الموافقة المستنيرة في الأخلاقيات البحثية

Informed Consent

• Informed consent is a process, not just a signature.
• It's obtained before the study begins.
• The subject needs a copy of the consent form.
• The process continues throughout the study.

What is Informed Consent?

• A process where a participant voluntarily agrees to participate in research after understanding all relevant aspects.

Informed Consent in Ethical Guidelines

• Nuremberg code (1947): "The voluntary consent of the human subject is absolutely essential."
• Respect for human subjects (autonomy) is a fundamental ethical principle behind informed consent.
• Obtaining informed consent from capable individuals; extra safeguards for those with limited decision-making capacity.

Requirements of Informed Consent

• Competence: Adult (18 years or older), no mental retardation, no coma, no dementia.
• Voluntariness: No coercion, undue inducement, or exploitation.

Elements of Informed Consent

• Research, purpose, procedures (including experimental ones), expected duration.
• Potential risks and discomforts, and steps to mitigate them.
• Potential benefits to the subject(s) or others. (monetary compensation isn't a benefit.)
• Alternative procedures.
• Confidentiality of records.
• Contact information, including contacts for questions regarding the study and injuries resulting from the study.

Informed Consent Process

• Information provision.
• Comprehension assessment.
• Voluntariness assurance.

Types of Informed Consent

• Consent: For competent adults.
• Surrogate Consent: For children, minors, or those with limited capacity; needs parental/guardian permission (in accordance with applicable regulations, child verbal consent required for ages 7 - 12, child written consent required for ages 13-17).
• Assent: Child's agreement to participate in research.
• Verbal Consent: All written consent elements included, but consent is obtained verbally (e.g., phone surveys).
• Short Form: Primarily for language barriers; consent is translated into the subject's native language.

Special Situations

• Children: Process varies based on age.
• Pregnant women: Consent can be gained from the woman only, if the study aims to meet the mother's health needs, and the father is unavailable.
• Cognitive impairment: Consent is obtained from the legal guardian, where the person has such impairment.
• Non-English speakers: Get a translator, ensure language comprehension and submit the translated consent form.
• Illiterate/Blind: A witness should be present, information should be read aloud and thumbprints are sometimes used as a method of verification.

Readability

• Informed consent should be easily understood.
• The text should be simple, and understandable by someone in the 6th grade.
• Avoid medical jargon.
• Language must be translatable to the subject.

Conclusion

• Informed consent is a continuously ongoing process.
• The validity of the process depends on obtaining consent from the respective parties.