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
Comments