Full Board Review

Human Research Protections Program

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researchintegrity@wwu.edu

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Why do some studies need Full Board review?

The 2018 Common Rule (45 CFR 46) regulates research with highly vulnerable populations by requiring Full Board review: Subpart B (Pregnant Individuals, Fetuses, and Neonates), Subpart C (Prisoners), and Subpart D (Minors). For all federally funded studies, the WWU IRB will convene to review research involving these groups. However, a reasonable assessment of risk and mitigation does not always require convened Board review. In contrast, some minimal risk social-behavioral studies technically meet requirements for Expedited review, but a convened IRB discussion would be more appropriate for additional protections.​

This page offers some insights into the HRPP process for determining review level, but the examples are not exhaustive. To avoid scope creep and unnecessary bureaucracy, we approach studies on a case-by-case basis and work closely with the researcher(s) to provide the highest protections for participants while conducting appropriate reviews. The HRPP wishes to support researchers in their endeavors—no matter how complex—but if you would like to discuss strategies for lowering risk and thus review level, contact the HRPP for individual guidance.

All Full Board submissions must provide complete protocol information so that reviewers may assess potential risks and offer mitigation revisions, if applicable. A complete submission needs to include recruitment materials, consent forms, screeners and instruments (see exceptions below under Common Questions below), CITI certification and other additional relevant training certifications, and applicable site permissions. The HRPP cannot process incomplete submissions.

For approved Full Board protocols, you will need to follow all Protocol Management requirements for post-approval actions, including submitting a formal Continuing Review Application. 

Full Board Review Process

The IRB meets one to two times per term during the academic year, depending on protocol submissions. The IRB does not meet during the summer months, when faculty reviewers are not on formal contract.

Only Full Board applications have submission deadlines: 3 weeks before the scheduled meeting. To ensure sufficient time for review and risk assessment, studies that miss the deadline will be considered at the next scheduled meeting. 

  • If your submission is complete and ready for review, the HRPP Administrator will conduct a pre-review for minor issues (consistency, clarity, and general best practices) and provide you with initial feedback within 2-3 business days. You'll then need to address feedback and resubmit materials in 2-3 business days. Once received, the HRPP Administrator will assign primary and secondary reviewers to lead the convened Board discussion (although all Board members will receive and review protocol materials).
  • You (and if applicable, your faculty advisor) will be invited to attend the meeting briefly to answer questions and offer input. This opportunity allows us to discuss your project congenially, and it streamlines approval because you can provide clarifications on the spot vs. the Board having to speculate and follow up with extensive questions after the meeting.
  • Approximately 2-3 business days after the meeting, the HRPP will notify you (and your faculty advisor, if applicable) of IRB decisions and revision requirements. You may then complete revisions and resubmit on your own timeline (unless the protocol needs to return to the convened Board for discussion).
  • Full Board protocols receive a one-year approval and if not concluded in the period, require a Continuing Review Application.

Common Questions

Many discussions in recent years note that requiring Full Board review for all studies that might enroll pregnant individuals puts an undue burden on researchers, which can lead to unfairly excluding this population from important research studies. If your study involved strenuous physical activity or highly stressful psychological tasks, and if you intentionally enroll pregnant individuals, your project will need Full Board review to ensure the best protections both for the pregnant individual and the fetus.

But if study tasks are no more difficult or upsetting than a person would encounter in normal, daily life OR if you are not deliberately recruiting pregnant persons, then the project might meet criteria for Expedited review. If a person becomes pregnant during the course of a study, then depending on the nature of the research activities, the IRB might need to consider whether additional protections for the individual(s) are warranted. In that case, contact the HRPP for guidance as soon as possible.

According to the federal regulations, no. However, the reason for additional protections with this population lies with concern about voluntary consent. If someone is under supervision and must answer to various authorities, will that person feel free to decline a study or stop participating? To ensure ethical practices, the WWU IRB reviews at the Full Board level all studies involving interaction/intervention with incarcerated persons, parolees, juvenile offenders, or anyone for whom consent might be compromised due to heightened supervision.

Often, pedagogical research on normal educational practices meets Exemption criteria. Other research with minors might meet Expedited review criteria if it poses minimal risk and does not enroll very young children as participants. The following characteristics would likely require Full Board review (suggested ages are possible guidelines, not set policy):

  • Direct interaction with children below 13
  • Asking about sensitive or upsetting topics with minors below 16
  • Asking about any illegal activities
  • Requesting a full waiver of parental/guardian permission
  • Complex interventions
  • Enrolling minors with cognitive impairments

 

 

 

Some likely aspects that would require review by the convened board:

  • Collecting illegal or highly sensitive information when participant identities are directly or indirectly identifiable
  • Studies involving significant deception (e.g., video recording participants without their knowledge)
  • Some international research (especially where questions exist about safety of participants or researchers, or confidentiality of sensitive data)
  • Other vulnerable populations (not specifically identified in regulations) such as persons experiencing homelessness and/or diminished decisional capacity