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IN MEDICAL SCIENCES
Ngatidjan
RESEARCH ETHICS
pharmaceutics,
medical devices,
radiation and imaging,
surgical procedures,
medical records,
biological samples,
epidemiological,
social and psychological.
RESEARCH ETHICS
(Loedin, 2004)
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BIOMEDICAL RESEARCH :
Animal,
population,
individually,
isolated cell, tissue / organ,
Microorganism,
diseases, biological weapon etc.
Human,
population,
individually,
isolated cell, tissue / organ.
RESEARCH ETHICS
RESEARCH ETHICS
STUDY ON HUMAN
Experimental study
give treatment / intervention
food, drug, devices, inflict certain condition
Non-experimental study
case control
cohort
cross sectional
survey
(observation or interview)
explore things in subject right
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RESEARCH ETHICS
ETHICAL BASIS
of studies on human
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RESEARCH ETHICS
Historical background
1. Before 19 century
therapy, empirical based use the most effective.
3. Scandals
Tuskegee scandal poorly syphilis patient
NAZI scandal captured subject of study.
RESEARCH ETHICS
History ethics?:
1. Tuskegee scandal
a study conducted by Tuskegee Institute (Alabama 1930 1972)
in Mason country (82% of residence were black and poor; 36% of them
were suffering from syphilis)
the patients did not receive any medical treatment at all although penicillin
was available (the study was to know the course of the disease).
the scandal was discovered by a journalist, Jean Heller.
the study was then stopped by government authority without any trial.
RESEARCH ETHICS
RESEARCH ETHICS
STUDY ON HUMAN
Experimental study
give treatment / intervention
food, drug, inflict certain condition
Non-experimental study
case control,
cohort,
cross sectional,
Ethical Consideration
survey
(observation or interview)
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SIENTIFIC BASED
1. Reason (background),
2. Aims of the study,
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SIENTIFIC BASED
7.
8.
Data storing.
9.
Data analysis.
Reporting publication.
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Justice,
Human right,
Confidential,
Beneficence,
Non malfeasance.
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2. Justice
treat everyone in the same manner according to
morally right and proper, dignity and their right.
randomization is an example.
balance of the right and responsibility
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3. INFORMED CONSENT
Information process
Comprehension
Volunteerness to join consent
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3. INFORMED CONSENT
Informed
having information
an information process must happened
Consent
to give assent or approval
compliance in or approval of what is done
or proposed by another
agreement as to action or opinion
Volunteerness
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3. INFORMED CONSENT
a set of subject statement consists of :
the volunteerness to joint in a study
after having informations of a study, including :
the procedure of the study
the risk or any uncomfortable condition may occur
the advantage of the study
any alternative therapy can be given
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3. INFORMED CONSENT
Sufficient information
about the study (research)
aims of the study
procedure
benefit
risk
any alternative (if intervention applied)
contact person
the possibility of stop in joining participating
comprehension
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3. INFORMED CONSENT
Volunteerness
pressure free free from the following things :
give, reward, present etc. no inducement participations
status (student from teacher, soldier from commander)
threat (refuse to joint will get bad mark, will not be serviced)
fear (fear about future live if refuse to joint into the study)
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3. INFORMED CONSENT
individual consent
(in developed community, urban area).
community consent
(in underdeveloped community, and may
represented by key person).
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3. INFORMED CONSENT
Expressed
orally
written
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4. CONFIDENTIAL
Information
data, sample / materials have to be kept as a screed.
selective disclosure of information.
Respondent identity
respondent's identity have to be transformed
to identity number (respondent`s number)
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4. CONFIDENTIAL
Client data is confident
- be ware about data handling and storing.
is it unlinked or linked information.
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5. BENEFICIAL BENEFICENCE
Maximizing benefit,
inform to subject about the benefit of the study.
coordinate with relatives to maximize the benefit.
accommodate the need of the subject ( patients care).
participation of relatives (for instance his, her, their family).
to understand the important of the study.
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6. DO NO HARM (NONMALFICENCE)
Minimizing possible harm.
- prevent causing harm or doing wrong.
(does not do thing that is taboo).
- prevent the occuring of harm to patient and harmful publicity.
- respect to social mores (for some reason).
- sensitive to different culture
do not encounter to existing culture.
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6. DO NO HARM (NONMALFICENCE)
Minimizing possible harm.
inclusion criteria
exclusion criteria
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6. DO NO HARM (NONMALFICENCE)
Blindness masking?
to avoid bias.
may use a placebo (negative control treatment) or
standard treatment (positive control treatment)
may be as single masking, double masking or triple
masking etc.
ethical considerations?
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6. DO NO HARM (NONMALFICENCE)
Placebo involvement?
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Subject recruitment
inclusive and exclusive subjects
vulnerable subjects
Rescue procedures
Informed consent
Confidential respondent identity IN (identity number)
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RESEARCH MISCONDUCT
Data fabrication,
Data falsification,
Plagiarism data stealing,
or other practices that seriously deviate from those that are
commonly accepted within the scientific community for
proposing, conducting and reporting research.
author involvement (for anyone who did not involve in a
research or without permision),
there is no any acknowledgement to anyone who actually
did most of the research work (i.e. students).
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ETHICAL CLEARANCE
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ETHICAL CLEARANCE
a written statement concerning the ethical property of
study on human (or animal)
issued by an IRB (institutional review board)
in the Faculty of Medicine UGM :
Komisi Etik Penelitian Kedokteran dan Kesehatan
(Medical and Health Research Ethics Committee Faculty of
Medicine Universitas Gadjah Mada RSUP Dr. Sardjito)
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The roles :
To review biomedical research for contributing and
safeguarding the dignity, rights, safety, and well-being of all
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Conditions of appointment
Office(s)
Quorum requirements
Independent consultants
Education of EC member
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Composition of IRB
Health and medical scientists,
(At least one of) animal health practitioner,
(At least one of) law practitioner,
(At least one of) lay person.
Chairman,
Secretary,
Members.
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Decision making
Communication decision
Follow-up
Documentation & archiving
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EELEMENTS OF REVIEWING
Example aspects have to be reviewed :
Scientific design and conduct of the study,
Recruitment of research participants,
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3. Ethical Clearance
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ngatidjansp@gmail.com
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