✅ INFORMED CONSENT PROCESS (ICP)

📘 Definition (ICH-GCP Based)

The informed consent process is a continuous, interactive process by which a subject voluntarily confirms willingness to participate in a clinical study after being fully informed of all aspects of the trial that are relevant to the decision to participate.

➡️ It is documented by a written, signed, and dated Informed Consent Form (ICF).

📗 Introduction – Key Concepts

Informed consent is not just signing a form, it is about:

✔️ Understanding the study
✔️ Voluntary decision-making
✔️ Ongoing communication

Important points:

The consent document is essential, but discussion with a knowledgeable research team member is equally important.
Investigators must educate, not merely disclose information.
Subjects should be allowed to ask questions at any time — before, during, and after the trial.
Therefore, informed consent is an ongoing interactive process, not a one-time event.

📙 Objectives of Informed Consent

To protect the rights, safety, and well-being of subjects
To ensure voluntary participation
To promote ethical and transparent research
To support autonomous decision-making

📕 Essential Steps in the Informed Consent Process

🔹 1. Obtaining informed consent from every subject

Mandatory in all clinical studies
No subject can be enrolled without consent (except approved emergency exceptions).

🔹 2. Consent must be obtained before trial participation

Before:

Screening procedures
Sample collection
Any trial-related activity

🔹 3. Subject must sign the consent form

Consent must be:

Written
Signed
Personally dated

Confirms voluntary agreement.

🔹 4. Legally Acceptable Representative (LAR)

If the subject:

Cannot write
Cannot understand
Is from a vulnerable population (e.g., children, cognitively impaired, unconscious)

➡️ Then consent must be taken from the Legally Acceptable Representative (LAR).

Examples:

Parent / guardian (children)
Court-appointed guardian
Authorized caregiver (as per law)

🔹 5. Investigator’s responsibilities

The person obtaining consent must:

Be qualified and trained
Clearly explain:

Purpose of the study
Procedures
Risks and benefits
Alternatives
Confidentiality
Compensation and injury policy
Right to withdraw

The following must sign and personally date the consent form:

✔️ Study subject / LAR
✔️ Investigator (or authorized designee)
✔️ Impartial witness (if applicable)

🔹 6. Role of Impartial Witness

Required when:

Subject/LAR cannot read
Subject is illiterate

The impartial witness must:

Be independent of the study
Be present during the entire consent discussion
Ensure there is no coercion or undue influence

The relationship of the witness to:

Subject
[1]Investigator
Study
➡️ must be documented

📒 Witness Attestation

After:

Information is read and explained
Subject/LAR gives oral consent
Subject/LAR signs the ICF

➡️ The witness must sign and date the form.

By signing, the witness confirms that:

Information was accurately explained
It was apparently understood
Consent was freely given

📓 Key Features of a Proper Informed Consent Process

🔁 Ongoing, not one-time
🗣️ Two-way communication
🧠 Focus on understanding
🚫 Free from force, pressure, or manipulation
📄 Properly documented

📔 Simple Flow

Identify eligible subject
Provide Participant Information Sheet
Explain study in understandable language
Allow time for questions
Confirm understanding
Obtain voluntary agreement
Signatures & dates
Give copy to subject
Continue consent discussions throughout study

🎯 Exam-Oriented Points

Informed consent = process + document
Must be obtained before any trial procedure
Must be voluntary, informed, documented
LAR signs when subject is incapable
Impartial witness required for illiterate subjects
Investigator must be qualified
ICP is an ongoing ethical obligation

🧾 One-Line Summary for Students

“Informed consent is a continuous ethical and legal process that ensures a subject’s voluntary participation in research after fully understanding all relevant aspects of the study.”

✅ Steps in Obtaining the Informed Consent

Obtaining informed consent is a systematic, ethical, and documented process. It must ensure that the subject understands the study and participates voluntarily, without any pressure.

🧭 Step-by-Step Informed Consent Procedure

🔹 1. IRB / IEC Approval

Obtain prior approval of the informed consent document from the Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
Only the approved version of the consent form may be used.
Any modification requires re-approval before use.

➡️ No consent process is valid without ethics committee approval.

🔹 2. Provide the Consent Document

Present the Participant Information Sheet / Informed Consent Form (ICF) to the prospective subject.
Language must be:

Simple
Non-technical
Understandable to the subject.

🔹 3. Explain the Study Clearly

The investigator (or authorized trained person) must explain:

Purpose of the research
Study procedures
Duration of participation
Responsibilities of the subject

Information must be given in a neutral, non-coercive manner.

🔹 4. Encourage Questions and Discussion

The subject must be prompted to ask questions.

Mandatory discussion includes:

✔️ Risks and discomforts
✔️ Expected benefits
✔️ Alternative treatments or procedures
✔️ Confidentiality
✔️ Compensation and injury management
✔️ Right to refuse or withdraw at any time

➡️ All questions must be answered honestly and completely.

🔹 5. Provide a Copy of the Consent Form

Give the subject a copy of the consent document.
Allow them to read it fully at their own pace.

🔹 6. Allow Adequate Decision-Making Time

Subject must be given enough time to:

Think
Discuss with family/friends
Consult their physician if desired

➡️ No rushing, no pressure, no inducement.

🔹 7. Assess Understanding

At a follow-up meeting, the investigator should ask open-ended questions, such as:

“Can you explain what this study is about?”
“What are the possible risks?”
“What are your rights if you join this study?”

This step confirms that the subject has correctly understood:

Nature of the study
Procedures
Risks and benefits
Voluntary nature of participation

🔹 8. Obtain Voluntary Signature

If the subject:

Demonstrates adequate understanding
Freely agrees to participate

➡️ The subject signs and personally dates the informed consent form.

Also required (as applicable):

Investigator’s signature
Legally acceptable representative
Impartial witness (if subject is illiterate)

A signed copy must be given to the subject.

🔁 Important Emphasis

Informed consent is a process, not an event.
Understanding is more important than documentation.
Consent must be re-confirmed when:

New risks emerge
Protocol changes occur
Long-term studies continue.

🧠 Flowchart for Students

IRB Approval
⬇️
Provide ICF
⬇️
Explain study
⬇️
Encourage questions
⬇️
Give copy of ICF
⬇️
Allow decision time
⬇️
Assess understanding
⬇️
Voluntary signature
⬇️
Continuous consent process

🎯 Exam-Oriented Key Points

Ethics committee approval is mandatory before consent
Risks, benefits, and alternatives must always be explained
Adequate time must be given for decision-making
Understanding must be assessed using open-ended questions
Consent must be voluntary, informed, and documented

📝 One-Line Summary for Blog/Notes

“Obtaining informed consent involves ethics approval, clear explanation, opportunity for questions, assessment of understanding, and voluntary documentation, ensuring ethical participation in clinical research.”

✅ SPECIAL CONSIDERATIONS IN INFORMED CONSENT

Certain populations require additional ethical protections because they may have limited ability to understand or decide independently. The most important among them are:

Children
Incompetent individuals

🧒 INFORMED CONSENT IN CHILDREN (PEDIATRIC SUBJECTS)

Children are considered a vulnerable population because they usually cannot legally provide valid informed consent.

🔹 Key Ethical Principles

When children are involved in research:

The study must be ethically justified
Specific benefits of participation must be clearly explained
Possible discomforts and risks must be honestly described
The child’s welfare always takes priority over research goals

🔹 Parental Permission

Parental/guardian consent is mandatory for all research involving children.
Depending on the risk level, consent is required from:

✔️ One parent is sufficient when:

The study involves minimal risk, or
The study offers a direct potential benefit to the child.

✔️ Both parents are required when:

The study involves more than minimal risk,
And no direct benefit is expected for the child.

🔹 Child’s Assent

In addition to parental consent, the child’s assent must be obtained whenever the child is capable of understanding.

🔸 What is assent?

Assent means the child affirmatively agrees to participate in the research.

It is:

Not legally binding consent
But an ethical requirement

🔹 Age and Understanding

Typically, children above 7 years of age are considered capable of giving assent.
Assent should be obtained using a separate, age-appropriate assent form.
The explanation must be:

Simple
Non-threatening
Suitable for the child’s level of understanding.

🔹 Important Teaching Point

Even if parents consent, a child’s objection should be respected, unless the study offers a life-saving or essential therapeutic benefit.

🧠 INFORMED CONSENT IN INCOMPETENT INDIVIDUALS

This group includes people who cannot adequately understand or communicate decisions, such as:

Individuals with severe mental disability
Patients with advanced dementia
Unconscious or delirious patients
Elderly persons with major sensory or cognitive impairment

🔹 Use of a Proxy / Legally Acceptable Representative (LAR)

When a subject is incompetent:

➡️ Consent must be obtained from a Legally Acceptable Representative (proxy).

Examples:

Court-appointed guardian
Legal caregiver
Authorized family member (as per law)

🔹 Responsibilities of the Proxy

The proxy must:

· Act in the best interest of the subject

· Discuss the decision with:

Family members
Treating physicians
Caregivers

· Ensure that the decision reflects what the subject would have chosen if competent (substituted judgment principle).

🔹 Investigator’s Ethical Duties

The investigator must ensure that:

The research is necessary for this population
Risks are minimized
Rights and dignity are fully protected
The subject is involved as much as possible in the discussion, even if full consent cannot be given.

📌 Quick Comparison Table (For Teaching & Blog)

Aspect	Children	Incompetent Individuals
Parental/LAR consent	Mandatory	Mandatory
Assent	Required when capable (>7 yrs)	Seek subject’s opinion if possible
Risk protection	Very strict	Very strict
Ethical basis	Best interest + developing autonomy	Best interest + substituted judgment

🎯 Exam-Oriented Key Points

Children and incompetent persons are vulnerable populations
Parental consent is compulsory for children
Assent is an ethical requirement, not legal consent
Both parents are required when risk > minimal without benefit
In incompetent subjects, consent must be taken from a legally acceptable representative
Decisions must reflect what the subject would choose if competent

📝 One-Line Summary

“Special populations such as children and incompetent individuals require enhanced informed consent procedures involving parental or proxy permission, along with assent whenever possible, to ensure ethical and lawful participation in research.”

✅ INFORMED CONSENT IN EMERGENCY SITUATIONS

Emergency situations present unique ethical challenges because the subject’s life may be at immediate risk, and there may be no time or ability to obtain standard informed consent.

Most clinical research regulations (ICH-GCP, national drug rules, and ethics guidelines) therefore allow a limited emergency exception to informed consent — under strictly controlled conditions.

📌 What is Emergency Use?

Emergency use refers to the use of an investigational product in a life-threatening situation where:

Immediate intervention is required
The subject is unable to give consent
A legally acceptable representative (LAR) is not available in time

🧭 Core Ethical Principle

Even in emergencies, the guiding principles remain:

Protection of life
Respect for human rights
Independent medical judgment
Strict documentation and review

Emergency use is an exception, not a routine practice.

📝 Regulatory Requirements Before Emergency Use

If an investigator determines that there is not enough time to obtain informed consent from the subject or LAR, the following steps are mandatory:

🔹 1. Independent Medical Review

The investigator’s decision must be reviewed by another physician
This physician must be:

Qualified
Independent
Not part of the clinical study team

➡️ This protects against bias and misuse.

🔹 2. Written Certification Must Be Obtained

Before using the investigational product, the investigator must document written certification confirming all of the following:

✔️ (1) Life-threatening situation

The subject is facing a life-threatening or severely debilitating condition requiring immediate intervention.

✔️ (2) Inability to obtain subject consent

The subject is unable to communicate
Or is unconscious/incapacitated

Therefore, informed consent cannot be obtained directly.

✔️ (3) Insufficient time to obtain LAR consent

There is not enough time to locate and obtain consent from the legally acceptable representative before treatment must begin.

✔️ (4) No satisfactory alternative therapy

There is no generally accepted standard therapy that offers an equal or greater likelihood of saving the subject’s life.

🔁 After the Emergency Intervention

As soon as possible:

Inform the subject (if recovered)
Or inform the legally acceptable representative
Obtain formal informed consent for:

Continuation in the study
Use of collected data

Report the emergency use to:

Ethics Committee / IRB
Sponsor (as required)

⚠️ Important Points

Emergency consent waiver is temporary and situation-specific
It does not remove the need for consent, it only delays it
Independent physician review is mandatory
Full documentation is legally critical
Ethics committee oversight must follow

🧠 Simple Flow (For Students)

Life-threatening emergency
⬇️
No time + subject incapacitated
⬇️
Independent physician review
⬇️
Written certification (4 conditions)
⬇️
Emergency use of investigational product
⬇️
Inform subject/LAR ASAP
⬇️
Obtain formal consent + notify IRB

🎯 Exam-Oriented Key Points

Emergency use is allowed only in life-threatening situations
Independent physician confirmation is required
Four written certifications are mandatory
No equally effective standard therapy must exist
Post-emergency consent and ethics reporting are compulsory

📝 One-Line Summary for Notes/Blog

“In emergency situations where life is threatened and consent cannot be obtained, investigational products may be used only after independent medical review, strict written certification, and subsequent ethics committee reporting.”

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Tuesday, January 20, 2026