Information for Researchers

Does My Project Need Review by the IRB:

Investigators must submit research involving human subjects to the HSRO. In some instances, investigators might not know if their proposed project meets the regulatory definitions of “research” involving “human subjects.” Click here to find out if your project meets these definitions.

 

How to Submit to the IRB:

Once you are ready to start your study, click here to find out the necessary steps.

 

Forms & Templates:

Once you have opened a submission, be sure that the correct Forms & Templates are used.  Answer the questions and click Continue to save your information.  When you reach the end, click the Finish button. 

 

Ancillary Committees:

Your study may require specilized review by an Ancillary Committee which is conducted in parallel with the IRB review. You will need to contact the committee assigned to your study and submit the research to that Committee according to the Committee’s requirements.

 

Policies, Procedures, & Regulations:

This page provides information to ensure that you are aware of and comply with all applicable policies and procedures of the University to meet your obligations.

 

Translations:

If a researcher intends to enroll subjects who do not adequately read the English language, informed consent documents should be translated into a language comprehended by the potential subjects. More information on translations can be found here.

 

Single IRB & Reliances:

This page provides information for Research sites and personnel who are not part of the University of Miami (UM) and are not covered by the UM’s IRB review. Likewise, if you are collaborating on a study that will involve an external central IRB, the UM HSRO must be involved in the coordination of the central IRB review.