Ethics Informed Consent

(EIC) Form
Principles, Processes, and Considerations
Outline of Presentation
Review of Ethical Considerations in Research

What is Informed Consent

History of Informed Consent (Documentary Basis)

Types of Informed Consent

Basic Elements of a Written Informed Consent

Documents
Steps In Obtaining Informed Consent
SAMPLE Informed Consent
 Basic Elements of a Written Informed
Consent Documents
A statement that the study involves research;

An explanation of the purpose of research and

the expected duration of the subject's
participation;

A description of the procedures to be followed

and identification of any procedures that are
experimental;
• A description of any foreseeable risks or
discomforts to the subject, an estimate of their
likelihood and a description of what steps will be
taken to prevent or minimize them;

• A description of any benefits to the subject or to

others that may reasonably be expected from
the research. Monetary compensation is not a
benefit;
•A statement describing to what extent
records will be kept confidential,
including a description of who may have
access to research records;
• For research involving more than minimal risk, an
explanation and description of any compensation and
any medical treatments that are available if research
subjects are injured; where further information may
be obtained and whom to contact in the event of a
research-related injury;
•Information on the amount of
remuneration/compensation, if any,
that will be provided to subjects;
•An explanation of whom to contact for
answers to pertinent questions about
the research and the research subject's
rights
•A statement that participation is
voluntary and that refusal to
participate or discontinuing
participation at any time will
involve no penalty or loss of
benefits to which the subject is
otherwise entitled.
STEPS IN OBTAINING INFORMED
CONSENT
 • Explain the study to the potential
subject verbally

STEP 1:
• provide the potential subject the
 Explaining the written consent form or information
Research sheet 

• meet with the potential participant and

address any additional questions or
concerns he or she might have.
• Answer questions, but also ask questions to
further the discussion and elicit questions
from the potential participant. 
• Ask Open Ended and Non Directive Question
to ensure the respondents understand key
information of the study Step 2:
Assessing Subject
• Assess whether the potential Comprehension
participants adequately understands
the study
• Assess whether the potential participants
can make informed decision to participate
in the study or not.
 • Ensure subjects is provided with
the approved consent form

• Obtain the signature of the participant (or the

STEP 3: legally-authorized representative or parent(s),
 Documenting the when approved) as well as the person obtaining
Informed Consent consent.
• Give subjects a signed copy and keep the
original signed copy in your research file.

• Append the Consent Form as part of the

Research Files
 SAMPLE OF AN INFORMED CONSENT FORM