RESEARCH PROTOCOL APPLICATION

INSTRUCTIONS

SUBMIT COMPLETED APPLICATION AND ALL SUPPORTING DOCUMENTS TO:

The signature page must be signed by all applicable investigators and must be submitted to the IRB office via:

Email – nobles.penny@navicenthealth.org (as scanned .pdf file)

Campus Mail – Mail Stop 113

Mail – Medical Center of Central Georgia, Institutional Review Board, 777 Hemlock Street, MSC 113, Macon, Ga 31201

General Information

Study Title:

Sponsor: Sponsor or other Protocol #:

Anticipated Start Date:	Anticipated End Date:

Type of Study:	☐ Drug	☐ Device	☐ Humanitarian Device

Other:

Drug/Device FDA Status:	☐ FDA approved	☐ FDA approved (Humanitarian)	☐ NOT FDA approved

Clinical Trial Phase: ☐ Phase II	☐ Phase III	☐ Phase IV (post marketing surveillance)	☐ n/a

INVESTIGATOR INFORMATION

PRINCIPAL INVESTIGATOR (PI) (Refer to the IRB PI eligibility requirements.)

Name:

Full Title:

Department:	Phone:

Email:

CO-INVESTIGATOR (CO-I)

Name:

Full Title:

Department:	Phone:

Email:

CO-INVESTIGATOR (CO-I)

Name:

Full Title:

Department:	Phone:

Email:

CO-INVESTIGATOR (CO-I)

Name:

Full Title:

Department:	Phone:

Email:

ADDITIONAL RESEARCH PERSONNEL INFORMATION

Do you have additional research personnel (Sub-investigators, key personnel, research assistant, etc.)?

☐ YES	☐ NO If yes, Please least each person and their role.

Principal Investigator Assurance and Acknowledgement

I certify that the information provided in this application is complete and accurate. As the principal investigator, I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human participants, and strict adherence to any stipulations designated by the IRB. I accept and will conform to all federal, state, and institutional provisions concerning the protection of human participants in research. I will ensure all personnel involved in the research will be appropriately trained for all procedures used in this project.

I agree to conduct the research involving human participants as presented in this protocol application as approved by the Navicent Health Institutional Review Board (IRB), and am qualified to perform the procedures described herein. I will submit any proposed changes/modifications for review and approval before they are implemented. I agree to notify the IRB/Office of Research Compliance of any adverse events that may occur during the study. I also assure that I will follow through with storage and destruction of data as outlined in the protocol. I understand that Navicent Health owns the research data. If I choose to transfer to another institution, I will notify the Navicent IRB immediately and will need Navicent Health approval to take the data with me.

I have reviewed the risks and benefits associated with this study and it is my professional opinion that the potential risks in this study are outweighed by the potential benefits

If I am a student investigator on this research application, I further agree to meet with my faculty advisor on a regular basis to discuss the progress of my study. I agree to meet with my faculty advisor to solve protocol issues as they arise.

I understand the data collection (including recruitment) is not permitted until final approval is granted by the IRB.

Principle Investigator Name (printed)	Signature	Date

Co-Investigator Acknowledgement

(All co-investigators must submit an acknowledgement)

I certify that I have read this protocol application and that the information is complete and accurate. I ensure that the principal investigator is qualified to perform the procedures described. I understand that I will be included in all email correspondence related to the protocol application including questions from the IRB committee and approval notifications.

I further agree to meet with the principal investigator on a regular basis to monitor the progress of the study. I agree to be available and to personally supervise the student investigator in solving problems as they arise. I will arrange for an alternate Co-Investigator to assume responsibility if I become unavailable, as when on vacation or short business trips. I will arrange for an alternate Co-Investigator to assume responsibility if I go on extended sabbatical, leave, or transfer to another institution.

Co-Investigator Name (printed)	Signature	Date

Co-Investigator Acknowledgement

(All co-investigators must submit an acknowledgement)

I certify that I have read this protocol application and that the information is complete and accurate. I ensure that the principal investigator is qualified to perform the procedures described. I understand that I will be included in all email correspondence related to the protocol application including questions from the IRB committee and approval notifications.

I further agree to meet with the principal investigator on a regular basis to monitor the progress of the study. I agree to be available and to personally supervise the student investigator in solving problems as they arise. I will arrange for an alternate Co-Investigator to assume responsibility if I become unavailable, as when on vacation or short business trips. I will arrange for an alternate Co-Investigator to assume responsibility if I go on extended sabbatical, leave, or transfer to another institution.

Co-Investigator Name (printed)	Signature	Date

Co-Investigator Acknowledgement

(All co-investigators must submit an acknowledgement)

I certify that I have read this protocol application and that the information is complete and accurate. I ensure that the principal investigator is qualified to perform the procedures described. I understand that I will be included in all email correspondence related to the protocol application including questions from the IRB committee and approval notifications.

I further agree to meet with the principal investigator on a regular basis to monitor the progress of the study. I agree to be available and to personally supervise the student investigator in solving problems as they arise. I will arrange for an alternate Co-Investigator to assume responsibility if I become unavailable, as when on vacation or short business trips. I will arrange for an alternate Co-Investigator to assume responsibility if I go on extended sabbatical, leave, or transfer to another institution.

Co-Investigator Name (printed)	Signature	Date