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This document outlines the protocol application for conducting research involving human subjects at Cal Poly Pomona, detailing the study's purpose, methodology, and compliance with ethical standards.
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How to fill out protocol application - cal

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How to fill out Protocol Application - Cal Poly Pomona IRB

01
Start by reviewing the IRB guidelines provided by Cal Poly Pomona.
02
Obtain the Protocol Application form from the Cal Poly Pomona IRB website.
03
Fill in the required information about the research project, including the title, researchers, and purpose.
04
Describe the methodology, including participant recruitment, data collection, and analysis plans.
05
Address potential risks to participants and outline how you will minimize these risks.
06
Include a detailed informed consent process, explaining how participants will be informed about the study.
07
Attach any additional documents required, such as surveys or consent forms.
08
Review the completed application for accuracy and completeness.
09
Submit the application electronically or in person as directed by the IRB.

Who needs Protocol Application - Cal Poly Pomona IRB?

01
Researchers, faculty, and students at Cal Poly Pomona who are conducting studies involving human participants need to submit a Protocol Application to the IRB.
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IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
Your protocol will be reviewed by IRB administrators to ensure that your study follows principles of sound scientific design, and that your study is conducted in ance with federal regulations, state law, and institutional policies.
IRB membership must be sufficiently qualified through experience and expertise of its members to represent and consider issues such as race, gender, community attitudes and cultural backgrounds to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
21 CFR 56.107(c) requires at least one member of the IRB to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area. Most IRBs include physicians and Ph. D. level physical or biological scientists.
The IRB must include both men and women, at least one member whose primary concerns are in science areas, one whose primary concerns are nonscientific areas, and at least one member who is not otherwise affiliated (either directly or through immediate family) with No person shall be excluded from serving on the IRB
Reviewing identifiable data, even with no interactions with the subjects themselves, is conducting human subjects research. These individuals will need to be listed on the IRB application.
Amend (modification): After IRB approval, when the PI(s) would like to change things to the approved protocol, they must submit an Amendment Submission. Renew: When the protocol is close to the expiration date, the PIs will receive notifications.
Achieve a minimum score of 6.5 on the IELTS (International English Language Testing System). This test must have been taken within 2 years. Some individual graduate programs may require higher scores, so please review program-specific requirements.

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The Protocol Application for Cal Poly Pomona IRB is a formal document that researchers must submit to obtain ethical approval for research involving human subjects.
All faculty, staff, and students conducting research involving human subjects at Cal Poly Pomona are required to file a Protocol Application with the IRB.
To fill out the Protocol Application, researchers must complete all sections of the application form, providing detailed information about the research project, methodology, and any potential risks to participants.
The purpose of the Protocol Application is to ensure that all research involving human subjects is conducted ethically, safeguarding the rights and welfare of participants.
The application must report information such as the research objectives, participant recruitment methods, informed consent process, risk assessment, and data collection procedures.
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