Research Ehics. Metode Penelitian Basic Principles of Ethics

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1 Research Ehics Metode Penelitian Basic Principles of Ethics 1. Respect for Persons: This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from research subjects (or their legally authorized representatives). 2. Beneficence: This principle requires that researchers maximize benefits and minimize harms associated with research. Researchrelated risks must be reasonable in light of expected benefits. 3. Justice: This principle requires equitable selection and recruitment and fair treatment of research subjects. The Belmont Report, US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 2 1

2 Autonomy in Research Voluntary participation Adequate information to makeinformed consent Comprehension Full disclosure of risks and benefits No undue inducement Voluntary termination Continuing i disclosure Legally authorized representative Culturally appropriate consent 3 1. Respect for persons Autonomy capacity to deliberate about personal goals and action Requires giving weight to a person s opinions and choices and refraining from obstructing their action unless they are detrimental to others Respect for freedom of action Respect for different cultural values Requires giving protection to those with diminished autonomy 4 2

3 2. Beneficence Common definition acts of kindness or charity that go beyond strict obligation Making efforts to secure well being Doctor s duty an obligation Do no harm and maximize benefit and minimize harm In research not to injure one person despite benefits that may accrue to others Risk/ benefit assessment When is it justifiable to seek certain benefits despite the risks involved? When should benefits be foregone because of the risks? 5 Beneficence Macro orientation in scientific research Society recognizes longer term benefits and risks that result from improvement of knowledge and development of new procedures. Micro orientation Individual investigators and sponsors should plan how risks may be minimized and benefits maximized. 6 3

4 Individual benefit Community benefits Social benefits Types of Benefits 7 Types of Community Benefits in Health Research Provision of health care in resource poor communities Salaries, infrastructure, incentives to research participants, etc. Sustaining health care improvements by planning for gradual phase out with the community and local authorities Appropriate training and technology transfer. Access to trial products, infrastructure and knowledge by the research participants, the community and the host country. 8 4

5 Community Benefits Post study benefits may also include: a) disseminating the study results with the study participants, the community and health authorities; b) presenting results in simple, understandable language; c) establishing personal contacts and attendance of community meetings Justice Equal treatment Different treatment requires justification (experience, age, deprivation, competence, merit, position, etc.) What is deserved giving a person the benefit one is entitled to Fair distribution Associated with political representation, taxation, punishment, etc. 10 5

6 Integrity Discerning what is right and what is wrong Acting on what you have discerned, even at personal cost Saying openly that you are acting on your understanding of right from wrong 11 Integrity in Research Intellectual honesty in proposing, performing, and reporting research Accuracy in representing contributions to research proposals and reports Fairness in peer review Collegiality in scientific interactions, including communications and sharing of resources 12 6

7 Misconduct in Research Research misconduct: To do fabrication, falsification or plagerism during hypothesis, conduction or presenting the research. Fabrication (dry labbing/desk research): to make up the results and record and report them Falsification: To manipulate research material, research process, to change or destroy the data or results of a research Plagiarism: To use the ideas, works, results or words of other people without getting permission 13 Gross plagiarism: Plagiarism To copy a printed material as a whole without t modifying i To copy some parts of a printed material To copy a printed material that has been copied from others Smooth plagiarism: To copy a printed material by modifying To present someone s ideas as if they are yours 14 7

8 Playing with Data Trimming: To exclude extreme values in a data set or add new data to a set to achive a desirable result. Cooking: To make multiple measurements and to use the ones you want. Forgery: To create imaginary data from nowhere Salamisation: To divide the results of a research into multiple parts and report them as seperate studies. 15 What Pressures Violate Scientific Integrity? Publication demands d (publish or perish) Tenure decisions Availability of grant money Getting rich Slf Self perpetuating concepts (polywater) Getting MPH from a famous university...??? 16 8

9 What Happens if You Misconduct? Nobody finds out You send the research to a medical journal and the referee finds out that you are lying One of your colleagues catches you and tells everyone 17 What Happens if You Misconduct? You are thrown out of your institute or your organisation Your academic life is over You find yourself on newspapers You find yourself alone You may be charged 18 9