Before applying for review at the IRB ensure that you are currently certified as a researcher of human subjects. You can apply for certification here.  The NIH certification must be renewed every 3 years. The IRB will not pay for researcher certification. 

Once your mandatory certification is completed you are free to utilize the following forms to apply for review. Please read each and every one carefully and fill them out appropriately.

 

General Application Documents

Research Project Application Form

Must be completed in its entirety in order for the IRB to review the proposed research.

Research Project Closure Form

Must be completed within 3 months of the cessation of research or by the research project approval expiration date, whichever comes first.

Informed Consent Documents      

Elements of Informed Consent

Informed consent form must include these elements in sequential order and in language which the participants can understand.

Research Project Consent Form

Form to provide information and acquire consent from research participants.

Research Project Parent/Guardian Permission Form

Form to provide information and acquire consent from research participants under the age of 18 through their parents or guardians. This form is to be used in conjunction with the Research Study Assent Form for students under 18 years of age.

Research Project Assent Form (Under 18 years of Age)

Form to provide information and acquire consent from research participants under 18. This form is to be used in conjunction with the Research Project Parent/Guardian Permission Form.

Research Duration Documents          

Adverse Incident Reporting Form

Must be completed any time a research subject experiences an adverse reaction to, or unexpected event following, an intervention posed by the research.

Annual Review Form

Must be completed each year prior to the anniversary of the initial approval date.

Research Project Modification Form

Must be completed in order to request changes of substantive details to a previously approved research proposal.

Classroom Assignment Documents    

Classroom Assignment Application Form

For class assignments that require IRB review, submit this form.

Classroom Assignment Research Consent Form

For class assignments that require IRB review, use this form to provide information and to acquire consent from research participants 18 years of age and older.

Class Assignment Research Parent/Guardian Permission Form

For class assignments that require IRB review, use this form to provide information and acquire consent from the parents of research participants under 18 years of age. This form is to be used in conjunction with the Class Assignment Research Assent Form.

Class Assignment Research Assent Form

For class assignments that require IRB review, use this form to provide information and acquire assent from research participants under 18 years of age. This form is to be used in conjunction with the Class Assignment Research Parent/Guardian Permission Form.

Supplemental 

HIPAA Authorization Form and Appendix A

Form and guidelines for compliance to the Health Insurance Portability and Accountability Act as it relates to the protection of health information.

If you have any questions, please contact the IRB Review Committee at (305) 866-8384.

 

Once all necessary forms have been completed please begin sending proposals to:

American Academy of Stem Cell Physicians IRB

1001 N.E 125th St., N. Miami, FL, 33161

Or to IRBchair@aaoscp.com 

You may be asked to adjust your proposal based on provided feedback on enhancements and clarifications needed prior to determining the type of review necessary for the proposal. During the submittal process, if a PI does not follow up on a request within 90 days, the application will be considered abandoned. The application process would start again from the beginning.

If there are changes to your proposal after it has been approved, you need to notify the IRB using the Research Project Modification Form.

If in the course of the study something negative happens to the subject then you must notify the IRB using the Adverse Incident Reporting Form. The IRB will then notify the Federal Office of Human Protection as required by law. Please note that this process must be followed regardless of the perceived seriousness of the incident, or whether or not you agree with the subject that something negative has occurred. If the subject reports an incident, then you must follow up within 48 hours of learning of the incident.

If your research duration is longer than one year, you will need to submit an Annual Review Form prior to the anniversary of your research project application’s approval.

Once you have finished gathering data, you will need to submit a Research Project Closure Form to the IRB. This notifies the IRB that its oversight responsibilities are over. Studies classified as “Exempt” do not require submission of this form.