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 sIRB Study-Site Welcome Flyer (Opens in a new tab) for a quick reference guide.
- Refer to the NMDP Single IRB Manual for Local Institutions (Opens in a new tab) 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 (Opens in a new tab) 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.
- Find your Site Management page from your Dashboard under My Studies.
- 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—10-CBA v3.1 (Opens in a new tab)
- IRB Authorization Agreement Template—ACCESS v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—All BMT CTN studies v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—CSIDE v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—Database and Repository v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—Database only v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—MajesTEC-4 1.0 (Opens in a new tab)
- IRB Authorization Agreement Template—OPTIMIZE v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—RCI BMT MEASURE v2.1 (Opens in a new tab)
- IRB Authorization Agreement Template—TransIT v2.1 (Opens in a new tab)
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 (Opens in a new tab)
- Chinese Traditional Short Form (Opens in a new tab)
- English Short Form (Opens in a new tab)
- French Short Form (Opens in a new tab)
- Hebrew Short Form (Opens in a new tab)
- Korean Short Form (Opens in a new tab)
- Polish Short Form (Opens in a new tab)
- Portuguese Short Form (Opens in a new tab)
- Russian Short Form (Opens in a new tab)
- Serbian Short Form (Opens in a new tab)
- Spanish Short Form (Opens in a new tab)
- Tagalog Short Form (Opens in a new tab)
- Vietnamese Short Form (Opens in a new tab)