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Ethical Clearance

Ethics’ Committee on Reproductive Health Research


Medical School, University of Sumatera Utara

Prof. dr. Delfi Lutan, MSc., SpOG(K)


WHO Collaborating Center for Research in
Human Reproduction
Medan, October 2017
1
What is the ethical clearance ?

Ethical Clearance is an approval of the ethic’s


committee on reproductive health research
based on the certainty of ethics that have both
of the international and national quality.

2
Why should the ethical clearance is needed
by every researcher on Reproductive Health
Research ?
Because the ethical clearance (approval to
implement the research) is needed to meet the
legal aspect’s procedure of research on medical/
reproductive health that have already agreed as
a global (not in-contradiction to the legislation
rule that has obtained, the suitability, and the
morality).

3
What is an importance to get the Ethical
Clearance from the Ethic’s Committee to
implement reproductive health research ?

Having the ethical clearance is one of the


protection mechanisms toward the subject and
researcher that are involved in the reproductive
health research.

4
When and how long the process to get an
ethical clearance ?

Ethical clearance has to be gotten before the


research is started and the process to get it
has to be waited for one month.

5
What is the requirement to get an approval
(ethical clearance) ?
1. Requested by researcher who have a competency to implement
the reproductive health research (as individually and group).
2. Give two copies of research protocol.
3. Attach two copies of researcher’s CV and the budget estimation.
4. Fill in the two copies of standard form that is given by the ethic’s
committee on reproductive health research.
5. Attach two copies of the explanation of research’s activity
concern all the aspect of research that will be done with the
clearly language that could be understood by the subject of
research.
6
What kind research should attach an ethical
clearance ?

Every research on reproductive health that is


involves a human (even as group or individually)
or animal as the subject of research)

7
What kind research that is included on the
reproductive health research ?

Reproductive health research is the biomedical


research which is included research on the
pharmaceutical, medical apparatus, radiation
and imaging, medical record, biological material,
also research on epidemiological, social and
psychology (WHO).

8
What is the institution that has a capability to
give an ethical clearance ?

The institution that has a capability to give an


ethical clearance is the Ethics’ committee on
Reproductive Health Research.

9
What is the ethic’s committee on
reproductive health research ?
• The ethic’s committee on reproductive health
research is an independent organization that has a
member both of the non-expert and the entire
different scientist.
• This committee has a duty to give an assessment
and review/consideration toward the research
protocol on reproductive health which using a
human and other as the research subject.

10
What is the duty of the ethic’s committee on
reproductive health research ?

• Their duty is to helping the researcher whose


doing the medical/reproductive health research,
in or outer the environment of Sumatera Utara
University, to give the assessment,
consideration, and approval to implement the
research.

11
WIRHDC MEDAN 12

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