Etika Penelitian Dr.meita

7/29/2019 Etika Penelitian Dr.meita

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Research EthicsEthics in Medical Research

Dr. Meita Dwi Utami, MSc

PSPD FKK UMJ


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Medical progress depends on

clinical research (Fadel, 2010)

Allah created disease and its cureexcept senility (death). Sons of

Adam seek the cure but not use

haraam things (Al Hadith)


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A selective history of clinical research

Who When What

Ibnu Sina 900 C.E. Water borne transmission

Hippocrates Hippocratic method: Observation in a

disease

Frederich II 1200 C.E. Effect of exercise on digestion

Wren 1656 First IV line for first blood transfusion

Anthonj van Leeuwenhoek 1674 Microscopy bacteria, yeast,

protozoa,

Van Helmont 17th century Effect of bloodletting in fever

James Lind 1747 Sailor experiment nutritionscurvy


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Research components

Research

Who

When

Whom

How

Where

What


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Components of research

AspectsWhat Aim of the research? Risks? Benefits?

When Retrospective? Prospective? Cohort?

Where Laboratory? Hospital? Community? etcHow Clinical trials? Observation? Survey?

Laboratory test? Etc

Whom The subjects of experiment: human,

microorganisms, environment, etc

Who YOU??!!!!


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ILMU DAN SARANA BERFIKIR ILMIAH

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LOGIKA

MATEMATIKA

KHASANAH DUNIA RASIONAL RAMALAN

ILMU DUNIA EMPIRIS (HIPOTESIS)

INDUKSI PENGUJIAN

FAKTA

DEDUKSI

STATISTIKA METODE

PENELITIAN


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RESEARCH

Research is the repeated search tothe unknown

Hypothesis (cause-effect) Thesis Cause Independent variable

Effect Dependent variable


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Characteristic of Research

1. Problem oriented2. Curiosity3. Originality4. Phenomena: Law and Keteraturan5. Goal Generalization6. Cause and Effect Study7. Accurate measurement8. Sound and known methods and

techniques

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RESEARCH

PROCEDURES

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MEMILIH MASALAH PENELITIAN

MERUMUSKAN MASALAH DAN TUJUAN

MERUMUSKAN HIPOTESIS

MEMILIH PENDEKATAN

(METODE PENELITIAN)

MENENTUKAN SUMBER DATA

MENENTUKAN DAN MENYUSUN INSTRUMEN

MENGUMPULKAN DAN ANALISIS DATA

MEMBUAT KESIMPULAN dan LAPORAN

Studi

Pendahuluan

Merumuskan TOPIKAtau JUDUL

TEORI, HUKUM, DALIL

MENENTUKAN VARIABEL


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Scientific Methods

Characteristics of Scientific Method

1. Based on facts

2. Free from prejudice

3. Using analytical priciples

4. Objective measurements

5. Has hypothesis

6. Quantitative techniques

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The Ten Commandments for Picking a Research Project

(C. Ronald Kahn, M.D, NEJM, 330: 1530, 1994)

Anticipate the Results Before Doing the First Study

I. Pick an Area on the Basis of the Interest of the Outcome.

II. Look for an Underoccupied Niche that has Potential.

III. Go to Talks and Read Papers outside Your Area of Interest.

VI. Build on a Theme.

VI. Find a Balance Between Low-Risk and High- Risk Projects, but

Always Include a High-Risk, High Interest Project in Your

Portfolio.

VII. Be Prepared to Pursue a Project to any Depth Necessary.VIII. Differentiate Yourself from Your Mentor.

IX. Do Not Assume that Outstanding, or Even Good Clinical Research

is Easier Than Outstanding Basic Research.

X. Focus, Focus, Focus.fkk umj


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Relation of Problems, Goals and Conclusions

in a Research

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Problems:

Question

Goals:

Answer

Conclusions:A defined answer


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History of Medical Research Ethics

Year Documents

1948 Nuremberg Code: International Code of Ethic

1954 NIH CC Medical Board: call for informed consent and protocol

review

1963 FDA requires informed consent

1964,

2000(rev)

Declaration of Helsinki

1993, 2002

(rev)

International ethical guidelines for Biomedical Research Involving

Human Subject


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Dr. R, a general practitioner in a small rural town,

is approached by a contract research organization

(C.R.O.) to participate in a clinical trial of a new

non-steroidal antiinflammatory drug (NSAID) for

osteoarthritis. She is offered a sum of money for

each patient that she enrols in the trial.

The C.R.O. representative assures her that the trialhas received all the necessary approvals, including

one from an ethics review committee.

Dr. R has never participated in a trial before and ispleased to have this opportunity, especially with

the extra money.


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Some principles from DoH:

Paragraph 15 of DoH:

...every proposal for medical research onhuman subjects must be reviewed and

approved by an independent ethics

committee before it can proceed.

Ethics Review Committee Approval


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...medical research involving humansubjects must be justifiable on scientific

grounds.

Scientific Merit


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Paragraph 17 and 21 of DoH:

...social value has emerged as animportant criterion for judging whether a

project should be funded.

Social Value


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If the risk is entirely unknown, then theresearcher should not proceed with the

project until some reliable data are

available

Risks and Benefits


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Paragraph 24, 26, 27 and 29 of DoH:

(Nuremberg code)

The voluntary consent of the human

subject is absolutely essential.

Informed Consent


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...the physicians role in the physician

patient relationship is different from the

researchers role in the researcher-

research subject relationship

Conflict of roles


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...research subjects have a right to

privacy with regard to their personal

health information

Confidentiality


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...there have been numerous recent

accounts of dishonest practices in the

publication of research results

Honest reporting of the results


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Integrity

investigators should be qualified and

competent to conduct the study by virtue

of their education and experience

.plus Honesty


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UI Komite Kaji Etik FKUI Unhas Komisi Etik FKUH UGM Pusat Kajian Bioetik dan

Humaniora Kedokteran

Setiap RS biasanya memiliki Komite Etik


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In our country .

Komnas Etik Penelitian Kesehatan

Komisi Etik membahas usulan-usulan penelitin

biomedis yang menggunakan manusia sebagai

subyek penelitian, baik untuk kegiatan

penelitian yang dilakukan oleh unit-unit

penelitian di lingkungan Badan Litbangkes,ataupun kegiatan penelitian yang dimonitor

oleh Badan Litbangkes.
http://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_1/KMK%20No.%20562%20ttg%20Komisi%20Nasional%20Etik%20Penelitian%20Kesehatan.pdf


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Sekretariat Bersama Komisi Etik Penelitian

dan Komisi Ilmiah

Gedung Sekretariat Badan Litbangkes

Jl. Percetakan Negara, No. 29

Jakarta Pusat, 10560

Telp. 021 4261088 ext. 114 / 127

Kunjungi website

http://www.litbang.depkes.go.id


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Dr. R should not have accepted so quickly. She should first

find out more about the project and ensure that it meets

all the requirements for ethical research.

In particular, she should ask to see the protocol that was

submitted to the ethics review committee and any

comments or conditions that the committee put on the

project. She should only participate in projects in her area

of practice, and she should satisfy herself about the

scientific merit and social value of the project. If she is not

confident in her ability to evaluate the project, she should

seek the advice of colleagues in larger centres.

She should ensure that she acts in the best interests of her

patients and only enrols those who will not be harmed by

changing their current treatment to the experimental one

or to a placebo.


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She must be able to explain the alternatives to her patients

so they can give fully informed consent to participate or

not to participate.

She should not agree to enrol a fixed number of patients as

subjects since this could lead her to pressure patients to

agree, perhaps against their best interests. She should

carefully monitor the patients in the study for unexpected

adverse events and be prepared to adopt rapid corrective

action.

Finally, she should communicate to her patients the results

of the research as they become available.


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Conclusion

The history of clinical research can be

traced to all cultures.

The future requires information exchange

to maximize progress in health care.

Ethical clearance is strongly advised in

medical research with human being as

the subject.


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Whats past is prologue

(Wil l iam Shakespeare, The Tempest)

Wassalamu alaikum Wr.Wb


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References

World Medical Association, Medical Ethics Manual:

Chapter 5, 2005.

59th World Medical Association General Assembly.

Declaration of Helsinki: ethical principles for medical

research involving human subjects. 2008.

NIH, History of Clinical Research and Choosing a

Research Question, 2008.

Fadel, Ethics of Clinical Research: An Islamic

Perspective, JIMA vol. 42, 2010.

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