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ETIKA DAN DESAINPENELITIAN
Disampaikan oleh:
ADJI PRAYITNO
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Pokok Bahasan
1. Introduction to ethics in research
a.Definition
b.Major approach to ethics
c. Principles of ethical conduct
d.Economic regulation of research
e.Political regulation of research
f. Institutional Review Board
2. Ethical issues and human participants in research3. Ethical issues and nonhuman subjects in research
4. Ethical issues and scientific integrity
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Definisi
Ethics is a branch of philosophy that dealswith distinctions between right and wrong
with the moral consequences of human
actions.
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Major Approaches To Ethics
1) Deontological Approach2) Ethical scepticism
3) Utilitarianism
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Deontological Approach
This approach states that1. we should identify and use a Universal
code when making ethical decisions.
2. An action is either ethical or not ethical,
without exception.
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Ethical scepticism
This is the relativist viewpoint, stating that
1. ethical standards are not universal but
are relative to one's particular culture and
time.
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Utilitarianism
This is a very practical viewpoint, stating that
1. decisions about the ethics of a study should
depend on the balance of the consequences and
benefits for the research participants and the
larger society.2. The utilitarian approach is used by most people
in academia (such as Institutional Review
Boards).
3. "Do the potential benefits outweigh the risks
associated with this research?"
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Principle Of Ethical Conduct
1. Integrity, respect for human, beneficenceand justice
2. Consent
3. Research merit and safety4. Ethical review and conduct of research
(Human Research Ethics Handbook, NHMRC Commonwealth of Australia 2002)
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Economic Regulation of Research
1. Economic regulation is the issue of who
sponsors your research as well as how
much money you get.
2. It's the ethical duty of a researcher to get
their results published somewhere. This is
called dissemination of your research, and it
requires that you find the most appropriate
and scholarly outlet that you can.
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Political Regulation of Research
1. Historically, governments have had to put serious restrictions on researchers. In
fact, the origin of codes of research ethics can be traced to the NUREMBERGCODE, a list of rules established by a military tribunal on Nazi war crimes during
World War II. The principles outlined in the Nuremberg Code include:
2. Voluntary consent
3. Avoidance of unnecessary suffering
4. Avoidance of accidental death or disability5. Termination of research if harm is likely
6. Experiments should be conducted by highly qualified people
7. Results should be for the good of society and unattainable by any other means
8. One of the outcomes of the HEW guidelines was the establishment of
INSTITUTIONAL REVIEW BOARDS (IRBs) at colleges and universities acrossAmerica. At first, IRBs were seen as a hindrance on academic freedom by faculty
researchers, but they came to be accepted, especially after 1981 when the revised
HHS guidelines exempted most social science and criminal justice research from full
review by creating a category of "expedited" review.
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Institutional Review Board
1. This is a board consisting of professionals and lay people whoreview research proposals to insure that the researcher willadhere to ethical standards in the conduct of the research.
2. Researchers must submit a Research Protocol to the IRB forreview
3. Three of the most important categories of review are exemptstudies, expedited review, and full board review
4. Much S1 pharmacy research falls in the exempt category:being exempt from certain requirements and full committeereview because the study involves no or minimal risk
5. Studies with children, prisoners, and fetal participants arenever exempt
6. Even if your study ultimately falls in the exempt category, it isstill essential that you follow the ethical guidelines
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3 Ways to Encourage Ethically
There are three ways, and three ways only, to encourage participation
ethically (Senese 1997):1) Anonymity: Promise and keep your promises of anonymity. After
identifying your sampling frame, try to forget about taking names orany other unique identifiers. Reassure people that you won't go tothe media. Fill them in on what journal outlet you have planned.
2) Confidentiality: This is what you should promise if you can't keepanonymity. In other words, use confidentiality if you can't guaranteeanonymity. It requires that you guarantee that no one will beindividually identifiable in any way by you, that all your tables,reports, and publications will only discuss findings in theaggregate.
3) Informed Consent: Be honest and fair with your subjects. Tell themeverything they want to know about your research. Be aware of anyhidden power differentials that might be pressuring them toparticipate.
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Evidence-based management:
Research designs
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Empirical circle
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Research designs: 4 elements
Randomization
Comparison
Before vs after
Prospective vs retrospective
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Randomized controlled study
Controlled before-after study
Cohort / panel study
Before-after study
Post-test only study
Survey
Case study
Experiment
Quasi-experiment
Observational study
Longitudinal study
Cross-sectional study
Qualitative study
Research designs: terms
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CBA: controlled before-after study
In a controlled before-after study two or more
groups are compared with each other, usuallycomprising one group in which an intervention is
carried out (experimental group) and one group
where no or an alternative intervention isconducted (control group).
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=
CBA: controlled before-after study
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In the case of randomization, the groups compared with each
other are selected entirely randomly, for example by drawing lots.
This means that each participant (or other unit such as a team,
department or company) has an equal chance of being in theintervention or control group. In this way, the influence of any
distorting factors is spread over both groups so that these groups
are as comparable as possible with each other with the
exception of the intervention.
Better (but not always feasible): randomization
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=
Randomized controlled study (RCT)
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Cohort / panel study
Starting point: intervention/exposure (independent variable)
Longitudinal study where large groups of people or
companies (cohort / panel) are followed over a long
period to see (prospective) whether differences occur
among the groups.
=
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Case-control study
Starting point: outcome (dependent variable)
Longitudinal study in which one group of people or companieswith a particular outcome is compared retrospectively with a
group that does not have this outcome.
=
VS
VS
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Examples of (flawed) case-control studies
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versus
Study in which data are obtained or particular
characteristics are measured of a population before
versus after an intervention / exposure / event, to
measure the effect or correlation.
Before-after study
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=
Posttest-only
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Cross-sectional study
Study in which data of a statistically significant sample of
a population (managers, CEOs, employees) is gathered
at one point in time. It provides a snapshot of the current
condition but does not explain cause and effect.
Cross-sectional studies
include surveys
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Cross-sectional study
?
?
?
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Study in which a large number (qualitative or quantitative)
of aspects of a single case (organization or team) was
investigated in depth over a long period within the casesown context.
Case study
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Experimental research
True experiment: RCT
Quasi experiment: CBA
Experimental research refers to studies where the
researcher manipulates one (or more) variable and
controls the other variable(s) to determine whether there
is a causal relation between the manipulated variable andthe outcome.
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Observational research
Natural experiment
Cohort / panel study
Case-control study
Observational research refers to studies where the
researcher merely observes but does not intervene,
with the intention of finding correlations among the
observed data
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Qualitative research explores and tries to understand people's
beliefs, experiences, attitudes, behaviour and interactions. It
generates non-numerical data. The best-known qualitative research-
methods include in-depth interviews, focus groups, documentary
analysis and participant observation.
Qualitative research includes
Case studies
Ethnographic studies
Field research
Grounded theory approach
Qualitative research
L it di l h
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Longitudinal research
Cohort / panel study
Repeated measures
Times series
A longitudinal study is an observational study that
involves repeated observations (measurements)
of the same variable(s) over long periods of time
(sometimes years or even decades).
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Mixed methods
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Better than a single study:a replication study
Better than a replication study:
a systematic review / meta analysis
If there were 100 studies, 99 of which gave a negative
result (where, say, the new intervention appeared to benot effective), while one had a positive result (were the
intervention appeared effective), it would obviously be a
mistake to consider only the single positive study.
But .
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Systematic review / meta-analysis
The intention behind a systematic review is to identify as fullyas possible all the scientific studies of relevance to a particular
subject and to assess the validity and authority of the evidence
of each study separately. As the name indicates, a systematic
review takes a systematic approach to identifying studies andhas the methodological quality critically appraised by multiple
researchers independently of each other, as a consequence of
which the review is transparent and reproducible and can be
monitored. The use of statistical analysis techniques in asystematic review to pool the results of the individual studies
numerically in order to achieve a more accurate estimate of
the effect is termed a meta-analysis.
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?
Systematic review / meta-analysis
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1. Randomized controlled study
2. Controlled before-after study
3. Cohort / panel study
4. Before-after study
5. Post-test only study
6. Survey
7. Case study
A. Experiment
B. Quasi-experiment
C. Observational study
D. Longitudinal study
E. Cross-sectional study
F. Qualitative study
Which terms belong together?
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Reference
1. Dusana Rybarova, Ethics in Research
2. Human Research Ethics Handbook, NHMRC Commonwealth
of Australia 2002
3. James Betts, Recognising Research: Approaches & Designs
4. CEBM Research Design