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DSM Decision Flowchart for Research Involving Humans or Human-Derived Materials

National Heart, Lung, and Blood Institute
National Institutes of Health

September 2011

Alternative text to DSM Decision Flowchart for Research Involving Humans or Human-Derived Materials 
Complete the steps in one of the paragraphs below labeled one, two, three, four, or five.
1. If the research is IRB exempt, send the IRB exemption notification to NHLBI. No additional actions are required.
2. If the research is not IRB exempt, is a clinical trial, and the clinical trial meets one of the following criteria (is a phase 3 clinical trial, conducted at multiple sites, high risk, or involves a vulnerable population), an IRB-approved DSM plan is required and a DSMB is generally required. Send IRB approval to the NHLBI Grants Management Officer or Contracts Officer with a copy to the Program Official. For Type 5 noncompeting renewal, report adherence to DSM plan, summarize any DSM issues that have occurred, and report any changes in the risk of the study participation. No additional actions are required.
3. If the research is not IRB exempt, is a clinical trial, and the clinical trial does not meet one of the following criteria (is a phase 3 clinical trial, conducted at multiple sites, high risk, or involves a vulnerable population), an IRB-approved DSM plan is required. Contact your program official to determine if a DSMB or OSMB is required. Send IRB approval to the NHLBI Grants Management Officer or Contracts Officer with a copy to the Program Official. For Type 5 noncompeting renewal, report adherence to DSM plan, summarize any DSM issues that have occurred, and report any changes in the risk of the study participation. No additional actions are required.
4. If the research is not IRB exempt, is not a clinical trial, and the research involves greater than minimal risk, an IRB-approved DSM plan is required. Contact your program official to determine if a DSMB or OSMB is required. Send IRB approval to the NHLBI Grants Management Officer or Contracts Officer with a copy to the Program Official. For Type 5 noncompeting renewal, report adherence to DSM plan, summarize any DSM issues that have occurred, and report any changes in the risk of the study participation. No additional actions are required.
5. If the research is not IRB exempt, is not a clinical trial, and the research does not involve greater than minimal risk, certification of minimal risk status may be required. Send IRB approval to the NHLBI Grants Management Officer or Contracts Officer with a copy to the Program Official. For Type 5 noncompeting renewal, report any changes in the risk of the study participation. No additional actions are required.

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Last Updated: September 27, 2011

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