Guides: Dissertation Seminar-EDUL 8301: Institutional Review Board--Introduction

Institutional Review Board Introduction

The Institutional Review Board (IRB) is an administrative body established to protect the rights and well-being of human subjects recruited to participate in research activities in accordance with federal regulations set forth in Title 45, Part 46 of the code of Federal Regulations (45 CFR 46), known as the “Common Rule.

This guide is intended to provide information, links to resources including books and video to assist researchers in their understanding of IRB requirements. We encourage Prairie View A&M University researchers to visit the Institutional Research Board website for official information and forms.

https://www.pvamu.edu/research/compliance/207-revision-v1-2/

The Institutional Review Board (IRB) is responsible for reviewing all research projects involving human subjects at Prairie View A&M University. All research projects involving human subjects/participants, conducted by Prairie View A&M University faculty, staff or students, must be approved by the IRB, prior to the beginning of work.

To schedule an appointment for a protocol consultation or pre-review, please contact the Office of Research Compliance.

What is an IRB Protocol

A protocol is the precise and detailed design for conducting a research study; specifically, it is the study plan submitted to an IRB for review. Because of the ethical concerns of research involving humans, research that is not classified as exempt from federal regulations [45 CFR 46.104 /or 21 CFR 56.104] must be conducted under an IRB-approved protocol. The following guidelines are provided to assist you in writing a complete research study protocol.

Prairie View A&M University IRB Protocol Forms--Please go to the link below to access the forms.

https://www.pvamu.edu/research/compliance/207-revision-v1-2/irb-forms-2/

CLASS PROJECTS, THESIS AND DISSERTATIONS

Research projects conducted exclusively for undergraduate or graduate courses may or may not require IRB review. Please prepare a description of the class project and email it to the Office of Research Compliance at research@pvamu.edu for a review and decision regarding your class project.

In general, those class projects whose purpose is training, an educational exercise, or professional development, and not research and whose results will never be shared outside the classroom, do not require an IRB review. If the results of the class project will be published and/or shared outside of the classroom, then the research project will most likely require an IRB protocol.

Consult the Office of Research Compliance before beginning any class research project.

Thesis and Dissertations

All Thesis and Dissertation Research Projects MUST be described in a protocol and reviewed by the IRB.

After receiving approval for your thesis or dissertation project from the appropriate authority, fill out the IRB Protocol Form and submit it to the Office of Research Compliance (ORC) for review and approval by the IRB.

Institutional Review Board by the Office of Human Research and Protection

Purpose and definitions of common related terms

The purpose of the IRB is to ensure the adequacy of the research plan, to minimize risks, and to maximize the benefits for human subjects who participate in research.

Research is defined (45 CFR 46.102(d)) as “a systematic investigation, including methodology, development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition includes formal investigations from which the results will be publicly disseminated, pilot projects, exploratory research, and educational research.

IRB Approval is required to do research undertaken by students for classroom work, independent study, senior design, nursing professional practice projects, surveys, master’s degree theses, sponsored programs or any purpose not specifically listed. This includes research with human subjects conducted for non-academic purposes, as well. Some Quality Improvement projects may require submittal to an IRB before they can be officially determined as "not research".

Human Subjects
Human subjects are defined (45 CFR 46.102(f)) as “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or the collection of identifiable private information.”

Intervention includes both physical procedures by which data is gathered (blood pressure readings, exercising, equipment design, etc.) and manipulations of the subject or the subject’s environment (heat, light, temperature, etc.).

Interaction includes communication or interpersonal contact between the investigator and subject (interviews, focus groups, surveys, etc.). Private information includes academic, financial, medical, and other documents about behavior that occurs in a context in which the subject can reasonably expect that no recording is taking place, or information the subject has provided for a specific purpose that can reasonably expect will not be made public.