briefing slides

Briefing on the process of ethics review
September 2013
Dept of Sociology, NUS
What is the ethics review?
 The ethics review of your research
proposal takes place only if you involve
human subjects.
 The ethics review focuses on two main
related principles: the protection of
research subjects and informed consent.
How does the IRB define “Research”?
IRB defines “research” as “a systematic
investigation, including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge.”
The intention to contribute to generalizable
knowledge usually implies the publication of a
paper from the study in a professional journal or
a presentation of the research in an
international conference.
Who needs to apply?
 Any research that may be published must go through
DERC clearance. If it also involves vulnerable populations
or possibility of risk to subjects, we will then advise you on
your further application to IRB. [n.b.: All Masters/Ph.D.
students should be expecting to publish].
 If you are not intending to publish, you do not require
IRB clearance, even if your research involves vulnerable
populations or the possibility of risk to subjects.
 However, if your research does involve vulnerable popns
or risk, you should take special care to discuss ethical
aspects thoroughly with your supervisor, who will
help you decide if the research is appropriate for Honours
level or not.
Honours students:
 Hons students not intending to publish do not need to go
through DERC review. [To date, most HTs have not been
published, but some have!]
 If you have any thought of publishing, please do apply to
DERC, because publisher may ask to see proof that research
went through ethical review – a problem if it didn’t!
 Either way, and especially if there is any possible
risk to subjects, or vulnerable populations are
involved, you should give serious consideration to the
ethical aspects of your research, and discuss them thoroughly
with your supervisor.
 Even if not publishing, DERC will be happy to offer
further advice if you or yr supervisor have any concerns.
Ethical review procedures have grown out of a
concern to protect people in general, and
vulnerable populations especially.
In the past, some harmful and irresponsible
medical experiments targeted such groups
without telling them what the research was
really about.
Read more about the history behind the need for ethical
The Nuremberg Code 1949 (Directives for Human
Experimentation) – a reaction to cruel and immoral medical
experiments conducted by Nazi doctors like Joseph Mengele in
concentration camps during WWII:
The Tuskegee Syphilis Experiment (Alabama, USA, 193272) leading to The Belmont Report 1974; even worse US
experiments w. prisoners, soldiers, and mental patients in
Guatemala (1946-48), revealed only in 2010!)
NUS article on ethics guidelines:
What is the NUS definition of
‘vulnerable populations’?
Students, subordinate populations
Medical patients
People with limited citizenship protections (e.g. migrant
People engaged in illegal activities
Pregnant women
The educationally disadvantaged
People with mental disabilities
Children and youth (n.b. very strong reasons why
sociological research with children is urgently needed,
and it can be done ethically!)
If you are doing [publishable] research with a vulnerable
population, you must have your research supervisor
included as Co-PI (Principal Investigator). After DERC has
reviewed your proposal, it will send it to IRB with a
recommendation (either for ‘full review’, or ‘expedited
If research is low-risk, but on a vulnerable population, and
you intend to publish, it would still go through IRB.
DERC can approve research with low-risk, non-vulnerable
populations without reference to IRB (at all levels
including Masters and PhD research).
Protection of Research Subjects
 Does the study uphold the human
subjects’ right to privacy and autonomy?
 What is the level of risk that subjects
may face?
 How would the study benefit research
How does the study contribute to
knowledge in the social sciences?
Subjects’ right to privacy and autonomy:
(1) Confidentiality of information collected from subjects
needs to be guaranteed.
(a) Omitting personal identification of research subjects or
recording only personal identification that is absolutely
(b) De-linking personal identifiers of each subject from your
data on that subject and using code numbers or
(c) Destroying information on subjects’ identifiers as soon
as possible (store safely meanwhile).
(n.b. there may be instances where anonymity is less
desirable/essential, or impossible to guarantee.)
Subjects’ right to privacy and autonomy:
Respect for the subjects’ autonomy is a fundamental
principle in research ethics and it is implemented by the
principle of INFORMED CONSENT.
Subjects must be given full information on what the
research entails for them so that they can make an
informed and autonomous decision on whether to
participate or not to participate in your study. Use the
Participant Information Sheet (PIS) and Consent Form
Subjects’ right to privacy and autonomy:
(3) What if I want to do research online?
This raises a whole lot of new and interesting questions!
Private/public distinctions are not always clear; be aware
that protecting confidentiality may be much trickier.
Below are some links to discussions of internet ethics:
What is the level of risk that subjects may
face by participating in your study?
Risk refers to the type and magnitude of harm
that the study may inflict on human subjects.
Defined as three levels:
 More than minimal risk
 Minimal risk
 Less than minimal risk
Examples of real or potential harm:
Subjects are observed without
their knowledge while involved
in what they consider a personal
and private activity
Interviews include
topics and questions
that cause extreme
anxiety and/or distress
to subjects
Subjects are asked
questions on
sensitive topics
and their answers
are recorded with
their personal
Subjects are promised confidentiality
but they are asked to disclose their
personal beliefs and opinions in a
public setting, e.g. focus group
discussion, third parties present.
How would the study benefit research
Consider carefully the standard answer: “no
benefit to subjects but benefit to ‘society’ or ‘the
 Is this answer true in your case?
How does the study contribute to knowledge in
the social sciences?
From a knowledge perspective, a social science study is
ethically justified if, while protecting subjects from harm,
it contributes in some way to the welfare of humanity
and/or to the advancement of knowledge in one or more
of the social sciences.
Solid conceptual
Appropriate and welldesigned methodology
DERC Application Form
 The DERC Application Form is a tool
designed to assist you, the researcher, to protect
your intended research subjects from harm by
designing your study systematically and
 The DERC Application Form assists you by
asking you relevant questions.
Step by step explanation of how to
complete the forms
 The DERC Application Form
 The Participant Information
Sheet (PIS)
 The Consent Form (CF)
(Download them from the DERC website: )
For a general discussion of social research ethics,
Earl Babbie (2001), The Practice of Social
Research (9th Edn).
Ch. 18: The Ethics and Politics of Social Research.
Pp. 468-88. (Belmont, CA: Wadsworth)
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