- Informed Consent is one of the most important elements of system ensuring the ethics of medical experiment & protection of rights of study subjects.
- Informed Consent is the process by which subject voluntary confirms his/her willingness to participate in one or another clinical trials, after having been informed of all aspects of study.
- Informed consent should be documented by means of written, signed & dated informed consent forms (ICFs).
MAIN PRINCIPLES OF INFORMED CONSENT
The Subject should be informed of the following: –
- Purpose of trial.
- Method of trial.
- Study Drugs & treatment regimens.
- Available alternative treatments.
- Potential risk and benefits & possible discomforts.
The Subject should understand that: –
- Informed consent should be given freely.
- Consent should not be obtained through inducement or coercion.
- He/she may withdrawal from study at any time.
- Withdrawal from study will not affect his/her future medical care.
As Per New Drugs& Clinical Trial Rule (NDCT Rule) 2019
In all trials, a freely given, informed, written consent is required to be obtained from each study subject.
Investigator must provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical & understandable by study subjects.
Informed Consent Form & Patient Information Sheet must be approved by IEC/IRB & furnished by Central Licensing Authority (CLA).
Any Changes in Informed Consent documents should be approved by IEC/IRB & submitted to CLA before such changes are implemented.
Unconscious person/ Minor / Severe mental illness/ disability – Informed consent obtained from legally acceptable representative (LAR).
If LAR is unable to read and write an impartial witness should be present who must append his/her signature to ICF.
Paediatrics – Subject are legally unable to provide written ICF & are dependent on their parents / legal guardians to assume responsibility for their participation in clinical studies.
- Written IC should be obtained from the parent/legal guardian.
- Mature minor and adolescents should personally sign and date a separately designed written assent form.
Vulnerable Subjects – An Audio- Video recording of informed consent process.
Anti-HIV, Anti-leprosy Drugs Clinical Trials – Only Audio recording of Informed consent process of individual Subjects.