What This Does
Support is provided for research involving human subjects, research handling personal information, surveys, interviews, behavioral log analysis, and similar activities, from confirming whether ethics review is required to preparing application documents and responding to resubmission requests.
- Target Users: Researchers, URA, research ethics officers, graduate students
- Issues to Solve: It is difficult to judge whether ethics review is necessary, it is unclear how to write the application form, and applications are returned just before the research begins
- Expected Effects: Clarify the procedures required before starting research and improve the consistency between participant protection and the research plan
Required Inputs
- Research Overview: Purpose, target participants, methods, data to be collected
- Participant Information: Age, attributes, presence of vulnerable status, recruitment method
- Collected Information: Personal information, special care-required personal information, audio/video, presence of existing data
- Presence of Intervention/Invasiveness: Medical intervention, psychological burden, physical invasiveness, etc.
- Institutional Regulations and Forms(Optional): Ethics review application form, explanatory document, consent form template
- Desired Research Start Date(Optional): Used to calculate the review schedule backward
What It Produces
- Organizing Whether Ethics Review Is Required: Whether required, not required, or needs confirmation, and the reason
- Application Preparation Checklist: Required documents, points of contact, unresolved matters
- Application Form Draft Support: Draft descriptions of research purpose, methods, participant protection, obtaining consent, and data management
- Resubmission Response Plan: Revision policy and draft reply for each point raised
Procedure
1. Organize the research type
Classify the research content from the following perspectives.
| Perspective | What to Confirm |
|---|---|
| Target | Whether it involves human subjects, or only existing samples/existing information |
| Data | Whether it handles personal information, special care-required personal information, anonymized processed information, or pseudonymized processed information |
| Method | Whether it is a survey, interview, observation, intervention, experiment, or log analysis |
| Risk | Possibility of physical or psychological burden, disadvantage, or privacy infringement |
| Participants | Whether it involves minors, patients, students, employees, or other groups requiring consideration |
2. Make a provisional determination of whether review is required
Organize as follows, and confirm the final judgment with the ethics review office of the affiliated institution.
- Review is likely required: New data is collected from human subjects, personal information is handled, or there is invasiveness, intervention, or psychological burden
- Needs confirmation: Only publicly available data, but there is a re-identification risk; using class and work data for research; data transfer in international collaborative research
- May not be necessary: Uses only fully public statistical information, cannot identify individuals, and does not contact subjects
If you are unsure, do not conclude that it is "not necessary"; instead, list the contact points and the issues to confirm.
3. Identify the required documents
In accordance with your institution's forms, confirm at least the following.
- Ethics review application form
- Research plan
- Explanatory document for participants
- Consent form or consent acquisition procedure
- Recruitment text, survey items, interview guide
- Data management plan, anonymization/pseudonymization procedures
- Whether joint research agreements, data provision agreements, or outsourcing agreements are required
4. Create descriptions for participant protection
Describe the following concretely in the application form.
- Participation is voluntary, and there is no disadvantage from not participating or withdrawing
- Explain the research purpose, required time, data to be collected, and scope of use
- How to withdraw consent and the scope within which withdrawal is possible
- Storage location of personal information, access permissions, retention period, and disposal method
- Processing to ensure individuals are not identified at the time of publication
- Means to stop or seek consultation if psychological burden or discomfort occurs
5. Work backward from the schedule
Work backward from the desired research start date for the following.
- Internal pre-check of the application form
- Ethics review committee deadline
- Notification of review results
- Revision/resubmission period
- Research start date after approval
Clearly state not to begin participant recruitment, consent acquisition, or data collection before approval.
6. Respond to requests for revision
Organize revision comments in the following format.
| Point raised | Underlying concern | Revision policy | Draft reply |
|---|---|---|---|
| Content of the point raised | Risk the committee is concerned about | What to revise and how in the application form | Concise response |
Even when a rebuttal is necessary, first acknowledge the committee's concern, then present supporting materials and alternative measures.
Judgment criteria
- Whether ethics review is required varies by research field, data to be collected, subjects, and the regulations of the affiliated institution
- Applicable guidelines and forms may differ for medical research, social science research, and educational practice research
- Confirm personal information protection, research ethics, contracts, and information security separately as distinct issues
- If there are overseas clouds, external outsourcing, or international collaborative research, add confirmation of data transfer and contracts
Common mistakes and countermeasures
| Mistake | Countermeasure |
|---|---|
| Immediately assuming that "because it is an anonymous survey, review is unnecessary" | Confirm recruitment method, attribute information, free-text description, and re-identifiability |
| Only the consent form was created and the explanatory document is weak | Write the research purpose, risks, withdrawal method, and contact information for participants |
| Coerciveness remains in requests made in class or the workplace | Separate the requester from the evaluator and clearly state that there is no disadvantage even if one does not participate |
| Start recruitment before approval | Separate acts that can begin the research from preparatory acts, and set the start date after approval |
| The data storage period is ambiguous | Clearly state the storage period, storage location, deletion method, and responsible person |
Quality standards
- Do not overstate whether review is required, and clearly indicate the points that should be confirmed with the affiliated institution
- Participant protection, obtaining consent, and data management are consistent with the research method
- The descriptions in the application form, explanatory document, and consent form do not contradict each other
- The tasks that must not be started before approval are clear
- Responses to requests for revision are written as risk mitigation measures rather than emotional rebuttals
Available Tools
- Read: Reading the research plan, application form, explanatory document, and revision comments
- Write: Creating a checklist, draft application form, and draft reply
- WebSearch / WebFetch: Confirming the latest guidelines from the affiliated institution, ministries and agencies, academic societies, etc.
- Bash: Document list, deadline table, character count check