Institutional Review Board
 

Walden University is committed to conducting its research involving human subjects under rigorous ethical principles. The university’s Institutional Review Board (IRB) has been established to comply with existing regulations of the federal government. Specifically, the university follows the Federal Policy for the Protection of Human Subjects (45 CFR 46). University research ethics forms and guidance can be found at www.WaldenU.edu/irb.

 

Scope of Authority of the Institutional Review Board

The Institutional Review Board (IRB) is required to review all research proposals, formal and informal, funded or not, that are prepared by students, instructors, and staff, especially those that involve the use of human participants. The IRB is legally required to ensure all the following standards are met:

• Risks are justified in terms of related benefits to the participants.
• Participants engage in research willingly and knowingly to the extent possible.
• Research methods are appropriate to the objectives of the research.
• Research methods are the safest possible and are consistent with sound research design.
• Participants’ privacy is protected.
• Research is monitored.

To accomplish these purposes, researchers are required to complete the appropriate applications and obtain the board’s approval whenever research involving human participants is proposed, prior to beginning research with human participants. A human participant is a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information. Research is a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalized knowledge.

 

All research projects involving collection or analysis of data (whether from surveys, interviews, observation, student or employee work products, or records of any type) must be reviewed and approved by the IRB. Moreover, no member of the university community may commence any research procedure involving human participants until it has been approved by the IRB. The only categories of research that do not need to be submitted for IRB approval are literature reviews and hypothetical research designs.

 

Institutional Review Board Membership

The Institutional Review Board (IRB) consists of staff and instructors from each of Walden’s major research areas as well as one member not affiliated with the university. The members of the IRB are selected by the school and college associate deans and are appointed by the executive director of the Center for Research Support. Selection criteria include content expertise, research experience, and knowledge of professional and academic ethics. The IRB meets weekly and requires a quorum to take a vote. A quorum is considered present at a meeting when three-fifths of the members are in attendance. A majority vote can approve, approve with stipulations, or disapprove a research proposal. IRB decisions cannot be appealed, but the IRB chair will work with the researcher(s) to get a proposal into an approvable state.

 

Information Required for Review

Information provided to the IRB should be written in a nontechnical manner and should be suitable for understanding by a diverse audience. While the information below is required, students must consult www.WaldenU.edu/irb for a full description of the IRB application and review process:

• A brief overview of the study, including research questions and/or hypotheses.
• A description of how participants will be recruited and selected for participation, including any advertisements, recruitment letters or scripts, and financial remuneration offered to participants.
• Statements of how informed consent will be obtained and how participants will be informed of the voluntary nature of their participation, including the right to opt out of the study without penalty, and knowledge of the process of expressing concerns to the primary investigator.
• An explanation of the research methodology to be used, including copies of all data collection instruments (e.g., interview protocols, survey instruments, standardized and non-standardized questionnaires).
• An explanation of how collected data will be stored and disposed, including audio and videotapes.
• An explanation of what risks are involved, how subjects are protected, and whether risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge to be gained.