Infromed consent

CONTENT
1. Introduction
2. Purpose
3. What is informed consent form
4. Elements of informed consent
5. Process
6. Electronic consent

INTRODUCTION
• Millions of volunteers participate in government and industry sponsored
clinical trial each year.
• Prior to agreeing to participate, every volunteers has right to know and
understand what happen during clinical trial .
• This is called as informed consent and this process that can help to
decide whether or not participating in a trial is right for you .

PURPOSE
• Prospective Subject Will ………
 Understand nature of research
 Be informed of purpose, risks, and benefits, and
alternative therapies.
 Make a Voluntary Decision about Participation

DEFINING INFORMED CONSENT
Informed consent is defined by the ICH for GCP
 “ 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.

WHAT IS INFORMED CONSENT FORM
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 .
 Providing all relevant information to the volunteer/ patient.
 The patient/ volunteer understanding the information provided
Voluntarily agreeing to participate.
 A basic right.

INFORMED CONSENT ALLOWS
INDIVIDUALS:
 To determine whether participating in research fits with
their values and interests.
 To decide whether to contribute to this specific research
project.
 To protect themselves from risks.
 To decide whether they can fulfill the requirements
necessary for the research.

INFORMED CONSENT OF SUBJECT:
Prior to the beginning of the Study
– The Investigator(s) should obtain the Ethics Committee’s approval
for
– The written informed consent form and
– All information being provided to the Subjects and / or their legal
representatives or guardians as well as an impartial witness.

 The information should be given to
– the Subjects and / or their legal representatives or guardians in a
language and at a level of complexity that is understandable to the
Subject(s) in both written and oral form, whenever possible
 Subjects, their legal representatives or guardians should be given
adequate opportunity and time to enquire about the details of the Study
and all questions answered to their satisfaction.

 The Investigator(s), Sponsor or staff of the Institution should not
pressure or unreasonable influence a potential Subject to participate or to
continue to participate in the Study.
 Careful consideration should be given to ensuring the freedom of
consent obtained from members of a group which Classified according
to various structure- such as medical, pharmacy and nursing students,
subordinate hospital and laboratory personnel, employees of the
pharmaceutical industry, and members of the armed forces

 Persons with
– incurable diseases,
– in custody,
– unemployed or needy,
– in emergency rooms,
– homeless persons,
– wanderers, any ethnic or racial minority groups should be
considered as dangerous population whose mode of consent should
be carefully considered and approved by the Ethics Committee.

 Prior to the Subject’s participation in the Study the written
Informed Consent form should be signed and personally saw by
(i) The Subject or
(ii) If the Subject is incapable of giving an Informed Consent for
example children, unconscious or suffering from severe mental
illness or disability, by the Subject’s legal representative or
guardian or
(iii) If the Subject and his legal representative or guardian is unable
to read / write, An impartial witness who should be present
during the entire informed consent discussion
(iv) The Investigator

 By signing the consent form the witness certifies that the
information in the consent form and any other written
information was accurately explained to, and apparently
understood by, the Subject or the Subject’s legal representative
or the guardian, and that informed consent was freely given by
the Subject or the Subject’s legal representative or the guardian.

HOW DOES INFORMED CONSENT APPLY TO CHILDREN'S??
1. Children do not have the decision-making capacity to provide informed consent.
2. Since Therefore, parents or other surrogate decision-makers may give informed
permission for diagnosis and treatment of a child, preferably with the assent of the child
whenever possible.
3. Other disagreements in care may result in court orders that specify what treatment should
occur (for example, blood transfusions), or in the court-ordered appointment of a
guardian to make medical decisions for the child.
4. Depending on the type of research, the IRB may make provisions for “assent” of
children
Assent
A child’s affirmative agreement to be a participant in research. It is a term used to express willingness to participate
in research by person who are by definition too young to give informed consent but who are old enough to
understand the proposed research in general, its expected risks and possible benefits, and the activities expected of
them as subjects.

AGE>/=18
YES NO
Subject and person
obtaining consent sign the
ICD
Parent, guardian, witness, and
person obtaining consent sign the
ICD
1. Child age : 7-12 verbal assent
2. Child age : 13-17 written assent required

INFORM CONSENT IN PREGNANT WOMEN
Researchers should obtain informed consent from both
the pregnant woman and the father, consent of the father
is not necessary if…
1. The purpose of the study is to meet the health needs of
the mother.
2. The identity or where about of the father can not be
reasonably ascertained.

INFORMED CONSENT FORM IN NON ENGLISH SPEAKING
PERSON
1. Ideal is to use consent translated to participant’s native language
2. A copy of the consent document must be given to each subject.
While a translator may be helpful in facilitating conversation with
a non-English speaking subject, verbal translation of the consent.
3. Document must not be substituted for a written translation.

INFORMED CONSENT IN ILLITERATE PERSON
 An investigator may enrol individuals, who can speak and
understand English,
 The potential subject must be able to place a written mark on the
consent form.
 After that the subject must also be able to:
1.Comprehend the concepts of the study and understand the risks
and benefits of the study as it is explained verbally, and
2. Be able to indicate approval or disapproval for study enrollment.

BELMONT REPORT
 Expanded the definition of Informed consent.
 Participants-kept informed throughout the experiment,
 Understand risks and benefits.
 Protection of vulnerable group.

ELEMENTS IN INFORMED CONSENT FORM
1.Protocol number or name of study
2.Purpose of the study.
3.Duration of study and subject involvement
4.A statement that the protocol, and the informed consent were reviewed with the participant, including
the risks and benefits of the study.
5.Alternative treatment options discussed.
6.Confidentiality record
7.No of subjects
8.Compensation for injury
9.Time for questions to be asked and answered.
10.Description of the participant’s decision
11.Contact details
12.Travel reabusment
13.Subject responsibilities
14.Subject satisfaction
15.Use understandable language
16.Copy of consent was given to the participant
17.Sign copy of ICF

IN ADDITION, THE FOLLOWING ELEMENTS MAY ALSO BE
REQUIRED, DEPENDING ON THE TYPE OF STUDY:
1.Any alternative procedures or courses of treatment that might be as advantageous
to the participant as the ones to which she/he is going to be subjected.
2.If there is a possibility that the research could lead to any stigmatizing condition,
for example HIV and genetic disorders, provision for pretest- and post-test
counselling.
3.Insurance coverage if any, for research-related or other adverse events.
4.Foreseeable extent of information on possible current and future uses of the
biological material and of the data to be generated from the research.

iii)Right to prevent use of her/his biological sample, such as DNA, cell-line, etc., and
related data at any time during or after the conduct of the research.
iv)Risk of discovery of biologically sensitive information and provisions to safeguard
confidentiality.
v)Post research plan/benefit sharing, if research on biological material and/or data
leads to commercialization.
vi) Publication plan, if any, including photographs and pedigree charts.
Other specifics are as follows:
i)Period of storage of the sample/data and probability of the material being used for
secondary purposes.
ii)Whether material is to be shared with others, this should be clearly mentioned.

RESPONSIBILITY OF RESEARCHERS
1.The researcher should only use the EC approved version of the consent form, including
its local translations.
2.Adequate information necessary for informed consent should be communicated in a
language and manner easily understood by prospective participants.
3.In case of differently abled participants, such as individuals with physical, neurological
or mental disabilities, appropriate methods should be used to enhance the participants’
understanding, for example, braille for the visually impaired.
4.There should be no restriction on the participant’s right to ask questions related to the
study or to discuss with family and friends or take time before coming to a decision.

6.The researcher must ensure that the participant is competent and has understood all
aspects of the study and that the consent is given voluntarily. Where the participant
and/or the LAR are illiterate, an impartial literate person, not connected to the research,
should be present throughout the consent process as witness.
7. The researcher should administer a test of understanding whenever possible for
sensitive studies. If need be, the test may be repeated until the participant has really
understood the contents.
5.The researcher should not give any unjustifiable assurances or influence or intimidate a
prospective participant to enroll in the study.

8.When a participant is willing to participate but not willing to sign or give a thumb
impression or cannot do so, then verbal/oral consent may be taken on approval by
the EC, in the presence of an impartial witness who should sign and date the consent
document. This process can be documented through audio or video recording of the
participant.

WAIVER OF CONSENT
The researcher can apply to the EC for a waiver of consent if the research involves less
than minimal risk to participants and the waiver will not adversely affect the rights and
welfare of the participants
The EC may grant consent waiver in the following situations:
• Research cannot practically be carried out without the waiver and the waiver is scientifically
justified;
• Retrospective studies, where the participants are de-identified or cannot be contacted;
• Research on anonymized biological samples/data;
• Certain types of public health studies/surveillance programmes/programme evaluation studies;
• Research on data available in the public domain; or
• Research during humanitarian emergencies and disasters, when the participant may not be in a
position to give consent. Attempt should be made to obtain the participant’s consent at the
earliest.

PROCESS
A consent form is provided by the sponsor
with the study protocol or created by the
site investigator.
The consent form is personalized by
each site, adding local contact names
and numbers.
The consent from is approved for use by
the institutional review board(IRB)
Investigator or designated study personnel
informs the patient about the study ,purpose,
risks, and potential benefits.

The patient is allowed time to read the consent
form, ask questions and consider participation.
Patient or legal representative signs and dates
the consent form. The sponsor and/or IRB may
require additional signatures
The patient given a copy of the consent form
and study treatment and procedures can be
started

INFORMATION SHOULD INCLUDE IN INFORMED CONSENT FORM
1.Why the research is being done
2. What the researchers hope to accomplish
3. A description of what will be done during the study and how long you are expected to
participate
4. The risks to you from participation in the study
5. The benefits that you can expect from participation in the study
6. Other treatments that are available if you decide not to participate in the study
7. Verification that you have the right to leave the study at any time, and that standard
medical care will be provided without penalty if you choose to withdraw from the study.
8. Although an informed consent document must be signed before enrollment in a study, it
is important to remember that informed consent is a process that continues throughout the
study.
9. You may ask questions of the health care providers at any time before, during, or after
the study.

Informed Consent Worksheet
Date of Consent:__________________ Name of Study: ________________________IRB Study Number:__________________
Patient Name:_____________________ Patient MRN:____________________ Study ID#:________________________
The following has been explained to the potential study subject, and the subject has been offered the opportunity to ask questions regarding the study:
TOPIC COMMENTS
Purpose of the study _________________________________
Qualifications to participate _________________________________
Location and participants _________________________________
What will happen during the study _________________________________
Risk and benefits _________________________________
Study related injury or illness _________________________________
Alternative treatments _________________________________
Confidentiality _________________________________
Study costs _________________________________
Compensation _________________________________
Who to contact with questions _________________________________
Voluntary participation _________________________________
Termination of participation _________________________________
Questions or comments: __________________________________________________________________
__________________________________________________________________
Does the patient state an understanding of the study and procedures and agree to participate?
___yes ___no
_____________________________________ __________________________
Person administering consent Date / Time
Signed copy given to patient? ___yes ___no Copy in patients chart? ___yes ___no

CONSENT FORM
INFORMATION SHEET
•1. Introduction
• 2. Purpose of
research
• 3. Type of
research
intervention
• 4.
Participation
selection
• 5. Voluntary
participation
•6. Procedure
CONSENT
CERTIFICATE

INTRODUCTION
 Briefly state who you are and explain that you are inviting them to participate
in the research you are doing.
 Inform them that they may talk to anyone they feel comfortable talking with
about the research and that they can take time to reflect on whether they want
to participate or not.
 Assure the participant that if they do not understand some of the words or
concepts, that you will take time to explain them as you go along and that they
can ask questions now or later.

PURPOSE OF RESEARCH
 Explain in lay terms why you are doing the research.
 The language used should clarify rather than confuse. Use local and
simplified terms for a disease, e.g. local name of disease instead of
malaria, mosquito instead of anopheles, “mosquitoes help in
spreading the disease” rather than “mosquitoes are the vectors”.
 Avoid using terms like pathogenesis, indicators, determinants,
equitable etc.
 There are guides on the internet to help you find substitutes for
words which are overly scientific or are professional jargon.

TYPE OF RESEARCH INTERVENTIONS
 Briefly state the type of intervention that will be undertaken.
 This will be expanded upon in the procedures section but it may
be helpful and less confusing to the participant if they know from
the very beginning whether, for example, the research involves a
vaccine, an interview, a biopsy or a series of finger pricks.

PARTICIPATE SELECTION
 State why this participant has been chosen for this research. People often wonder
why they have been chosen to participate and may be fearful, confused or
concerned.
 Voluntary participations.

PROCEDURES AND PROTOCOL
A. Unfamiliar Procedures
This section should be included if there may be procedures which are not familiar to the
participant.
If the protocol is for a clinical trial:
1) involving randomization or blinding, the participants should be told what that means and
what chance they have of getting which drug (i.e. one in four chances of getting the test
drug).
2) involving an inactive drug or placebo, it is important to ensure that the participants
understand what is meant by a placebo or inactive drug.
3)which may necessitate a rescue medicine, then provide information about the rescue
medicine or treatment such as what it is and the criterion for its use.

If the protocol is for clinical research:
Firstly, explain that there are standards/guidelines that will be followed for the treatment
of their condition. Secondly, if as part of the research a biopsy will be taken, then explain
whether it will be under local anesthesia, sedation or general anesthesia, and what sort of
symptoms and side effects the participant should expect under each category.
For any clinical study (if relevant):
If blood samples are to be taken explain how many times and how much in a language
that the person understands.

B. Description of the Process
Describe to the participant what will happen on a step-by-step basis. It may be
helpful to the participant if you use drawings or props to better illustrate the
procedures. A small vial or container with a little water in it is one way of showing
how much blood will be withdrawn.
 Duration
 Side effects
 Risks
 Benefits
 Reimbursements
 Confidentiality
 Right to refuse or withdraw
 Alternative to participation
 Who to contact

ELECTRONIC CONSENT
These are electronic processes that use various, and possibly multiple, electronic formats such as
text, graphics, audio, video, podcasts or interactive websites to explain information related to a
study and to document informed assent/consent from a participant or LAR.
The process, electronic materials, method of documentation (including electronic/ digital
signatures), methods used to maintain privacy of participants, confidentiality, and security of the
information as well as data use policies at the research site must be reviewed and approved by the
EC
In addition to electronic consent, if required a paper/soft copy of the document is needed for
archiving and a paper/soft copy is also given to the participant.
Interactive formats, if used, should be simple to navigate.
Electronic methods should not be used if participants, for any reason, indicate a lack of
comfort with electronic media.

Infromed consent

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