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ETIKA DAN DESAINPENELITIAN

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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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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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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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?

?

?


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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


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


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

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