Elements of IC

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Elements of informed consent

The IC Form can have two parts:

• Information Sheet (to share information about the research with the study participant)

• Certificate of Consent (for obtaining signatures)

Sometimes patient Information sheet and Informed Consent form can be clubbed together.

Checklist for study Subject’s informed consent document (ICD)

Following are the essential elements of an ICD:

1. Statement that the study involves research and explanation of the purpose of the research

2. Expected duration of the Subject’s participation

3. Description of the procedures to be followed, including all invasive procedure and

4. Description of any reasonably foreseeable risks or discomforts to the Subject

5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected Subject should be made aware of this.

6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.

7. Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject’s medical records

8. Trial treatment schedule(s) and the probability for random assignment to each treatment (for randomized trials)

9. Compensation and/or treatment(s) available to the Subject in the event of a trial-related injury

10. An explanation about whom to contact for trial related queries, rights of Subjects in the event of any injury

11. The anticipated prorated payment, if any, to the Subject for participating in the trial

12. Subject’s responsibilities on participation in the trial

13. Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled

14. Any other pertinent information

(Source: Schedule Y of Drugs and cosmetics (II Amendment) rules, 2005 Ministry of Health and Family welfare (Department of health) Govt. of India)

Note: The word “Subject†appears here as this has been copied verbatim from the source mentioned