IRB Policies and Procedures
These resources will help you navigate the NMDP Institutional Review Board (IRB) policies and procedures.
IRB Standard operating procedures
- SOP-00010 (v. 2) NMDP IRB Materials Required for Review (Legacy S00038) (Opens in a new tab) (PDF)
- SOP-00017 (v. 2) NMDP IRB Investigator Responsibilities (Legacy S00048) (Opens in a new tab) (PDF)
- SOP-00140 (v. 2) Unanticipated Problems Involving Risks to Participants or Others (Legacy S00407) (Opens in a new tab) (PDF)
- SOP-00053 (v. 2) NMDP IRB Managing and Reporting Non-Compliance with Human Research Protecting Programs Requirements (Legacy S00213) (Opens in a new tab) (PDF)
- SOP-00135 (v. 2) IRB Suspension, Termination, and Administrative Closure of Research (Legacy S00399) (Opens in a new tab) (PDF)
- SOP-00241 (rev 8) NMDP IRB Reliance Agreements and Cooperative IRB Reviews (Legacy S000592) (Opens in a new tab) (PDF)
- SOP-00308 (rev 5) NMDP IRB Protocol Exceptions, Deviations, and Temporary Variances (Legacy S00693) (Opens in a new tab) (PDF)
- SOP-00007 (rev 12) NMDP IRB General Policy (Legacy S00035) (Opens in a new tab) (PDF)
- SOP-00008 (v. 2) NMDP IRB Orientation and Training (Legacy S00036) (Opens in a new tab) (PDF)
- SOP-00012 (v. 3) NMDP IRB Protocol Review (Legacy S00040) (Opens in a new tab) (PDF)
- SOP-00013 (v. 2) NMDP IRB Expedited, Emergency, and Exempt from Regulation (Legacy S00041) (Opens in a new tab) (PDF)
- SOP-00015 (v. 3) NMDP IRB General Consenting Requirements (Legacy S00045) (Opens in a new tab) (PDF)
IRB policies
- IRB Approval of Consent Documents (Opens in a new tab) (DOC)
- PL-00013 (rev 8) Activities Subject to IRB Jurisdiction (Legacy P00019) (Opens in a new tab) (PDF)
- PL-00042 (rev 3) Advertisements for Recruiting Subjects to Research Studies (Legacy P00054) (Opens in a new tab) (PDF)
- PL-00052 (v. 2) Applicable Federal and State Laws Regarding Human Subjects Research (Legacy P00069) (Opens in a new tab) (PDF)
DHHS, OHRP, and FDA federal regulations and guidance
- DHHS regulations on the Protection of Human Subjects (45 CFR 46) (Opens in a new tab)
- OHRP guidance documents (Opens in a new tab)
- FDA regulations on the Protection of Human Subjects (21 CFR 50) (Opens in a new tab)
- FDA regulations on Institutional Review Boards (21 CFR 56) (Opens in a new tab)
- FDA guidance documents (Opens in a new tab)