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1. By-
Aniket Namdev
Student ID 6173

2.  There are a millions of volunteers participate
in the government and industry sponsored
clinical trial each year.
 Prior to agreeing to participate, every
volunteer has right to know and understand
what happen during the clinical trial.
 This is called as Informed consent and this
process that can help to decide whether or not
to participating in a trial is right for you.

3. Prospective subject will-
 Understand Nature of research.
 Be informed of purpose, risks, benefits
and alternate therapies.
 Make a voluntary decision about
participation.

4.  Definition according to ICH GCP:
 “ A process by which a subject voluntarily
confirms his or her willingness to participate
in the particular trial, after having been
informed of all aspects of the trials that are
relevant to the subject’s decision to
participate”
 Informed consent is documented by means
of written, signed and dated informed
consent form.

5.  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 understanding the information provided
Voluntarily agreeing to participate.
 A basic right.

6.  To determine whether participating in
research fits with their values and interest.
 To decide whether to contribute to this
specific research project.
 To protect themselves from risks.
 To decide requirements necessary for the
research.

7.  In seeking informed consent following
information shall be provided to each subject:
1. Description of clinical investigation.
2. Risks and discomfort.
3. Benefits.
4. Alternative procedures or treatments.
5. Confidentiality.
6. Compensation and medical treatment in event of injury.
7. Contacts.

8. The ICF should appear in the subject’s hands, properly filled as:
 Page 1: Title
 Each page: the page number, including total pages, other applicable
data (e.g. protocol number, version number, stamp of ethics committee
approval)
 Space for signatures and date.
 A statement that the study involves research experiment
 The reason for the study
 Available alternative treatments
 The details of the study methods
 Possible/ expected risks, both serious and not serious
 Possible benefits
Contd…

9. A declaration that participation is voluntary, that
subjects who refuse to participate or withdraw from the
study will not be penalized.
Contact information.
A declaration regarding confidentiality.
Information regarding the procedure to follow if an
adverse event occurs.
A warning that the study may involve currently
unforeseen risks.
A statement that the investigator may withdraw the
subject from the study without the subject’s consent
An assurance that subjects will be informed of relevant.

10. If new information appears, especially medical knowledge,
that may affect the subject’s decision to continue
participation:
 The information must be given to the subject
 The ethics committee should re-examine the study
 The consent form may need revision.
Reasons for revisions may include:
Protocol amendments.
Recognition of risk to subjects not previously anticipated but not
warranting discontinuation of study.
Results of interim analyses showing significant changes in anticipated
risk, benefit, or efficacy that may affect subject willingness to continue
participation.
Change of investigator or of study site location.

11. 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 names and numbers.
 The consent forms is approved for the use by
institutional review board.
 Investigator or designated study personnel
informs the patients about the study, purpose, risks,
and potential benefits.
Contd…

12. The patient is allowed 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 patients given a copy of the consent form
and study treatment and procedures can be
started.

13. The study must not conflict with the
subject’s health insurance. Most
studies will insure the subjects from
risks arising out of the trial.
In the USA: use HIPAA-compliant
language.

14. Subjects who understand spoken
English but cannot read require an oral
explanation in the presence of a witness.
Subjects who do not understand
English may be enrolled if:
• The contents are translated.
• The contents are verbally explained in
the presence of a witness.

15. A child should be respected.
A child can make independent decisions
after the age of fourteen.
One cannot presume that a child will
never wish
to participate.
First try to carry out the trial in adults.

16. Two consent forms are required: one for the
child (assent), one for the parents
(permission).
As in adults, assent not required if mental or
physical disability renders the child incapable.
The ethics committee may waive the
requirement of the child’s assent in some
situations.

17. Creates a mutual trust between the patient and the
physician by opening the important pathways of
communication.
 Helps patients to take greater measure of responsibility
in the course of their treatment by having more extensive
knowledge to their condition and its impact on their
personal life.
 Allows the physician to take care of patient more
effectively by having more information of patients
including the value basis for granting or withholding
consent.