Informed_Consent flashcards

Informed Consent in Clinical Trials

Understand the valid informed consent process according to current guidance and regulations.
Understand issues surrounding informing patients and gaining consent.

Principle No. 25: Participation must be voluntary.
- Consultation with family or community leaders is acceptable, but individuals must freely consent to participate in research.
Principle No. 26: Participants must be adequately informed.
- Key elements to disclose include: aims, methods, funding sources, conflicts of interest, institutional affiliations, anticipated benefits and risks, and any discomfort involved.
- Participants must be informed about their right to refuse to participate.
- Special attention to information delivery methods and ensuring understanding is essential.
- A qualified individual must seek written consent; if not possible, non-written consent must be documented and witnessed.
- Subjects should be informed about the general outcome of the study post-participation.

Defined as a process where a subject voluntarily confirms willingness to participate in a trial after being informed of all relevant aspects.
Documentation must include a signed and dated Informed Consent form as per ICH GCP E6.

Recommendation: At least 24 hours should elapse between providing the patient information sheet and signing the consent form.

Participant Information Sheet (PIS):
- Describes the clinical trial, enabling informed decisions and supporting conversations.
Informed Consent Form (ICF):
- Documents that the consent process has occurred, signed by both the participant and the individual obtaining consent.

Consent should be taken by:
- A qualified physician or an appropriately qualified individual (Declaration of Helsinki, Fortaleza, Brazil, October 2013).

Includes:
- Coercion or unreasonable incentives.
- Insufficient time to decide.
- Inadequate or incorrect information provided.
- Solely verbal consent or consent obtained by someone without the capacity to consent.
For consent to be valid, it must be given voluntarily, informed, and documented.

Typically includes feedback from a lay member regarding:
- Appropriateness of length and language.
- Clarity of purpose and explanation of jargon.
- Explanation of randomization and quantified risks.

Age Considerations:
- Different PIS versions for varied age groups, including specific formats for pediatric parents/guardians.
Knowledge Considerations:
- Patients with recurrent diseases might better understand medical language. Prior knowledge assists in coping with the consent process.
Alternative Formats:
- Use of visuals and alternative media (videos, audio) to cater to diverse needs and enhance understanding.
- Engagement of Patient and Public Involvement and Engagement (PPIE) methodologies.

Children:
- Require parental/guardian consent alongside their assent.
Mentally Impaired Individuals:
- Consent obtained by legal representatives with documented proof for understanding.
Language Barriers:
- Ensure consent is translated accurately with independent interpreters available.

Reasons patients participate:
- Self-interested optimism, altruism, desire to please doctors.
Reasons patients decline:
- Lack of invitation, fears about being a 'guinea pig', practical barriers, and concerns regarding randomization.

Demographics:
- Gender, socioeconomic status, and educational attainment significantly influence volunteer rates and adherence to treatments.

Must be delivered by authorized professionals with appropriate training.
Ensure that patients and guardians are fully informed, recognizing that delivering information does not ensure understanding.
Consider cultural norms when adapting information regarding consent.

Formative Assessment:
- Unmarked assignment with multiple-choice and answer questions for student submission.