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This document is a submission form for research protocols involving human participants, detailing the study's objectives, methodologies, participant demographics, and ethical considerations.

How to fill out new protocol submission form

How to fill out New Protocol Submission Form for Studies Involving Human Participants

1. Gather necessary information about the study, including objectives, methodology, and participant criteria.
2. Complete the personal and institutional information section, providing details about the principal investigator and sponsoring institution.
3. Outline the research methodology, detailing study design, data collection methods, and statistical analysis plans.
4. Describe the participant recruitment process, including inclusion and exclusion criteria.
5. Ensure to address informed consent procedures, specifying how participants will be informed about the study.
6. Include a risk assessment section, identifying potential risks to participants and outlining plans for minimizing them.
7. Provide details on how data will be managed, stored, and protected to ensure participant confidentiality.
8. Review the completed form for accuracy and completeness before submission.
9. Submit the form to the appropriate ethics review board or institutional review board (IRB) for approval.

Who needs New Protocol Submission Form for Studies Involving Human Participants?

1. Researchers conducting studies involving human participants.
2. Institutional review boards (IRBs) that require documentation for ethical review.
3. Academic institutions that mandate ethical compliance for research projects.
4. Funding agencies requiring proof of ethical oversight for grant applications.

People Also Ask about

What is a PhS document?

The information you provide in this Personal History Statement will be used in the background investigation to assist in determining your suitability for the position of California Peace Officer, in ance with POST Commission Regulation 1953.

What is IRB approval for human subjects?

Both sponsors and independent researchers working on behalf of sponsors are subject to IRB oversight. Sponsors will submit their protocol and information about the investigational product (IP). They'll also submit the template consent documents and any other materials patients will receive to explain the trial to them.

What does PhS stand for in grants?

Purpose. This Policy applies to all research funded or proposed for funding by the Public Health Service of the U.S. Department of Health and Human Services (“PHS”), including the National Institutes of Health (“NIH”).

What are the IRB protocol documents?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

What is the PhS assignment form?

This form is available in nearly all competing NIH application form packages and allows you to provide specific application assignment and review information to referral and review staff.

What is a PhS form?

An IRB protocol is a group of documents that conveys all the necessary information about your research with human subjects to IRB reviewers (e.g., consent form, IRB application).

What is a PhS investigator?

PHS defines Investigator as the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research, or proposed research. Investigators may include collaborators or consultants.

For pdfFiller’s FAQs

What is New Protocol Submission Form for Studies Involving Human Participants?

The New Protocol Submission Form for Studies Involving Human Participants is a document that researchers must complete to obtain approval before initiating a research study that includes human subjects.

Who is required to file New Protocol Submission Form for Studies Involving Human Participants?

All researchers and institutions conducting studies involving human participants are required to file the New Protocol Submission Form to ensure ethical standards and compliance with regulatory requirements.

How to fill out New Protocol Submission Form for Studies Involving Human Participants?

To fill out the New Protocol Submission Form, researchers should provide detailed information about the study's purpose, methodology, participant recruitment, informed consent process, and potential risks and benefits.

What is the purpose of New Protocol Submission Form for Studies Involving Human Participants?

The purpose of the New Protocol Submission Form is to assess the ethical implications of the proposed research, ensuring that the rights and welfare of participants are protected throughout the study.

What information must be reported on New Protocol Submission Form for Studies Involving Human Participants?

The form must include information such as study title, principal investigator details, study design, participant criteria, informed consent procedures, risks involved, and data management plans.