Research Forms - Miami Children’s Hospital

IRB Forms:
Please download the forms as needed and submit to the Office of Research Administration (ORA). It is best to save the documents on your computer rather than opening them with your Internet browser. If you have any questions about these forms, please call the ORA at (305) 663-8523.

Forms for Sponsored Clinical Research Studies:
Approval of a sponsored research study at MCH consists of:

1. IRB review of your study, which is conducted by Western Institutional Review Board (WIRB) and

2. Administrative review of financial and contractual documents by the Office of Research Administration (ORA)

Click here to get the documents that you will need to submit to the ORA.

Forms for Other Research Studies:
Some forms of research conducted at MCH are minimal risk and fall into certain categories.

Click here for a list of those categories.

Click here to get the documents that you will need to submit to the ORA.

Forms for Retrospective Chart or Database Research:

What Form Do I Use?
Click on the category that best describes the research you plan to do:

1. Preliminary review of PHI to identify potential patients for a study or to design a research protocol

2. Retrospective review of PHI for research when it is impractical to obtain informed consent of the patients before reviewing the records and the disclosure of PHI is minimal risk to the subject

3. Retrospective review of PHI to identify possible research subjects, but a person who is not an MCH-employee or business associate will recruit them into the study and obtain consent (as part of an existing protocol)

4. Retrospective research using any PHI collected from a deceased patient's records (if patient was deceased prior to the study)

5. Retrospective review of PHI where a limited data set will be created

6. Retrospective review of PHI to create a de-identified subset of data, whether fully de-identified or statistically de-identified

7. Creating a research database of PHI or a bank of human specimens that can be linked back to PHI, that is not part of an existing study

Emergency Use of Investigational Drug or Device

IACUC Forms:

Form A: New Protocol Transmittal Form

Form B: Protocol Revision Request Form

Form C: Protocol Continued Review Form

Form D: Protocol Closure Form