Informed Consent Process
Informed Consent process forms a mandatory step in clinical research in which a potential participant or a volunteer is provided with comprehensive information about the study purpose, benefits, risks, procedures and alternatives to a investigational treatment, in understandable manner and the participant agrees without undue coercion.
If the potential participant is incompetent to decide for themselves, is a minor or suffers from some cognitive impairment, such individuals are provided with LAR-Legally Authorized Representative, who is responsible for decision making on their behalf and therefore this person participates in process of informed consent.
The consent form agreement is documented and the process of informed consent continues throughout the trial as the participant is continuously informed about changes, implications and major outcomes of study which may affect their decision to continue participating in it or not.
The Informed consent should be- in a language that LAR or participant can comprehend, lacking in exculpatory language
Informed Consent should share information about-
risks and discomforts that maybe faced by participant, benefits, alternative treatments available, confidentiality protection, compensation and medical treatment that will be provided in event of injury, contacts of physicians or clinical researchers in order to answer participants concerns or questions regarding research, voluntary participation- the participants should be made aware of fact that they can withdraw from trial anytime without any penalty.
Informed consent process is not just the signature of a volunteer it is an essential complete process.
https://www.fda.gov/media/88915/download
This process helps in conduction of ethical clinical trials. Can you think of conditions in which the trial team might be provided with waiver from process of getting Informed Consent?
MBH/PS