctor before making a decision. Background Every day the body produces billions of new white blood cells, red blood cells and other blood cells. All of these blood cells are produced in the bone marrow which is located inside most of the bones in the body. The blood cells then move into the blood stream where they fight infection, provide energy and help clot the blood. Occasionally, something goes wrong with the growth and behavior of these blood cells and a blood disease develops. While many blood diseases can be treated, much work still needs to be done to find safer and more effective cures. Who can donate to the CCBR BioBank? All children treated for a blood disorder are eligible to contribute samples to the CCBR BioBank. What will happen if I decide to donate to the CCBR BioBank? Sample Donation We are inviting you to donate small samples of blood or bone marrow (up to 5 mls, 1 teaspoon). We would also like to collect any left over blood, DNA stem cells, Cerebrospinal Fluid (CSF) or leukapheresis product (white blood cells) for storage in the CCBR BioBank and for use in future research projects. All of these samples will be collected during a clinical procedure necessary for the diagnosis or treatment of your (suspected) blood disorder. No additional procedures will be required. 1. Collection of Bone Marrow You may need to have checked bone marrow procedure to see whether the bone marrow is involved. If so, you may need follow up bone marrow procedures. throughout your treatment. If you agree to participate in the CCBR BioBank we request that a doctor take an extra amount of your bone marrow (about 2-5 millilitres, or ½ - 1 teaspoon) when a sample is required for clinical reasons. Page 2 of 9

3 2. Collection of Blood Samples, CSF and Leukapheresis products If, after routine clinical procedures there is any blood, CSF or leukapheresis products left over, we ask your permission to store these left over samples in the CCBR BioBank,. 3. Collection of left over DNA from Cytogenetic analysis In order to make your diagnosis, the clinical cytogenetics laboratory may need to isolate DNA in your bone marrow/blood. We would like to ask your permission to store any left over DNA in the BioBank after these tests have been completed. Even if you agree to donate this left over DNA, the clinical cytogenetics laboratory will keep a small amount for the unlikely need for re testing or additional testing on a sample representing your bone marrow/blood at this point in your diagnosis. However, there is always a chance that the amount of DNA deemed reasonable for re testing or additional testing may not be sufficient. 4. Collection of left over stem cells If you are donating peripheral blood stem cells or bone marrow harvested stem cells for a stem cell transplant (either for yourself or for a family member) and the transplant does not take place as planned, or there are cells left over after transplant, those samples will be kept frozen in storage for 10 years. Following the 10 year period you are given the option to have the samples stored in an alternate storage facility, for example Life Bank, donate them to the CCBR BioBank or have them destroyed. In the event that an abundant stem cell collection occurs and there are more cells than clinically required, a small volume may be given to the CCBR BioBank provided you have agreed. This will be at the discretion of your doctor and the director of the apheresis program (the program in which stem cells are collected). 6. Use of old biospecimens If you had a previous diagnosis of a malignancy in the past there may be old (archived) biospecimens l stored in the Department of Pathology and Laboratory Medicine. Often these are no longer required for clinical purposes; would you be willing to donate these old (archived) specimens to the CCBR BioBank? To be absolutely clear that we understand what you have decided upon, please check the boxes on the following page to tell us your wishes: Page 3 of 9

4 Yes No Collection of Bone Marrow I agree to have up to 2-5 milliliters (or ½-1 teaspoon) of bone marrow taken at the same time as a sample is required for clinical purposes for the CCBR BioBank. Collection of left over biospecimens I agree to donate the following left over biospecimens to the CCBR BioBank. Yes No Blood Yes No CSF Yes No Leukopheresis Products Yes No DNA Yes No Stem Cells Yes No N/A Use of old biospecimens I agree to donate old (archived) biospecimens that have previously been stored and are no longer required for clinical purposes. Collection of Data To better understand what scientists may see when doing their research on your samples in relation to your disease and its treatment we will review your medical chart at various time points throughout the period of time you participate in the CCBR BioBank, and collect your health related information. Information that will be collected may include all or some of the following: 1) Medical history from the time of diagnosis and throughout treatment and follow up. 2) Medications you have received for your disorder. 3) Results from laboratory and medical tests. 4) Demographic information, such as date of birth, gender, and ethnic background. 5) Information about your treatment. Both your samples and your medical information will be assigned a unique BioBank number so that none of your samples or health information will have your name on it. No information that discloses your identity will be released. In addition to the above information, we would like your permission to be able to contact you in the future about possible other research which may be unrelated to the scope of research carried out by the CCBR BioBank. Please indicate in the box below if you are willing to be contacted in the future, this contact may be by telephone. As stated above only the BioBank Coordinator will have access to your personal or contact information and thus it would be his/her responsibility to contact you. I am willing to be contacted in the future regarding other research I am not willing to be contacted in the future regarding other research Page 4 of 9

5 What will my samples be used for? At this time the specific research project your samples will be used for is undetermined. Scientists will have to obtain ethical approval as well as submit an extensive proposal to obtain samples from the CCBR BioBank. Samples will be used primarily for research into blood and cancer related disorders, however if you are willing to donate your samples to be used in any type of research, please indicate this as your wish by initialing the statement below. I am willing to donate my samples to be used in any type of medical research I am only willing to donate my samples to be used for cancer or blood research Scientists worldwide will be able to apply for your samples. If you wish for your samples to be used by international researchers, please indicate this as your wish by initially the statement below. Please note that legislation may differ between countries. The CCBR BioBank will NOT release personal identifiers such as your name and date of birth but as always in scientific research there is an inherent risk of loss of confidentiality. I consent to having my samples used by international researchers. I consent to only having my samples used by Canadian researchers How long will samples be collected and stored? If you decide to donate samples to the CCBR BioBank and sign this consent form, samples will be collected for the duration of the time you receive treatment and follow-up care for your disease and you will NOT be asked to consent again. You will be informed, at the time of your procedure, that a sample is being collected for the CCBR BioBank. Samples will be stored indefinitely in the CCBR BioBank. The CCBR BioBank will do their best to re-contact you on your 18 th birthday to discuss your continued participation in the BioBank. Where will the samples be stored? Samples will be stored in a secure freezer in an access limited laboratory of the CFRI. Only CCBR BioBank staff will have access to this freezer. What are the possible harms and side effects associated with donating to the CCBR BioBank? Since only a small sample of biological material will be collected for the BioBank and no additional procedures are being requested, it is unlikely that there will be any harm to you. It should be noted that the amount of biological sample taken from you has been carefully considered. Under no circumstances will additional procedures occur just for the purpose of obtaining samples for the BioBank. Because certain demographics, specifically your date of birth, diagnosis and sex are being collected, there is a risk of your identity being revealed but all efforts will be made to minimize that as a possibility. The CCBR BioBank function is to store your samples and match them with reputable investigators who have ethical approval for their work. NO genetic analysis of your samples will be carried out by the CCBR BioBank. However, genetic studies may be carried out with your samples once they have been released to an investigator. The intention of the CCBR BioBank is Page 5 of 9

6 to maintain confidentiality at all times. However, there is a very small risk that information gained from genetic research could eventually be linked to you and possibly other members of your biological family. What are the benefits of donating to the CCBR BioBank? You will not directly benefit from donating samples to the CCBR BioBank. We hope that any information learned from the research conducted can be used in the future to benefit other people with blood disorders. Research done with your samples may help to develop new treatments. How much of my time will donating to the CCBR BioBank take? Aside from the time it takes you to read this consent form and ask questions regarding the banking of your samples, participation in this research will not require any time on your part. What if I choose not to donate? If you do not wish to donate to the BioBank you will continue to receive the accepted standard of care. Your doctor will do the usual studies and tests that children with blood disorders normally get. There is no difference in treatment between those who wish to donate and those who do not wish to donate. What happens if I decide to withdraw my consent to participate? Participation in the CCBR BioBank is entirely voluntary. You may withdraw from donating to the CCBR BioBank at any time and request that the samples that have been collected be destroyed. If you decide to withdraw, there will be no penalty or loss of benefits to which you are otherwise entitled, and your future medical care will not be affected. In order to withdraw from the BioBank you may contact your physician or you can notify the BioBank Coordinator, Tamsin Tarling directly at , extension Upon notice of withdrawal, a form will be completed by the CCBR BioBank coordinator. Please note that any information that has been gathered from your medical chart(s) and your samples will be destroyed but that it will not be possible to remove information derived from your samples prior to notification of withdrawal. In addition, it may not be possible to destroy samples and medical information that has already been distributed to investigators. What happens to my samples if the bank has to close? You will be informed by letter if the bank closes. All samples as well as paper and electronic documentation will be destroyed. What will donating to the BioBank cost me? You will not incur any expenses as a result of donation of samples to the CCBR BioBank. You will not be paid for donating any samples for research purposes. You will not be paid for donating samples for research purposes. You will not financially benefit from discoveries or commercial products developed from samples you have donated. The CCBR BioBank will provide samples to researchers on a cost recovery basis; this is to ensure that the CCBR BioBank remains sustainable. NO profit will be made. What happens if something goes wrong? If you become injured or unexpectedly ill as a consequence of donating to the BioBank, your medical condition will be evaluated and medical care will be provided by one of the investigators or you will be referred for appropriate treatment. Page 6 of 9

7 Signing this consent form in no way limits your legal rights against the sponsor, investigators, or anyone else involved in the CCBR BioBanking initiative Will donating to the CCBR BioBank be kept confidential? Your confidentiality will be respected to the extent permitted by applicable laws and regulations and your medical and study records will not be publicly available. Your identity will not be used in any reports that arise from any studies in which your samples are used. All samples will be de-identified and given a unique code number. The BioBank Coordinator is the guardian of the BioBank medical information portion of the database. Only he/she will have access to your personal identifying information. The BioBank Coordinator may give de-identified information from your records to a researcher only under conditions where the clinical information is necessary for the specific research project. All information associated with the CCBR BioBank will be kept in a password protected database and in locked filing cabinets, only accessible by the BioBank coordinator. Reports and results of research done with your samples will not be given to you or your doctor. These reports will not be put in your medical records. The research using your samples will not affect your care. Research records and medical records identifying you may be inspected in the presence of the Investigator or his or her designate by representatives of any funding agencies, and the UBC Research Ethics Boards or applicable BioBanking agencies for the purpose of monitoring the BioBank. However, no records which identify you by name or initials will be allowed to leave the Investigators' offices. Your rights to privacy are protected by the Freedom of Information and Protection of Privacy Act of British Columbia. This act lays down safeguards respecting your privacy and gives you the right of access to your information. You will also have the right to correct any errors in this information if necessary. Further details about this act are available upon request. Please note that the same legislation will not necessarily apply in different countries. The CCBR BioBank may release your samples to a foreign investigator (with your permission, see page 3) but as stated previously your name and date of birth will not be released and the research project for which your sample will be used MUST have prior ethical approval. Who do I contact if I have questions about donating to the CCBR BioBank? If you have any questions or would like to have more information about donating to the BioBank you can contact Dr Suzanne Vercauteren, BioBank Chair and Principal Investigator at or the BioBank Coordinator, Tamsin Tarling at (604) extension Who do I contact if I have questions or concerns about my rights in relation to donating to the CCBR BioBank? If you have any concerns about your rights in relation to donating to the CCBR BioBank, please contact the Research Subject Information Line at the UBC Office of Research Services by at RSIL@ors.ubc.ca or by phone at (604) or the toll free line at CCBR BioBank Initiative - Information and Consent Form Blood Disorders By signing this consent form I am agreeing to the collection of clinical information and donation of samples to the CCBR BioBank for the entire time period that I receive treatment and/or Page 7 of 9

8 follow-up at C&W Health Centre of BC. This time period may last several years depending on my disease. I understand that donating to the CCBR BioBank is entirely voluntary. I may refuse to have samples and clinical information collected from me at any time without having to explain my decision. Checking in the boxes beside each of these statements indicates I have read and understood them. I have read and understood the subject information and consent form. I understand that I am consenting to the banking of my samples for future research projects, which are as of now, are undefined. I understand that the use of my samples will be for research purposes only. I understand that should any commercial products be developed from subsequent research, the CCBR will assert all rights arising from use of my samples. I understand that I will not be paid should this research result in a commercial product. I have had sufficient time to consider the information provided and to ask for advice if necessary. I have had the opportunity to ask questions and have had satisfactory responses to my questions. I understand that during the course of my treatment, I will not be re-consented every time I donate a sample to the BioBank I understand that all of the information collected will be kept confidential and will only be used for scientific objectives. I understand that donation to the CCBR BioBank is voluntary and that I am completely free to refuse to participate or withdraw from participating at any time without changing the quality of care that I receive. If I chose to withdraw my samples will be destroyed, if that is my choice. I understand that I am not waiving any of my legal rights as a result of signing this consent form. I understand that there is no guarantee that donating samples to the CCBR BioBank will provide any benefits to me. I understand that information will be collected from my medical chart(s) for research purposes. I have read this form and I freely consent to donating samples to the CCBR BioBank based on the information provided. I have been told that I will receive a dated and signed copy of this form. Name of Parent/Guardian (Please Print) Signature of Parent/Guardian Date I have asked the participant if they have any questions regarding the information in this consent form. The participant has understood the nature of my answers to any of their questions regarding the information contained in this consent form. Name of designate obtaining consent Signature of designate obtaining consent Date Name of translator (if applicable) Signature of translator (if applicable) Date Copy to: Participant Clinic chart BioBank Coordinator Page 8 of 9

9 Childhood Cancer Blood Research Program BioBanking Initiative Decline to Consent Form I have explained the Childhood Cancer and Blood BioBanking initiative to Insert Participant Name (Please Print) and his/her questions have been answered He/she has declined to participate in the Childhood Cancer and Blood Research BioBank initiative on dd/mm/yy In indicating the above, this participant s decision will be entered into the BioBank database so that he/she will not be approached again for participation in the Childhood Cancer and Blood Research BioBanking initiative. Name of Physician or designate (Please Print) Signature of Physician or designate Date Copy to: Participant Clinic chart BioBank Coordinator Page 9 of 9