Article Summary
- IRB approval for medical device usability testing in Japan is not always required, but is determined through a risk-based approach, considering factors such as patient involvement, clinical settings, invasive prototypes, or physician participation in treatment decisions.
- Early planning is critical in Japan, as IRB processes typically take 6–8 weeks, with fixed monthly review cycles and strict submission timelines.
- Regardless of the decision, teams must clearly document the rationale for obtaining or not obtaining IRB approval, ensuring alignment with regulatory expectations and smoother review processes.
At Uism, we frequently receive questions from clients about whether their specific usability study requires IRB* approval.
While IRB review is required for clinical research, its applicability to usability testing is less straightforward and often sits in a gray zone. In this guide, we outline how to determine whether IRB approval is required, based on practical considerations and risk.
*IRB (Institutional Review Board) is an ethics committee that reviews research involving human subjects to ensure participant safety, rights, and welfare are protected. In Japan, IRB oversight is guided by ethical guidelines for research involving humans.
Why Usability Testing May Require IRB
Medical device usability testing is generally not considered clinical research. However, specific study characteristics may require ethical review.
1. Testing with Patients
Studies involving actual patients require the most careful consideration. You must assess whether participation introduces any risk (physical or psychological) to the patient’s health or treatment. This is especially important when working with vulnerable populations such as:
Patients with serious/terminal conditions
Individuals with severe mental health conditions
Elderly individuals with cognitive impairment
children
In such cases, IRB approval is strongly recommended.
A key principle is minimizing unnecessary exposure to risk. Therefore, you must clearly justify why patients are required instead of general users.
2. Other Factors That May Trigger IRB
Even if patients are not involved, IRB may still be required depending on the study design. Key triggering factors include:
- Testing in real clinical environments (e.g., hospitals or clinics)
- Use of realistic or invasive prototypes (e.g., injectors)
- Physician involvement in diagnosis or treatment decisions
- Evaluation of medical effectiveness or safety
- Positioning the study as clinical evidence for regulatory submission
The Risk-Based Approach
The decision to obtain IRB approval is risk-based.
Low-Risk Studies
- No involvement of vulnerable populations
- Use of mock devices or simulated environments
- Conducted outside clinical settings
If IRB is not pursued, you must document the rationale clearly.
High-Risk Studies
- Testing in real clinical environments
- Use of invasive prototypes
- Physician involvement in diagnosis or treatment
Why IRB is Recommended for Summative Evaluations
IRB approval is strongly recommended for summative (validation) studies because:
- Results are often used in submissions to PMDA
- PMDA may question the absence of IRB approval where risk is present
- It demonstrates ethical oversight and due diligence
Recommended Actions:
- Conduct and document a risk assessment for every study
- Include IRB timelines in project planning (typically 6–8 weeks)
- Consult an external IRB early if there is uncertainty
IRB Application Overview
Japan has a unique IRB process, which often requires more time from submission to final decision. It is therefore important to plan ahead and consider the following elements when preparing your IRB application.
| Details | |
|---|---|
| IRB meeting frequency | Varies by institution (typically once a month) |
| Document submission | ~14 days before meeting |
| Review outcomes |
|
| IRB types |
|
| Typical total timeline | 6-8 weeks with revisions; expect more for higher-risk studies |
| Cost | Budget ¥100,000-¥200,000 minimum per review |
*Terms apply as each IRB has different timeline and difficulty levels.
Core IRB Application Documents
Document requirements differ by review board, so please refer to your selected IRB’s website for a complete list. Please note that it is essential to use consistent wording across all documents to clearly state that the study is not clinical research. Typical documents include:
1. IRB Application Form
2. Research Protocol
- Study objectives
- Methodology and procedures
- Participant selection criteria
3. Informed Consent Documents
- Study purpose
- Personal information and video recording handling (what is recorded, why it is necessary, who will access it, storage period, third-party sharing, etc.)
- Participant rights (withdrawal without disadvantage, compensation policy)
Critical Documentation: Distinguish from Clinical Research
Your documentation (protocol, application, consent forms) should explicitly state that the study:
- Is not a clinical trial
- Is conducted as design verification/validation under JIS T 62366-1
- Does not involve diagnosis or treatment decisions
- Does not evaluate medical effectiveness or safety
- Is not intended as clinical evidence for regulatory approval
In Japan, IRBs often do not distinguish between clinical trials and usability studies in their processes. Clear positioning is therefore critical to avoid delays.
Conclusion
A risk-based approach should be applied to both formative and summative evaluations. However, IRB approval is strongly recommended for summative studies, as it supports regulatory submission and demonstrates ethical rigor.
If you are planning medical device usability testing in Japan, we recommend evaluating your study carefully against these criteria. When in doubt, consult with an experienced external IRB early to ensure a smooth and compliant process.
Human Factors Research
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