What is Informed Consent?
• Definition: The process by which a participant
voluntarily agrees to participate in a clinical
trial after being fully informed about the
nature, risks, benefits, and rights.
• Legal and Ethical Requirement: Ensures
participants understand the trial’s purpose,
procedures, and their right to withdraw at any
time without penalty.
Importance of ICF
• Protects Participant Rights: Ethical trials avoid
coercion.
• Promotes Transparency: Fosters trust and
clarity.
• Ensures Ethical Conduct: Prevents unethical
trials.
• Compliance with Regulations: Required by
global regulatory bodies (e.g., GCP, FDA, EMA).
Key Components of Informed Consent
• Study Title: Clear and concise title of the trial.
• Study Purpose: Objective of the trial.
• Inclusion Criteria: Eligibility requirements for
participants.
• Study Procedures: Description of procedures, visits,
and tests.
• Risks and Benefits: Explanation of potential risks and
benefits.
• Confidentiality: How personal data will be handled.
• Right to Withdraw: Emphasizing the voluntary nature
of participation.
Informed Consent Process
• Step 1: Information Disclosure: Providing written and
verbal information.
• Step 2: Discussion: Answering participant questions.
• Step 3: Obtaining Consent: Participant signs and dates
the consent form, doctor sings and puts date on the
form. 2 originals are signed and dated. One copy
belongs to the patient, another is stored with patients
records.
• Step 4: Documentation: Ensuring consent form is
stored securely and process is described in patient’s
record.
Explanation of the Trial
• What the trial is about: The study’s
objective and methodology.
• How participants will be Involved:
– Description of treatments, visits, and tests.
Study Design Overview
• Randomized Control Trials : Random
assignment to study arms.
• Blinded Studies: Single-blind, double-blind.
• Observational Studies: Observing without
intervention.
• Clinical Trial Phases: Phase 1-4 (safety,
efficacy, post-marketing surveillance).
Potential Risks and Benefits
• Risks: Clearly describe potential side effects or
harm.
• Benefits: Discuss the potential advantages,
but clarify there is no guarantee.
• Risk-Benefit Ratio
Use of non-technical language
Participant Rights
• Right to Withdraw: Participants can leave the
study at any time, with no penalty.
• Confidentiality: Personal data will be kept
confidential unless legally required to disclose.
• Voluntary Participation: No coercion, and
participants must be fully informed before
giving consent.
Challenges in Informed Consent- Vulnerable
Populations
• Elderly: Cognitive impairment, sensory
limitations. Solution: Simplified forms, family
involvement, visual aids
• Children: Need both assent and parental consent.
• Low Literacy: Participants with limited reading
comprehension. Solution: Oral explanations,
video recordings.
• Non-native Speakers: Language barriers.
Solution: Translated forms and access to
interpreters.
The Role of Investigators in Informed Consent
• Ensuring Understanding:
– Investigators must confirm that participants
understand the consent form.
• Open Communication:
– Investigators should be available to answer any
questions or concerns.
Impact of Informed Consent on Study Results
Clear informed consent increases the likelihood
of participant retention and compliance with
trial protocols.
Importance of Continuous Informed Consent
• Ongoing Process:
– Consent isn’t just obtained at the start, but should
be readdressed if trial conditions change.
