What types of review does the WGU IRB Conduct?

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:

 

  1. The boundaries research and the accepted and routine activities of professional practice
  2. The assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
  3. Appropriate selection of human subjects for participation in research
  4. The nature and definition of informed consent in various research settings

 

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:

 

  • Anonymous surveys
  • Analysis of existing or public data
  • Interactive telephone and online surveys
  • Educational measures of normal instructional improvements that would occur routinely in the classroom and are not unique to research activities
  • Group comparisons without risks

 

Exempt - 45 CFR 46.101(b)

 

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:

 

  • Capstones using simulated data
  • Data gathering conducted in established or commonly accepted educational settings, involving regular educational practices (e.g., pre/posttests for TWS/TPA)
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement)
  • Anonymous survey procedures, interview procedures, or observation of public behavior
  • Research involving the collection or study of freely available de-identified existing data, documents records, pathological specimens, or diagnostic specimens 
  • Research that does not employ methodology on human subjects

 

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:

 

  1. Involve identifiable interviews and focus groups.
  2. A vulnerable category of subjects that place restrictions on their autonomy or make them susceptible to exploitation. See list below in “Full Review” section.
  3. Create a conflict of interest (such as when the investigator or an entity may benefit from the project in ways that bias research activities or results).
  4. Involve participant observations in a non-public setting.
    • Involve the use of primary data about WGU students, prospective students or alumni ("WGU data").
  5. All research proposing the use of WGU data must be approved by the WGU office of Institutional Research.
  6. Studies where the relationship of the investigator and the subjects create employment, psychological, or reputational risks – such as a supervisor with subordinates or sensitive topics with co-workers.
  7. Proposals dealing with sensitive topics (see full IRB below).

 

Capstone course mentors 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:

 

  • IT and Business Capstone Projects that involve investigations about the effectiveness of an intervention, strategy, technique or the improvement of an organization.
  • Teachers College Capstone Projects that involve:
  1. Practice-based teaching or administration projects in school settings for licensure or endorsements (e. g., Teaching Performance Assessment (TPA) or Teacher Work Sample (TWS).
  2. Research about the development and delivery of an instructional unit in P-12 schools and other settings, unless surveys, interviews, focus groups, audio/video recordings, or participant observation is part of the action research. (45 CFR 46 Subpart D).
  3. Some action research in commonly accepted adult educational settings (such as vocational/technical education, college and university environments) involving normal educational practice is usually exempt from IRB oversight unless voice, video, digital, or image records are collected (45 CFR 46.101(b); Federal Register 1998).
  • Nursing College Capstone Projects that involve:
  1. De-identified, anonymous, or publicly available data (i.e., legacy capstones). 
  2. And program or quality improvement projects (i.e., field experience capstones).
  • Institutional Research Projects conducted by WGU's Institutional Research (IR) department for the purposes of program and university improvement using WGU student data, publicly available data, or anonymous survey data.
  • Employee Research Projects conducted under the auspices of another institution of higher education or medical institution if the sponsoring institution's IRB has exercised oversight.

 

Expedited Review – 45 CFR 46.110

 

To enable more immediate approval of human subjects research without the involvement of all IRB members the regulations enable "expedited" reviews. 

 

  • These must be done by the IRB chair or other designated and qualified member of the IRB appointed by the chair.
  • Research activities that present no more than a minimal risk to human subjects are eligible for expedited IRB review.

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.

 

  • The reviewing IRB member may require additional information to clarify a proposal and may confer with other IRB members and knowledgeable WGU advisors (e.g., capstone supervisor and/or course mentor)
  • The reviewing IRB member may exempt, approve or escalate a research proposal to full IRB review.
  • The IRB member may not disapprove a proposal.
  • The reviewing IRB member will inform the full IRB of the status of all expedited reviews.

Examples of proposals qualifying for expedited review under federal guidelines (45 DFR 46.109) include:

 

  • Research on individual or group characteristics or behavior about perceptions, motivation, language, communication, cultural beliefs or practices, social behavior, oral history, and program evaluations.
  • Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
  • Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  • Teacher education candidates who use surveys, interviews, or observe students while teaching and conducting regular classroom activities as part of their action research.
  • Teacher education candidates who conduct their action research capstones in contexts that are not commonly accepted educational settings of P-12 school, adult vocational/technical education, college, and university.  This may include training locations in business, industry, health care, military, and community organizations.
  • Research involving the use of primary WGU data with prior approval by WGU’s Institutional Research office.

 

Full Review– 45 CFR 46.109

Research proposals that are not exempt and do not qualify for expedited IRB review must be presented for Full IRB review.  Proposals requiring Full review may include:

 

1. Research involving deception as part of the experimental design (e.g. use of placebo’s).

2. Research involving vulnerable populations including, but not limited to:

 

  • Prisoners (45 CFR 46 Subpart C)
  • Children (outside of established educational settings involving routine program improvement activities; 45 CRF 46 101 (b); Subpart D)
  • Pregnant women (45 CFR 46 Subpart B)
  • Human fetuses and neonates (45 CFR 46 Subpart B)
  • Socially or economically disadvantaged
  • Homeless
  • Patients (in dependent states like hospitalization)
  • Lesbian, gay, bi-sexual, transgendered
  • Decisionally-impaired
  • Undocumented individuals
  • Participants with physical impairments
  • Elderly
  • Terminally ill

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:

 

  1. Political affiliations or beliefs of students or their parents
  2. Mental or psychological problems of students or their families
  3. Sexual behavior or attitudes
  4. Illegal, anti-social, self-incriminating, or demeaning behavior
  5. Critical appraisals of close family members
  6. Legally recognized privileged relations, like with lawyers, physicians, and ministers
  7. Religious practices, affiliations, or beliefs of students or their parents
  8. Income (other than law-required for determining eligibility for programs or financial assistance)

 

 

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