- Informed Consent Form
Every year, a number of clinical trials are conducted in the field of healthcare, and needless to say, these trials need a good number of volunteers who are required to participate and allow the testing of a new treatment in their body. Prior to the agreement to participate in a trial, the volunteers must understand what they are going to do in the trial process. They must converse with concerned people in detail about each and every aspect of the trial and then they should decide whether to participate in the trial or not. Here comes the concept of INFORMED CONSENT(IC).
Definition
“An informed consent is 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 subjects’ decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form (ICF)’’
The informed consent process is all about the protection and respect for the research subjects. Informed consent is a precondition for the volunteer’s participation in the trial. It must be done before enrolling any participant in any type of trial which involves human subjects. The aim of the informed consent process is to provide sufficient information to the interested volunteers which enables them to make conscious decisions on whether to participate or not to participate in trial/study or to continue participation in the trial/study.
Purpose of Informed Consent
- Maintaining and respecting subjects will.
- Explaining individual’s rights of participation in the trial.
- Voluntarily decision making about participation in the trial.
- Keeping informed the human subjects about aim, procedure, risk, benefits, and other various aspects of the trial.
Importance of Informed Consent
- Helps participant to decide whether its worth to participate in the trial or not.
- Helps to protect the participants from any expected risks.
- Helps to ensure that participation in the trial will not violate the participant’s values and rights.
- Helpful to understand if interested participants are able to meet the requirements required for particular research.