National Marrow Donor Program (Nmdp)

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation

in Patients with Medicare Coverage

Informed Consent to Participate in Research

I. INVITATION AND PURPOSE

The Center for International Blood and Marrow Transplant Research (CIBMTR), the research program of the National Marrow Donor Program (NMDP)/Be The Match, invites you to take part in a research study because:

· you have (patient’s disease)

· you intend to undergo a stem cell transplant and,

· your healthcare costs are covered by Medicare.

Currently the US Centers for Medicare and Medicaid Services (CMS) will only pay for the cost of a stem cell transplant for your disease if the patient is participating in a research study approved by CMS. This study is approved by CMS.

The goal of this research is to determine if stem cell transplants are beneficial for patients with your disease. The results of this study will help CMS decide if transplants for your disease will be covered by Medicare in the future.

II. STUDY PROCEDURES

This study does not require you do to anything. If you participate, medical data about your disease and your transplant will be sent to the CIBMTR. Your doctor will send data to the CIBMTR before and after your transplant, and then once a year for at least five years. Your medical data will be combined with the medical data of other recipients receiving a stem cell transplant with the same disease as yours. The combined data will be analyzed by researchers to determine if stem cell transplant is an effective therapy for your disease.

III. POSSIBLE Risks and Benefits to PARticipating in the STUDY

Since taking part in this study only involves sending medical data to the CIBMTR, 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. Your treatment center and the CIBMTR have procedures in place to keep your data private. No identifiable information about you will be given to the researchers, nor will it be published or presented at scientific meetings.

By participating in this study, Medicare will pay for your stem cell transplant. Future patients whose healthcare costs are covered by Medicare may also benefit from this study by having their transplant costs paid by Medicare.

IV. COnfidentiality

Your treatment center and the CIBMTR will not intentionally tell anyone that you are taking part in this study. Your treatment center and the CIBMTR have procedures in place so that no one outside the CIBMTR will know which data are your data.

The NMDP/CIBMTR or CMS may ask your treatment center if they can look in your medical record. These data reviews are done from time to time to make sure that the data in the database are correct. When you agree to take part in this study, 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 required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

V. REIMBURSEMENT AND COSTS

You will not be paid for taking part in this study. It will not cost you anything to take part in this study.

VI. VOLUNTARY PARTICIPATION IN AND WITHDRAWAL FROM THE STUDY

It is up to you if you want to participate in the study. If you choose not to take part in the study, you will still be able to get healthcare or any other services that you have a right to receive, and you will not lose any benefits which you should receive. However, if Medicare is your only source of payment for your transplant, you will only receive a transplant if you participate in this study.

If you decide to take part in the study, you may change your mind at any time in the future, however any data previously collected will still be used for the study. If you do quit, Medicare may not cover the cost of your stem cell transplant. If you do quit, this will not affect your relationship with your treatment center or the CIBMTR.

VII. Alternative to Participation

You may choose to not take part in this study. If you choose not to take part in this study, Medicare will not pay for the cost of your stem cell transplant. You may receive your transplant as scheduled, but you would need to find another funding source to cover the costs. You also could decide not to have a stem cell transplant. If you choose not participate in this study, your doctor will discuss with you other treatment options besides transplant.

VIII. QUESTIONS OR CONCERNS

If you have questions, concerns, or complaints about the study, please contact (Treatment Center Physician) (telephone number) or (Study PI’s name and title) (Study PI’s phone #).

If you have questions or concerns about your rights as a research subject or about potential risks and injuries, please contact Roberta King, 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 a Patient Services Coordinator with Be the Match® Patient and Health Professional Services at 1-888/999-6743 or . You will be given a copy of this consent form for your records.

IX. RECIPIENT/SUBJECT’S Statement of Consent

I have read this consent form, and I have been given the opportunity to ask questions. I voluntarily agree to take part in this study. My data may be used in the research study as defined in this consent form.

Recipient/Subject Signature Date

national marrow donor program®
institutional review board
Consent Form approval date:
July 30, 2017
Do not sign this form after the
Expiration date of: July 29, 2018

______

Print Name of Recipient/Subject

Certification of Counseling Healthcare Professional

I certify that the nature and purpose, the potential benefits, and possible risks associated with submitting data to the study 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.

Document #: F01049 rev. 2 IRB-2002-0063, Database CMS Studies, Version 2.0

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