Get the free Application for Expedited or Full Review of Research Using Human Subjects - pittstate

This document is an application for the expedited or full review of research involving human subjects, required by the Committee for the Protection of Human Research Subjects at Pittsburg State University.

How to fill out application for expedited or

How to fill out Application for Expedited or Full Review of Research Using Human Subjects

1. Begin by downloading the Application for Expedited or Full Review of Research Using Human Subjects form from the designated website.
2. Read the instructions carefully to understand the requirements for the application.
3. Fill out the cover page with your research title, principal investigator information, and other required details.
4. Provide a detailed description of the research study, including objectives, methodology, and significance.
5. Outline the inclusion and exclusion criteria for participant selection.
6. Describe how you will obtain informed consent from participants.
7. Discuss potential risks to participants and the measures you will take to minimize these risks.
8. Include information about data privacy and how participant confidentiality will be protected.
9. Review the entire application for completeness and accuracy before submission.
10. Submit the application to the appropriate review board or ethics committee along with any required documents.

Who needs Application for Expedited or Full Review of Research Using Human Subjects?

1. Researchers conducting studies involving human subjects.
2. Institutions or organizations that require ethical review of research projects.
3. Anyone seeking expedited or full review due to specific ethical concerns.

People Also Ask about

What is research with humans called?

Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects.

What is an expedited review of research?

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.

What is the meaning of human research?

For a project or study to be considered Human Subjects Research, it must meet two criteria: It must meet the definition of research, which is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Who completes an expedited IRB review?

An expedited review must be performed by the IRB Chair or by an experienced IRB member designated by the IRB Chair, i.e. a member with demonstrated knowledge and application of research ethics in human subject protections of at least one year.

What is an example of a human subject?

Some examples of human subjects: A subject may be either a healthy individual or a patient. data obtained from medical records – even if the data is recorded without identifiers. tissue used in research that possesses or is linked* to any kind of identifiable information.

What is research using human subjects?

Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are identifiable is considered “research involving human subjects.” Some research may qualify for an exemption from federal regulatory requirements but is still considered to be human subjects research.

What qualifies for an IRB exemption?

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 a research study using human subjects?

Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects.

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What is Application for Expedited or Full Review of Research Using Human Subjects?

The Application for Expedited or Full Review of Research Using Human Subjects is a formal document submitted to institutional review boards (IRBs) that outlines a researcher's proposal for a study involving human participants, providing details necessary for the IRB to assess ethical considerations and compliance with regulations.

Who is required to file Application for Expedited or Full Review of Research Using Human Subjects?

Any researcher, including students, faculty, or staff, who intends to conduct research involving human subjects must file this application with the IRB to obtain approval before starting the study.

How to fill out Application for Expedited or Full Review of Research Using Human Subjects?

To fill out the application, researchers must provide comprehensive details about the study's purpose, methodology, risks, benefits, recruitment methods, informed consent processes, and data management practices, following specific guidelines set forth by the reviewing institution's IRB.

What is the purpose of Application for Expedited or Full Review of Research Using Human Subjects?

The purpose of the application is to ensure the protection of human participants by allowing the IRB to evaluate the study's ethical considerations, potential risks, and compliance with federal regulations, ensuring that research is conducted safely and ethically.

What information must be reported on Application for Expedited or Full Review of Research Using Human Subjects?

The application must report information including the study title, principal investigator's contact information, study objectives, participant selection criteria, study procedures, potential risks and benefits, informed consent processes, and how the confidentiality of participant data will be maintained.