Informed Consent Form ppt

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 18 YEARS 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

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.