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Pengantar Etika Penelitian(Introduction to Research Ethics)

Dr. Amalia Muhaimin, MSc.

Department of Bioethics; Research Ethics Committee

Faculty of Medicine, Universitas Jenderal Soedirman

Branches of Bioethics

Bioethics

Publichealthethics

Clinicalethics

Researchethics

Environ-mentalethics

Bioethicseducation

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Learning objectives

1. Historical background

2. Issues in research ethics

3. Research ethics guidelines

4. Basic principles in research ethics


What is research ethics?

What do you know about research ethics?

What is the historical background?


Historical Background


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



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Avicennas Cannon

1. The drug must be free from any extraneous acc idental quality

2. It must beused on a simple, not a composite, disease3. The drug must be tested with two contrary types of disease,

because sometimes a drug cures one disease by its essentialqualities and cures another by its accidental ones

4. The quality of the drug must correspond to the strength of thedisease

5. The time of action must be observed, so that essence andaccident are not confused

6. The effect of the drug must be seen to occur constantly or inmany cases, for if did this not happen, it was an accidental effect

7. The experimentation must be done with the human body, fortesting a drug on a lion or a horse might not prove anything aboutits effect on men

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NAZI Human Experimentations

1. Experiments on twins

2. Bone, muscle, and nerve transplantation experiments

3. Head injury experiments

4. Freezing experiments

5. Malaria experiments

6. Mustard gas experiments

7. Sulfonamide experiments

8. Sea water experiments

9. Sterilization experiments10. Experiments with poison

11. Incendiary bomb experiments

12. High altitude experiments


The Nuremburg Trials (1946-1947)

To prosecute the accused Nazi

doctors

A list of ethical guidelines for

the conduct of research The

Nuremberg Code

The Nuremberg Code consisted

often basic ethical principlesthat the accused violated.

Birth ofmodern research ethics


The Nuremburg Code

1. Participants must voluntarily consent to research participation

2. Research aims should contribute to thegood of society

3. Research must be based on sound theory andprior animal testing

4. Research must avoid unnecessary physical and mental suffering

5. No research projects can go forward where serious injury and/or deathare potential outcomes

6. The degree ofrisk taken with research participants cannot exceedanticipated benefits of results

7. Proper environment and protectionfor participants is necessary

8. Experiments can be conducted only by scientifically qualified persons

9. Human subjects must be allowed to discontinue their participation atany time

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



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The Tuskegee Syphilis Study


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

1932 Study starts. Black men with syphilis are enrolled

told to be treated, but not treated in actuality Not treatingis 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 treatsyphilis;men in study are not treated, but syphilis declines.

1969 CDC reaffirms need for study and gains local medicalsocieties' support

1972 Study ends.

1973 Congress holds hearings and a class-action lawsuit isfiled on behalf of the study participants.



The Helsinki Declaration

Developed by the World Medical Association (WMA)

Revised and updated periodically since 1964 last update inOctober 2013 during the 64th WMA General Assembly,Fortaleza, Brazil

Basic ethical principles for conducting biomedical research

Contains all the basic ethical elements specified in theNuremberg Code but then

Advances further guidelines specifically designed to address

the unique vulnerabilities of human subjects


The unique principles developed within the Helsinki

Declaration:

The necessity of using an independent investigator to reviewpotential research projects

Employing a medically qualified person to supervise the

research

The importance of preserving the accuracy of researchresults

Suggestions on how to obtain informed consent from researchparticipants

Rules concerning research with children and mentallyincompetent persons

Evaluating and using experimental treatments on patients

The importance of determining which medical situations andconditions are appropriate and safe for research


Research ethics guidelines1. Avicennas Cannon

2. Nuremburg Code

3. Helsinki Declaration

4. Belmont Report

5. Animal Welfare Act*



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Do you know of any issues

on research ethics in

Indonesia?

12/18/2014

The Case of H5N1 NAMRU 2 Indonesia(2005 2009)


Issues in research ethics

Authorship

Peer review

Conflicts of interest

Data management

Research misconduct

Research with animals Research with human subjects


1. Research Misconduct

Defined as fabrication, falsification, or plagiarism* in:

- proposing,

- performing,

- reviewing research,

- reporting research results

(US Office of Science and Technology Policy, 2000)

Research misconduct does not include honest error or

differences of opinion.


Fabrication is making up data or results and recording or

reporting them.

Falsification is manipulatingresearch materials, equipment,

or processes, or changing or omitting data or results such that

the research is not accurately represented in the research

record.

Plagiarism is the appropriation of another persons ideas,

processes, results, or words without giving appropriate credit.



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2. Research with animals

Why use animals?

Testing new pharmaceuticals, Teaching tools for medical students,

Experimental subjects for new surgical procedures, etc.

The Animal Welfare Act in 1966 (last revised in 2006):

1. Insure that animals intended for use in research facilities are

provided humane care and treatment

2. Assure the humane treatment of animals during

transportation in commerce;

3. Protect the owners of animals from the theft of their animals

by preventing the sale or use of animals which have been

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1. Autonomy To respect each participant as a person capable of making an

informed decision

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

Other principles related:

privacy, confidentiality, vulnerability

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3. Research with human subjects

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2. Beneficence

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.


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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