This document discusses informed consent in research involving human subjects. It covers three main topics: 1) informed consent, which requires providing sufficient information to participants, ensuring their comprehension, and voluntary participation; 2) Institutional Review Boards which review research to ensure ethical standards are met; and 3) preparing a research protocol for review boards, which typically includes sections on objectives, methods, and protecting human subjects.

1. .

2. I Obtaining Informed
Consent
II IRBs(Institutional
Review Boards)
III Protocol Preparation

3. I Informed Consent :
Voluntary agreement to participate in a
study about which the potential subjects
has enough information and understands
enough to make an informed decision.
This can occur only when at least
the following three conditions are
fulfilled:
1.Suppliance of sufficient information.
2.Comprehension on the part of the subject.
3.Voluntary participation, in which the subject is
free from undue pressure or coercion.

4. 1.Suppliance of Sufficient Information
what is Sufficient Information? It depends on the
situation you are carring out the research.
Different institutions including different
Universities and Governments may have different
Interpretations of complete disclosure.
For example many review boards requires
that learners must be informed about
the procedures ,purposes and potential risks and
benefits.

5. Is Withholding Information Ever
Necessary ?
Generally researchers are advised to provide as
much information as possible but in second language
research sometimes it is not necessary to fully
disclose all the information.
In this case three conditions will often need to be
met:
1. Incomplete disclosure is essential to the aims
of the research.
2. No risks are undisclosed.
3. Participants will be given an opportunity to
be debriefed after the study.

6. 2. Participant Comprehension in
Informed Consent
In addition to supplying sufficient information
the researcher is also responsible for ensuring
participant comprehension it means that the informed
consent document should be provided in language
understandable to them given their age,educational
background,mental capacity and language proficiency
including literacy.

7. One general suggestion is to write
the consent documents so that they
are understandable to people who
have
not graduated from high school.
For low-proficiency language learners it
may be necessary to provide a translation
of the consent document in the learners
first language.
(Translated forms are often presented on
reverse side of the sheet.)
Also a translator can explain the consent
form of the learner.

8. 3. Voluntary participation
Invitation to participation in research must involve
neither threats of harm nor offers of inappropriate
rewards.
In second language research if classroom teachers invite
their students to participate in a study although it is clear
that there will be no extra points or higher grades the
best option for teacher would be not to do the research
him/her self and ask a third person to carry it out.
Some universities even forbids the
teachers to do research on their
own students.

9. II IRBs(Institutional Review
Boards)
A committee established to review
research involving human subjects to
ensure it is in compliance with ethical
guidelines laid down by government and
unversities.
IRB is often used interchangeably with
Human Subjects Committee and Ethics ReviewBoards

10. Development of research codes
of ethics
* The Nuremberg Code(1949)
which has the basis of many ethical codes
contain ten directive for human
experimentation :
Voluntary participation,fully informed
consent,being necessary and fruitful for
society, avoiding unnecessary physical and
mental suffering and injury, allowing
withdrawal for participants,etc.

11. * The Declaration of Helsinki(1964)
Like Nuremburg code,it emphasizes the
importance of the voluntary consent and
protection of the subject,the subjects freedom
to withdraw from the research,and the idea
that potential benefits should outweigh likely
risks.

12. III Preparing Protocol for the IRB
protocol is an application to an IRB
for approval to do research. This often
includes a template for an informed
consent.
A protocol is generally requires the
following sections(these sections may
differ in different institutions and
universities):

13. 1.Précis(also known as abstract):a short
overview of the study’s objectives,population,
design,etc is needed
2.Introduction:Background information is
provided along with a review of literature.
3.Objective:Goals of the study and whenever
possible hypothesis.
4.Design and Method:discribtion of how
participants will be chosen and how the
treatment is administered
5.Data Analysis:Explanations of how the
outcome will be measured.
6.human subject protection Hope to be
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