Date post: | 12-Jul-2015 |
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I Obtaining Informed
Consent
II IRBs(Institutional
Review Boards)
III Protocol Preparation
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.
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.
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.
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,educationalbackground,mental capacity and language proficiency including literacy.
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.
3. Voluntary participation
Invitation to participation in research must involve neither threats of harm nor offers of inappropriaterewards.
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.
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
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.
* 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.
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 informedconsent.
A protocol is generally requires the following sections(these sections may
differ in different institutions and universities):
1.Précis(also known as abstract):a short overview of the study’s objectives,population,design,etc is needed2.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 administered5.Data Analysis:Explanations of how the outcome will be measured.6.human subject protection Hope to be
Useful…