Irb Reciprocity Application Form

IRB RECIPROCITY APPLICATION FORM

Application to Submit Protocols to the Relying/Reviewing IRBs for PRCTRC Studies

Type of study: / Institution FWA# Reviewing Relying
New Study / MSC 00005561
Approved Study with Amendment / UCC 00001103
PHSU 00000345

Protocol Information

Project Title

Sponsor

Protocol Number

Principal Investigator

School
Department
Telephone
Mailing Address
E-mail

Co-Principal Investigator

School
Department
Telephone
Mailing Address
E-mail

Co-Principal Investigator:

School
Department
Telephone
Mailing Address
E-mail
Justify your request for IRB Reciprocity:
IMPORTANT NOTICE: Before submitting this application to your local IRB, please verify that it has all the required signatures.

Submitted Documents to the Relying/Reviewing IRB:

Reviewing IRB Application Form

/

Bio-sketch

Conflict of Interest

Letter of collaboration from the Performance

Site(s) (collaborators, approval of facilities used,

etc.)

/

Human Subjects Training Certificate HIPAA Training Certificate

Protocol

/

Instruments

Plan for managing multicenter study
(if applicable)

Informed Consent/Assent Document (English &

Spanish Versions)

/

Other (Specify)

All these documents must be sent electronically to the IRB representative of your Institution, (if applicable):

Principal Investigator’s Certification:

• I certify that the information provided in this application is complete and correct.
• I certify that I will follow my IRB-approved Protocol.
• I accept complete responsibility for the conduct of this study, the ethical performance of the project, and the protection of the rights and welfare of the human subjects who are directly or indirectly involve in this project.
• I will comply with all applicable federal or local laws regarding the protection of human subjects in research.
• I will ensure that the personnel working in this study are qualified and will follow the IRB-approved protocol.
• I will not modify this protocol or any attached materials without first submitting an amendment to the previously approved protocol and receiving subsequent IRB approval from the reviewing IRB.

Principal Investigator (Printed Name): Date:

______

Principal Investigator’s Signature

Dean/Department Director Assurance Statement-

This is to certify that I have reviewed this research protocol and I attest to the competency of the investigator(s) to conduct the project and I authorize the Principal Investigator to conduct the Study under this Faculty/ Department
Dean/Department Director: ______Date: ______
(Printed Name)
Dean/Department Director’s Signature: ______
To be completed by the Relying IRB
DateReviewed:
After reviewing this research protocol, the following decision was made:
Accept to relying
Require clarification
Deny the relying. The local IRB will be the reviewing IRB of Record
Reason for disapproval:
Chairperson (Printed Name): Date:
______
Chairperson Signature

IRB Reciprocity Application 1 | RKS

Revised April 2016