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IRB NHSR Inquiry

About This Form

Not Human Subjects Research (NHSR) inquiries are used to determine if a project meets the regulatory definition of human subjects research. If the IRB determines that a project does not meet the regulatory definitions, we will send you a determination letter that states IRB approval is not required for your project. If the IRB determines the project does meet the regulatory definition of human subjects research, you will need to submit a new full study application in Cayuse to obtain IRB approval.

NHSR review is not provided for the following projects, which need to be submitted as a new protocol in Cayuse:
- Projects that involve coded data or specimens
- Projects involving FDA regulated products
- Any other projects that meet the regulatory definition of human subjects research

If you would like to submit an NHSR inquiry, please answer the questions below.

1. What is the title of your project? *This question is required.

2. Please provide some information about yourself. *This question is required.

Name
Email Address
Department/Program

3. What is your role at CSUDH? *This question is required.

4. Student researchers are required to have a faculty advisor who serves as the Principal Investigator of record for IRB submissions.

Please provide the name of the faculty member overseeing this study. *This question is required.

4. Are you doing your study as part of a thesis project? *This question is required.

4. Is your study intended to produce generalizable knowledge?

By "generalizable knowledge," we mean that you intend to use your study results to understand populations or situations beyond the specific people who participated directly in your study. *This question is required.

5. Here's some more information that might help you:

If your study is intended to develop or contribute to generalizable knowledge, you might:
- make parts of your research design (procedures, methods, and instruments), and your analyzed findings, available for peer review and replication
- publish or present this study at an academic/professional conference or competition
- share your results through the media

However, you might not be contributing to generalizable knowledge if:
- the research only involves methodology and data collection from human subjects as part of course requirements
- study results will be used only in the instructional setting and not shared outside of it

With these ideas in mind, do you think your study is intended to produce generalizable knowledge? *This question is required.

5. Does your study include data provided by live human subjects?

Do count existing data that came from interaction, communication, or intervention with live people.
Do not count data, information, or specimens from individuals who are now deceased. *This question is required.

6. Are any of the data or information reported by subjects about their own experiences, or experiences of other individuals they know?

Do count information that the subjects are providing about themselves and/or their personal experiences.
Do not count information provided by people if it is only factual, objective information about a non-human entity such as an agency, policy, workplace, etc. *This question is required.

6. Are all of the data you want to use publicly available?

This means the data already exist and are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. *This question is required.

6. Please provide a brief description of your study in lay language. This should not be a scientific abstract. *This question is required.

7. Please briefly describe the population being studied, including the participants you plan to enroll and/or the existing data you plan to use. *This question is required.

8. Please briefly describe the study procedures and methods you intend to use. *This question is required.

When you are ready to submit, please click the button below.