Expedited Review
Human Research Protections Program
What does "minimal risk" mean?
When you collect identifiable information in connection with possibly sensitive responses, your project will need to identify and mitigate potential risks to participants. Projects that pose minimal risk to participants but do not meet Exemption criteria will go through Expedited Review. According to the 2018 Common Rule, "minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” In other words, participating in the study would not pose any more risk than individuals face in daily life.
All Expedited 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 Expedited protocols, you will need to follow all Protocol Management requirements for post-approval actions.
Expedited Review Process
At WWU, depending on the complexity of a study and the potential risk involved, the following individuals might oversee expedited reviews: the HRPP Administrator, the IRB Chair, or other IRB members, based on applicable expertise. If the study poses greater than minimal risk to participants, reviewers may recommend elevating the protocol to the convened IRB to review and vote whether to approve the protocol or other actions. Alternatively, researchers may wish to consult with the HRPP about ways to alter study design or procedures to lower potential risks and thus the revie level. (Otherwise, the HRPP does not typically require revisions to methodology, unless such changes would significantly lower risk.)
The WWU HRPP reviews primarily the following expedited research categories under 45 CFR 46.110. Visit the Office for Human Research Protections Expedited Review page for information about Categories 1 (clinical drug and medical device studies) and 2 (collection of blood samples).
No. Reviewers will assess your application with care and intentionality to help identify and minimize any reasonable risks to participants. Reviewers will also note inaccuracies and inconsistencies, because federal regulations and HRPP policies require a complete, accurate protocol on file to issue approval. Approval timelines might be slightly faster than a full-board review process, but that depends on the quality of the submitted protocol and need for revisions.
Reviewers will not interfere with or require changes to your methodology unless it elevates participant risk and needs mitigation.
Sensitive refers to collecting data that is highly personal, controversial, or potentially causing more than typical psychological distress. If a participant's identifiable data were somehow disclosed beyond the study team, could the person face embarrassment or social stigma? Could the person's job security or relationships in the workplace be impacted?
In these cases, reviewers will look to see that the application has a robust plan to ensure confidentiality in collecting the data as well as storing the data.
A person's direct identifiers (name, email, phone number) are linked to their individual responses. OR enough indirect identifiers (e.g., demographics) are linked to responses so that a combination could reasonably reveal a participant's identity (particularly an issue with small populations).
Read the guidance on Anonymity, Confidentiality, and Privacy for more information.
Federal 45 CFR 46.101 Expedited Review Categories
Prospective collection of biological specimens for research purposes by noninvasive means.
Examples:
- Hair and nail clippings in a non-disfiguring manner
- Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
- Permanent teeth if routine patient care indicates a need for extraction
- Excreta and external secretions (including sweat)
- Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue
- Placenta removed at delivery
- Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
- Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
- Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
- Sputum collected after saline mist nebulization
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
Examples:
- Physical sensors applied to the body surface or used at a distance that do not involve putting significant amounts of energy into the participant or invade the participant's privacy
- Weighing or testing sensory ability
- Magnetic resonance imaging with FDA-approved scanners
- Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography
- Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
The current Common Rule (45 CFR 46.101) primarily reflects a biomedical focus (routine "clinical practice") and does not account for minimal-risk human participant research that collects various biometrics through observation, measurement, and non-intrusive wearable devices (such as in kinesiology, EEG, or perception studies).
Thus, for non-federally funded research, the WWU HRPP expands Expedited Category 4 to certain minimal risk biobehavioral projects (e.g., studies that collect data using non-invasive wearable devices, biometric monitors, or sensors), even though these studies do not represent “clinical practice.”
(Most Expedited research at WWU falls under Cat. 4 or 7.)
Research involving materials (data, documents, records, or specimens) collected or to be collected for non-research purposes (e.g., medical treatment or diagnosis).
Note: The HRPP may apply this category for research materials if the researcher's role is analysis only. That is, if a colleague provides (separately approved) data to another researcher and ensures confidential handling, that researcher may apply for expedited review for conducting analysis. (For extremely minimal risk studies that will analyze non-sensitive data, the project might meet Exemption criteria. Contact the HRPP for guidance before initiating study activities.)
Examples:
- Conducting retrospective chart review of an individual's medical records for which the researcher has approved access
- Analyzing specimens that contain identifiable information (e.g., name or medical record number)
- Evaluating trends in school grade distribution and attendance from records that contain identifiable information
Collection of data from voice, video, digital, or image recordings made for research purposes.
Recording Examples:
- Audio or video recordings of interviews or focus groups
- Video recordings of participants completing an intervention or task
- Digital recordings of Zoom/Teams meetings or interviews
Where audio recordings would not reasonably lead to individual identification, the study might meet Exemption criteria. However, if collecting or retaining any type of recording could significantly elevate risk to participants (potential invasion of privacy or breach of confidentiality), the protocol may require Full-Board review.
If recordings do not include identifiable data and were not made for research purposes, Exemption criteria might apply.
Research on individual or group characteristics or behavior — including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior — or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies.
Note: This type of research could meet Exemption Cat. 2 criteria, and you might be able to submit an Application for Exemption. Before completing and submitting an Expedited protocol application, review the guidance on Exempt Research, and contact the HRPP if you have questions about appropriate submission form and review level.
Examples:
- A researcher conducts a focus group with university students about whether they live or behave significantly differently than when they are at home. Topics include political and religious beliefs, sexual orientation, etc.
- A graduate student interviews early-career women of color who are teachers in a local school district about support and mentorship from supervisors.
- Two faculty members conduct online surveys and follow-up interviews with adult residents of multiple states in the Pacific Northwest, the Midwest, and the Deep South to compare access to and personal experiences with marijuana.
(Most Expedited research at WWU falls under Cat. 4 or 7.)
Full-board approved studies may be downgraded to Expedited review under certain conditions: no new participants will be enrolled, research activities have concluded except for possible follow-up and data analysis, no new risks are identified, and Categories 2-8 do not otherwise apply.