Please click on the categories for exemption to determine if you research project falls under Exempt Studies . There will be 6 different categories and if your research project falls under 1 of those 6 categories, please complete an Application for Exemption Form and submit this to firstname.lastname@example.org.
HUD Studies will not receive exempt approval from the IRB Chair. ICFs are not required for HUDs unless research information is being gathered to support a premarket application.
|Categories for Exemption Form||Application for Exemption Form|
Principal Investigators submitting studies not qualifying as exempt are required to complete and submit an Application for Initial Submission Form in addition to the study protocol, an FDA approval letter( or IDE # or IND#), FDA 1572 (when applicable), Patient Informed Consent (assent of a minor for projects involving minors from ages 7-17) and Financial Disclosure Form. The entire submission should be submitted to email@example.com. If you should have any questions please call Erica Lusk at 972-566-6060.
- All submissions must be submitted electronically
- All documents must be submitted on letter head (ICFs, protocols and etc.)
- All Submissions should be submitted by 4:00 p.m. of the deadline date.
Annual Review and Study Closure
If you are requesting an annual review, quarterly review or study closure, it is required that you complete the Continuation/Progress form and submit a clean ICF . The form will be used to review and evaluate your progress of the research project. Please complete the form and submit it to firstname.lastname@example.org. If you should have any questions please call Erica Lusk at 972-566-6060.
|Continuation / Progress Form|
If you are requesting any type of waiver you can write a letter and state what type of waiver you are requesting and the reason.
Financial Disclosure Instructions for Public Health Service Funded Investigations
Any investigator serving as the principal investigator/program director of a PHS (e.g. NIH, FDA, CDC) funded study must comply with financial disclosure as specified in 42 CFR 50.604 and 50.605. A detailed summary of this policy as it applies to PHS funded studies approved by the MCDH Institutional Review Board can be found here. In addition to completing the financial disclosure form, each investigator must complete training regarding financial disclosure at least once every four years. This training may be completed on-line at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Please provide a copy of the certificate of completion of the tutorial with the financial disclosure form.