About

Widener University Institutional Review Board (IRB)

Widener University is firmly committed to adhering to basic ethical principles underlying the acceptable conduct of research involving human subjects. The purpose of the Widener University Institutional Review Board (IRB) is to review proposed human subjects research in order to ensure that the rights and privacy of human subjects are protected and that the risk of harm is minimized. The IRB acts as an advocate for the research subject.

Purpose

The primary purpose of the Institutional Review Board (IRB) is to inform and protect human subjects that participate in research. Therefore, the primary goal of the IRB is to develop and implement policies and guidelines governing research conducted by faculty, students, and staff of Widener University or by outside agencies and researchers using university facilities or resources. All policies and guidelines developed will be in agreement with federal regulations regarding human research.

To this end, the IRB provides guidance to investigators regarding how to best protect the rights of human participants through the construction of research protocols and informed consent documents that meet federal and local requirements for human research. The IRB provides guidelines that will assist researchers in developing research protocols that are ethically protective of study participants.

The IRB reviews proposals for research involving human participants conducted by Widener faculty, students, and staff or outside agencies and researchers using Widener facilities or resources. For more information about the review process, please click on the IRB Application Procedure and IRB Review Process links.

IRB Review of Research

Using the principles outlined in Title 45 CFR Part 46, the role of the IRB in reviewing human subject research is as follows:

• The IRB will review and have the authority to approve, require modifications in order to secure approval, or disapprove all research activities. The IRB will require that information given to subjects as part of informed consent is in accordance with NIH CFR guidelines.
• The IRB will require documentation of informed consent or may waive documentation in accordance with Title 45 CFR Part 46 guidelines.
• The IRB will notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
• The IRB will conduct continuing review of research at intervals appropriate to the degree of risk posed to study participants. A review of approved protocols will be conducted at least once per year.