Informed consent
Informed consent definition : A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject’s decision to participate.
Informed consent is documented by means of a written, signed and dated informed consent
form.
The goal of the informed consent process is to provide people with sufficient information so
that they can make informed choices about whether to begin or continue participation in
clinical research.
In the context of clinical trials, autonomy, beneficence, and justice are foundational ethical
principles that guide the conduct of research involving human participants. These principles
are part of the Belmont Report, which provides a framework for ethical research practices
Autonomy refers to the right of individuals to make informed and voluntary decisions
about their participation in a clinical trial without coercion or undue influence.
Beneficence involves the obligation to maximize potential benefits and minimize
potential harms to participants in a clinical trial.
Justice refers to the ethical obligation to treat all participants fairly and equitably,
ensuring that the benefits and burdens of research are distributed fairly.
Informed consent guidelines:
1. ICMR (Indian Council of Medical Research) “Ethical Guidelines for Biomedical
Research on Human Subjects” Published in 2000 and revised in 2006
2. 2. ICH ICH Guidelines E6 section 4.8 under GLP (Good Clinical Practices)
The Process and procedure of Consent
Steps in the Informed Consent Process:
1. Initial Contact:
Establish rapport with the potential participant or patient.
Provide initial information about the study or procedure to gauge interest.
2. Detailed Information Session:
Conduct a thorough discussion about the study or procedure.
Use written consent forms that outline all necessary information in detail.
Answer any questions the individual may have to ensure understanding.
3. Assessment of Understanding:
Assess the individual's comprehension of the information provided.
This can be done through open-ended questions or by asking the individual
to explain the information in their own words.
4. Decision Making:
Allow the individual ample time to consider the information and discuss it
with family, friends, or advisors if they wish.
Respect the individual's decision, whether they choose to consent or decline.
5. Documentation:
Obtain written consent using a form that the individual signs. This form
should be dated and include a statement confirming that the individual has
received and understood all the information.
Provide a copy of the signed consent form to the individual for their records.
Key Components of Informed Consent:
1. Disclosure:
Information Provision: Comprehensive information must be provided to the
participant or patient. This includes the purpose of the procedure or study, its duration,
required procedures, potential risks, benefits, and any alternatives.
Comprehensibility: Information should be presented in a language and manner that
is understandable to the individual. Avoiding medical jargon and using plain language is
essential.
2. Capacity:
Competence: The individual must have the capacity to understand the
information provided and make an informed decision. This includes assessing the individual's
mental status and cognitive ability.
Assistance: If the individual lacks capacity, a legally authorized representative
(such as a guardian or power of attorney) may provide consent on their behalf
3. Voluntariness:
Free from Coercion: The decision to consent must be made freely without
any form of coercion, undue influence, or pressure. Participants should feel comfortable
making their decision without fearing negative consequences.
Right to Withdraw: Individuals must be informed that they have the right to
withdraw their consent at any time without any penalty or loss of benefits to which they are
otherwise entitled.
How does informed consent apply to children?
1. Children do not have the decision-making capacity to provide informed consent.
2. Since Therefore, parents or other surrogate decision-makers may give informed
permission for diagnosis and treatment of a child, preferably with the assent of the child
whenever possible.
3. Other disagreements in care may result in court orders that specify what treatment should
occur (for example, blood transfusions), or in the court-ordered appointment of a guardian to
make medical decisions for the child.
Inform consent in pregnant women
Researchers should obtain informed consent from both the pregnant woman and the father
Consent of the father is not necessary if
1. The purpose of the study is to meet the health needs of the mother.
2. The identity or where about of the father can not be reasonably as curtained
Informed consent in illiterate person
An investigator may enroll individuals, who can speak and understand English, The potential
subject must be able to place a written mark on the consent form. After that the subject must
also be able to:
1. Comprehend the concepts of the study and understand the risks and benefits of the study as
it is explained verbally, and
2. Be able to indicate approval or disapproval for study enrollment.
