protocol for a research sample repository for hematopoietic cell

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Center for International Blood and Marrow Transplant Research

PROTOCOL FOR A RESEARCH SAMPLE

REPOSITORY

FOR

HEMATOPOIETIC CELL TRANSPLANTATION,

OTHER CELLULAR THERAPIES

AND MARROW TOXIC INJURIES

Principal Investigator: Stephen Spellman, M.S.

CIBMTR Assistant Senior Scientific Director

Director, Immunobiology ResearchVice President, Research

National Marrow Donor Program

500 N. 5

Street

Minneapolis, MN 55401-1206

JuneMay 202119

Version 132.0

ClinicalTrials.gov Identifier: NCT04920474

© 202119 National Marrow Donor Program
®
                                           
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Table of Contents 
 
1.    Background .................................................................................................................. 3 
1.1  National Marrow Donor Program ........................................................................... 3 
    1.2  Center for International Blood and Marrow Transplant Research®…....………...3 
1.3  Establishment and Purpose of the Research Sample Repository ............................ 3 
2.  Eligibility to Participate in the Research Sample Repository ..................................... 4 
2.1  Hematopoietic Cell or Other Cellular Therapy Donors Eligibility Criteria ........... 4 
2.2  Cord Blood Units Eligibility Criteria .................................................................... 54 
2.3  Hematopoietic Cell or Other Cellular Therapy Recipients Eligibility Criteria .... 54 
2.4  Patients With Marrow Toxic Injury Eligibility Criteria ....................................... 54 
2.5  Informed Consent to Participate in the Research Sample Repository ................ 545 
        2.5.1  Minor Assent.....................................................................................................5 
2.5.2  Cord Blood Specimens......................................................................................56 
3.         IRB Approval Process for Research Sample Repository ...................................... 56 
3.1  IRB Approval 
Process……………………………………………………………………...….56 
4.  Collection of Samples............................................................................................. 
764.  Collection of Samples............................................................................................. 7 
   4.1   Pre-transplant or Cellular Therapy Collection of Donor and Patient Blood 
Samples………………………………………………………………………….…6
7 
         4.1.1  Unrelated and Related Donor Transplants or Cellular Therapy ......................6        
7         
4.1.2  Autologous Transplants or Cellular Therapy………………………………….7        
8         
4.2   Post-transplant or Cellular Therapy Collection of Patient Blood 
Samples…….….87     
4.3   Patients With Marrow Toxic Injury ........................................................................8 
4.4   Donors for Tissue Type Characterization and Algorithm Enhancement ................8   
   4.5  Collection of CBU 
Specimens.................................................................................98 
5.   Sample 
Processing.........................................................................................................98 
   5.1  Cell 
Storage..............................................................................................................98 
   5.2   Cell Transformation..................................................................................................9 
  5.3   Cell Expansion..........................................................................................................9           
5.4   Vial Labeling ...........................................................................................................9 
6.   Duration of Sample Storage at the Research Sample Repository..................................9 
7.   Access to Samples 
........................................................................................................109 
    7.1   Who May Request Access to Samples 
....................................................................109 
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7.2 How Requests Are Reviewed/Approved

...............................................................10..9

8. Use of Research Repository Samples for Research Studies

.......................................110

8.1 Linked (Anonymous) Research .......................................................................... 110

8.2 Delinked (Anonymous) Research ..........................................................................11

8.3 Studies Outside the Scope of this Protocol

............................................................121

8.4 Data Available With Samples............................................................................ 1312

8.5 Restrictions on Sample Usage at the Investigative Site .................................... 1312

8.6 Public Release of Data Generated on Samples…………………………………...12

9. Participant Withdrawal from the Research Sample Repository

……………………........................................132

10. Confidentiality ............................................................................................................13

10.1 Coded Sample Inventory and Links to Personal Identifiers.................................13

10.2 Certificate of Confidentiality ............................................................................ 143

10.3 Reporting Requirements for Research Sample Requests ...... 141310.3 Reporting

Requirements for Research Sample Requests ............................................................... 14

1. Background

1.1 National Marrow Donor Program

The National Marrow Donor Program

(NMDP) was established in 1986 as the result

of a Federal contract that was awarded to create and maintain a registry of volunteer

hematopoietic cell (HC) donors. Physicians search the NMDP/Be The Match

Registry on behalf of patients in need of an HC transplant who have no suitably

matching related donor. As part of the Federal contract the NMDP was required to

collect outcomes data and research samples on patients who received a product

through NMDP. In 1999 the NMDP added a Cord Blood Registry to provide more

donor source options for patients in need of an unrelated HC transplant or cellular

therapy. In 2006, the NMDP was awarded a subcontract by the Medical College of

Wisconsin to serve as the Related Transplant Research Repository for the Stem Cell

Therapeutic Outcomes Database (SCTOD). The Medical College of Wisconsin –

Center for International Blood and Marrow Transplant Research (CIBMTR) holds the

federal contract to operate the SCTOD.

In addition, the Federal contract also recognized that the NMDP could play a critical

role in responding to contingency events; primarily radiation and chemical exposures

occurring either accidentally or resulting from military or terrorist actions that cause a

marrow toxic injury.

1.2 Center for International Blood and Marrow Transplant Research

The International Bone Marrow Transplant Registry (IBMTR), located with the

Department of Medicine of the Medical College of Wisconsin, was established in

1972 to monitor and study outcomes of bone marrow transplants. In 2004 the NMDP

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and IBMTR established the Center for Blood and Marrow Transplant Research

(CIBMTR). The CIBMTR is a research affiliation between the NMDP and the

Medical College of Wisconsin. The CIBMTR has both a Minneapolis campus

located within the NMDP offices and a Milwaukee campus at the Medical College of

Wisconsin. The NDMP Research Program is accomplished through the CIBMTR.

1.3 Establishment and Purpose of the Research Sample Repository

In 1987 the NMDP established the Research Sample Repository which is currently

located at the NMDP Biorepository Services facility in New Brighton, Minnesota

with a backup location at the Coriell Institute for Medical Research in Camden, New

Jersey. The primary objective of this repository is to make blood samples available

for research studies related to histocompatibility and HC transplantation or other

cellular therapy. Blood samples are donated by donors, CBUs and recipients who

have registered, donated or received a HC transplant or other cellular therapy covered

under the C. W. Bill Young Transplantation Program. Details of the research sample

inventory are available at

http://www.cibmtr.org/Samples/Inventory/Pages/index.aspx.

The Research Sample Repository maintains updated standard operating procedures

(SOP) for all aspects of operation including but not limited to: sample receipt, sample

handling, sample culture, sample labeling, sample storage and sample retrieval and

shipment.

The following are types of studies that the samples may be used for without obtaining

additional consent from the recipient. Studies to:

• Investigate molecular explanations for histocompatibility or clinical outcome

revealed through analysis of genomic, epigenetic, or other biomolecular data;

• Determine and evaluate the factors that affect transplant or cellular therapy

outcome;

• Study the distribution of HLA tissue types in different populations; e.g., study

tissue typing differences between different racial and ethnic populations to

help develop methods to improve tissue matching between donors and

recipients, including testing of rare HLA types.

• Studies of the success of transplantation, cellular therapies or supportive care in

the management of marrow toxic injuries.

• Use for delinked (anonymous) research.

2. Eligibility to Participate in the Research Sample Repository

2.1 Hematopoietic Cell or Other Cellular Therapy Donors Eligibility

Criteria

Donors are eligible to participate in the Research Sample Repository if they have

donated or are scheduled to donate HCs or cellular therapy products to an allogeneic

recipient either by a marrow harvest or by apheresis. This includes adults with and

without decision making capacity and children.

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All donors registered on the NMDP Registry, regardless of whether they have been

requested to donate a product for a patient, are eligible to participate in the Research

Sample Repository.

2.2 Cord Blood Units Eligibility Criteria

Testable material from CBUs (Specimens) infused at treatment centers covered under

the C. W. Bill Young Transplantation Program are eligible for inclusion in the

Research Sample Repository. Material may be submitted by participating treatment

centers, centralized laboratories and CBBs.

2.3 Hematopoietic Cell Transplantation or Other Cellular Therapy

Recipients Eligibility Criteria

All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are

eligible to participate in the Research Sample Repository. This includes adults with

and without decision making capacity and children.

2.4 Patients with Marrow Toxic Injury Eligibility Criteria

In the event of a radiation exposure accident, the NMDP has a radiation injury

treatment network, whose purpose is to collect data to understand the outcomes of

patients treated under these circumstances. Any patient who is treated for a marrow

toxic injury at a center participating in the NMDP's Radiation Injury Treatment

Network (RITN) is eligible to participate in the Research Sample Repository. This

includes adults with and without decision-making capacity and children. Eligible

patients may have received support care only, growth factor support, HSC transplant

or other appropriate medical treatment for marrow toxic injury. Treatments applied

are at the discretion of the care facility and are not determined by the NMDP or

CIBMTR.

2.5 Informed Consent to Participate in the NMDP Research Sample

Repository

All participants, with the exception of CBU specimens, will be provided information

about participation in the Research Repository and must sign an Institutional Review

Board (IRB) approved informed consent document indicating their consent to

participate in the repository. The center where consent is obtained is responsible for

maintaining the written consent form and documentation of the minor assent decision.

To confirm that participants have given consent to participate in the Research Sample

Repository, the first form submitted to the Research Database on a participant

includes confirmation that the participant signed the informed consent document.

Institutional IRB policies must be followed regarding re-consent of minor patients

when those patients reach the age of majority.

Non-U.S. centers contributing samples to the Research Sample Repository will

provide written assurance that the submission of samples has on-going oversight by

their local Ethics Review Board/Medical Ethics Committee and all regulations are

followed.

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2.5.1 Minor Assent

The Research Sample Repository includes pediatric patients and related

donors. The procedural risk involved in this protocol meets the

definition of minimal risk set forth in 45 CFR 46.102 (i) “Minimal risk

means that the probability and magnitude of harm or discomfort

anticipated in the research are not greater in and of themselves than

those ordinarily encountered in daily life or during the performance of

routine physical or psychological examinations or tests.” Participation

on this protocol requires a routine blood draw.

Adequate provisions must be made for soliciting and documenting

assent of the children and permission of their parents or legal guardians,

as set forth in 45 CFR 46.408.

• The research procedures do not involve more than minimal risk;

therefore, assent will be sought from all minors 7 to 17 years of age

capable of providing assent.

• Age appropriate information will be provided to minors 7 to 11 years of

age and minors 12 to 17 years of age.

• Local Institutional Review Boards will be responsible for determining

how assent will be documented.

• The research in this protocol is covered by 45 CFR 46.404; therefore,

the written permission of the parent or legal guardian is required.

• The minor may only participate in the research if the minor and a parent

or legal guardian agree to the minor’s participation. If either the parent

or the minor declines participation in the study, the minor shall not be

enrolled in the study. If the minor lacks the capacity to provide assent,

parent or legal guardian permission is sufficient.

2.5.2 Cord Blood Specimens

• Specimens obtained from a CBU used for transplant or cellular therapy

do not involve human subjects according to the Office for Human

Research Protections guidance released August 10, 2004 entitled,

“Guidance on Research Involving Coded Private Information or

Biological Specimens” by virtue of meeting the following criteria:

• The specimens were not collected specifically for inclusion in the

Research Sample Repository and related research activities, but

rather for use in transplantation or cellular therapy.

• The NMDP, treatment centers and centralized laboratories

cannot readily ascertain the identity of the specimen donors

because the coded identifying information key is held by the

CBB and will not be shared with the NMDP

3. IRB Approval Process for Research Sample Repository

All treatment centers and donor centers must obtain IRB-approval for the protocol

and consent forms prior to submitting patient and donor blood samples to the

Research Repository. The center may obtain IRB approval either through their local

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IRB or delegate review to the NMDP IRB through and IRB Authorization

Agreement. The center’s designated IRB may not waive informed consent

requirements under this protocol. Patients and donors must provide informed consent

for submission of blood samples to the Research Repository.

This protocol and its associated consent forms are provided to centers on the

CIBMTR website, www.cibmtr.org.

International centers must follow their own national regulations and provide

assurance to the CIBTMR that national regulations are being followed.

3.1 IRB Approval Process

• The protocol and consent forms may be modified to include the name of

the local institution, local institutional contact, and to conform to other

similar non-substantive format or content changes required by the center's

designated IRB.

• The modified template protocol and consent forms must be reviewed and

approved by the center’s designated IRB.

• Any substantive changes to the protocol or consent forms

suggested or stipulated by the local IRB must be reviewed and approved

by the NMDP IRB.

• The IRB approval letter and the IRB-approved protocol and consent

forms must be submitted to the NMDP IRB Office.

• Centers may begin submitting blood samples as soon as the

site’s Principal Investigator notification from NMDP IRB Staff

acknowledging that an IRB-approved protocol and consent form is in

place at the center.

• The above process is followed for each continuing review period if the

center has not transitioned the protocol to the 2018 Common Rule

requirements. If the center transitioned the protocol to the 2018

Common Rule requirements, then the above process is only followed

when there are amendments to the protocol or consent forms. If there is

a lapse in IRB approval, the center will not be allowed to submit blood

samples to the NMDP until IRB-approval has been obtained.

• In cases where the center is relying on the NMDP IRB for this protocol

the center does not need to obtain any additional IRB approval.

4. Collection of Samples

4.1 Pre-Transplant or Cellular Therapy Collection of Donor and

Patient Blood and Tissue Samples

Blood samples should be collected as indicated on the Research Repository Critical

Facts Sheet and/or study specific consents.

4.1.1 Unrelated and Related Donor Transplants or Cellular Therapies

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Patient pre-transplant or cellular therapy samples are collected prior to the patient

starting the preparative regimen for the transplant or cellular therapy. Up to thirty

fifty milliliters (30 50 mL) of blood can beare collected from adult patients. For

pediatric patients where the collection of the full sample is medically

contraindicated, adjusted volumes will be outlined in study specific documents. as

little as one milliliter (1 mL) of blood may be collected. Previously collected

blood or tissue diagnostic samples may be requested for evaluation of primary

disease for specific studies. Sample collection specifications will be outlined in

each consent specific to the research study.study specific documents.

Unrelated dDonor samples are collected either prior to the HSC or cellular

therapy collection or after the collection, whichever is the most convenient and

safe for the donor. Up to thirtyfifty milliliters (30 50 mL) of blood can beare

collected from adult donors.

In cases where donor or patient blood samples are not available, samples may

consist of any material that could potentially yield testable DNA. Types may

include red cell pellets, extracted DNA, dried blood on filter paper, viable cells,

and any other testable material.

4.1.2 Autologous Transplants or Cellular Therapies

Patient pre-transplant or cellular therapy samples are collected prior to the patient

starting the preparative regimen for the transplant or cellular therapy. Up to thirty

fifty milliliters (30 50 mL) of blood can beare collected from adult patients. For

pediatric patients where the collection of the full sample is medically

contraindicated, adjusted volumes will be outlined in study specific documents.as

little as one milliliter (1 mL) of blood may be collected.

4.2 Post-transplant or Cellular Therapy Collection of Patient Blood

and Tissue Samples

Post-transplant or cellular therapy samples may be requested on an event and/or

calendar driven basis for allogeneic and autologous patients for specific research

studies that fall within the objectives of this protocol. Events may include diagnosis

of a secondary primary malignancy, disease relapse, diagnosis of acute or chronic

graft versus host disease or other clinically relevant event. Up to fiftythirty milliliters

(530 mL) of blood can be are collected from adult patients. For pediatric patients

where the collection of the full sample is medically contraindicated, adjusted volumes

will be outlined in study specific documents.as little as one milliliter (1 mL) of blood

may be collected. Previously collected tissue samples may be requested for events

including diagnosis of primary disease and or a secondary primary malignancy as

well as other events listed above.

Patient participation in the event or calendar driven sample collection is not

dependent on prior participation in the Research Sample Protocol. In each case,

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consent specific to the research study will be obtained from the patient at the time of

the event driven or calendar driven sample collection. Sample collection

specifications will be outlined in study specific documents. These studyproject

specific consent forms will fall under the umbrella of this protocol. Sample collection

will not be initiated until the NMDP IRB has approved the consent form and patient

consent has been obtained.

4.3. Patients With Marrow Toxic Injury

Samples are collected prior to the patient starting a preparative regimen if a transplant

or cellular therapy is directed. Otherwise, samples are collected whenever convenient

and safe for the patient. Up to fiftythirty milliliters (530 mL) of blood can beare

collected from an adult. For pediatric patients, where the collection of the full sample

is medically contraindicated, adjusted volumes will be outlined in study specific

documents.as little as one milliliter (1 mL) of blood may be collected.

In cases where blood samples are not available, samples may consist of any

material that could potentially yield testable DNA. Types may include red cell

pellets, extracted DNA, dried blood on filter paper, viable cells, and any other

testable material.

4.4 Donors for Tissue Type Characterization and Algorithm

Enhancement

Samples from registered volunteer donors with rare tissue types are collected after

registration at a time convenient and safe for the donor. Up to fifty milliliters

(50 mL) of blood are collected from an adult.

In cases where blood samples are not available, samples may consist of any

material that could potentially yield testable DNA. Types may include red cell

pellets, extracted DNA dried blood on filter paper, viable cells, and any other

testable material.

4.5 Collection of CBU Specimens

CBU specimens may consist of any material remaining at the Cord Blood Bank,

treatment center, or NMDP Confirmatory Typing Laboratory that could potentially

yield testable DNA. Specimen types include red cell pellets, extracted DNA, dried

blood on filter paper, viable cells, and any other testable material.

5. Sample Processing

5.1 Cell Storage

Donor and patient samples are stored as whole blood, peripheral blood mononuclear

cells, cell lysates, extracted DNA, stabilized RNA, serum and plasma. These samples

are stored in liquid nitrogen and/or –80°C freezer or as dried blood on filter paper.

These samples are processed and stored according to standard operating procedures.

Cord blood specimens are received and stored frozen.

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5.2 Cell Transformation

An attempt is made to generate an Epstein-Barr Virus (EBV)- transformed

B-Lymphoblastoid Cell Line (B-LCL) on donor and patient samples as needed to

replenish inventory. B-LCLs provide a renewable source of DNA. Cell lines are

developed according to standard operating procedures. No attempts are made to

transform cord blood material because of the limited volume and absence of an

effective procedure.

5.3 Cell Expansion

Transformed cells may be expanded in culture to replenish depleted inventory stores.

5.4 Vial Labeling

Samples are labeled with an identification number that includes no identifying

information assigned to the donor, patient or CBU, and the date the sample was

prepared and frozen.

6. Duration of Sample Storage at the Research Repository

Research samples will be stored at the repository until the material has been

exhausted or the repository is discontinued. The NMDP/CIBMTR is the custodian of

all samples in the Research Repository and may at its discretion destroy samples that

it determines should not be retained. NMDP may transition responsibility to another

custodian that meets all necessary requirements. If the repository is permanently

closed all stored sample material will be destroyed.

Samples may be maintained beyond the death of the participant. In this case, samples

will only be used for the histocompatibility related studies or completely anonymous

research studies outlined in the “Use of Research Repository Samples” section below.

7. Access to Samples

7.1 Who May Request Access to Samples

Representatives of participating centers and investigators or research groups may

request access to research samples contained in the Research Sample Repository for

the purpose of conducting research. Medical Directors and Coordinators from the

NMDP network may request and be provided samples collected by their own centers,

provided there are sufficient aliquots in the Repository to do so.

7.2 How Requests Are Reviewed/Approved

Samples are released according to policies established and maintained by the

NMDP/CIBMTR. Briefly, requests are reviewed by NMDP/CIBMTR staff who

determine if committee approval is needed to release the sample(s). Participating

centers requesting samples from subjects from their own center for the specific

purpose of treating a donor or a patient do not need committee approval to access the

samples. Requests for samples for use in a research study that includes correlation

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with clinical outcome data must be reviewed and approved for scientific merit by a

CIBMTR Working Committee. Following CIBMTR committee approval, the

Repository Oversight Committee must approve the release of the samples for the

study. If the study is scientifically sound, the Research Repository Principal

Investigator performs an administrative review of the study protocol to ensure that it

is within the limits defined in the Research Repository protocol and is covered by the

participant’s informed consent document for the Research Repository. Requests for

samples for use as reference or quality control material must be reviewed and

approved by the Repository Oversight Committee and the Research Repository

Principal Investigator prior to release of the samples.

In summary, all sample requests must meet the following release criteria prior to

distribution of samples:

• The proposed use of samples falls under the acceptable uses defined under

section 8.1 for linked research or 8.2 for anonymous research per Research

Repository Principal Investigator.

• The proposed study is deemed scientifically sound, feasible and high impact

through acceptance by a CIBMTR Working Committee or

• The planned use is for reference or quality control material only.

• The proposed study is approved by the Repository Oversight Committee.

• Consent status is confirmed in the CIBMTR database.

8. Use of Research Repository Samples for Research Studies

The Research Repository Principal Investigator will administratively review each

study proposal after it has been approved for scientific merit. If the Research

Repository Principal Investigator determines that the study proposal falls within one

of the listed categories of research, then consent beyond the initial consent obtained

from the Repository participant is not necessary nor is full committee review.

8.1 Linked Research

Linked research is any research where a mechanism exists to trace data or samples

back to the identity of the research subject. This includes, but is not limited to, any of

the following research that investigates factors influencing the outcomes of unrelated

and related donor HCT and cellular therapies:

• Studies of histocompatibility including HLA typing, analysis of allele and

haplotype frequencies in different populations, evaluation of microsatellites and

single nucleotide polymorphisms, examination of minor

histocompatibliltyhistocompatibility antigens, or other factors known or found to

be involved in donor / recipient histocompatibility.

• Studies of immune regulatory systems including interleukins, interferons, tumor

necrosis factors and others as these may influence the outcomes of transplantation

or cellular therapy.

• Studies of molecules involved in natural defense systems such myeloperoxidases,

oxidative enzymes, perforins, defensins, adhesion molecules and others.

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• Studies of other molecules that may influence the outcomes of transplantation or

cellular therapies including coagulation factors and coagulation regulators,

platelet and endothelial cell functional and regulatory systems, complement

systems, and others.

• Studies of molecular systems known or found to be involved in the proliferation

or maintenance of hematopoietic and immune systems including growth factors,

cell surface and cytoplasmic receptors, cell cycle regulators, DNA and gene

regulatory molecules, DNA telomeres, and others.

• Studies of global genetic diversity through genome-wide association studies or

other techniques to evaluate the impact of other genetic factors on transplant or

cellular therapy outcome.

• Studies of the success of transplantation, cellular therapies or supportive care in the

management of marrow toxic injuries.

8.2 Delinked (Anonymous) Research

Delinked (anonymous) research is research where it is impossible under any

circumstances to trace data or samples back to the identity of the research subject.

Any research project may be proposed for anonymous research, examples include:

• Studies that require self-identified race/ethnicity or other demographically defined

healthy and/or disease controls.

• Studies that need HLA specific immune stimulators for in vitro assays.

Such projects follow the process for review and approval as outlined in Section 7.2.

• Samples provided for anonymous research will have identifiers removed and

replaced with appropriately designed, non-traceable serial numbers.

• Subject to the “Data Available with Samples” section below, samples may be

combined with outcome data from NMDP/CIBMTR databases prior to

anonymization. In such instances, all personal identifying information including

names, ID numbers, birthdates, addresses, admission dates, hospitalization sites,

etc. will be removed. Personal identifiers deemed necessary for the research, e.g.,

zip codes, will only be provided following Research Repository Principal

Investigator.

8.3 Studies Outside the Scope of this Protocol

In cases where an investigator proposes research that does not fall under the

guidelines set forth in the “Use of Research Repository Samples” section above, the

proposal will be reviewed for scientific merit according to NMDP/CIBMTR policies.

If approved based on the scientific merit, the study will be subject to IRB review and

approval, including a determination of the requirements for additional informed

consent, if any.

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8.4 Data Available With Samples

Research studies using Research Repository samples may include data from the

NMDP/CIBMTR Research Database, subject to provisions of the Research Database

protocol and NMDP policies and procedures.

8.5 Restrictions on Sample Usage at the Investigative Site

• The intended use for the Research Repository samples is to facilitate research

projects.

• Commercial use of samples from the Research Sample Repository is strictly

forbidden without the prior written consent of the NMDP.

• Third-party distribution of any of the samples from the Research Sample

Repository is strictly forbidden without the prior written consent of the NMDP.

• Upon request, the requestor shall return to the NMDP any samples obtained from

the Research Sample Repository.

• After testing is complete, samples must be disposed of according to local and state

biohazardous waste laws.

• Samples must not be retained indefinitely.

• Requestor will not receive any identifying information with the samples that

could possibly be used to link the sample to the contributing individual.

8.6 Public Release of Data Generated on Samples

Research studies using Research Repository samples funded through the National

Institutes of Health (NIH) are subject to the public data release policies of the NIH.

The deposition of testing data from Research Repository samples into the NIH

database of Genotypes and Phenotypes (dbGAP) will be permitted under the

following conditions:

• Access to sample data through dbGAP is limited to the controlled-access data

process and use limited to research purposes defined in the consent.

9. Participant Withdrawal from the Research Sample Repository

At any time, a participant may request that his or her sample be removed from the

Research Sample Repository. The participant may make this request either directly to

the NMDP/CIBMTR or through his or her corresponding treatment or donor center.

Any unused sample will be destroyed.

10. Confidentiality

10.1 Coded Sample Inventory, Links to Personal Identifiers and Staff

Training and Access

All records pertaining to the identity of participants in the NMDP Research

Repository will be kept private and confidential. Personal identifying information will

only be released with the express written permission of the participant.

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Blood samples and all records associated with blood samples will be labeled only

with an alphanumeric code that contains no personal identifiers. A link does exist

between the participant’s name and the alphanumeric code. This link is not available

to staff at the NMDP Research Sample Repository. The link will never be released to

an investigator.

Access to all information in the Research Sample Repository is tightly controlled with

passwords and logins at multiple levels. Access to the Research Sample Repository is

limited to those employees who have specific job responsibilities related to the

repository.

All research staff at the CIBMTR and the NMDP maintain up-to-date training in

protection of human subjects. This training is received through the Collaborative IRB

Training Initiative (CITI) program. This is a web-based training program offered

through the Biomedical Research Alliance of New York (BRANY).

Additionally, NMDP and MCW maintain appropriate technical and organizational

measures for the adequate protection of the security and privacy of its systems and

data. These protections comply with the United States National Institute of Standards

and Technology, Security Controls for Federal Information Systems (NIST 800-53),

and all other applicable security and data privacy requirements. These safeguards are

audited annually by a qualified independent auditor; results are reported to CIBMTR

management for timely resolution.

10.2 Certificate of Confidentiality

This research is covered by a Certificate of Confidentiality from the Federal

Government. The research team will not disclose or use information, documents, or

biospecimens that may identify participants 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 a court subpoena, unless the participant consented

for this use. The Certificate cannot be used to refuse a request for information from

personnel of the United States federal or state government agency sponsoring the

project if that information is needed for auditing or program evaluation.

10.3 Reporting Requirements for Research Sample Requests

Progress reports on the status of research using samples obtained from the Research

Sample Repository must be submitted as required by the NMDP/CIBMTR.