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. PurposeResearch 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.

e.g. survey + interview -> MRI scan.
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.