INFORM CONSENT FORM AND ITS ELEMENTS



INTRODUCTION 

Each year, millions of people take part in clinical trials supported by the government and industries, Each volunteer has the right to know what truly happens during clinical research before deciding to participate. This is known as informed consent and this process helps to decide whether or not involved in a trial is good for you.

A freely written, study-specific informed consent is obtained from the patients prior to their enrolment as a subject in a clinical trial and the beginning of any trial-related procedures for the benefit of:

  • Rights of the patients 

  • Safety and well-being of the patients 

  • Interests of patients participating 


PURPOSE OF INFORMED CONSENT FORM

The goal of an informed consent form (ICF) is to provide participants with information related to clinical trials as well as to obtain a patient's signature for participation in trials

When a potential participant gives their informed permission, the clinical trial's purpose, their involvement in it, and how it will be conducted are all explained to them.

ELEMENTS OF INFORMED CONSENT FORM (ICF)

The features listed below should be present in ICF in order to comply with regulatory requirements

This study outlines its methodology and goal.

  • 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.


REFERENCE

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


Student Name: Afrah Ahmed 

Student ID: CSRPL_STD_IND_HYD_ONL/CLS_015/012033

Qualification: Pharm D (V Year)

e-Mail ID: afrahahmed418@gmail.com



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