What is the informed consent form?
Whenever you are proposing research with human participants you must provide a form, known as an Informed Consent Form (ICF), with each proposal to indicate that the research participant has decided to take part in the research of her/his own free will.
What is ICF in clinical research?
ICF – Informed Consent Form – An informed consent form (ICF) is used to ensure everyone involved in clinical research is a willing participant, with full knowledge of the potential risks and benefits to the extent that this is possible.
Who can take informed consent in a clinical trial?
In general any member of a research team may take informed consent from study participants so long as the following points are met: For research requiring ethical approval the process for gaining consent from participants must be approved by the Research Ethics Committee (REC).
How do you write an informed consent form?
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.
How is informed consent obtained?
Informed consent is obtained using a short form consent process (when approved by the IRB). The participant has decision-making capacity, but cannot read, write, talk or is blind. The participant’s guardian/legally-authorized representative cannot read, write, talk or is blind.
What are the types of consent forms?
Types of Consent/Assent
- Written Informed Consent Document:
- Waiver of Signed Documentation of Informed Consent:
- Waiver or Alteration of SOME Informed Consent Elements:
- Waiver of ALL Informed Consent Document Elements:
- Oral Informed Consent Script: