Is IRB approval required

[Cadet133]

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Im doing a study on hypertension in hospitalized patients. I am currently a resident. If I want to review charts for the sole purpose to design a research study or to assess the feasibility of conducting a study, is IRB approval required? All I want to do is access patients charts from a given time frame who meet certain age requirements and record the age and BP. No patient identifiers will be recorded

 

[SurfingDoctor]

Im doing a study on hypertension in hospitalized patients. I am currently a resident. If I want to review charts for the sole purpose to design a research study or to assess the feasibility of conducting a study, is IRB approval required? All I want to do is access patients charts from a given time frame who meet certain age requirements and record the age and BP. No patient identifiers will be recorded

Never hurts to go through the process. If you are collecting data, but in a retrospective manner, it’ll usually undergo expedited review.

 

[235009]

Im doing a study on hypertension in hospitalized patients. I am currently a resident. If I want to review charts for the sole purpose to design a research study or to assess the feasibility of conducting a study, is IRB approval required? All I want to do is access patients charts from a given time frame who meet certain age requirements and record the age and BP. No patient identifiers will be recorded

Absolutely requires IRB approval because of the part I bolded above. Will likely go through expedited review since here is no harm to the patient outside of mishandling data which you will need to address in your application.

 

[pbrocks15]

What are you planning on doing though with that initial set of data?

If you are using it for yourself to mentally see if such a project is feasible, I think it might be appropriate to skim the charts. But if you are to use that data in the future for the specific project, then perhaps not so much.

 

[GirlsGoneGaga]

Im doing a study on hypertension in hospitalized patients. I am currently a resident. If I want to review charts for the sole purpose to design a research study or to assess the feasibility of conducting a study, is IRB approval required? All I want to do is access patients charts from a given time frame who meet certain age requirements and record the age and BP. No patient identifiers will be recorded

I’d say absolutely yes to IRB approval. Esp since you’re intending to examine human subjects. Doesn’t hurt to be safe


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[gbwillner]

YES. You will have access to patient records. That opens risks to patients, no matter how small. An IRB is required. If no changes are made to patient management as part of your study (which seems likely), then you can request an EXPEDITED IRB, which takes less time to get through.

Good luck