Guides: IRB-Institutional Review Board Resources: 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.

Contact information below:

Office of Research Compliance
Wilhelmina Delco Building, Room 120
Email: researchcompliance@pvamu.edu
Contact Telephone Numbers: (936) 261-1553 , (936)261-1589, (936) 261-1588

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.