Get the free Request for Determination of Non-Human Subject Research

This document is used to determine whether a research project qualifies as human subject research according to federal regulations and institutional policy.

How to fill out request for determination of

How to fill out Request for Determination of Non-Human Subject Research

1. Begin by downloading the Request for Determination of Non-Human Subject Research form from the appropriate institutional website.
2. Fill in your name and contact information in the designated fields.
3. Provide a brief title for your research project.
4. Describe the purpose and objectives of your research clearly.
5. Specify the methods you will use to conduct your research.
6. Indicate that your research does not involve human subjects by checking the appropriate box.
7. Include any additional documentation or supporting materials required by your institution.
8. Review your form for completeness and accuracy.
9. Submit the completed form according to your institution's submission guidelines.

Who needs Request for Determination of Non-Human Subject Research?

1. Researchers conducting studies that do not involve human subjects.
2. Faculty members needing approval for studies involving non-human entities.
3. Students requiring determination for academic projects that focus on non-human research.

People Also Ask about

What is a non human subject research?

What is Non-Human Subject Research (NHSR)? Also known as "NHSR". Any project that does not involve research, a human subject, or a clinical investigation, as defined above.

Who determines whether a research study is non-exempt human subjects?

3. Is the human subjects research exempt? The determination of whether a research study is non-exempt human subjects research is usually made by an institution's Human Research Protection Program (HRPP) or IRB office.

Who usually determines whether a research study is non-exempt human subjects?

3. Is the human subjects research exempt? The determination of whether a research study is non-exempt human subjects research is usually made by an institution's Human Research Protection Program (HRPP) or IRB office.

What happens if you do research without IRB approval?

Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

What makes a research study exempt?

“Exempt” research are human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories (as described below).

What is an example of a Nhsr?

Research activities that may meet the criteria for NHSR include use of cadaveric materials or data; outdated blood products (from the Red Cross or other blood banks); deidentified data or specimens from an existing study, from a non-research source, or from a publicly available repository if they meet the requirements.

Who has authority to make decisions of approval for human subjects in research?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In ance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Who makes the final decision whether a research study involving human subjects is exempt from IRB review and approval?

Exempt Research At the NIH, the IRBO Director or designee has the exclusive authority to determine that human subjects research is exempt under 45 CFR 46. (See 45 CFR 46.104 of the 2018 Common Rule and 45 CFR 46.101(b) of the pre-2018 Common Rule.)

For pdfFiller’s FAQs

What is Request for Determination of Non-Human Subject Research?

A Request for Determination of Non-Human Subject Research is a formal procedure that researchers use to clarify whether their study involves human subjects. If the research does not involve human subjects, it may be exempt from review by an Institutional Review Board (IRB).

Who is required to file Request for Determination of Non-Human Subject Research?

Researchers conducting studies that may not involve human subjects are required to file a Request for Determination of Non-Human Subject Research to ensure compliance with ethical guidelines and regulations.

How to fill out Request for Determination of Non-Human Subject Research?

To fill out a Request for Determination of Non-Human Subject Research, researchers typically need to provide details about the study's design, objectives, methods, and the type of data being collected to demonstrate that human subjects are not involved.

What is the purpose of Request for Determination of Non-Human Subject Research?

The purpose of the Request for Determination of Non-Human Subject Research is to ensure that research activities are appropriately classified and to confirm that studies not involving human subjects do not require IRB review, thereby streamlining the research process.

What information must be reported on Request for Determination of Non-Human Subject Research?

The information that must be reported typically includes the study title, purpose, methodology, subjects involved (if any), data collection methods, and a justification for why the research does not involve human subjects.