Informed consent

Informed consent

Informed consent is a foundational ethical and legal requirement in clinical trials. It ensures that participants voluntarily agree to take part in a study after being fully informed of its purpose, procedures, risks, benefits, and alternatives. This process upholds individual autonomy and supports ethically sound research.

Purpose of Informed Consent

The goal of informed consent is to:

• Protect the rights, safety, and well-being of participants
• Promote transparency and trust in the research process
• Ensure participants make voluntary and informed decisions

Informed consent is not merely a signed document—it is a continuous, interactive process between researchers and participants.

Key Components of Informed Consent

According to international ethical guidelines (e.g., Declaration of Helsinki, CIOMS, ICH-GCP), a valid informed consent process must include:

Purpose of the Study

• Why the trial is being conducted
• Whether it is investigational or therapeutic

Procedures

• What participation involves (e.g., tests, treatments, follow-up)
• Duration of participation

Risks and Discomforts

• Known and potential risks
• Side effects of interventions

Benefits

• Expected personal and societal benefits
• Clarification that benefits are not guaranteed

Alternatives to Participation

• Other available treatments or care options

Voluntary Participation

• Emphasis on the right to decline or withdraw at any time
• Assurance that medical care will not be affected

Confidentiality

• How data will be stored, shared, and protected

Compensation and Costs

• Details of reimbursements or expenses covered
• Availability of compensation for trial-related injury

Contact Information

• For questions about the study, rights, or harms

Special Considerations

Vulnerable Populations

Additional protections are required for:

• Children or minors
• Individuals with cognitive impairment
• Prisoners or institutionalized persons
• Economically or educationally disadvantaged populations

Language and Comprehension

• Consent forms must be written in plain, non-technical language
• Translations should be available in local languages
• Researchers must assess comprehension through verbal discussions or comprehension checks

Ongoing Consent

Informed consent should be revisited if:

• New risks are identified
• Protocol changes significantly affect participants
• There is long-term follow-up or re-consent is required for data sharing

Digital and Remote Consent

Electronic informed consent (eConsent) is increasingly used, especially in decentralized trials. It may include:

• Interactive multimedia presentations
• Online comprehension quizzes
• Electronic signatures

eConsent must still meet the same ethical and legal standards as traditional consent.

Documentation and Review

• Consent forms must be reviewed and approved by an ethics committee or institutional review board (IRB)
• A signed and dated Informed Consent Form (ICF) should be obtained before any trial-specific procedures
• A copy of the signed form must be provided to the participant

'See also:' Clinical Trials Ontario Consent Form Templates

Integration with Trial Conduct

Informed consent affects:

• Recruitment and retention strategies
• Compliance with Good Clinical Practice (GCP)
• Data validity, as participation without proper consent may invalidate findings

Conclusion

Informed consent is more than a regulatory checkbox—it is an ethical commitment to transparency, respect, and participant autonomy. Properly implemented, it builds trust, enhances participant engagement, and strengthens the integrity of clinical research.

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Bibliography

1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 8th ed. Oxford University Press; 2019. Chapter 4: Respect for Autonomy and Informed Consent.
2. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292(13):1593–1601.
3. Kass NE, Chaisson L, Taylor HA, Lohse J. Length and complexity of US and international HIV consent forms from federal HIV network trials. Journal of General Internal Medicine. 2011;26(11):1324–1328.
4. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-Related Research Involving Humans. CIOMS; 2016. Available from: https://cioms.ch
5. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. WMA; 2013. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

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Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.