Informed consent process and procedures

1. Siddu K M
M Pharm 1st Year
Department of Pharmaceutics
Al Ameen College of Pharmacy
INFORMED CONSENT
PROCESS AND PROCEDURES

2. CONTENTS
1. DEFINITION
2. INFORMED CONSENT GUIDELINES
3. THE PROCESS OF CONSENT
4. THE PLAN OF CONSENT PROCESS
5. ELEMEMTS OF ICF
6. COMPONENTS OF ICF

3. Definition:
• 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 subject’s decision to participate.
• Informed consent is documented by means of a written, signed and
dated informed consent form.
• The goal of the informed consent process is to provide people with
sufficient information so that they can make informed choices about
whether to begin or continue participation in clinical research.

4. Informed consent guidelines:
1. ICMR (Indian Council of Medical Research)
“Ethical Guidelines for Biomedical Research on Human Subjects”
Published in 2000 and revised in 2006
2. ICH
ICH Guidelines E6 section 4.8 under GLP (Good Clinical Practices)

5. INFORMATION
COMPREHENSION VOLUNTARINESS

6. Information provision and sharing by research team
Discussion and interaction between researchers and potential participants
True understanding
Acceptance or rejection of participation
Agreement to participate End of contract
Follow up

7. The Process of Consent
• Choose the right environment and location to obtain consent.
• Involve multiple health care personnel as necessary.
• Include family members in the process as warranted.
• Ensure that the subject or LegallyAuthorized Representative is
competent.
• Ensure the subject or LAR has sufficient understanding.
• Continue the process of consent throughout the study.

8. The Plan of Consent Process
1. Identify obstacles to participation in study and ways to overcome
obstacles
2. Identify words subject may not understand
3. Compile “FrequentlyAskedQuestion” list
4. Decide who will do consent discussion
5. Decide where consent discussion will be held
6. Provide adequate time to explain study to subject.
7. Provide adequate time for subject to read and consider and for questions
to be answered

9. Who can sign the Informed Consent
Form?
1. Subject or Legally Acceptable Representative (LAR)
2. Person conducting review of consent.
3. Impartial witness

10. Elements of Informed Consent Form:
1. Essential elements
a) Purpose
b) Risks
c) Benefits
d) Confidentiality
e) Compensation
f) Contact information
g) Voluntary participation

11. 2. Additional elements
a) Withdrawal criteria.
b) Additional costs to subjects.
c) Statement that there may be risks which are unforeseeable.
d) Approximate number of subjects in study.
e) Statement that will be told of new findings.

12. Components of ICF
(according to ICMR guidelines, 2006)
1. Important Information about the Research Study.
2. What is the study about and why are we doing it?
3. Benefits of taking part in the study.
4. Possible risks that might result from being in the study.
5. Certificate of Confidentiality.
6. What will happen to the information collected after study period is over.
7. Compensation for being part of the study.
8. Possible expenditures to a subject to be part of study.

13. 9. Who can profit from study results.
10. Choices to a subject if they don’t wish to take part in the study.
11. Voluntariness
12. Contact information of subject.
13. Contact information of study team.
14. Consent : Name , Signature and Date
15. Parent or LAR : Name, Signature and Date

14. References :
1. Research Ethics and Compliance/ University of Michigan
2. Obtaining and Documenting Informed Consent/University of California, San
Francisco.

15. THANKYOU