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Types of review

How the IRB examines research protocols

Human subjects research in the United States is governed by the Department of Health and Human Services (HHS) regulations under Title 45 of the Code of Federal Regulations, Chapter 46 (45 CFR 46). Further guidance and leadership is administered by the Office of Human Research Protections (OHRP). WSU follows the regulations and guidance from these institutions and is also responsible for enforcing its own institutional policy related to research. Research with human participants will fall under certain categories, depending on the procedures, population, and risk level of the study. This determination is made by the HRPP.

Three levels of review

Level of ReviewDo the regulatory requirements under 45 CFR 46 apply?Who Reviews?Average time for initial review
ExemptNo1 HRPP Staff (+1 board member if needed)10-12 Business days
ExpeditedYes2-3 Board members10-12 Business days
Full BoardYesConvened Full Board12-15 Business days

Exempt

Regulatory reference: 45 CFR 46.104

Certain research may be exempt from regulatory requirements and will not require review by the board. These studies must meet the criteria under the exempt categories. An exemption determination application (informally called the “exempt application”) must be submitted to the HRPP. While these projects are exempt from review by the board, they must be reviewed by the HRPP for the determination.

Six categories for Exempt research:

Category 1 – Educational Research
Research conducted in established or commonly accepted educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 – Survey/Interview/Focus Group/Observation
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording).

Research in this category that collects both sensitive and identifiable data are required to submit an addendum for Limited IRB Review (LIR). LIR will be conducted to ensure appropriate data protection measures are in place.

The following is not allowed under this exemption category:

  • Interventions
  • The collection of biospecimens
  • Research with children, except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observation of public behavior if the investigator does not participate in the activities being observed

Category 3 – Benign Behavioral Interventions
Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on or be offensive or embarrassing to the participants) with adult participants who prospectively agree to the intervention and collection of information through verbal or written responses (including data entry) or audiovisual recording.

Research in this category that collects both sensitive and identifiable data are required to submit an addendum for Limited IRB Review (LIR). LIR will be conducted to ensure appropriate data protection measures are in place.

The following is not allowed under this exemption category:

  • Research with children
  • Deception without prior agreement; Participants must be informed of, and agree to, any deception prior to participation.
  • Physiological data collection methods (e.g., EEG; wearable devices; blood pressure monitors)

Category 4 – Secondary Data Analysis of Identifiable Data/Specimens
Secondary research for which consent is not required: secondary research uses of identifiable private information or identifiable biospecimens. “Secondary research” refers to studies that utilize data that has been collected, or will be collected, for purposes other than the proposed research. This can include but is not limited to: clinical data or biospecimens, patient chart data, restricted/limited datasets available through an agency or company, or identifiable data collected by other studies.

Note: If the data is de-identified prior to you receiving it, it may not meet the federal definition of “human subjects” research and review may not be required. Researchers should submit the Human Subjects Review Determination Form (docx) to receive confirmation from the HRPP to determine if review is required.

Category 5 – Government Research
Research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Category 6 – Taste Evaluations
Taste and food quality evaluation and consumer acceptance studies.

Expedited review

Regulatory references: 45 CFR 46.110; 45 CFR 46.111

Types of research that involve no more than minimal risk may be eligible for expedited review. Minimal risk research that does not meet the criteria under the Exempt categories can be reviewed using the expedited process. Use the non-exempt application form to apply.

“Expedited” is a regulatory designation that means the full board does not need to convene in order to review the project. An expedited review is completed by select board members designated by the HRPP, rather than by the convened IRB.

Annual renewal, or “continuing review”, is typically not required for Expedited studies unless the HRPP deems it necessary. Protocols that do not require continuing review must submit a simple “status update” at least once annually to inform the board that the study remains active, requires changes, or has closed. Following approval, the principal investigator is responsible for reporting deviations, adverse events, or changes in the study. Please see our Reporting Events & Deviations page for more information.

These protocols may be elevated to full-board review if reviewers determine the study involves more than minimal risk to participants. Some may also be bumped down to Exempt if the project meets the proper criteria.

Full-board review

Regulatory reference: 45 CFR 46.111

Studies that are not eligible for expedited review or that involve more than minimal risk are required to be reviewed by the full board.
Use the non-exempt application form to apply.
The meeting schedule can be found here: Full Board Meeting Dates

Complete protocols must be distributed to the board well in advance of the meeting date, so deadlines for submission of protocols for full board review are typically 10 working days prior to the meeting date.

Before approval can be granted, the proposed research must be reviewed at a convened IRB meeting with a quorum (a majority of the voting members) present. More than minimal risk protocols require continuing review at least annually (unless an alternative review period is designated by the board). Once a study has only data analysis remaining, continuing review can be conducted via the expedited review process.

If the board determines that the study poses no more than minimal risk, it may choose to reclassify the project as expedited for future reviews.

Following approval, the principal investigator is responsible for reporting deviations, adverse events, Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO), Non-Compliance, or changes in the study. Please see our Reporting Events & Deviations page for more information.

Changes to an approved study

Amendments

Before researchers can change or adjust the study design, procedures, personnel, or any of the materials/documents used within the study, they must submit the following to the IRB:

  • Amendment request form
  • Updated application
  • Relevant materials, such as recruitment materials, consent forms, and/or data collection materials that need to be updated as a result of the changes.
Personnel Changes

When making personnel changes to a study, researchers should use the following process:

  1. Changes in Key Personnel (e.g. PIs, Co-PIs, Co-Is, Coordinators who act as the primary contact, site contacts): Submit an Amendment Request Form along with the updated application, consent documents, and any other materials that need to be updated as a result of the change in personnel. If you are changing the PI, we will also need confirmation from the previous PI and the new PI (simple email will suffice).
  2. Changes in Other Personnel (e.g. Research Assistants, Data analysts): Submit only the application with the changes reflected in the personnel list; cross out those who are no longer part of the study.

The IRB must be able to track the active personnel on all studies. The personnel list on your application serves as the record of active personnel and this document must therefore be updated before any new research personnel begin work on the project.

Administrative Changes/Corrections

Should you need to make any minor changes or corrections, such as correcting typos in a consent form or slightly adjusting a clause on a recruitment flyer, please use the simple process below:

  • Send us an email explaining the situation and attach the updated materials
  • We will document the materials to align our records of your research.
  • No further review or forms are necessary*

*Note: If the change affects the design, procedures, risk to participants, data management, or any other fundamental aspects of the study, a formal Amendment will be required. The “Administrative Change”  process is meant for extremely minor changes or corrections that do not fundamentally impact the research or the risk to participants.

Comprehensive changes

Changes to the study that are deemed substantial as compared to the originally approved project may require a new application. In rare instances, the overall purpose and design of the study can change after the approval, depending on the population, context, or nature of procedures. Please contact the IRB with questions.

Additional types of review

Continuing Review

Continuing Review is required for protocols reviewed at the full board level and for certain protocols reviewed at the expedited level when designated by the IRB. Most protocols reviewed at the expedited level do not require continuing review, however, annual status reports are required so that the IRB may monitor and maintain accurate records of active research.

Post-approval Review

Also known as “post-approval monitoring,” this is conducted once research protocols involving human participants have been approved and are underway to ensure adequate protection of human participants. All protocols are subject to post-approval review, however, the focus of post-approval review is on more than minimal risk research or research involving vulnerable participants. See our Post-Approval Review page for more information.

118 Designation

For researchers seeking a grant from a federal department or agency, it may be unclear if the study will be funded. In these situations, the agency may require the investigators to submit a letter from the IRB indicating that the project will be reviewed if the grant is awarded. Under the regulations, the IRB can issue a 118 Designation for the investigators to include in their grant proposal. This designation does not constitute a full review and approval. If the grant is awarded, the investigators are required to submit the project to the IRB for review prior to beginning human subjects research activities.

Please use the 118 Designation Form to apply.

Reportable events, unanticipated problems, deviations

In any study, promptly report the following to the IRB.

Adverse events or unanticipated problems

Submit an IRB/HRPP Reporting Form if anything unplanned happens during research that could negatively affect the research or a human participants. Such events may include the following:

  • Unanticipated problems involving risks to subjects or others, and
  • Any untoward or unfavorable medical occurrence in a human subject, whether the occurrence is considered related to the individual’s participation in the research

Deviations

Submit an IRB/HRPP Reporting Form  if any member of the research team does not follow the approved protocol. A deviation includes any change, divergence, or departure from the study design or research protocol procedures that:

  • Is under the investigator’s control, and
  • Has not been approved by the IRB and/or the sponsor

Please see our Reporting Events & Deviations page for more information.

When a project is completed

Submit a close out report.