kuliah etika research

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

Ngatidjan 1 RESEARCH ETHICS

Biomedical research :

pharmaceutics,

medical devices,

radiation and imaging,

surgical procedures,

medical records,

biological samples,

epidemiological,

social and psychological.

(is not just basic medical sciences)

RESEARCH ON MEDICAL SCIENCES

(Loedin, 2004) Ngatidjan 2 RESEARCH ETHICS

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? Ngatidjan 3 RESEARCH ETHICS

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.


5 RESEARCH ETHICS Ngatidjan

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

ETHICAL BASIS

of studies on human


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),

Historical background


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

History ethics?:


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.


STUDY ON HUMAN

Experimental study give treatment / intervention food, drug, inflict certain condition

Non-experimental study case control, cohort, cross sectional,

survey

(observation or interview)

explore subject right

Ethical Consideration


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.


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.


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. Reporting publication.


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.


BASIC PRINCIPLES OF ETHICS

Respect for person,

Justice,

Human right,

Confidential,

Beneficence,

Non malfeasance.


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 Ngatidjan 16 RESEARCH ETHICS

3. INFORMED CONSENT

Information process

Comprehension

Volunteerness to join consent


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 Ngatidjan 18 RESEARCH ETHICS

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 Ngatidjan 19 RESEARCH ETHICS

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 Ngatidjan 20 RESEARCH ETHICS

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


individual consent

(in developed community, urban area).

community consent

(in underdeveloped community, and may

represented by key person).

3. INFORMED CONSENT


3. INFORMED CONSENT

Expressed orally

written

Implied or tacit (silent, understanding each other)

normal or constructive consent

emergency consent

(consent in an emergency situation)


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)


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

4. CONFIDENTIAL


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.

5. BENEFICIAL BENEFICENCE


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.

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 according to individual patient characteristic (pregnant etc.)

according to disease characteristic (severity, duration,

complicating disease, failure to response to drug etc.)



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?


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.



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)


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).


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.


ETHICAL CLEARANCE

AND IRB (EC)


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)


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

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



Membership requirement

Term of appointment

Conditions of appointment

Office(s)

Quorum requirements

Independent consultants

Education of EC member



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.

Composition of IRB


Submitting an application

Reviewing

Decision making

Communication decision

Follow-up

Documentation & archiving

IRB and SOP


Independent and competent

ethical review is the cornerstone

for the development of health

IRB (EC) REVIEW


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

EELEMENTS OF REVIEWING


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 Ngatidjan 43 RESEARCH ETHICS


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