Research Ethics 2:

Ethical Review

DR. AMALIA MUHAIMIN, M.SC. (BIOETHICS)

HEALTH RESEARCH ETHICS COMMITTEE
SCHOOL OF MEDICINE
UNIVERSITAS JENDERAL SOEDIRMAN
Learning Objectives
2

Students should be able to explain why ethical review is

needed in research
Students should be able to explain what components are to
be reviewed in an ethical review
Students should be able to explain components of informed
consent for research involving human subjects

Blok Medical Research Program 2 6/14/2013

1.Why Ethical Review?
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All research must be scientifically AND ethically sound.

Three primary ethical principles:
Autonomy obligation to respect each participant as a
person capable of making an informed decision
Beneficence obligation to attempt to maximize
benefits for the individual participant and/or society, while
minimizing risk of harm
Justice equitable selection of participants and equal
distribution of benefits and burdens among the population
group(s)

Blok Medical Research Program 2 6/14/2013

2. What components are reviewed?
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1. Significance of study objectives, background,

preliminary studies
2. Researchers competence formal and informal training
3. Research design and methods inclusion+exclusion
criteria, sampling method, randomization, blinding,
procedures, etc.
4. Balancing risks and benefits
5. Respect for human dignity: informed consent,
confidentiality , vulnerable subjects, competence
6. Fairness participant selection, equal distributio of
benefits and burdens
7. Researchers responsibility and integrity
Blok Medical Research Program 2 6/14/2013
Who does an ethical review?
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Institutional Review Board (IRB)

Research Ethics Committee (REC)
Komisi Etik (Penelitian) (Kesehatan) (KEPK)
lembaga/institusi/RS
Komisi Nasional Etik Penelitian Kesehatan (KNEPK)
Balitbangkes Depkes RI

Ethical Clearance
= Kelayakan Etik
= Persetujuan Etik

Blok Medical Research Program 2 6/14/2013

3. Informed Consent
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Other names:
Persetujuan Tindakan Medik (PTM) pelayanan
kesehatan di RS
Persetujuan Setelah Penjelasan (PSP)
Lembar Informasi dan Kesediaan (LIK)

Blok Medical Research Program 2 6/14/2013

What are the components of an ethically valid
informed consent?
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Disclosure
Understanding
Voluntariness
Competence
Consent written consent, oral consent,
assent

Blok Medical Research Program 2 6/14/2013

Informed Consent
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1. Purpose of the study

The purpose of this research is

2. Voluntary participation
Your participation in this study is voluntary. You are free
to not participate at all or to withdraw from the
study at any time despite consenting to take part
earlier.

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3. Duration, procedures of the study and

participants responsibilities

The procedure/s to be carried out is/are (state the

procedure/s of the research and how the
participant has to take part in the study). You will
need to undergo the following visits and procedures
(state the expected duration of participation,
including the number and duration of visits to the
research site and what happens at each visit).

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4. Potential benefits
Participation in this study may benefit you/others by (state
all the actual and potential benefits).

5. Risks, hazards and discomforts

(Any potential or actual risks, hazards and discomforts should
be clearly defined)

6. Reimbursements
You would be paid a sum of Rs. (state any payment to the
participant indicating the amount, when it would be paid and
any conditions attached to it).

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7. Confidentiality
These data will never be used in such a way that you could
be identified in any way in any public presentation or
publication without your express permission.

8. Termination of study participation

You may withdraw your consent to participate in this
study at any time, with no penalty or effect on medical
care or loss of benefits.

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9. Clarification
If you have questions about any of the tests / procedures
or information please feel free to ask any of the persons
listed below. (State a list of persons with contact
details from whom the participant can ask
questions and clarify any doubts and their contact
details).

Blok Medical Research Program 2 6/14/2013

Waiver of Informed Consent
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1. Study of public benefit or service programs; or

2. If the IRB finds and documents all of the following:
. (a) no more than minimal risk to the subjects;
. (b) the waiver will not affect the subjects rights/welfare
. (c) the research could not practicably be carried out
without the waiver or alteration; whenever appropriate,
the subjects will be provided with additional information
after participation.

How about oral consent??

Blok Medical Research Program 2 6/14/2013

Reference
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Forum of Ethics Review Committees - Sri Lanka (FERCSL).

Ethics Review Committee Guidelines. 2007. Available at:
http://www.searo.who.int/LinkFiles/RPC_Review_Commi
ttee_Guidelines.pdf
Jonsen AR, Siegler M, Winslade WJ. Clinical Ethics: A
Practical Approach to Ethical Decisions in Clinical
Medicine. New York: McGraw Hill; 2002.
Lemmens T, Singer PA. Bioethics for clinicians: 17. Conflict
of interest in research, education and patient care. CMAJ
1998; 159: 960-5.

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