Before you take part in any clinical trial at KG Hospital, you will be given clear information, time to ask questions and the freedom to decide. Consent is your choice — and it continues throughout the study.
These principles guide every consent discussion at our Clinical Research Centre — from the first conversation, through signing, to the last study visit.
Participation is voluntary, without coercion or undue influence.
Purpose, procedures, risks, benefits and alternatives are explained.
Information is provided in a language understandable to the participant.
Adequate time is given for questions and clarification.
The investigator ensures the participant has understood.
Only EC-approved ICF and PIS are used.
Consent is obtained before any study-specific procedures.
Consent is written, signed and dated.
A signed copy of the ICF is provided to the participant.
Additional safeguards are applied where applicable.
A witness is required for an illiterate participant or LAR.
You may withdraw at any time without loss of standard care.
Re-consent for protocol changes or new safety information.
Consent is continuous throughout the study.
How consent is documented depends on the participant’s condition. Select a situation to see who gives consent, who fills in the ICF and what each signature box requires.
| Participant condition | Consent given by | ICF filled by | Subject | LAR | Investigator (PI/Co-I) | Witness |
|---|
Our study team will always take the time to explain. You can also download this guide or read more about your rights as a participant.
Prepared by the Clinical Research Centre, KG Hospital, for general information. Study-specific consent requirements are set out in each Ethics Committee-approved ICF and PIS.