The document outlines the key elements that must be included in an informed consent process and document according to various guidelines. It discusses the definition of informed consent, the process of obtaining consent which includes provision of information, comprehension, and voluntary participation. It also describes the key components that must be included in an informed consent form such as the purpose of the study, risks and benefits, confidentiality, compensation, and voluntary participation. Reference guidelines from ICMR, ICH GCP, FDA and CFR are provided on the required elements of informed consent.

1. INFORMED CONSENT
PROCESS AND PROCEDURES

2. CONTENTS
1. DEFINITION
2. INFORMED CONSENTGUIDELINES
3. THE PROCESSOFCONSENT
4. THE PLANOFCONSENT PROCESS
5. ELEMEMTSOF 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 (IndianCouncil of Medical Research)
“EthicalGuidelines for Biomedical Research on Human Subjects”
Published in 2000 and revised in 2006
2. ICH
ICHGuidelines E6 section 4.8 underGLP (GoodClinical 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 ofConsent
• 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 ofconsent 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 LegallyAcceptable 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 newfindings.

12. Components of ICF
(1.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 ofConfidentiality.
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. ⚫The information that must be provided in an
informed consent document is specified in(US
FDA) 45 CFR 46.116, 21 CFR 50.20, and ICH
GCP 4.8.10.
45 CFR 46.116 & 21 CFR 50.20 - General
requirements for informed consent.

15. 2.ICH GCP 4.8.10 GUIDELINES:
Both the informed consent discussion and the written informed consent form and any
other written information to be provided to subjects should include explanations of the
following:
⚫ (a) That the trial involves research.
⚫ (b) The purpose of the trial.
⚫ (c) The trial treatment(s) and the probability for random assignment to each
treatment.
⚫ (d) The trial procedures to be followed, including all invasive procedures.
⚫ (e) The subject's responsibilities.
⚫ (f) Those aspects of the trial that are experimental.
⚫ (g) The reasonably foreseeable risks or inconveniences to the subject and, when
applicable, to an embryo, fetus, or nursing infant.
⚫ (h) The reasonably expected benefits. When there is no intended clinical benefit to the
subject, the subject should be made aware of this.
(i) The alternative procedure(s) or course(s) of treatment

16. ⚫ (j) The compensation and/or treatment available to the subject in the event of
trial-related injury.
⚫ (k) The anticipated prorated payment, if any, to the subject for participating in the
trial.
⚫ (l) The anticipated expenses, if any, to the subject for participating in the trial.
⚫ (m) That the subject's participation in the trial is voluntary and that the subject may
refuse to participate or withdraw from the trial, at any time, without penalty or loss
of benefits to which the subject is otherwise entitled.
⚫ (n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority
will be granted direct access to the subject's original medical records for
verification of clinical trial procedures and/or data, without violating the
confidentiality of the subject, to the extent permitted by the applicable laws and
regulations and that, by signing a written informed consent form, the subject or

17. ⚫ the subject's legally acceptable representative is authorizing such
access.
⚫ (o) That records identifying the subject will be kept confidential and, to
the extent permitted by the applicable laws and/or regulations, will not
be made publicly available. If the results of the trial are published, the
subject’s identity will remain confidential.
⚫ (p) That the subject or the subject's legally acceptable representative will
be informed in a timely manner if information becomes available that may
be relevant to the subject's willingness to continue participation in the
trial.
⚫ (q) The person(s) to contact for further information regarding the trial
and the rights of trial subjects, and whom to contact in the event of trial-
related injury.
⚫ (r) The foreseeable circumstances and/or reasons under which the
subject's participation in the trial may be terminated.
⚫ (s) The expected duration of the subject's participation
in the trial.

18. References :
1. Research Ethics andCompliance/University of Michigan
2. Obtaining and Documenting InformedConsent/University of California, San
Francisco.

19. THANKYOU