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© 2015 National Marrow Donor Program®NMDP IRB Approved 07/30/2015through 07/29/2016Document #: F00575 rev. 10IRB-1991-0002 Donor Repository Parent/Legal Guardian, Version 10.0Page 1of 4Contributionof a Blood Sample to the Research Sample RepositoryMinor Related DonorParent/Legal GuardianResearch PermissionFormI.INVITATION AND PURPOSEThe Center for International Blood and Marrow Transplant Research (CIBMTR), the research programof the National Marrow Donor Program (NMDP)/Be The Match,invitesyour child to take part in the Research Sample Repository. A repository is a place where blood samples are frozen and stored. The blood samples are used for research.The CIBMTRis trying to learn more about what makes bone marrow, blood stem cell and cord blood transplants work well. Although the exact study for which Research Repository samplesmay be used is not known at this time, the following are types of studiesin which thesesamplesmay be included. Studies to:Improve the understanding of tissue matching for related and unrelated donors and recipients;Determine and evaluate the factors that affect transplant outcome;Study the distribution of tissue types in populations; for example, variousracial and ethnic populations,to help develop methods toimprove tissue matching between donors and recipients.Investigators may conductresearch studies with stored blood samples that have had all identifiers removed.The CIBMTR may allow investigators to use these anonymous samples for many other kindsof studies.Any research project may be proposed for anonymous research, such as:Studies that look for the presence of traits linked to other diseases, like diabetes.II.PROCEDURESIf you allow your child to take part in theResearch Sample Repository, and your child agrees to participate, a sample of blood (up to two tablespoons) will be collected from a vein in your child’s body. The blood will be collected either just before your child’s bone marrow or blood stem cell donation, or shortly after thedonation. Your child’s blood sample will be frozen and stored indefinitely for possible use in future research studies. Cells from your child’s blood may be grown in the lab so there are more of them that can be used in research studies. DNA, the genetic portion of the cells, may be used in some of the studies.Allresearch studies using blood samples must first be approved by a group of scientistswithin the CIBMTRas well as the RepositoryOversight Committee. The proposed studywill also be reviewedto make sure the research is consistent with the types of studies described above. III.POSSIBLE RISKS AND BENEFITS TO PARTICIPATING IN THERESEARCH SAMPLE REPOSITORYCollecting the sample of blood will likelycause minor discomfort at the site where the blood is taken. For example, some bleeding and/or a small bruise may occur. Infection is rare, but could occur. If your childisuncomfortable at the sight of blood he/shemay feel light-headedor faint.
© 2015 National Marrow Donor Program®NMDP IRB Approved 07/30/2015through 07/29/2016Document #: F00575 rev. 10IRB-1991-0002 Donor Repository Parent/Legal Guardian, Version 10.0Page 2of 4There is a small risk that an unauthorized personcould find out which blood sample is yourchild’s. Your child’s donor center and the CIBMTRhave procedures in place to keep your child’s data private. No identifiable information about your childwill be given to the researchers, nor will it be published or presented at scientific meetings.Your childwill not be helped by taking part in the Research Sample Repository. However, this research may help future patients who need a transplant.IV.CONFIDENTIALITYYourchild’sdonorcenter and the CIBMTRwill not intentionally tell anyone that your childistaking part in the Research Sample Repository. Your child’s donor center and the CIBMTR haveprocedures in place so thatno one outside the CIBMTRwill know which sample is yourchild’s. V.REIMBURSEMENT AND COSTSYou and your child will not be paid for taking partin the Research Sample Repository.It will not cost you anythingfor your child to take partin the Research Sample Repository.VI.VOLUNTARY PARTICIPATION IN AND WITHDRAWAL FROM THE RESEARCHSAMPLE REPOSITORYParticipating in this research study is up to you and your child. If your childchoosesnot to take part, or if you choose not to allow your child take part in the Research Sample Repository, your childwill still beable to get all donor services he/she has aright to receive. If your child does not participate, your childwill not lose any benefits which he/she should receive. If your childdecidestotake part, and if you allow your child to participatein the Research Sample Repository,you or your childmay change your mind at any time in thefuture.If your childquits, your child’sblood sample will be destroyed. Thiswill not affect yourchild’srelationship with the donationcenter or the CIBMTR.VII.ALTERNATIVE TO PARTICIPATIONYour childmay choose not to take part in the Research Sample Repositoryand you may choose not to allow your child to participate. If your child doesnot participate in the Research Sample Repository yourchild’sbone marrow or blood stem cells will still be used fortransplant, but a blood sample will not be collected or sent to the Research Sample Repository.VIII.IN THE EVENT OF INJURY DURING BLOOD DONATION TO THE RESEARCH SAMPLE REPOSITORYThe risk of injury to your childis considered small. However, if an injury does occur, treatment (including first aid, emergency treatment and other necessary care) will be available. If your child is injured please call the following individual at the site where your child donatedbone marrow or PBSCs: ____________________________________ (telephone number).You do not waive any legal rights by signing this form.