RESEARCH ETHICS

IN MEDICAL SCIENCES

Ngatidjan

Department of Pharmacology and Therapy FoM UGM

Medical and Health Research Ethics Committee
Faculty of Medicine, Universitas Gadjah Mada RSUP Dr. Sardjito
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RESEARCH ON MEDICAL SCIENCES

Biomedical research :

pharmaceutics,
medical devices,
radiation and imaging,
surgical procedures,
medical records,
biological samples,
epidemiological,
social and psychological.

(is not just basic medical sciences)

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(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.

have to be clear on ethical aspect why?

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Research in Biomedical, Clinic and PH

May involves :
Animals (healthy or artificially sick),

Human (healthy or getting sick),

Isolated cells, tissues, organs or other body components,

(from animals or human),

Groups of people or community.
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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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ETHICAL BASIS
of studies on human

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Historical background
1. Before 19 century
therapy, empirical based use the most effective.

2. Since 19 century therapy based on scientific methods

scientific based therapy, ethical scandal ethical aspect?

3. Scandals
Tuskegee scandal poorly syphilis patient
NAZI scandal captured subject of study.

Nuremberg code (1947),

Universal declaration of human right (UN 1948),
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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.

2. Nazi (Nuremberg) scandal

Nuremberg doctor trial on captured people as the subjects.
the study was discovered in correlation with Nuremberg military tribunal.

ethical basis Nuremberg code

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NUREMBERG CODE 1947

Voluntary.
Must have fruitful result.
Based on the result on animal experimentation.
As to avoid unnecessary physical or mental suffering.
Not an life-death harmful result.
Degree of risk should never exceed the humanitarian.
Proper and adequate facilities.
Scientifically qualified researcher.
Subject may withdrawn freely from the study.
Experimentation may be stopped anytime if harmful result observed.
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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)

explore subject right

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ETHICAL BASED OF A RESEARCH

1. Reasonable ( scientific based),
2. Managable feasible,
3. Scientific merit,
4. Social merit (beneficence),
5. Competence,
6. Subject welfare,
7. Do no harm.
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SIENTIFIC BASED
1. Reason (background),
2. Aims of the study,

3. Design (appropriate design),

4. Subject criteria (inclusive or exclusive criteria),

5. Sample size (the reasonable number of subject),

6. Randomization.
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SIENTIFIC BASED
7.

Data collecting (methods, procedure, etc.).

8.

Data storing.

9.

Data analysis.

10. Endpoint of the study

primarily,
secondary.

11. The length of time for the study.

12.
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Reporting publication.
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ETHICAL BASED OF A RESEARCH

1. Reasonable ( scientific based),
2. Managable feasible,
3. Scientific merit,
4. Social merit (beneficence),
5. Competence,
6. Subject welfare,
7. Do no harm.
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BASIC PRINCIPLES OF ETHICS

Respect for person,

Justice,

Human right,

Confidential,

Beneficence,

Non malfeasance.

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BASIC PRINCIPLES OF ETHICS

1. Respect for person
Respect for person as human (humanity)
Respect for autonomy self determination
Respect for the right

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

person can be contacted in an emergency condition

the possibility of stop joining in the study
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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)

consent or willing to participate in 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

Implied or tacit (silent, understanding each other)

normal or constructive consent
emergency consent
(consent in an emergency situation)
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4. CONFIDENTIAL
Information
data, sample / materials have to be kept as a screed.
selective disclosure of information.

The use of data or sample

as the purposes stated or the aims of the study

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.

linked information anonymous code.

written or verbal interview (recorded).

do not give any chance to trace certain

(interesting) 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.

Less minimal risk may occured,

Scientific requirement investigator competence,
Maintain individual welfare.
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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

according to individual patient characteristic (sex, age etc.)

according to disease characteristic (severity, duration etc.)
in or out patients

exclusion criteria

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according to individual patient characteristic (pregnant etc.)

according to disease characteristic (severity, duration,
complicating disease, failure to response to drug etc.)
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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?

Is used when no any standard treatment for the disease.

Effective if the effect of test drug is much influenced by

subjective factor (pain, comfort etc.)

Is appropriate for mild to moderate condition of disease,

contraindicated for life threatening state of disease.

no placebo for study of infection therapy etc.

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ETHICAL ASPECTS OF A PROPOSAL

Aims of the study

Design of the study

Methods
Treatments

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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AGAINST ETHICS IN DOING RESEARCH

Repeat what other people did on the same topic, etc.
Stealing the idea,
Data falsification,
Submit a proposal which is (the research) had be done,
Without any informed consent (research on human),

Put someone name who is never involve in the research,

Ignore anyone who had ever contributed in the research, etc.
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ETHICAL CLEARANCE

AND IRB (EC)

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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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Institutional Review Board (IRB)

Established by an institution
which responsible for health and medical sciences

development faculty / school of medicine

The roles :
To review biomedical research for contributing and
safeguarding the dignity, rights, safety, and well-being of all

actual or potential research participants

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Institutional Review Board (IRB)

Carrying out review of proposed research

before commencement of the research

Regular evaluation of ethics of on going
research that received a positive decision
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Institutional Review Board (IRB)

Membership requirement
Term of appointment

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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IRB and SOP

Submitting an application
Reviewing

Decision making
Communication decision

Follow-up
Documentation & archiving
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IRB (EC) REVIEW

Independent and competent
ethical review is the cornerstone
for the development of health
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EELEMENTS OF REVIEWING
Example aspects have to be reviewed :
Scientific design and conduct of the study,
Recruitment of research participants,

Care and protection of research subjects

Protection of research participant confidentiality
Informed consent process
Community consideration
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HOW TO GET ETHICAL CLEARANCE

1. Good written proposal of study on human (or animal)
Scientific aspect
Ethical aspect

2. Research proposal is submitted to IRB

Review it is communicated to researcher
Presentation to clarify communication
Rewrite resubmit re-review communication

3. Ethical Clearance
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ngatidjansp@gmail.com

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