Medical
NIH Protocol
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NIH Protocol

1
Develop a research proposal
2
Identify potential risks and benefits of the research
3
Complete training on research ethics and regulatory compliance
4
Prepare a research protocol document
5
Submit the research protocol to the principal investigator
6
Approval: Principal Investigator
7
Review and revise the protocol as needed
8
Submit the revised research protocol to IRB
9
Approval: IRB
10
Complete the informed consent document
11
Submit the informed consent document to IRB for approval
12
Approval: Informed Consent Document
13
Recruit and screen study participants
14
Obtain informed consent from each participant
15
Conduct the research according to the approved protocol
16
Report any deviations or adverse events to the principal investigator and IRB immediately
17
Monitor participant safety and welfare throughout the study
18
Summarize and analyse research data
19
Submit a final report to the principal investigator and IRB
20
Approval: Final Report