The IRB process

• How do I start the submission process?

• What documents do I need in order to submit my study to the IRB?

• How long does it usually take to get a study approved by the IRB?

Submission Process

Once you have settled on a study design, you will need to write a proposal (see: current projects/proposals). Email this proposal to Dr Bhattacharyya (mouchumi.bhattacharyya@commonspirit.org) and be prepared to present your idea at the RAQ committee. This is a local research committee that meets once a month on the second Thursday. It is generally helpful to have a few slides to facilitate your presentation.

IRB documents

Every study is a little bit different and there is no single comprehensive list of all the things you will need to get IRB approval. Having said that, here are some documents that you will almost definitely need.

1. Data collection form(s)

2. Signed approval from the RAQ

3. Study proposal

4. IRB application (filled out on the IRBNet)

5. Consent form(s) (if needed, eg prospective trials)

6. Research routing form

All necessary forms can generally be accessed on IRBNet. The Commonspirit consent form template can also be accessed by using the link.

Here is a more detailed paper from the IRB illustrating the process

Here is a paper giving example of verbiage for retrospective data analysis and statistical considerations

Timeframe

The timeframe from submission to approval can vary from several weeks to several months depending on the research team's experience navigating the IRB process and on the complexity of the study. Typically, retrospective studies are considered minimal risk and once all the documents are ready take several days for approval. Approval may be delayed if the IRB believes the documents need revision.

Prospective studies, and studies that the IRB believes pose more than minimal risk, usually take several weeks, and possibly longer if revision to the IRB application is required.

A common and avoidable cause of delay is completion of the CITI training and creating the IRBNet profile.