Requirement for Informed Consent Form (ICF)
An Informed Consent Form (ICF) is a crucial document in ethical research or medical practices.
Here’s a simple explanation:
- Purpose: The ICF tells you why the research or medical procedure is being done.
- Procedures: It explains what will happen during the research or procedure, and what you, as a participant, need to do.
- Risks and Benefits: The ICF will outline any potential risks or benefits that may come from participating.
- Rights: It informs you that participation is voluntary and you can withdraw at any time without penalty.
The language used in the ICF should be understandable to the participants. Any technical or medical terms should be explained using common or lay terminology. For example, a term like “anemia” would be explained as a “decreased number of red blood cells”.
Remember, the goal of an ICF is to ensure that you are fully aware and understand what you’re agreeing to when participating in a study or procedure. If you have any questions or something isn’t clear, you should feel comfortable
asking for more information.
* IREC will only accept Informed Consent Form that fulfill the above criteria.
Research that requires Informed Consent
- Questionnaire/Survey
- Interview
- Physical/Medical Assessment
- Clinical Trials
- Human tissue sampling
Research that may not require Informed Consent
- Covert Observations
- Retrospective (need ensure no identification will be recorded)
- Case study
- Experimental (using non-identifiable human tissue)