INFORMED CONSENT FORM (ICF) AND ITS ELEMENTS

Introduction

The concept of informed consent stands as a pivotal pillar in the fields of medical research, healthcare, and ethical practice. At its core, informed consent emphasizes the significance of individual autonomy, the right to be fully informed, and the ability to make informed decisions about one's own health and participation. Millions of volunteers participate in government and industry-sponsored clinical trials every year. Central to this principle is the "Informed Consent Form," a document that embodies transparency, communication, and the protection of human rights. This form serves as a tangible embodiment of the ongoing process of informed consent, bridging the gap between complex medical information and the understanding of the individual. 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 following:

• The Participants' Rights

• Participant's safety and well-being

• Participants' interests

Definition

• An informed consent form is a procedure by which a subject voluntarily confirms his or her willingness to participate in a specific trial after having been informed of all trial-related information that is important to the subject's decision to participate in a specific clinical trial, according to the definition provided by the ICH GCP.

• An informed consent form that has been written down, signed, and dated is used to record informed consent.

• In other words, informed consent is the process by which the health care professional informs the patient about the many components of the trial, such as the goal, advantages, potential risks, alternative offers given the procedure, etc.

• After receiving the necessary information, those who are interested willingly consent to take part in the research study and complete the informed consent form.

• The process of informed consent is essential for all clinical trials.

• In a clinical experiment, obtaining informed permission is both ethically and legally required.

• A communication procedure is required for informed consent:

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

Importance of ICF

• Understand the nature of research.

• Every patient has the right to get all the relevant information and ask questions before receiving any treatment.

• Through this process, volunteers will get all the required information about the trial related to purpose, risks and benefits, and alternative therapies.

• Decide whether or not to participate voluntarily.

• Proper informed consent also provides freedom to potential subjects to say no without feeling guilty or fearing repercussions.

Elements of the informed consent form (ICF)

Part 50.25 of the 21 CFR provides the components of informed consent. It includes the basic elements which must be present in the informed consent and additional elements which have to be provided when appropriate.

In order to meet regulatory standards, ICF must have the properties stated below

The purpose and methodology of this investigation are outlined

• Participation time and approximately how many subjects were there 

• Description of the steps that will be taken during the participant's enrolment

• Clinical trial experimental techniques that will be carried out

• Description of any potential dangers or discomforts associated with the trial

• Any outcome that would be advantageous to the participants

• Alternative methods or therapies that could benefit the participant

• Participants' obligations

• Confidentiality of records and personal information to what extent proceeded

• Compensation and medical care in the event of injury

• Observation that participation is optional

• Participants may be able to refuse treatment or withdraw without losing any of their rights to benefits

• Any additional expenses the participant will incur

• Predicted events or reasons a participant could decide to stop participating in the study

• Procedures for termination

• Premature ending

• Signatures with date

Conclusion

• In a clinical trial, both the aspects that is the timing to obtain informed consent and how perfectly it is done are very crucial.

• The elements within an Informed Consent Form play a vital role in ensuring that individuals are respected as active participants in their own healthcare and decision-making processes.

• The investigator or study coordinator is generally responsible for obtaining informed consent forms from the study subjects.

• The informed consent process basically involves of disclosure of information by health care providers to the patients, adequate comprehension by the patients, and the voluntary decision to participate in the trial by the patients

References

1. https://www.unigoa.ac.in/uploads/confg_docs/20201229.073758~ICMR_2017_INFORMED_CONSENT_PROCESS.pdf 

2. https://research.virginia.edu/irb-hsr/elements-consent-form 

3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=50.25 

4. https://research.uoregon.edu/manage/research-integrity-compliance/human-subjects-research/informed-consent 

Student Name: Sk Mohin

Student ID: 153/082023

Qualification: M. Pharmacy

e-Mail ID: skmohin67@gmail.com