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(World Medical Association

Declaration of Helsinki) ..

..

(volunteer) (participant)

(Forum for Ethical Review Committees in Thailand FERCIT)




(Council for International Organizations of Medical Science CIOMS)
(Ethical Conduct for Research Involving Humans)


..

.






..
..

..

.
..


..

..
(standard operating procedure )

.
..

(biomedical research)
..



( )
..

..


.

..

.

biomedical science social
science research The Belmont Report ,
, .. Belmont
Conference Center Smithsonion ..

The Belmont Report

(Respect for person)
(Beneficence)
(Justice)
. (Respect for Person)
.. (respect for human dignity)
(interest)

..
(free and informed consent)





.. (respect for vulnerable
persons)
/

.. (respect for privacy and
confidentiality)

. (Beneficence, Non-Maleficence)
.. (balancing risks and
benefits)













(
)

.. (minimizing harm)

.. (maximizing benefit)






. (Justice)
(fairness) (equity)

. (Informed Consent Process)






















..

(information sheet)

(informed consent)
()
()

()
()
()

()

()
( )
()

()
()

() ()
()

() / /

()
()
()

()
()

()

()
..
()




()

()


()

()

. (Inducement)

(invite)

.. /

.. (phase I clinical trial)


(phase III)

..

/ /


..



. (Privacy and confidentiality)
..
(integrity)


..
()

()

()

()

(identification)

()

()

(social discrimination)

()

..

..
()





(authorized
person)
()

()

..

. (Vulnerable Group)








..
..

..
..

..

..

..

..

..

..

.
(beneficence)
(risk/benefit ratio)
(risk)
(benefit)


(harm)

..
..

..
..


..

..

.
..
(risk or harm)

..

..


..





..

(minimal risk)
(slight minor increase)

..

(distributive justice) (burden)
(benefit)









(fairness)






(
)

.
..

..

..
( )

.. ( )

..

..



..
(participant)


..

..

..

(case
record form)

..
(standard operating procedures)

.
..

()
(
)



()

()


()
(
)
..


..

.
..

..


.
..


..



( )

..

( conflict of
interest)

..

() /
()

()

() /
/

..
(minimal risk)
(amendment)

..

..
/
..

.
..
(
)



.
..

..

.
..



..


..

..

..

.
..

..

..

.

..



..

. (Clinical Trial)


() ()
()
() (local made) (efficacy)

(double blind)


post-marketing surveillance study

..
()

()

.
.
.
.

. ()
()

(terminate) (withdrawal)


..





..

..









()
(retractors)

()
/


()

()
(placebo)

(sham surgery)












(observational study)
randomized controlled trial




(minimal risk non-significant risk)
(significant risk)




/




()

(electrical pacemaker)



(beneficence) (
)

(fail)



..

..

(placebo)



()
()
()

() placebo effect
() (minor condition)

(irreversible
harm)
()




..

()

() (stopping rule)
, (interim

analysis)


()

. (Epidemiological Research)

. (identifiable data) , ,
(identifier)

. , (potentially identifiable, coded, reidentifiable)

. , , , (de-identified, not re-identifiable,
anonymous data)

..

() / ... /

()


..

()

()
minimal risk
() (public benefit)
()
..

..

..




..

..


..

..

..


..

. (Social Science Research)

..
..

..
..

..

..
..
..

..


..

. (Vaccine Trials)

(phase of trial)
..
(biological effect)
(immunogenicity)
(dose) (route of administration)
(low risk)
..

..
( )

(liveattenuated microorganism)

(recombinant DNA)

. (Use of Human Tissue Samples)

()

() (
)
()

.. (Prospective Studies)

()

()





()

()

()

()

()








()
(material transfer agreement)
... (Retrospective Studies)
()

()



()

()

. (
)
. ()
.

.
/
/
.
. minimal risk
.

.

.
()
(Material Transfer Agreement)

. (Human Genetic Research)

(interaction)









-

(social stigmata) 0

.. , (Biological Relative)
() (information) (consent)

() (
)
()

(linkage study)



..
()

(third party)

()


.. (Genetic Counseling)

.. (Gene Alteration)


(Gene Therapy)

.. (Eugenic Concern)





(mental support)

.. (Banking of Genetic Material)

()



()





.. (Commercial Use of Genetic

Data)

. (Human Gametes),
(Embryo, Embryonic Stem Cell) (Fetus)
(reproductive health)



(human gametes) (embryo)
(fetus)
(respect for the embryo and fetus)

.. (Human Gametes)
()

()



.. (Human Embryo)
(Embryonic Stem Cell)
(1)



(2)

() (human cloning)


..

..

(stem cell)

( ) ..

..
.

.

.

.

.


.

( )
..
() ()
..




( ) ..

..

()

()


(unrelated donor)


()

()





()
()



()
.
()

.
() /

()
()
.
:
.
()
()
()

()

(Donor Registration)
National Stem Cell Donor Program

()

()

()

..

/
( )
/


() ..


/

/ / /

/
(Human Cloning)
/


()

()

()
()

() () ()
()

()

()


()
(Pre-implantation Genetic Diagnosis)

() () () ()

( )

.
.

Good Clinical Practice (GCP)

.

. (Contract Research Organization; CRO)

.

CRO
CRO

. CRO
. CRO

.

CRO
CRO

* ICH-Good Clinical Practice Guideline 5

2543

.
. (
)

.
(Clinical Trial Protocol and Protocol Amendment) ICH

.
.

(remote electronic trial data systems)

.


.
.


(data trail) (edit trail)
.
.
.
.


. (transformed)

.

. (
)

.

. ICH



.

.
.

.
/
.
. GCP

.
.
.

.
.
(
)

(malpractice)
(negligence)
.

.

.
.
.
. GCP

.

. /

.
.



(route)
.

.

. (Characterized)
(

(
)

.

()


( )

.
.
.
(
)
.

.
.
.

. (

)
.

.
(specifications) ( )

.
.

.
.
.

.
.

.
. (safety updates)

.
.
.
.
.

GCP
.
.


.

.

GCP
.






(extensive written guidance)
GCP

.



.
.

()
.

.

.



.

. (subject recruitment rate)

.

.

(applications and submissions)


.

(drop out)

( )


.

GCP

.
.
GCP

.




.

.

. (summary)
/

.


.





.
.

.
.




.



.
.

GCP

.
. GCP




.

.

.

.


.

.
.

. ( )
.

. (
)
.

. (
) ()
( )
.
/
.
.
.

.
()
. (dosage regimen)

. GCP

.
.

* ICH-Good Clinical Practice Guideline 6
2543

.
(scientific integrity)

. ()

. /
(placebo-controlled)
(parallel design)

.
.
.
.
(dosage form)

.

()
. (stopping rules)
(discontinuation criteria)

. -
()
. (trial treatment randomization codes)

. (
)

.
.
.


. (
)
.

.
.
.

.
.

.
(
)

/
.
.
. (efficacy parameters)
.
.
. (safety parameter)
.
.


.
.
.

(planned interim analysis)
.

()

(power)
.


.
.
. (
/
)
. (

)
.

.
.
.
.
.
. ()

(cochlear) , (collagen) , ,
, , (internal stents)
,

(cardiopulmonary resuscitation),
cardiopulmonary bypass

(absorbable hemostatic agents)

(infusion pumps)

(contact lens)
,
(laparoscope) (hysteroscope)
(burns)

(nerve stimulator)

(Material Transfer Agreement; MTA)
MTA
.

. ......[] ( ....[].)
. ......[]....................................................( )
. / /
....[].

. :
(material) (original material)
(progeny) (unmodified descendant)
(organism from organism)
(unmodified derivative)
(unmodified functional sub-unit)

/ ....[].
(vector)
(modification) (
)
, ,
,

.
.

.
.
. ,


.
. ....[].
[ ]
[ ] / /
[ ]
[ ]
[ ] ,

.
( / /
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....[].
.
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) .. ....[].

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MTA

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: ...................................
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....................
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/ /

......................................................................
() ....................................................
/ .....................................................
/
.....................................................................

......................................................................
() ....................................................
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...........................................................................
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............................................................................

[] / .
. .
[] /
[] /

.. -
.


.

.

.

. .

. ..

.

. .

.

.

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.

. .

. ..

..-
.

.
.

.

.

.

. .

.
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.
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. . :
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.
.. .

- ..

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada,
Social Sciences and Humanities Research Council of Canada, Tri-council Policy Statement: Ethical
Conduct for Research Involving Humans. 1998 (with 2000, 2002, 2005 amendments).
Code of Federal Regulations Title 45 Part 46-Protection of Human Subjects (45 CFR 46) Revised June 18,
1991 (Effective August 19,1991) Edition October 1, 1993.
Council for International Organizations of Medical Sciences ( CIOMS). International Ethical Guidelines for
Biomedical Research Involving Human Subjects. 2001.
Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical
Review of Epidemiological Studies. 1991.
Dwip Kittaporn. Ethical Issues in Social Science Research.

-
.
European Epidemiology Group. Good Scientific Practice: Proper Conduct of Epidemiological Research.
ICH-Good Clinical Practice Guideline
, .
ICH. Harmonized Guideline for Good Clinical Practice. London: EMEA, 1998.
National Health and Medical Research Council, Australia. National Statement on Ethical Conduct in
Research Involving Human. 1999.
Office for Human Research Protections (OHRP). Institutional Review Board Guidebook, 1993.