Two students

Institutional Review Board

Human Participants Committee Review Requirements

Overview

The Institutional Review Board (IRB) at Notre Dame de Namur University oversees research for all the schools.

The primary goal of the IRB is to ensure that all research follows procedures for protecting human participants. The federal government has established regulations governing research using human participants. All proposals for research at NDNU must be submitted to the Institutional Review Board (IRB) for review and approval unless the research is exempt from IRB review under federal guidelines. These can be viewed at http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm.

To determine whether proposed research is exempt from IRB review, review the flowchart and Is My Project Research? links. This flowchart highlights key questions to help you anticipate whether a project should be submitted to the IRB for review. Regardless of whether the chart indicates review may be required, final determination of exemption must be made by someone other than the investigator.

Determination of exempt research is made through a process of administrative review. In cases of student research at the undergraduate level, administrative review may be conducted by a faculty member. In cases of student research at the graduate level, administrative review involves two faculty readers in the approval process.

It is important to document all research conducted under the auspices of NDNU, including exempt research. In cases of exempt research, the faculty member(s) conducting the administrative review must submit documentation of the determination of exemption to the IRB .

Definitions

Research is a planned systematic investigation designed to contribute to generalizable knowledge. A research investigator may be student, faculty, administrator or staff.

Human participant is a living individual about whom an investigator conducting research obtains data through intervention, observation or interaction, or identifiable private information.

Intervention includes physical procedures for gathering data and manipulations of the participant or the participant's environment for research purposes.

Interaction refers to communication or interpersonal contact between the participant and the investigator.

Private information refers to information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and also information that has been given to the investigator by an individual, and which the individual can reasonably expect will not be made public (such as a medical record). Private information is individually identifiable; that is, the identity of the participant is or may readily be ascertained by the investigator or other parties who may be familiar with the participant or the research project.