What is INFORMED CONSENT FORM

ELEMENTS OF ICF

ICF PROCESS

ICF PROCESS - DOCUMENTATION

TRANSLATION/BACK TRANSALTION OF ICF

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* * *

InformedConsent Form

Signature

Date

ICF – Important Elements

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.

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

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

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…

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…

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

The Consent Process can be regarded as vehicle of communication between PI and Subject

Opportunity for Questions and answers

Informed Consent Process

Informed Consent Process

Informed Consent Process

For Minors:

Parents or Legal Guardian has to sign and date the consent form

Assent form

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

SUMMARY

An informed Consent Process should be performed and documented in the manner that is :

Clear

Complete

Accurate

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

Translation of Informed Consent forms

A certified or qualified translator shall complete the translation from original translation into the other languageAll 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

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

Format of informed consent form for subjects participating in clinical trialStudy 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 mymedical 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 willnot 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 relationto it, even if I withdraw from the trial. I agree to this access. However, Iunderstand that my identity will not be revealed in any information released to third parties or published.

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 acceptableRepresentative :_______________Date : Signatory’s NameSignature of the Investigator : DateStudy Investigator’s NameSignature of the witnessDate

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 ?

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.