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Nova Southeastern University Institutional Review Board for Research with Human Subjects (IRB) New Protocol Submission Center Rep: Date Sent to IRB: To be completed by IRB Office Protocol Number:

How to fill out new protocol submission

How to fill out a new protocol submission:

1. Start by gathering all the necessary information and documentation required for the new protocol submission. This may include project details, research objectives, methodology, participant information, and any other relevant data.
2. Review the guidelines or instructions provided by the organization or institution where you need to submit the new protocol. Understanding the specific requirements and format will help you correctly fill out the submission.
3. Begin by providing a comprehensive title for your new protocol submission. It should accurately reflect the nature of your research or project.
4. Next, include a brief summary or abstract of your protocol. This should provide a concise overview of the research objectives, methodology, and expected outcomes.
5. Provide a detailed background and rationale for the new protocol. Explain why your research is important, its potential significance, and any previous work or studies that support your project.
6. Clearly outline your research objectives and hypotheses. State what you aim to achieve through your study and the specific questions you want to address.
7. Describe your proposed methodology and experimental design. Explain the procedures, methods, and techniques you intend to use in your research.
8. Include information on the participants or subjects involved in your study. Provide details regarding recruitment, inclusion/exclusion criteria, and any potential risks or benefits to the participants.
9. Discuss the ethical considerations and precautions you will take to ensure the wellbeing and rights of the participants. Address any potential conflicts of interest or issues related to confidentiality, consent, and data protection.
10. Describe the data analysis plan and statistical methods you will employ to interpret and draw conclusions from your research findings.
11. Outline a timeline for your project, including the start and end dates for each stage or task. This will help demonstrate that you have a clear plan and are organized in your approach.
12. Finally, proofread and review your submission before submitting it. Ensure that you have followed all the guidelines, the information is presented logically and coherently, and that there are no grammatical or spelling errors.

Who needs new protocol submission:

1. Researchers and scientists conducting studies or experiments that require ethical approval or oversight.
2. Institutions or organizations with established protocols for research projects, ensuring compliance with regulations and standards.
3. Regulatory bodies or ethical review committees responsible for reviewing and approving research protocols to protect the rights and welfare of participants.

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What is new protocol submission?

New protocol submission is the process of submitting a new research protocol for review and approval by the relevant authorities.

Who is required to file new protocol submission?

Researchers and individuals conducting new research studies are required to file new protocol submission.

How to fill out new protocol submission?

To fill out a new protocol submission, researchers need to provide detailed information about the research study, methodology, risks, and mitigation strategies.

What is the purpose of new protocol submission?

The purpose of new protocol submission is to ensure that research studies adhere to ethical standards, protect participants' rights, and mitigate risks.

What information must be reported on new protocol submission?

Information such as study design, participant recruitment procedures, data collection methods, and risk assessment must be reported on new protocol submission.