In digital research studies, informed consent means that participants are given clear, understandable information about the study and voluntarily agree to participate—typically through an electronic process—before any research data is collected.
A valid informed consent process generally includes the following elements:
1. Clear explanation of the study
Participants should be told, in plain language:
- The purpose of the research
- Who is conducting it
- What participation involves
- How long participation will last
- What tasks, surveys, app use, tracking, sensors, or data collection are involved
- Whether participation is one-time or ongoing
For digital studies, this may include explaining data collection through apps, websites, wearables, smartphones, browser activity, location tracking, social media, or passive sensors.
2. Description of risks and benefits
Participants should understand possible risks, such as:
- Loss of privacy or confidentiality
- Data breaches
- Re-identification of supposedly anonymized data
- Emotional distress from questions or tasks
- Unwanted disclosure of sensitive information
- Risks from algorithmic profiling or automated analysis
They should also be told about any expected benefits, while avoiding exaggerated claims.
3. Explanation of data collection and use
Digital research often involves complex data flows, so consent should explain:
- What data will be collected
- Whether data collection is active or passive
- How often data is collected
- Whether metadata, location, device identifiers, IP addresses, audio, video, biometrics, or behavioral data are collected
- How the data will be analyzed
- Whether artificial intelligence or automated decision-making will be used
- Whether data will be linked with other datasets
4. Information about data sharing and storage
Participants should be informed about:
- Who will have access to the data
- Whether data will be shared with researchers, companies, platforms, sponsors, or public databases
- Whether data may be transferred across countries
- How long data will be stored
- Whether data will be de-identified, anonymized, or encrypted
- Limits to confidentiality
5. Voluntary participation
Consent must be voluntary. Participants should know:
- They do not have to participate
- They can refuse without penalty
- They can withdraw later, if applicable
- Their access to unrelated services, care, education, or employment should not depend on participation
Digital consent should avoid manipulative design, such as confusing buttons, pre-checked boxes, dark patterns, or making refusal difficult.
6. Right to withdraw and data deletion limits
Participants should be told how to withdraw and what happens afterward.
For example:
- Can they stop using the app?
- Can they request deletion of their data?
- Will already-analyzed or de-identified data remain in the study?
- Are there legal, scientific, or technical limits to deletion?
This is especially important in studies using cloud storage, backups, blockchain, shared datasets, or anonymized data.
7. Comprehension
Participants must actually have a reasonable opportunity to understand what they are agreeing to.
Digital studies may support comprehension through:
- Plain-language summaries
- Short videos or graphics
- Layered consent forms
- FAQs
- Knowledge checks or quizzes
- Interactive explanations
- Translations and accessibility features
Simply clicking “I agree” is not enough if the information is hidden, overly technical, or misleading.
8. Capacity and eligibility
Researchers should ensure that participants are able to consent.
This may involve confirming:
- Age eligibility
- Legal capacity
- Whether parental permission or guardian consent is needed
- Whether assent is required for minors
- Whether the participant is in a vulnerable population requiring additional protections
9. Affirmative agreement
Consent should involve a clear, active indication of agreement, such as:
- Clicking “I consent”
- Signing electronically
- Checking an unchecked box
- Completing an e-consent process
- Providing recorded verbal consent, where appropriate
Pre-checked boxes, passive browsing, or buried terms of service generally do not constitute strong informed consent for research.
10. Documentation
Researchers usually need to document consent, depending on applicable ethics rules and institutional review board requirements.
Documentation may include:
- Timestamped electronic signatures
- Consent version number
- IP or device logs, where appropriate
- Records of what consent materials were shown
- Audit trails for updates or re-consent
11. Ongoing or dynamic consent when appropriate
In digital research, data collection may continue over time or study aims may change. In those cases, consent may need to be ongoing rather than a one-time event.
Participants may need to be re-consented if:
- New types of data are collected
- Data will be used for new purposes
- Data sharing practices change
- Risks materially change
- The study expands to new platforms or technologies
12. Contact information and oversight
Participants should know whom to contact for:
- Questions about the study
- Technical problems
- Privacy concerns
- Withdrawal requests
- Complaints or concerns about participant rights
Usually, this includes the research team and an ethics review board, institutional review board, or data protection contact.
In short
Informed consent in digital research requires more than an “I agree” button. It requires a transparent, understandable, voluntary, and documented process that explains what the study is, what data will be collected, how it will be used and shared, what risks exist, and what rights participants have—including the ability to decline or withdraw where applicable.