Monday, August 18, 2014

IRB Application Materials Checklist

When you are considering conducting research, you have to complete and submit an application to the IRB. We use a check list to ensure that we have all the require elements needed to properly assess each application. Often, initial applications are incomplete so I thought I would list here all the required components of an application.

Certificate from the Human Protections Administrator: when you submit your application I will review it and decide whether it is exempt or whether it requires submission to the full IRB. When I do, I generate a form that is sent back to you informing you of that decision.
IRB application: clearly, this is required. But I would say that 9 times out of 10, there are missing elements in the application. Please go through the entire application and complete every section, even the ones that don’t appear necessary to you (such as a question about the use of radiology when you are conducting a survey). There are also pull-down menus that you need to complete.
IRB application signature page: the final page of the IRB application is a signature page. It requires not just your signature, but that of your supervisor. Make ure that both of you have singed this prior to submission.

Personnel roster: This can be downloaded off the IRB website or from the portal. It requires you to list all the people involved in the project, and it asks you to define their role. All involved must have completed the NIH Protections of Human Research Participants training program and have an up-to-date certificate on file.
CV/biosketch: we are required to have a copy of your most recent curriculum vitae of NIH biosketch on file. This will the case for all the personnel involved in the study. For many of you, we already hold the information, but for anyone new, we will need it, and for those that are old, they should regularly updated.

PHRP certificate: this is the NIH required training. It can be accessed at When you are done, it will allow you to print a certificate. We track these in a database. They must be updated annually.
IRB approvals from other institutions: where applicable, we will need copies of IRB approvals from any other institution involved in the research.

Recruitment material: If you are recruiting participants for your study, the IRB needs to see your recruiting material, even copies of emails you intend to send.
Study materials: we need copies of the survey you intend to give, or the script you will use for recruitment or for conducting qualitative research (such as focus group).

Educational material: we need copies of any material provided to the patient or participant.
Informed consent document: this is critically important, and must be included with an application where applicable.

With the deadline  2015 ACC-RAC coming up, we usually see an increasing number of applications in August. This list here will help ensure you are able to have your application processed in timely fashion.




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