Relying on the NMDP IRB

The NMDP IRB serves as the single IRB (sIRB) for the NIH-funded Blood and Marrow Transplant Clinical Trials Network® (BMT CTN). Centers participating in BMT CTN studies are required to use the NMDP IRB as their IRB of record. The NMDP IRB also serves as a sIRB for some multi-site CIBMTR® (Center for International Blood and Marrow Transplant Research®) and NMDP research. If the study is federally funded, centers are required to use the NMDP IRB. If the study is not federally funded, centers may still choose to rely on the NMDP IRB as their IRB of record. The NMDP IRB may agree to serve as a single IRB for other studies on a case-by-case basis.

Refer to the NMDP Single IRB Manual for Local Institutions for helpful information about using the NMDP sIRB.

Refer to the IRBManager for Researchers and Staff User Guide for navigation instructions.

Enrolling in and using the NMDP sIRB

• To enroll a Signatory Institution in the NMDP Single IRB, submit the Single IRB Signatory Institution Enrollment and Local Context xForm from your Dashboard in IRBManager. This enrollment only needs to happen once per institution but must be completed prior to opening a study at your site using the NMDP IRB. The enrollment form is typically completed by your institution’s IRB office.
• To open a study using the NMDP sIRB, submit the NMDP sIRB Study-Specific Local Context Worksheet xForm from your Dashboard in IRBManager
• Other study-site specific submissions (e.g., consent form revisions, site PI changes, etc.) must be submitted within the study in IRBManager. Click into the study from your Dashboard under ‘My Studies’. Click the ‘Start xForm’ action on the left navigation and select the appropriate xForm. Refer to the NMDP Single IRB Manual for Local Institutions  to determine which xForm to use for your submission.

Submitting site-specific documents for NMDP IRB Review

Locally-developed materials not specific to a study (e.g., Short Forms, COVID-19 information sheets, institutional boilerplate consent language, etc.) must be submitted within your institution’s Site Management page in IRBManager by an institutional primary contact.

1. Find your Site Management page from your Dashboard under My Studies.
2. Click Start xForm on the left navigation and select the Site-specific Documents Submission xForm.

IRB Authorization Agreement Templates

The templates authorize the Signatory Institution to rely on the NMDP IRB for the studies and describe the division of responsibilities:

• IRB Authorization Agreement Template—OPTIMIZE v1.0
• IRB Authorization Agreement Template—All BMT CTN studies v1.1
• IRB Authorization Agreement Template—16-NTCD v1.1
• IRB Authorization Agreement Template—RCI BMT 17-SIBS v1.2
• IRB Authorization Agreement Template—CSIDE v1.1
• IRB Authorization Agreement Template—RCI BMT 17-CD33CART v1.1
• IRB Authorization Agreement Template—Database and Repository v1.1
• IRB Authorization Agreement Template—Database only v1.1
• IRB Authorization Agreement Template—ACCESS v1.0
• IRB Authorization Agreement Template—RCI BMT MEASURE v1.0
• IRB Authorization Agreement Template—TransIT
• IRB Authorization Agreement Form Template—10-CBA v2.2

NMDP's Short Forms for non-english speaking research participants

NMDP's Short Forms may be used by sites who are relying on the NMDP IRB for a study. No changes may be made to the form other than the insertion of the Study Title and Study Number.

• Arabic Short Form
• Chinese Traditional Short Form
• English Short Form
• French Short Form
• Hebrew Short Form
• Polish Short Form
• Portuguese Short Form
• Russian Short Form
• Spanish Short Form
• Vietnamese Short Form
• Tagalog Short Form
• Korean Short Form

Questions?

For questions about the NMDP Single IRB process, contact NMDPSIRB@nmdp.org