Informed_Consent flashcards

Informed Consent in Clinical Trials

Overview

• Course Title: MEDC0014

• Institution: UCL

• Date: 06-Mar-25

Learning Outcomes

• Understand the valid informed consent process according to current guidance and regulations.

• Understand issues surrounding informing patients and gaining consent.

Helsinki Principles

• 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.

Definition of Valid Informed Consent

• 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.

Aspects of Informed Consent

1. Competence: The person asking for consent must be competent.

2. Voluntariness: Consent must be given voluntarily.

3. Informed: Participants should have adequate information.

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

Consent Materials

• 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.

Valid Consent: Who Can Obtain It?

• Consent should be taken by:

  • A qualified physician or an appropriately qualified individual (Declaration of Helsinki, Fortaleza, Brazil, October 2013).

Characteristics of Bad Informed Consent

• 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.

Patient Information - Ethics Review

• 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.

Patient Information Needs

1. Age Considerations:

   • Different PIS versions for varied age groups, including specific formats for pediatric parents/guardians.

2. Knowledge Considerations:

   • Patients with recurrent diseases might better understand medical language. Prior knowledge assists in coping with the consent process.

3. 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.

Consent – Vulnerable Groups

1. Children:

   • Require parental/guardian consent alongside their assent.

2. Mentally Impaired Individuals:

   • Consent obtained by legal representatives with documented proof for understanding.

3. Language Barriers:

   • Ensure consent is translated accurately with independent interpreters available.

Motivation for Participation

• 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.

Participation Factors

• Demographics:

  • Gender, socioeconomic status, and educational attainment significantly influence volunteer rates and adherence to treatments.

Summary of Informed Consent

• 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.

Assessment

• Formative Assessment:

  • Unmarked assignment with multiple-choice and answer questions for student submission.