The WGU Institutional Review Board (IRB) ensures that WGU students and employees follow ethical principles of biomedical and behavioral research that protect human subjects. In carrying out the above, the IRB considers:
The WGU IRB has oversight of all research activities involving human subjects conducted by WGU students, employees, contractors, and by the institution. Under federal guidelines and WGU policy, all research activities involving human subjects must be presented to the IRB to assure that research is conducted in accordance with the basic ethical principles outlined in the Belmont Report. The WGU IRB reviews proposed research and some capstone projects to determine if they qualify as:
This section defines the qualifications and requirements for each category of IRB review. In most cases at WGU, project proposals qualify as either exempt from IRB oversight or eligible for expedited review due to the minimal risks posed to research participants. These studies typically include:
The exempt category represents those studies that pose minimal risk to subjects and do not include vulnerable populations. Project proposals, especially capstones, are typically classified as exempt from expedited or full IRB review when the proposed study involves one or more of the following types of activities:
Note: Some studies that employ observation, survey, or interview procedures may not qualify for exemption because the human subjects can be personally identified, are conducted with children/adolescents, or the research places the human subjects at risk.
Some project proposals that may be deemed exempt by the IRB are not research per se. For example, studies of program improvement in public schools using only class assignment and/or test score data where individuals cannot be directly identified or their participation is part of regular program activities are not categorized as "research." Similarly, evidence-based practice improvement projects in nursing, marketing studies, quality improvement studies, program and product evaluations, and organizational needs assessments are usually deemed exempt, not being research either.
Research activities will not be deemed exempt from IRB review if they:
Capstone course instructors and IRB evaluators are authorized by the WGU IRB to evaluate student research proposals and to decide whether a proposal is exempt from IRB review.
Employee, contractor, and WGU institutional research proposals should be submitted to the IRB chair to determine the appropriate type of review.
Examples of research proposals that may be considered exempt include:
To enable more immediate approval of human subjects research without the involvement of all IRB members the regulations enable "expedited" reviews.
Note: "Minimal risk" means that the likelihood of participants experiencing harm, stress or discomfort is no greater than what they might experience in everyday life.
Examples of proposals qualifying for expedited review under federal guidelines (45 DFR 46.109) include:
1. Research involving deception as part of the experimental design (e.g. use of placebos).
2. Research involving vulnerable populations including, but not limited to:
3. Research involving family members and subordinates whose participation may be coerced by a relationship to the investigator or other participants (e.g., a investigator/supervisor collecting data from subordinates).
4. Research where the investigator has potential conflicts of interest, such as supervisory or familial relations with participants, or a vested interest in outcomes.
5. Research on sensitive topics where, for example, participants may be at risk of social or reputational harm if their participation were known (see PPRA below).
6. Research designs with potentially harmful psychological or physical interventions;
7. Institutional Research Studies where the principal aim is research (not program improvement) and/or collaborative studies where another institution's IRB requires WGU's IRB decision as well.
Protection of Pupil Rights Amendment (PPRA)
Where surveys or researcher-developed instructional materials deal with these eight topics, the IRB will need to review parental/guardian consent (Protection of Pupil Rights Amendment, 2001). WGU requires full review of research even for adult participants if these topic (or similar) are investigated: