|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Regulations, Policies & Guidance|
|Research w/Vulnerable Populations|
|Research Using Human Specimens, Cell Lines or Data|
|Human Subjects Protections Training|
|NIH Inclusion Policies and Procedures|
|Frequently Asked Questions|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|NIH Staff FAQs|
Last Revised: February 11, 2010
||Related NIH Staff FAQs|
45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research:
"When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."
The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk.
Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to I/C-specific policies.