Informed consent is a process in which a patient or research participant is provided with information about a medical procedure or research study, including its risks and benefits, in order to make an informed decision about whether or not to participate. The informed consent process is a critical component of ethical medical practice and research and is intended to protect the rights and welfare of patients and research participants. Here are some key elements of the informed consent process: Information: The patient or research participant must be provided with information about the medical procedure or research study, including its purpose, procedures, risks, benefits, and alternatives. Capacity: The patient or research participant must have the capacity to understand the information provided and make a decision based on that understanding. Voluntariness: The decision to participate must be made voluntarily, without coercion or undue influence. Documentation: The informed consent process must be documented in writing, including the information provided, the decision made, and any questions or concerns raised by the patient or research participant. Ongoing consent: Informed consent is an ongoing process and must be re-evaluated if there are changes to the procedure or study, or if new information becomes available. Consent for minors: In the case of minors, informed consent must be obtained from a legal guardian or parent. The informed consent process is a fundamental aspect of ethical medical practice and research. It ensures that patients and research participants are fully informed about the procedures and risks involved and that they have the opportunity to make an informed decision about whether or not to participate.

1. Welcome
INFORMED CONSENT FORM
K.Sravanthi,
Pharm D intern,
Student ID:052/032023.
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2. INDEX
Introduction
Definition
Process of ICF
Elements of ICF
Assent
E-consent
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Introduction
 Every year millions of volunteers participate in government and industry-sponsored clinical trials each
year.
 Before agreeing to participate every volunteer has the right to know and understand what happens
during clinical trials.
 This is called informed consent, and this process can help you whether or not to participate in the trial.
 Before the enrollment of a patient in a clinical trial and beginning of any trail-related procedures,
voluntary written, study-specific informed consent is obtained from the participants for the protection of
the:
• Rights of the participants
• Safety and well-being of the participants
• Interests of the participants

4. 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. Informed consent is a communication process:
1. Between researcher and participant
2. Starts before the research is initiated
3. Provides all relevant information to the volunteer
4. The volunteer understands the information provided voluntarily and agrees to participate in the study.
5. A basic right
Purpose of informed consent form:
1. Understand the nature of research.
2. Be informed of Purpose, risks and benefits, and alternative therapies.
3. Make a voluntary decision about participation.
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5. Process of Informed consent form:
Information provision and sharing by the research team
Discussion and interaction between researchers
and potential participants
True understanding
Acceptance or rejection
of participation
Agreement to participate End of contract
(Written, verbal , witnessed, or recorded)
Follow-up
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Both the informed consent discussion and the written informed consent form and any other written
information to be provided to subjects should include explanations of the following:
(a) That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random assignment to each treatment.
(d) The trial procedures to be followed, including all invasive procedures.
(e) The subject's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an
embryo, fetus, or nursing infant.
(h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the
subject should be made aware of this.

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(i).The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their
important potential benefits and risks.
(j) The compensation and/or treatment available to the subject in the event of trial related injury.
(k) The anticipated prorated payment, if any, to the subject for participating in the trial.
(l) The anticipated expenses, if any, to the subject for participating in the trial
(m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise
entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct
access to the subject's original medical records for verification of clinical trial procedures and/or data,
without violating the confidentiality of the subject, to the extent permitted by the applicable laws and
regulations and that, by signing a written informed consent form, the subject or the subject's legally
acceptable representative is authorizing such access.

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(o) That records identifying the subject will be kept confidential and, to the extent permitted by the
applicable laws and/or regulations, will not be made publicly available. If the results of the trial are
published, the subject’s identity will remain confidential.
(p) That the subject or the subject's legally acceptable representative will be informed in a timely
manner if information becomes available that may be relevant to the subject's willingness to continue
participation in the trial.
(q) The person(s) to contact for further information regarding the trial and the rights of trial subjects,
and whom to contact in the event of trial-related injury.
(r) The foreseeable circumstances and/or reasons under which the subject's participation in the trial
may be terminated.
(s) The expected duration of the subject's participation in the trial.
(t) The approximate number of subjects involved in the trial.

9. 1. Protocol number or name of study
2. Purpose of study
3. Duration of study and subject involvement
4. A statement that the protocol, and the informed
consent were reviewed with the participant,
including the risks and benefits of the study.
5. Alternative treatment options
6. Confidentiality record
7. No. Of subjects Compensation for injury
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8. Time for questions to be asked and answered
9. Description of the participants decision
10. Contact details
11. Travel reimbursement
12. Subject responsibilities
13. Subject satisfaction
14. Use understandable language
15. Copy of consent given to the subject
16. Sign copy of ICF
ELEMENTS OF ICF

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ASSENT:
A child’s affirmative agreement to be a research participant. Mere failure to object should not,
absent affirmative agreement, be constructed as assent.
 Children don’t have the decision–making capacity to provide informed consent.
 Since Therefore, parents or other surrogate decision-makers may give informed permission for
diagnosis and treatment of a child, preferably without the assent of a child whenever possible.
 Depending on the type of research, the IRB may make provisions for the assent of children.
Electronic consent form:
 Electronic consent is a system that obtains informed consent from a research subject or their
legally authorized representative(LAR) using electronic-based processes and systems.
 The information is presented via computers, tablets, websites, and smartphones rather than on
paper.

11. Key features of E-consent forms and systems
include:
 Ability to access the forms from nearly anywhere at any
time
 Customizable forms that can include hyperlinks, videos,
spoken text, and games to help give patients a clear
understanding of the study protocol.
 Remote monitoring
 Standardized procedures that may decrease the need for
staff training across multiple sites.
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12. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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