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This document outlines the policies and procedures for determining if research involving human subjects qualifies for exemption from federal regulations at Oregon Health and Sciences University (OHSU).

How to fill out exempt research - ohsu

How to fill out Exempt Research

1. Identify the research project type and assess if it meets the criteria for exemption.
2. Complete the Exempt Research application form provided by the Institutional Review Board (IRB).
3. Provide a detailed description of the research, including purpose, methodology, and potential risks.
4. Specify the population involved in the research and how they will be recruited.
5. Include information on data collection methods and data protection measures.
6. Submit the completed application to the IRB for review.

Who needs Exempt Research?

1. Researchers conducting studies that involve minimal risk to participants.
2. Institutions looking to streamline the ethical review process for certain types of studies.
3. Project teams working in academic, medical, or social research fields.

People Also Ask about

What is the difference between exempt and expedited research?

Expedited level of review Projects not eligible for an exempt review may be eligible for an expedited review. Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk.

What is an example of an exempt review?

Examples of Commonly Exempted Research The following types of research are commonly processed under exempt review: Research on educational practices or educational curriculums. Benign behavioral interventions with adult subjects. Anonymous surveys or interviews on non-sensitive topics.

What is research exemption?

The common law research exemption is an affirmative defense to infringement where the alleged infringer is using a patented invention for research purposes. The doctrine originated in the 1813 decision by Justice Joseph Story appellate decision Whittemore v. Cutter, 29 Fed.

What qualifies as exempt research?

Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.

What is the difference between expedited and exempt research?

A research project is appropriate for Expedited review if it involves only minimal risk, but is not classified as Exempt. Minimal risk is defined as risk that is not greater than what one encounters in ordinary daily life or during the performance of routine physical or psychological examinations or tests.

What does exempt status mean in research?

Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.

What does expedited mean in research?

An expedited review, is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term “expedited” can be misleading: reviews of this type are not “quicker” or conducted with less rigor, but fewer reviewers are required for approval.

What does exempt research mean?

What does the term 'Exempt' mean in human subjects research? If your project receives an exempt determination, this means that the HRPP determined that your study qualifies for exemption under 45 CFR 46, the federal regulations that govern human subjects research.

For pdfFiller’s FAQs

What is Exempt Research?

Exempt Research refers to studies that are exempt from the regulations governing research involving human subjects. These studies typically pose minimal risk to participants and may involve certain categories of research outlined by regulatory bodies.

Who is required to file Exempt Research?

Researchers who conduct studies that fall under specific exempt categories defined by Institutional Review Boards (IRBs) or relevant regulatory authorities must file for Exempt Research status.

How to fill out Exempt Research?

To fill out Exempt Research, researchers must complete a specific application or form provided by their institution's IRB, detailing the study's purpose, methods, participant criteria, and any potential risks.

What is the purpose of Exempt Research?

The purpose of Exempt Research is to facilitate studies that do not pose significant risks to participants while ensuring ethical standards are maintained and compliance with regulations is upheld.

What information must be reported on Exempt Research?

Researchers must report information such as the study title, objectives, methodology, participant recruitment methods, potential risks, and how participant confidentiality will be maintained.