This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
Purpose
To oversee and monitor clinical trials to ensure participant safety and the validity and integrity of the data. This SOP is one of several describing clinical trial requirements; also see the Human Subjects section on Rules & Policies—Special Considerations.
Procedure
Clinical grant applications must comply with application instructions and NIAID Clinical Terms of Award. NIAID can award grants and contracts only if they comply with all policies.
For more information on DSMB requirements, refer to the NIH Policy and Guidance section on NIH’s Data and Safety Monitoring webpage.
Principal Investigators
- If you are conducting a multisite clinical trial involving interventions that pose a potential risk to the participants, you must have a DSMB to monitor the trial.
- Data and safety monitoring functions and oversight are distinct from the requirement for institutional review board (IRB) protocol review and approval.
- If the NIH Single IRB for Multi-Site or Cooperative Research policy applies to your study, send summary reports to the sIRB.
NIAID Staff
Read Trans NIAID Clinical Research Toolkit—Resources.
Contacts
Applicants or grantees with questions should read Contacting Program Officers and Grants Management Specialists.
DAIDS: Delta Saint-Vil
DAIT: James McNamara
DIR: Faith Bashore
DMID: OCRASafety@mail.nih.gov
DCR: Negin Atri
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.
Links
45 CFR 46, Protection of Human Subjects, HHS
Human Subjects Research Requirements in Grants SOP and other Rules & Policies—Special Considerations
Office for Human Research Protections, HHS