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Exempt Review

The review time is typically shorter than other categories of review (~6-8 days).

Only certain categories of research qualify as exempt, based on federal regulations. Students must still submit an HPRB proposal (and accompanying documents), so that the HPRB will understand how participants’ identity and privacy will be protected.

If the HPRB reviews a project and determines that it is “exempt,” no further oversight or review by the HPRB is necessary, unless there are changes to the nature or scope of the project.

Most of the research conducted at PLU that qualifies as exempt does so because it:

  1. measures the efficacy of educational practices in an educational setting.
  2. involves analysis, synthesis, or study of existing data or documents when these are publicly available or when the information is recorded in such a way that individuals are anonymous.
  3. involves the use of surveys, interviews, educational tests, psychological tasks or observation of public behavior when the obtained information is anonymous or when disclosure of the individual responses poses no risk of adverse consequences to the participant.

Anonymous >>>

Anonymous means that the individual participant cannot be identified from the data themselves, and no identifying information is linked to the data. Video and voice recordings are not anonymous. Interview or survey data in which recorded demographic characteristics or descriptions of specific incidents could easily lead to the recognition of the individual respondent are not anonymous.

Public behavior >>>

Public behavior is behavior occurring without the intervention of the researcher, and which the individual could reasonably expect to be observed. Observation of reactions to “staged” events and of behavior occurring in private settings (e.g., at home, in a bathroom stall) or in settings in which individuals have reasonable expectations of a limited audience (e.g., classrooms, meetings of identified groups) is not exempt.

Examples of adverse consequences include >>>

  • placing participants at risk of criminal or civil liability
  • damaging the participant’s academic standing or standing in any ongoing program, financial standing, employment status or employability, insurance status or insurability
  • damaging the participant’s reputation

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Expedited Review

This type of project requires a bit more review time than exempt research (~8-10 days).

Research using a wide range of methodologies can fall into this review category, including collection of data:

  • from voice, video, digital, or image recordings made for research purposes;
  • on individual or group characteristics or behavior (e.g., research on perception, cognition, motivation, identity, language, communication, religious or cultural beliefs or practices, and social behavior);
  • from surveys, interviews, oral histories, focus groups, program evaluation, or human factors evaluation; and/or
  • from behavioral interventions that are brief in duration, harmless, not physically invasive, not likely to have a significant adverse lasting impact and unlikely to be considered offensive or embarrassing by participants.

Research may qualify for expedited review if it involves:

  • no more than minimal risk to participants
  • no vulnerable populations

The HPRB will want to make sure that investigators are adequately protecting the privacy and confidentiality of participants.

Minimal risk >>>

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Vulnerable populations >>>

Vulnerable populations include children under 18 years of age, clinical populations, incarcerated populations, individuals who for one reason or another cannot provide informed consent.

Privacy >>>

Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Confidentiality >>>

Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission.

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Full Board Review

This type of review can take up to 1-2 months, depending on when you submit and when the board meets (3 or 4 times a semester; not in J-term/summer). Full board proposals can involve revisions before approval.

Research that does not qualify for exempt or expedited review, must be submitted for full board review. Full board review requires a convened meeting of the HPRB, with a majority of its members present. Submission deadlines are ~10 days before the committee meeting. This allows time for preliminary review by HPRB members, who provide feedback and questions to the Chair.

Please keep the following in mind:

It is often challenging for students to complete projects involving full board review in the span of just one semester, though we will do everything we can to make it possible.

Please see the HPRB meeting dates/submission deadlines for the relevant semester and evaluate feasibility.

We recommend that you assess carefully the maturity, sensitivity, and patience of any students who might submit a proposal for full board review. The types of projects requiring full board review involve vulnerable populations, sensitive topics, and/or more complex ethical considerations. Review may involve one or more rounds of stipulations (questions, concerns, recommendations) that students will need to address before approval can be granted. This takes time and commitment, and students need to understand that in advance if they plan to submit for full board review.

Please consider a consultation with the Unit Designate in your school/division or the HPRB chair. In some cases, we may be able to suggest modifications to projects that will make them eligible for expedited review instead of full board review (e.g., removing aspects of deception, finding non-vulnerable populations that will still provide valuable information).

Research requires full board review if it involves:

a.  vulnerable populations
(e.g., children under 18 years of age, clinical populations, incarcerated populations, individuals who for one reason or another cannot provide informed consent).

b.  intentional induction of stress, or where stress to participants might be an unintended consequence
For example:

  • the use of aversive or physically painful stimuli
  • the induction of emotional distress, such as embarrassment, frustration, anxiety, loss of self-esteem, anger, or sexual arousal
  • the induction of physical stress through procedures such as exercise, sleep deprivation

c.  potential for physical injury
Including the consumption of any substance, (e.g., coffee, tea, tobacco, over-the-counter medications)

d.  potential for ethical objections from participants
For example:

  • deception by the researcher or confederates
  • manipulations of participants’ attitudes or behavior
  • observation of behavior in non-public settings without advance consent

e.  collection of personally sensitive data requiring unusual procedures to ensure confidentiality

You can expect to hear back from the Chair within a few days of the full board meeting.

Typical HPRB actions include:

  • approval
  • request for revisions that can be approved by the HPRB Chair
  • request for revisions that must be re-reviewed by the Committee