Donor ID: GRID: © 2019 National Marrow Donor Program® NMDP IRB Approved July 16, 2019 Document #: F00444 rev. 17 IRB-2002-0063 Database Donor, Version 17.0 Page 1 of 4

Research Database for Hematopoietic Cell Transplantation and Cellular Therapies

Adult Unrelated Donor Research Consent Form

1. INVITATION AND PURPOSEThe CIBMTR® (Center for International Blood and Marrow Transplant Research®), a researchcollaboration of the National Marrow Donor Program® (NMDP)/Be The Match® and the MedicalCollege of Wisconsin, invites you to take part in a Research Database. The CIBMTR doesresearch with medical data from patients who have had a transplant or other cellular therapyand donors who donate bone marrow or blood stem cells. The goal of this research is to findways to make bone marrow and blood stem cell transplants, and other cellular therapies, workbetter. Although the exact studies for which Research Database data may be used are notknown at this time, the following are types of studies in which these data may be included.These are studies to:

• Determine how well recipients recover from their transplant or cellular therapy;

• Determine how recovery after a transplant or cellular therapy can be improved;

• Determine how a donor’s or recipient’s genetics impact recipient recovery after a transplantor cellular therapy

• Determine how access to transplant or cellular therapy for different groups of patients canbe improved;

• Determine how well donors recover from the collection procedures.

2. PROCEDURESAs part of your donation, data about your blood and tissue type, race, gender and age, andinfectious disease tests will be sent to the CIBMTR. Your cells may be tested to find out thenumber and types of cells, to make sure that the product is sterile, and to learn other things thatmay be important to the transplant or cellular therapy. Additionally, you will be contacted afterthe donation and asked questions to see if you are having pain or other symptoms related to thedonation. If you agree to take part in the Research Database, these data that have already beencollected will be used in research studies.Your donation-related data may be shared with researchers, collaborating organizations, orother registries outside the CIBMTR. The data that is shared will not include any information thatcould identify you. All research studies using data must first be approved by a group ofscientists within the CIBMTR. The proposed study will also be reviewed to make sure theresearch is consistent with the types of studies described above.

3. POSSIBLE RISKS AND BENEFITS TO PARTICIPATING IN THE RESEARCH DATABASESince taking part in the Research Database study only involves sending medical data to theCIBMTR, there are no physical risks to you if you agree to take part in the study.There is a small risk that an unauthorized person could find out which data are yours. Yourdonor center and the CIBMTR have procedures in place to keep your data private. Noidentifiable information about you will be given to the researchers, nor will it be published orpresented at scientific meetings.

Donor ID: GRID: © 2019 National Marrow Donor Program® NMDP IRB Approved July 16, 2019 Document #: F00444 rev. 17 IRB-2002-0063 Database Donor, Version 17.0 Page 2 of 4

You will not be helped by taking part in the Research Database. You will not directly receive any results generated from this research. However, this research may help future patients who need a transplant or cellular therapy.

4. CONFIDENTIALITYYour donor center and the CIBMTR will not intentionally tell anyone that you are taking part inthe Research Database. Your donor center and the CIBMTR have procedures in place so thatno one outside the CIBMTR will know which data are yours.The CIBMTR or the Food and Drug Administration (FDA) may ask your donor center if they canlook in your medical record. These data reviews are done from time to time to make sure thatthe data in the Research Database are correct. When you agree to take part in the ResearchDatabase, you agree to these reviews, which may include copying parts of your medical record.A description of this clinical study will be available on http://www.ClinicalTrials.gov, as requiredby U.S. Law. This website will not include information that can identify you. At most, the websitewill include a summary of the results. You can search this website at any time. (Identifier:NCT01166009)This research is covered by a Certificate of Confidentiality from the National Institutes of Health.The researchers with this Certificate may not disclose or use information, documents, orbiospecimens that may identify you in any federal, state, or local civil, criminal, administrative,legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is acourt subpoena, unless you have consented for this use. Information, documents, orbiospecimens protected by this Certificate cannot be disclosed to anyone else who is notconnected with the research except, if there is a federal, state, or local law that requiresdisclosure (such as to report child abuse or communicable diseases but not for federal, state, orlocal civil, criminal, administrative, legislative, or other proceedings, see below); if you haveconsented to the disclosure, including for your medical treatment; or if it is used for otherscientific research, as allowed by federal regulations protecting research subjects.The Certificate cannot be used to refuse a request for information from personnel of the UnitedStates federal or state government agency sponsoring the project that is needed for auditing orprogram evaluation by Health Resources and Services Administration (HRSA) or NationalInstitutes of Health (NIH) which is funding this project or for information that must be disclosedin order to meet the requirements of the federal Food and Drug Administration (FDA). Youshould understand that a Certificate of Confidentiality does not prevent you from voluntarilyreleasing information about yourself or your involvement in this research. If you want yourresearch information released to an insurer, medical care provider, or any other person notconnected with the research, you must provide consent to allow the researchers to release it.To expand research, it is helpful for researchers to share information they get from studyinghealth information. They do this by putting the information into one or more scientific databases,where it is stored along with information from other studies. Researchers can then study thecombined information to learn even more about health and disease. If you agree to take part inthe Research Database, some of your health information may be placed into scientificdatabases that can be accessed by researchers outside the CIBMTR. Researchers may be ableto see and use your information pooled with information from many other individuals, but yourname and other information that could directly identify you will never be placed into a scientificdatabase.

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5. REIMBURSEMENT AND COSTSYou will not be paid for taking part in the Research Database. It will not cost you anything totake part in the Research Database. Your data may be used for commercial projects and profit.If your data is used for commercial projects, you will not share in any profit.

6. VOLUNTARY PARTICIPATION IN AND WITHDRAWAL FROM THE RESEARCH DATABASEIt is up to you if you want to participate in the Research Database. If you choose not to takepart, you will still be able to get all donor services that you have a right to receive, and you willnot lose any benefits which you should receive.If you decide to take part in the Research Database you may change your mind at any time inthe future. If you do quit the Research Database, your information will not be included in anyfuture research studies. This will not affect your relationship with your donor center or theCIBMTR.

7. ALTERNATIVE TO PARTICIPATIONYou may choose not to take part in the Research Database. If you choose not to take part in theResearch Database you may still donate bone marrow or blood stem cells for the intendedrecipient, but your data will not be included in research studies.

8. QUESTIONS OR CONCERNSIf you have questions, concerns, or complaints about the Research Database, please contact

(Donor Center Medical Director)

at - or Dr. Douglas Rizzo, Senior Scientific Director at the CIBMTR. He can be reached at 1-414-805-0700. If you have questions or concerns about your rights as a research subject or about potential risks and injuries, please contact the NMDP IRB Administrator at 1-800/526-7809. If you wish to contact an independent third party not connected with this study about problems, concerns, questions, information, or input, please contact Be The Match Donor Advocacy at 1-800/526-7809, extension 8710. You will be given a copy of this consent form for your records. You do not waive any legal rights by signing this form.

9. AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION FOR RESEARCHPURPOSESThe CIBMTR collects some data on all donors. This helps the CIBMTR make sure it is doing thebest job it can and learn how to improve where needed. By signing this consent form, you allow

(Donor Center) to give the CIBMTR your demographic information (for instance: gender, age and ethnic background) and health information that was taken as part of the donation process (for instance: results from infectious disease testing and the physical exam and information on healing from the donation). This information will be used by the CIBMTR to evaluate operation of the registry, to report to its funding agencies, and to conduct research.

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This authorization does not have an expiration date. You have the right to cancel this authorization at any time by notifying Be The Match or the CIBMTR in writing that you are canceling the authorization. The address for Be The Match is 500 N. 5th Street, Minneapolis, MN 55401. If you cancel this authorization, any identifiable health information will not be used for research studies. If you cancel your authorization, this will not affect your right or access to healthcare or any other services you are entitled to receive at

(Donor Center).

10. DONOR'S/SUBJECT’S STATEMENT OF CONSENTI have read this consent form and I have been given the opportunity to ask questions. Ivoluntarily agree to take part in the Research Database. My data may be used in researchstudies as defined in this consent form.

Donor/Subject Signature Date

Print Name of Donor/Subject

Certification of Counseling Healthcare Professional

I certify that the nature and purpose, the potential benefits, and possible risks associated with the submission of data to the Research Database have been explained to the above individual and that any questions about this information have been answered.

Counseling Healthcare Professional Date

Use of an Interpreter: Complete if the subject is not fluent in English and an interpreter was used to obtain consent.

Print name of interpreter: Date:

Signature of interpreter: Date:

An oral translation of this document was administered to the subject in

(state language) by an individual proficient in English and (state language). See the attached short form addendum for documentation.