Consent Method Selector
Describe your participants, setting, risk level, and documentation needs to identify consent approaches that may fit your research.
Consent is a process, not only a form
The method should help participants understand the study and make a voluntary decision.
Written signatures are common, but they are not always the safest or most accessible option. Electronic, verbal, implied, assent-based, and waiver approaches may be appropriate in specific contexts.
The selector recommends a starting point and highlights safeguards, but it does not make an ethics determination.
Capacity
Participants must be able to understand and voluntarily decide, or an authorized representative may be needed.
Risk
Higher-risk and sensitive studies usually require stronger consent and documentation safeguards.
Setting
In-person, remote, anonymous, telephone, and records-based research require different procedures.
Documentation risk
A signed form can sometimes create the main identifying link to sensitive participation.
Common consent approaches at a glance
Use these categories as starting points for an ethics-reviewed process.
| Situation | Possible approach | Key consideration |
|---|---|---|
| Competent adults in person | Provide adequate information, time, questions, and a signed copy | |
| Remote or online participation | Document agreement and provide a downloadable or emailed copy | |
| Telephone, low literacy, or accessibility barriers | Use a script and ethics-approved documentation procedure | |
| Anonymous minimal-risk survey | Completion follows a clear information statement | |
| Signature creates added confidentiality risk | Consent still occurs, but no signed form is collected | |
| Minimal-risk records research with impracticable contact | Strict ethics criteria must be satisfied | |
| Children or adolescents | Use age-appropriate information and respect dissent | |
| Impaired decision-making capacity | Assess capacity and involve the participant as much as possible | |
| Longitudinal or evolving research | Reconfirm willingness when procedures, risks, or circumstances change |
What every consent process should address
- Purpose and procedures. Explain what participants will do and why the study is being conducted.
- Risks and benefits. Describe foreseeable burdens, discomforts, privacy risks, and potential benefits honestly.
- Voluntariness. Make clear that participation is optional and refusal will not result in penalty.
- Privacy and data use. Explain identifiability, access, retention, sharing, and future use.
- Withdrawal. Explain how participants may stop and what happens to data already collected.
Avoid using convenience as the only justification
A less formal method should not be selected merely because it is faster. Verbal, implied, or waived consent requires an ethical rationale related to risk, impracticability, accessibility, or participant protection.
Likewise, a signed form does not prove understanding. Consent materials should be readable, culturally appropriate, accessible, and delivered in a way that supports questions and voluntary choice.
Frequently asked questions
The appropriate method depends on participant age and capacity, study risk, data sensitivity, recruitment setting, identifiability, whether written signatures create additional risk, and the requirements of the reviewing ethics committee.
Written informed consent uses a signed document to record that a participant received relevant information, had an opportunity to ask questions, and voluntarily agreed to participate.
Electronic consent may be appropriate for remote or online studies when the system can present the required information, document agreement, verify identity when necessary, and provide participants with a copy.
Verbal consent may be suitable when literacy, accessibility, distance, culture, or documentation risk makes written consent impractical, subject to ethics approval and appropriate documentation by the research team.
A waiver of documentation allows consent to occur without collecting a signed consent form. It may be appropriate when the main link between the participant and the research is the signed form or when the study presents minimal risk and written documentation is not normally required outside research.
A waiver of consent allows research to proceed without obtaining individual consent when strict ethics criteria are met, such as minimal risk, impracticability, protection of rights and welfare, and additional information after participation when appropriate.
Implied consent is inferred from a voluntary action, such as completing an anonymous low-risk survey after reading an information statement. It still requires clear disclosure and ethics approval where applicable.
Children generally provide assent when developmentally capable, while a parent or legally authorized representative provides permission. Requirements vary by age, jurisdiction, institutional policy, and study risk.
Assent is a child's affirmative agreement to participate using age-appropriate information. Mere failure to object is not the same as assent.
Ongoing consent treats consent as a continuing process rather than a single form. It is particularly important in longitudinal, sensitive, qualitative, participatory, or changing studies.
Participants should usually be able to withdraw without penalty, although the extent to which already collected or de-identified data can be removed should be explained clearly.
No. The final consent process must be reviewed under applicable law, institutional policy, ethics requirements, and the specific risks and population involved.