This document discusses informed consent forms and processes. It covers key elements that should be included in informed consent forms such as study description, risks, benefits, confidentiality, compensation, voluntary participation, and contact information. It also describes the informed consent process as an ongoing communication between researcher and participant that begins before the study and continues throughout. Documentation of the informed consent process is important. The document also discusses translating informed consent forms into local languages understood by participants and having them back translated to ensure accuracy.

2. What is INFORMED CONSENT FORM
ELEMENTS OF ICF
ICF PROCESS
ICF PROCESS - DOCUMENTATION
TRANSLATION/BACK TRANSALTION OF
ICF

3. What is Informed Consent ?
MUST be Obtained PRIOR to – Any study procedure
being performed
The voluntary confirmation of
a subject’s willingness to
participate in a particular trial,
after having been informed
of all aspects of the trial
relevant to his/her decision
to participate in the trial
* * *
Informed
Consent Form
Signatur
e
Date

4. ICF – Important Elements

5. The aim of informed consent is to protect both the
patient and Investigator. The patient needs to be fully
aware of all procedures, risks, benefits of study
participation.
Each patient is given a verbal explanation of the
study aims, procedures, requirements possible risks
and benefits. This explanation should be given by
the investigator in the language understood by the
patient.

6. Elements…
 A statement that the study involves research
 A description of any foreseeable risks or discomforts to
the subjects
 A description of any benefits to the subject which may be
reasonably expected from the research
 A disclosure of appropriate alternative procedures or
course of treatments
 A statement describing the confidentiality of record
identifying subjects

7. Elements…
 An explanation of whether any compensation or any
medical treatment available if injury occurs
 A statement of whom to contact pertinent to questions
related to Subject’s rights and whom to contact in case of
research related injury
 A statement that subject participation is voluntary
and refusal from participation does not involve any
penalty or no loss of benefits to which the subject is
otherwise entitled and subject may discontinue any time
without penalty or loss of benefits to which the subject is
otherwise entitled

8.  A statement that a particular procedure may involve risk
to the patient (or embryo to foetus if the subject becomes
pregnant) which are currently unforeseeable.
 Anticipated circumstances under which the subject’s
participation may be terminated by the investigator with the
consent of the subject.
 Any additional cost to the subject that may result
from participation in the research
Elements…

9.  The consequence of subjects decision to withdarw from
the research and procedures for orderly terminaton of
participation by the subject
 The approximate number of subjects involved in the
study
 Informed Consent procedure shall be documented on the
written form approved by the IEC and signed and dated by
the subject or LAR at the time of obtaining the consent.
 A copy of signed consent form given to the person signing the
Consent
Elements…

10. INFORMED CONSENT AS A PROCESS
Informed consent is a communication process :
• between the researcher and the participant
• starts before the research is initiated
• continues throughout the duration of the study

11.  The Consent Process can be regarded as vehicle
of communication between PI and Subject
 Opportunity for Questions and answers
Informed Consent Process

12. Informed Consent Process

13. Informed Consent Process
For Minors:
Parents or Legal Guardian has to sign and date the
consent form
Assent form

14. Informed Consent Process-
Documentation
 Investigator/authorized study personnel should document the
following in the source file:
 Language and Version of the informed consent form used
 Date ICF was administered and signed by subject/Legal
Acceptable Representative (LAR)
 Details of Impartial Witness if applicable
 Questions posed by the Patient/relatives and the answers
provided to the same
 Personnel present during the informed consent process
 That a photocopy of a signed and dated ICF was given to the
patient

15. SUMMARY
An informed Consent Process should be performed and
documented in the manner that is :
Clear
Complete
Accurate

16. Translation of Informed Consent forms
Why is it necessary to translate the ICF ?
The information that is given to the subject or
representative shall be in a language understandable to
subject or representative. (21 CFR 50.20, ICH GCP 4.8.6)
Therefore it is mandatory to translate the informed
Consent Form and Patient Information Sheets into
local languages

17. Translation of Informed Consent forms
A certified or qualified translator shall complete the
translation from original translation into the other
language
All the translated and back translated documents may be
clearly identified by
 Title of the document
 Version Number and date, (Where applicable)
 Translated from which language to which language
 Date of Translation
 Name of the Translator
This information is to be present on the covering page, and in
the footer section

18.  The translated document should be back
translated into the original language by a different
certified/qualified translator
 The translator performing the translation shall not
have access to the original document and cannot be
the same person who performed the first translation
 You must the compare the back translation
with the original document to check the accuracy
of the first translation
Translation of Informed Consent forms

19. Format of informed consent form for subjects participating in clinical trial
Study Title:
Study Number :
Subject Initials :___________ Subject’s Name :____________
Date of births / age ________
Please initial
box
(Subject)
1. I confirm that I have read and understood the information sheet date [ ]
for the above study and have had the opportunity to ask questions
2. I understand that my participation in the study is voluntary and that I [ ]
am free to withdraw at any time, without giving any reason, without my
medical care or legal rights being affected.
3. I understand that the Sponsor of the clinical trial, others working on the [ ]
Sponsor’s behalf, the Ethics Committee and the regulatory authorities will
not need my permission to look at my health records both in respects of
the current study and any further research that may be conducted in relation
to it, even if I withdraw from the trial. I agree to this access. However, I
understand that my identity will not be revealed in any information
released to third parties or published.

20. 4. I agree not to restrict the use of any data or results that arise from this study [ ]
provided such a use is only for scientific purpose(s)
5. I agree to take part in the above study [ ]
Signature (or Thumb impression) of the Subject/Legally acceptable
Representative :_______________
Date :
Signatory’s Name
Signature of the Investigator : Date
Study Investigator’s Name
Signature of the witness
Date

21. Case Study
An investigator had administered consent ( a Tamil
Translation of ICF use) to a Tamil patient, even though the
investigator could not speak Tamil himself. He justified his
actions stating that the patient had come with his brother who
could speak both Tamil as well as English.
Is this be acceptable ?

22. Case Study - Answer
This is acceptable. However, it is definitely
recommended that a translator (could be a member of
study team who speaks both languages) should be
present during the process of obtaining consent. This
aspect should be taken care of before the beginning of
the trial. As per ICH –GCP section 4.8 the investigator
should ensure that the trial subject fully understands the
study.