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Should I submit an Amendment or a New Application?
Amendment vs New Application
In determining whether to amend an existing IRB protocol or to submit a new IRB application, PIs should consider the 3Ps: Purpose, Procedures, and Population.
| | Amendment | New Application |
|---|---|---|
| 1. Purpose | Research question and Study aims have not changed. | New research question and new study aims were introduced. e.g. To study the effects of sleep deprivation -> caffeine intake on classroom focus. |
| 2. Procedures | Procedures and interventions remain generally the same. e.g. Adding/ substituting one questionnaire with another similar one. | Procedures and interventions (involving new parameters) introduced are significantly different from existing ones. |
| 3. Population | Target population remains generally the same. e.g. Healthy adults 21 - 40 years old -> Healthy adults 21 - 60 years old | Different population being studied. e.g. Healthy adults -> Minors who contracted Covid within the past 3 months. |
An amendment should be submitted if the 3Ps are aligned; if not, a new IRB application should be created.
If the newly introduced procedures are led by a different investigator, then a new IRB application should be created.
Refer to the decision tree below or contact us for further advice.
Adapted from Harvard IRB.