Research Ethics

Ethics in Medical Research

Dr. Meita Dwi Utami, MSc PSPD FKK UMJ

 Allah created disease and its cure except senility (death). Sons of Adam seek the cure but not use haraam things (Al Hadith) Medical progress depends on clinical research (Fadel, 2010)

A selective history of clinical research

Who Ibnu Sina Hippocrates Frederich II Wren Anthonj van Leeuwenhoek Van Helmont James Lind 1200 C.E. 1656 1674 17th century 1747 When 900 C.E. What Water borne transmission Hippocratic method: Observation in a disease Effect of exercise on digestion First IV line for first blood transfusion Microscopy bacteria, yeast, protozoa, Effect of bloodletting in fever Sailor experiment nutrition scurvy

Research components
Who What When

Research
Where How Whom

Components of research
Aspects
What When Where How
Whom Who

Aim of the research? Risks? Benefits? Retrospective? Prospective? Cohort? Laboratory? Hospital? Community? etc Clinical trials? Observation? Survey? Laboratory test? Etc The subjects of experiment: human, microorganisms, environment, etc YOU??!!!!

ILMU DAN SARANA BERFIKIR ILMIAH

LOGIKA MATEMATIKA

DEDUKSI
KHASANAH DUNIA RASIONAL RAMALAN

ILMU

DUNIA EMPIRIS

(HIPOTESIS)

INDUKSI FAKTA STATISTIKA

PENGUJIAN

METODE PENELITIAN

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RESEARCH Research is the repeated search to the unknown Hypothesis (cause-effect) Thesis Cause Independent variable Effect Dependent variable

Characteristic of Research
1. 2. 3. 4. 5. 6. 7. 8. Problem oriented Curiosity Originality Phenomena: Law and Keteraturan Goal Generalization Cause and Effect Study Accurate measurement Sound and known methods and techniques

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RESEARCH PROCEDURES
TEORI, HUKUM, DALIL

MEMILIH MASALAH PENELITIAN

Studi Pendahuluan Merumuskan TOPIK Atau JUDUL

MERUMUSKAN MASALAH DAN TUJUAN

MERUMUSKAN HIPOTESIS
MEMILIH PENDEKATAN (METODE PENELITIAN) MENENTUKAN VARIABEL

MENENTUKAN SUMBER DATA

MENENTUKAN DAN MENYUSUN INSTRUMEN

MENGUMPULKAN DAN ANALISIS DATA

MEMBUAT KESIMPULAN dan LAPORAN

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Scientific Methods
Characteristics of Scientific Method
1. 2. 3. 4. 5. 6. Based on facts Free from prejudice Using analytical priciples Objective measurements Has hypothesis 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.
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Relation of Problems, Goals and Conclusions in a Research

Problems: Question

Goals: Answer

Conclusions: A defined answer

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History of Medical Research Ethics

Year
1948

Documents
Nuremberg Code: International Code of Ethic

1954

NIH CC Medical Board: call for informed consent and protocol review
FDA requires informed consent Declaration of Helsinki

1963 1964, 2000(rev)

1993, 2002 International ethical guidelines for Biomedical Research Involving (rev) Human Subject

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 trial has received all the necessary approvals, including one from an ethics review committee. Dr. R has never participated in a trial before and is pleased to have this opportunity, especially with the extra money.

Some principles from DoH:

Paragraph 15 of DoH: ...every proposal for medical research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed. Ethics Review Committee Approval

Some principles from DoH:

Paragraph 12 of DoH: ...medical research involving human subjects must be justifiable on scientific grounds.

Scientific Merit

Some principles from DoH:

Paragraph 17 and 21 of DoH: ...social value has emerged as an important criterion for judging whether a project should be funded.

Social Value

Some principles from DoH:

Paragraph 20 of DoH: If the risk is entirely unknown, then the researcher should not proceed with the project until some reliable data are available Risks and Benefits

Some principles from DoH:

Paragraph 24, 26, 27 and 29 of DoH: (Nuremberg code)

The voluntary consent of the human subject is absolutely essential. Informed Consent

Some principles from DoH:

Paragraph 31 of DoH: ...the physicians role in the physician patient relationship is different from the researchers role in the researcherresearch subject relationship Conflict of roles

...research subjects have a right to privacy with regard to their personal health information
Confidentiality

...there have been numerous recent accounts of dishonest practices in the publication of research results

Honest reporting of the results

Integrity
investigators should be qualified and competent to conduct the study by virtue of their education and experience
.plus Honesty

 UI Komite Kaji Etik FKUI Unhas Komisi Etik FKUH UGM Pusat Kajian Bioetik dan Humaniora Kedokteran Setiap RS biasanya memiliki Komite Etik

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.

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

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.

 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.

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.

Whats past is prologue (William Shakespeare, The Tempest)

Wassalamu alaikum Wr.Wb

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.