Informed Consent Form is an form where subject voluntarily shows his / her willingness to participate in clinical trial.

1. Prepared by : SHITAL DESALE

2. What is Informed consent
• A process by which a subject voluntarily
confirms his or her willingness to participate in
a particular trial, after having been informed of
all aspects of the trial that are relevant to the
subjects decision to participate.
• Informed consent is documented by means of a
written, signed and dated informed consent
form.

3. Types of Informed consent
ADULT CONSENT – PARTICIPANTS 18YEARS OF AGE AND OLDER
Standard Written Consent:
Applicability: Participants must…
• Be literate
• Feel comfortable signing forms
Oral Consent:
Applicability: Participants must…
• Be illiterate Be read the consent statement in the presence of a witness
• Feel comfortable signing forms
Oral Consent Form:
Signed by the PI and Witness
Short Form Written Consent:
• Statement that the consent script was read to the participant and understood.
• Signed by participant and witness

4. MINOR ASSENT – PARTICIPANTS MUST BE BETWEEN 7 AND
17 YEARS OF AGE• Standard Written Assent:
Applicability: Participants must…
• Be literate
• Feel comfortable signing a form
• The assent must be written in language that is accessible to the targeted age group
• Oral Assent:
Applicability: Participants must…
• Be illiterate
• Be read the assent statement in the presence of a witness
• Feel comfortable signing forms.
• Oral Assent Form:
• Signed by the PI and Witness
• Written in language that is accessible to the targeted age group
Short Form Written Assent:
• Statement that the assent script was read to the participant and understood.
• Signed by participant and witness

5. PARENTAL OR LEGAL GUARDIAN PERMISSION
• Standard Written Permission:
Applicability: The person signing must…
• Be the parent or legal guardian of prospective participant
• Be literate
• Feel comfortable signing forms
• Oral Permission:
Applicability: Participants must…
• Be illiterate
• Be read the consent statement in the presence of a witness
• Feel comfortable signing forms
• Oral Consent Form:
• Signed by the PI and Witness
• Contains all eight elements of informed consent
• Short Form Written Consent:
• Statement that the consent script was read to the participant and understood.
• Signed by the parent/legal guardian and witness
**Before a minor (aged 0 to 17 years) can be enrolled
in a study, parental permission must be obtained.

6. Consent
Process
The consent
process
begins when
you begin
recruitment
of subjects.
01
Informed
consent does
not end with
the signing of
a document.
02

7. Legally Acceptable Representative
• An individual or juridical or other body
authorized under applicable law to consent, on
behalf of a prospective subject, to the subjects
participation in the clinical trial.

8. Impartial Witness
• A person, who is independent of a trial, who
cannot be unfairly influenced by people
involved, with the trial, who attends the
informed consent process if the subject or
subjects legally acceptable representative cannot
read and who reads the informed consent form
and any other written information supplied to
the subject.

9. • The consent process is an on-going,
dynamic “conversation” with your subject
to ensure:
the person understands what’s being
asked of him/her;
that the person has an opportunity to ask
questions; and
that the person truly wants to continue in
the study.

10. Documentation of Informed Consent
• The consent form is one of the most
important ways to document your respect for
persons.