Pengantar Etika Penelitian (Introduction to Research Ethics)

Dr. Amalia Muhaimin, MSc. (Bioethics) School of Medicine Universitas Jenderal Soedirman

Learning objectives
1. 2. 3. 4. Historical background and aim Research ethics guidelines Main principles in research ethics Research ethics issues

Why research ethics??

Any experiences? Research ethics issues in Indonesia? What historical background???

Ibnu Sina (Avicenna) (980-1037)

Introduced experimentation into medicine and the idea of a set of rules for testing the effectiveness of treatments

Avicennas Cannon
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3.

4. 5.

6.

7.

The drug must be free from any extraneous accidental quality It must be used on a simple, not a composite, disease The drug must be tested with two contrary types of disease, because sometimes a drug cures one disease by its essential qualities and cures another by its accidental ones The quality of the drug must correspond to the strength of the disease The time of action must be observed, so that essence and accident are not confused The effect of the drug must be seen to occur constantly or in many cases, for if did this not happen, it was an accidental effect The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on men

The Nuremburg Trials

To prosecute the accused Nazi doctors, a list of ethical guidelines for the conduct of research the Nuremberg Code were developed The Nuremberg Code consisted of ten basic ethical principles that the accused violated.

Modern Research Ethics

Desire

to protect human subjects involved in research projects First attempt Doctors Trial of 1946-1947 a segment of the Nuremberg Trials for Nazi war criminals Experiments: the limits of the human body by exposing victims to extreme temperatures and altitudes how quickly a human could be euthanatized in order to carry out the Nazi racial purification policies most efficiently etc.

The Nuremburg Code

1. 2. Participants must voluntarily consent to research participation Research aims should contribute to the good of society

3.
4. 5. 6. 7. 8. 9.

Research must be based on sound theory and prior animal testing

Research must avoid unnecessary physical and mental suffering No research projects can go forward where serious injury and/or death are potential outcomes The degree of risk taken with research participants cannot exceed anticipated benefits of results Proper environment and protection for participants is necessary Experiments can be conducted only by scientifically qualified persons Human subjects must be allowed to discontinue their participation at any time

10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death

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The Tuskegee Syphilis Study

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The Tuskegee Syphilis Study (Black Men in US; 1932 - 1972)

1932 Study starts. Black men with syphilis are enrolled, are told to be treated, but are not treated in actuality. Not treating is hypothesized as giving some medical benefits. Penicillin not yet found 1945 Penicillin accepted as treatment of choice for syphilis. 1947 USPHS establishes "Rapid Treatment Centers" to treat syphilis; men in study are not treated, but syphilis declines. 1969 CDC reaffirms need for study and gains local medical societies' support 1972 Study ends. 1973 Congress holds hearings and a class-action lawsuit 12 is filed on behalf of the study participants.

Research ethics guidelines

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3.
4.

Nuremburg Code Helsinki Declaration Belmont Report Animal Welfare Act

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The Helsinki Declaration

Developed by the World Medical Association (WMA)

Revised and updated periodically since 1964 last update in 2000.

Basic ethical principles for conducting biomedical research and specifies guidelines for research conducted either by a physician, in conjunction with medical care, or within a clinical setting. Contains all the basic ethical elements specified in the Nuremberg Code but then Advances further guidelines specifically designed to address the unique vulnerabilities of human subjects solicited to participate in clinical research projects

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The unique principles developed within the Helsinki Declaration:

The necessity of using an independent investigator to review potential research projects Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects The importance of preserving the accuracy of research results Suggestions on how to obtain informed consent from research participants Rules concerning research with children and mentally incompetent persons Evaluating and using experimental treatments on patients The importance of determining which medical situations and conditions are appropriate and safe for research
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The Belmont Report of 1979 from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
The report outlines: 1. The ethical principles for research with human subjects 2. Boundaries between medical practice and research 3. The concepts of respect for persons, beneficence, and justice 4. Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection (justice) *

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The Nuremberg, Helsinki, and Belmont guidelines foundation of more ethically uniform research Governmental laws and regulations concerning the responsible conduct of research have since been developed for research that involves both human and animal subjects. How about Indonesia?? The Animal Welfare Act provides guidelines and regulations for research with animals.

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What are the main ethical principles that govern research with human subjects?
1. Autonomy

To respect each participant as a person capable of making an informed decision regarding participation in the research study
Ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions The principle of autonomy finds expression in the informed consent document.

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2.

Beneficence Refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit calculation must be performed.

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3.

Justice Demands equitable selection of participants, i.e., avoiding participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children. Equality in distribution of benefits and burdens among the population group(s) likely to benefit from the research.

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Terima kasih

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