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Good Research Practice

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Good Research Practice

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Good Research Practice

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Good Research Practice

Contents / /%% # 1 $ (Introduction and scope)

1

/%% # 2 + (Principles)

5

/%% # 3 ! (Planning the research)

11

/%% # 4 $ (Conducting the research)

19

/%% # 5 '# ," (Data management)

25

/%% # 6 ! (Reporting the results)

33

/%% # 7 ! - (Applying and exploiting the results) 39

/%% # 8 ! - .# (Conflict of interest) /%% # 9 , ! ' / 0 (Mentorship) :

41 45 47

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Good Research Practice

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Introduction and scope

- conveying information truthfully and honoring commitments, ACCURACY - reporting findings precisely and taking care to avoid errors, EFFICIENCY - using resources wisely and avoiding waste, and OBJECTIVITY- letting the facts speak for themselves and avoiding improper bias

HONESTY

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Good Research Practice

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Good Research Practice

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Principles

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Good Research Practice

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Good Research Practice

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Planning the research

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Good Research Practice

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Good Research Practice

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Conducting the research 4

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Good Research Practice

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Conducting the research

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Good Research Practice

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Conducting the research

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Good Research Practice

24

Data management 5 # - 69 6 6# " ' ! #66* 8 ' ' , #9 " 6 ' , #9 '& X * '>1" 6 Y Y ' ' 69 % '' ' 6 ' / ! 3 (sharing data) 69 ,'< 4 -4 6 " ' , @ 4 6#6 9'>1 (integrity) 6 % - ! 6-9 & '> '! 6 69 (data ownership) 69 % "% ' 6 '! 39 ' 6 69 %

' , "% < ,6 , ' ' * % ' / , % 4 % -9 & 6 + = # # - • ' 39" 69 4 '! ' < 4 / '! ' >! 6 * ' 69 (data sources) • " '> , 6 , , ! < ' ' # #* < ' ' ' 39 ' ! 69 ' # 69 , "% '# ! , ' *

< ' ' !39 % " '> 6 25

Good Research Practice

69 # * 6 ' "% 69 ! ,6 , ' * ' 69 , "% '"% , " '" " " 6 ' 6< ' ' # - (data collection) *

396 ' ' 6 69 " ' • ' # 1 • # '% . & !# '& / • # '# " #6* 8 69 '

6 * (archives) • # '# ,@ 1 • . &- ' 6 # & 6&1 • '! ' # + ' ' # * 6 # + 1 6 # - (recording the data) #* '' ' 6 69 ' 4 , " '9 #6* 4 (hard copy) ' ,^ 1 ' #1 (electronic copy) ' $ '9 . &# ' 4 69 6 ' (measurement) ' '# (observation) . &- - 4 # ' # $

26

Data Management

' ' 69 1. ' 69 , " #6* 4 6 - ' & # # ' ' ' 6' 6 69 ' 3 ' , ' ,6 '"% #6* 4 4 ' #' 6 '! / , (loose-leaf notebooks) ' ^ 6 ! 2. ' 4 69 " #6* 4 < ' #* ' ' 6 69 , ! ' ' 6 ! 4 69 # '> 3. ,6 ' , 69 4 " #6* 4 ,6 !< '"% 3 64 4 *3 ! , , 4. 3 & 6&1 # 69 ' 6 # '1 . &' # " (autoradiograph) 3 669< ' . & 6 ' 3 4 , " #6* 4 6 ' # ' # - 6 3 & 6&1 (chart) . &- ! $ @4 6 " !,6 # 6 '- ! 3 4 , " #6* 4 , ! ' / , " ^ 6 # '< 6 % % 6< #6* 4 @4 # 6 '- ' # , . &- ' ,^ 1, " # 6 !#6 < '! *% ,^ 1 !<^ '1, " #6* 4 5. ' 4 69 '"% # ' ' % # ' 66 . &' # ''!6 '! & /" ' 4 " - 9 6. 39 *6 9 / ' 1 '4 / (supervisor/advisor) '

' # 6-9 ! 6#6 9'>1 69 #6 #6 <

! ' # ' ' 6 6 6 !#6 />! < ' ' ! @ 6 #6* 4 / 4 / , 6 27

Good Research Practice

# # 4 '! ' ' # ' !6 '@ - 639 4 69 $ ! 6 ' ' 4 69 39 ' # !39 4 69 ! 6 , 7. 6& '1 " % 69 '"% & ' 8. 8 ' #1 '6 + ' ' # 6#6 * #63 (validate) & " 6 " , 4 , > $ !,6 -9 , " . 9. 69 ' #1 # '& 6&1 '! / , 10. # < ' '6 6& '1= (version) "% '!6 69 ! ' / , " 69 & !# 6 '- 6 "% '!6 69 , " ! ! 6 ' 4 ! , " ^ '16" 6 6 ' ' < ' '6 6& '1" #6 (update program) ' 6 ' # " 6 6 # # - (data protection) ' ' 6 69 ' ' / , & ' ' '

' # . ' 6 ' '!&E ,6 6 !#6 ' (research misconduct) ' ' " ' ! 1 69 " 6 69 # 6 ! 6 69 6 " 39 4 ' ' / 69 , 1. ' ' / 69 (data storage) ' • ' / #6* 4 69 / 3 4 69 , " . * . ! '< ' ''6 28

Data Management

' ' 69 • ' / #6* 4 69 / 3 4 69 , "

' ! ' 6 ' # , 6 • # ' ,^ 1 6& '1, " # 6 !#6 ! , • 6 !#6 & #. &, # * 2. '' / 6 (confidentiality) • '' / 6 69 # * ' # 6 @4 ' 6-4 69 ! % . & < ' ' * < ' ' 69 ! " # 6 '-'! * *6 ' 6 ' , ! , ' 6 % >! ''6 ' ' +''6 69 # * $ ! 6 '"% ' # ' % # #6 '" 6 # * ! , , • 69 ' # ! 69 ' !" 6 ' @4 ' ! , "% 69 '! / ! 69 ' #1 • ' !6 ' 4 ! ' / 69 ' '9 . &

= , 6 !#6 < =& !" '> 6 ' ' 69 ' '9 . & " . ! ' !6 6# ' ' ' . & ' ' '!6 6 6 69 ' '9 . & 6 ,

29

Good Research Practice

= 7 # - (retaining data) ' 6 ' ' / 3 ' 4 -9 ! , , '! ! ' • 69 86.96 @4 ' 6, -4 (specimen) # - 6 ! - 4 # ! 6 ' ' / = ' '9 6 4 ! ' / , 10 < ' ' #' # • " ' ' " 6 ' 6< ' ' ' , . % 69 < , '! ! 10 % • ' 69 !3 ' # 39 ' ' < '! '! , !" '! ! # 6 '- 6 9 " 6 , 6 ' • 4 ' 4 / ' # + '>#* '6 ' ' / , 20 & ! " ' 6 3 " '! ! - 6 6 • " ' ' / 69 ' *6-4 & +1 " '! >S 4 / # - (sharing data) • ,6 ' 3 69 # + '>! 69

! '!< % 1 '!% % % • 6 &6 &1 3 &' 3 ' ' < # 30

Data Management

' ' 69 " 39 ' * 9 69 , 6 '' '" 69 ,6 ! 6 6 # ! '' / 6 # #6 ' • ' ' 6 3 ' 3 69 ! 3 ,6 , ' # *3 ' 3 69 " , 6&'!' % 69 # '

31

Good Research Practice

32

Reporting the results 6

6 & '> '! '' / 6 (confidentiality) ! 6 (ownership) 69 !3 - - ' 3 &' 3 ' & !, ' ' '! 6 *>. & < 39 ' *> *X" # (scientific peers) ! '! 6 " 6 4 ' & " 6 ' 1 6'9 # '1, "% 6 !#6 ! 6 '!# + 3 & 6 9 6 */ % *3 ' (1) & 6 &1 3 '>1 (timely fashion) " '# ' 6 39 ' *> *X" # '! 6 (peer-reviewed journal) ' '# ' 6 % # @4 # , ' % '# ' 9 " 8 69 6 '8 % Entrez PubMed #6* % # ' 8 6' ' (2) # " ' '!%*6 % ' 6' '!% 6 " # $ ',6 3 &' 3 ' - 3 ' +''6& $ ' 3 ' " ' & , "% " % ' ' '* < '' / 39 @4 # '> ' 39 6 6 ' , ' ' 6' @4 ' '!< % 1# + '>! * *! *

1. * ' 3 % < ' ' 39 * (authorize) " & 6 &13 33

Good Research Practice

2.

3.

4.

5.

' ' * ' *6-4 # ' , 6 ' - ' ' , & & (internal peer review) ' # + '!< % 1 ' & 1# !' % 39 & +1 ' *

' *6-4 ' '# ' ! &6 &1 3 &' 3 ' 6 % ' ! 4 9 6# " # + '>% 6 ' ! # > /39 ' !39" * & '> &6 &1 3 &' ' 6 />1 /' * . ' " # '! !" 3 &' 3 ' 6 ' < =& ! * . * # ''6 " ' 6 69 + ' & & & " 3 9 # 6 '- @ , '6 69 ' *6 ' +''6 !/ ' 6-9 6 [ 6 < ' ' ' 396 " ' * " ' # " " '> !6 ' 3 &' 3 ' " '1 @4 '! # + '!< % 1 4

' = - # * 9! (authorship) 1. '"# % * " ' % 39 & +1 * '6 # ' 6 # < =& !# ' 6#' #'' 1 ! " " 6 ' * " # % '' 6 & & & # 6 ' # 6' 3 % " # + '>% , '"# % 39 & +1 ' , 6 # , < International Committee of Medical Journal 34

Reporting the results

'' 3 ' Editors (ICMJE) @4 ! 39 !6 % 9" ' % 39 & +1 '6 # #' #'' 1 @4 # < (1) '6 # ' 6 6 " 6 ! ' ' ', 6 @4 69 ' ' ' ! 13 ! ' 3 (2) ' ' ! # &6 &1 ' ' '* , " # '! # ! (3) " 6 % " ' = #* ! # &6 &1 2. * 6 # % $ , 6 "% # ' 6" '#' #'' 1 ' "# % , "

''6 '! (acknowledgement) % 39# # * * '"# % * % , "

''6 '! ' * * 3. '"# % 39 & +1 '! . , - ,6 6 !#6 • Honorary ' guest ' gift authorship 6 -4 '"# % 39 ,6 6 > * #6 39 & +1 ' '9 -9 "# % • Planted authorship 6 -4 '"# % 39 ,6 6 *>#6 39 & +1 ,6 , ' '9 -9 "# % • Denial of authorship 6 -4 ',6 "# % 39' 6 6 > * #6 ! 39 & +1 ' ' 39 ' 6, ' ,6 , 6 6 ! % ' % 39 & +1- 39 6 # ' 6" '#' #'' • Ghost authorship 6 -4 ' 39 '6 % 39 & +1 &' ! = ! # &6 &1 ,6 ' % ' % 39 & +1 • Relinquished authorship 6 -4 ' , & 35

Good Research Practice

4 ,6 "# % , "# % 39 ,6 39' 6 !6 ' ,6 6 > * #6 & & !6 % 39 & +1 4. " '> 3 # 4 & +1 ' ' #'! '"# % 39 & +1 '6 • 4 / ! ' 1 '4 / ' !6 % ' " ' % 39 & +1" 3 # &6 &1 '! 69 # 4 ' 6 3 & & +1 4 / 6 ' % 39 & 6 6 39 ! 6 # ' 6" '#' #'' 1 • ' 1 '4 / ! 4 / ' -4 ' % 39 & +1 " '> & +1 ' ' % 4 / % ' 6 * + , @4 ! ' " ! >! % • ' # # . '! " 3 &6 &1 &4 , " < , 4 / ', # # 6 !#6& & ! # ' ' 4 / , 6 > * . & 6 1 !# + ' " '> 6 ' 1 '4 / ' 1 '4 / ', ' # # 6 ' 1 '4 / ' 6 5. " ' = & &6 &1 3 &' 39 6 % ' # # ' 3 % < 39 & +1 !% ! # *3 ' ' ' % , />1 /'

36

Reporting the results

'' 3 '

1.

2. 3. 4. 5.

9 * *! * ' &6 &13 ' $ " , " 66 ! &6 &1 ' $ (series) ' Salami publication ' &6 &1 ' # ' & ' ' ' 4 -4 *>. &6 ' 6 > ' ' &6 &13 6 % & +1 6 & & " , ' 6 > ,6 ' # = (manuscript) , '# '6 4 (duplicate submission) ,6 ' &6 &1 69 " '# ' 4 @ " '# ' 9 6 3 (redundant or duplicate publication) ' &6 &1 6 . / 4 " '# ' 4 (secondary publication) # 6 '- , ( ) ''> + ' # '# '' ' ! % ( ) ' &6 &1 ' # ' ' 4 # 1 ( ) ' &6 &1 ' 3 9 ! *6 ' ' ( ) 69 ! ' 3 " ' # ' ' ' ( ) 6 6 '! / (footnote) , & 6 &1 % : 6 6 & 8 ' 4 / & 6 &1 ' ' " '# '.........; ! (=) " ' " '! * ' &6 &1 ' #

# # * . ' * *! * 1. 6 & 3 & " > * & 6 &1 3 &' 39 & +1 37

Good Research Practice

(research leader) !" (co-authors) # "$ %$ (correction or erratum) & '* + 2. , $ & & # $ * * /

, ! " $ * * #$ 0 "% (retraction)'* + 3. , & & # 1 1 (fraud) # 4 % #&

(research misconduct) / 5 0 /, * #/

, ! & " / • # 4 % #& 0 4

7 * * 5 & *5 #

4

% '* #8 / % /

'* &9 / + & 9 • 7 (fabrication) 0 *& $ % # & • * * (falsification) 0 * * &*9 / # $ # &

% 0 • &

0 $ & '/ & 9* * / / * !" 5 & * ' & " / & # : • (plagiarism) 0 5 / / * ! $ $ $ 8 $ '* % / * $ 38

Applying and exploiting the results 7 !

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!6 '! ' , "% ! , #9 3 '!< % 1 % & > % 1, 4 ' !6 '! ' ! 3 @4 - # + '!< % 1 (intellectual property rights) 1. ' 4 = , < =& ! @4 ' 6 . * # ''6 ' ! 6 6'!6 '! & / 2. '& '> '! ' & 1# # " # 3 , 3 &' ' &6 &1 3. ' & 1# ' 1 6'9 ' 6 3 3

3 39

Good Research Practice

'< * ' 6 % " 6 " #- 6 " - '! ' 6 % " 6 # + '!< % 1 4. 69 3 &' " - 69 3 # + '>! 4 ,6 # 6 '- # + '!< % 1, 5. " '> 6 '# 6 ' # * ' $ " 3 9

#- # 6 # * (material transfer agreement) />1 /' # 6 '! 39# % 6 % " 6 ! 1 ' 39' '# 6 # * < 6 ' @4 39" * , % -* '!# 1 '# 6 ' 6# < ,6 , ' * ' # + '!< % 1@ 4

4 ' '! 6 ' 1 ' # ! ! ' 3 % " ' 6. ' " '' / 6 (confidentiality agreements) . " ' 3 69 & # !6 ' # 3 '!< % 1 %

40

Conflict of interest 8 ! "# & 1 6'9 < 6 ' 9 "

6" ' ' 9 ' & 1 6'9" 6 ' & '!< % 1 # 6 " >! 6* !6 6 " ' ' , & 6 4 ! 6. .96 " ' !6 3 '!< % 16 % # + 1 ' # + ' 4 ' ' '4 / '6 * # '6 3 &6 &1 ' 6 3 '!< % 1 6 " 6@ # 1 ' , 3 '!< % 1 @ @4

, 3 '! . 1. 3 '!< % 1 @ ' (Financial Conflict) 2. 3 '!< % 1 @ & + ! (Conflicts of Commitment and Allocation of Time) 3. 3 '!< % 1 @ * ! (Personal and Intellectual Conflicts) ! "# (Financial conflict) ,6 '" 3 '!< % 1 ' 6 6@ # 1 ' ,6 , ' ' ' # 3 '!< % 1 , '

'!< % 1 @ ' ,6 ' 6-4 41

Good Research Practice

1. ' ' ' , ' 6'! #- 2. 3 '!< % 1 , ' # + 1 ' # + ' 6 '! #- 3. ' ' ' ' ' # 66 ' '' '# , ' '# # * . ' 8 ' 1 ' , 6 # ,' 4. ' , ' ' ' ''6 ' '4 / ' ''6 '& '> < ' ' . ' 8 ' 1 ' , 6 # ,' '# ' % ' = ' 6 International Committee of Medical Journal Editors , ! ! 6 !#6" '

' 3 '!< % 1 @ % ! 3 -4 *

3 '!< % 1 '

! 4 ' 6 &' 6" ' # 3 '!< % 1 @ 9 #6 3 '!< % 1 @ ' 4 4 ' . % " '# # * & !" 3 ' 4 6 ' ' 1. ' 3 '!< % 1 @ # #- !6 ' ' 2. ' 3 '!< % 1 @ ' 3. " 69 & & ' '3 '!< % 1 @ $

42

Conflict of interest

3 '!< % 1 @ ! "# * 9 (Conflicts of Commitment and Allocation of Time) 3 '!< % 1 @ & + ' 6 & + # ' ! ' ! " ' *6 * & + ,6 % # !" '4 / 4 / ' 6 '!%*6 % ' ! '' " 8 ! '4 / 6 Y Y " ''6 6 "% 4 '6 #- # & ,6 " 3 '!< % 1 @ & + ! -4 6 ! # 6 '- " $ < ' '" #* ' ' ! 1 " % " < ' ' 4 ,6 #6 ' 6 @ < ' ' 4 , ! "# /++ DD (Personal and Intellectual Conflict) ,6 ' '! 6 < ' ' ' '! 6 ' ' < & 8 6% ,6 % '# (personal conflict) ' 6 6 ' 6 % " #66 8 ' (intellectual conflict) ' '! 6 ' !' ' < ,6 "% 6 '9# 4 # * ' 6< 6 # * (bias) 6 ! '!6 '! ! # ' " #'* " $ 6 6 % ' 6 # < ,6 6 8 ' # '1 ,6 ' ! 39 & '> # '" * ''

& 6&1 !" ' 3 & ' 6 ' 4 / 43

Good Research Practice

' 1 '4 / & " & ' 6 ' 4 / '!# 3 # '

3 '!< % 1 @ # ' & ' '! *, # # 6 6 % ' 6 # " ' " ' 4 & / # " 39 '9 & " 39 # " , # # % - , 6 & " < =& ! " '> '4 / " 39 ' ' & " '# # " $

44

Mentorship 9 & " ' . & +1 & +1 ' ' #'! 4 / '! ' 1 '4 / ! 4 / 1 " '! $ % ' 1 #''" 4 / & 4 / # 6 '-" ' '" ' !F < " ' " ' % 39 & +1 (authorship) # + ' (patent) # + 1 (copyright) ' #''3 '!< % 1 4 +''6 ' 1 '4 / ' 4 -4 ! 6' 3 % 1. ' 1 '4 / " ' < 6 ' % ,6 "# % ' 39 " ' % 39 & +1< ,6 6 !#6 '! 3 , ' 3 # " , 2. ' 1 '4 / '# #' 6" 4 / ' '9 ' ! 6' 6 3 &' Y " & 4 / ' < =& ! ' &6 &13 '"# % " ' % 39 & +1 ! ' 3 1 ! " (thesis or dissertation) # # $ % (independent study) & # ! " (term paper) ' * ; + ,- . % . $- / . * 45

Good Research Practice

3. ' 1 '4 / 9 " "# 4 / & " 6 " 3 4 -9 !,6 ' 60 69 ' 1 '4 / ' • ' 3 ' #' # ' ! ' 69 4 " #6* 4 4 / (laboratory notebook) ! ^ 6' 6 69 • '> , 6 "% ' % ' 1 '4 / ' ' 6# '! 69 ! 69 #'* • = (manuscript) 4 / 39 ! ' " 6-9 " * # ! '"# % " ' % 39 & +1 • & 4 / '! ! & 6 !" '4 / ' 6 , ! • # # * " 4 / # 69 " ' '!%*6 . % >! ' 6

46

Appendix 8 + 9 # /7 ! < ' ' " $ 6 */ 1 ! , ' ' *6 ''6 ' ' +''6 (research ethics committee) ' : 6 */ 1; 6 ' 6-4 ' 6 # #6 ' " ' ! ' " % 69 # * # ' #- 6 ' 6-4 ' " 39 # % , 0 ,G! 9 /7 ! 6 &. . 2490 # ' 6< ' 2 6 ' & 1 @ ' % " '*> 39 -9 # %

& ' !6 ' & 1 @ 4 ' 6 Nuremberg '! '6 & & '> < / @4 '> ' , " % :Doctor~s trial; 3 " & 1 -9 & & / '! '% " ' , # ' , ' ' & 1 6' -9 6 *>+''6 ' +''6 ! [ 6 ! 9 " ' 10 @4 6 ' :Nuremberg Code; < 6 * ' " ! 6 * !6 # #6 ' < " 69 * '! & # " ' 6 #'! ' ' 9 47

Good Research Practice

" &. . 2507 & #6 6< '! :Declaration of Helsinki; @4 >S1 ' +''6 ' % % # '1, " & 1 6 ' ' '* , ' ' ' '* #* &. . 2543 ,' 6 ' +''6& 8 " % < , ' ''6 + ' % & * ' 6 ' # ' 8 6' , # , " &. . 2517 ' :Belmont Report; " ' ' % % # '1 !&E ''6 # '16

' +''6& 8 3 , (1) ' '&" * (Respect forperson), (2) '" *> '!< % 1 (Beneficence) ! (3) 6 * +''6 (Justice) ' ' 6 ' ' +''6& 8 , ' ' " '! # # , CIOMS International Ethical Guideline for Biomedical Research Involving Human Subjects, CIOMS Guideline for Epidemiological Research, ICH GCP, ! WHO GCP

6 '! , [ ' ' " 6 */ 1 # ' +''6& 8 ! [ 6 '! % Code of Federal Regulation Title 45 Part 46 # ' 8 6' ' " 6 45CFR46, Ethical Conduct for Research Involving Human '! Statement on Ethical Conduct in Research Involving Human '! # ' # ' '! , %6'6 ' +''6 ' " " '! , , : ' +''6 ' " % , ; ! 3 &' " &. . 2545 48

Appendix

. 3 ' '! * 1 ' +''6 & 8 3 & 6 "% ' & #'* , (1) * 6 6# 6 '- ! # " , " * # 6 1 ' 6 6 */ 1 '&" 1 ' ' *6 % ! % ' 6 < • 6 ' 6< ' ' < + ' ! ' !# + * " # '!" ' # " ' 6 < ' ' (Respect for free and informed consent) • 69 " * % ' 6< ' ' ' - " , !,6 ' # + # #6 ' • 6 ' 6" " 6 ' 6 ' , />1 /' • ,6 ' * 6 # (Respect for privacy) % ,6 ' * ' ' ,6 - 6 ' # < ,6 ' ' ,6 6 • ,6 9 " * # #6 ' ' ,6 '! '" $" * 9" . ! 6 ' ' " (coercion) ! ,6 " ' # 9 " & " * 6 # #6 ' < ,6 4 -4 6 # ' ! 4 (undue inducement) • ' / 6 39 / # #6 ' (Respect for confidentiality) • " '> * ! % ' 6 ' * " ' # " " ' ' 6 # #6 ' % !39 1 *6 39 39 E 39 <' 49

Good Research Practice

* , ' ' & / (Respect for vulnerable person) • ' " *6 6 ! 6 '!< % 1

'' / <' " *6 < ' !,6 # 6 '- " *6 39" , , • ' " !39 1 6 6 ' ' 39 ' 6 [ 6 • ' " 39 <'

6 39 '

6 [ 6 • ' % * *6 % ' >S1 ' 6 ' 6 + ' , ' ' ' 6 ' " 39 % • ' 6 />! 9 6 % # '! &> ! X +''6" $ • ' 6 3 '! # 6 (2) ' ' '! 6 '! 3 '!< % 1 6 #

' < < ' ' '" '!< % 1#9 #* ! 6 # ' # * (Balancing risk and benefit: Minimizing risk, Maximizing benefit) • ' ! *3 ' , 6 @4 6 > * - 6 ' (Scientific merit) ' ,6 - 9 !" 3 ' % - ,6 , ' # #6 ', # < ,6 #6 ' 4 - ' 3 ' +''6 50

Appendix

. 3 • '!< % 1 3 9 , ' < ' '' / ' % '' ' ' ,6 ' (remuneration) " 39 / # #6 ' '!< % 1" ' '! 6 '!< % 1 ! 6 # # #6 ' !, ' • '!< % 1 3 9 $ !, ' 3 ' 4 / • '!< % 1 ' # '1, ' • '!< % 1 6 # ' 4 39 / # #6 ' !%*6% • 6 # ' 6 ' 6 ' ' " 8 ! ' !#- ! # 6 39 / # #6 ' • ' ' (Physical harm) % • % 6= • ' 3 • ' '3 • 6,6 #! # (discomfort) % 6 < ,6 '!&' 10 • ' " (Psychological harm) % • 6 ' '6>1 . & Y Y @4 3 • 6 % '- 639 / # #6 ' & # 6& +1 '"% # ' #& • ' " 3 9 ' <' ' ' <' & +* ''6 - -4 * ' 51

Good Research Practice

• ' 8 ! ' !#- ! # 6 (Social and Economic harms) % • ' ' 6< ' ' " # & 6 4 6 • # < ,6 6 % % • 3 # #- !# 6 ' 39 / # #6 ' '' < / [ 6 '#9 # # + '! % Y Y (3)

6 ' '! '!< % 1 ! 6 # " * ! % # #6 ' #6 . (Distributive justice) # < • ,6 ! *6 ! % # #6 ' 6 & 8 ! % % # 3 6 *3 % • " '' / < ,6 69 *6 ' %*6% 3 9 4 / , '! ! 4 #' # ' , • 6 '! '& '> % ' +''6 6 6 '8 !< ' "# % ' # 3 '!< % 1 @ (conflict of interest) '& '> +''6 #* ' '! * 1"% ' +''6& 8 " ' " 6 */ 1

4 -4 X +''6 '! &> '! ' - , # ! ' 4 / # '1# * . &6 "% # 1 $ " ' 52

Appendix

. 3 ! # & 3 6 '! * 1"% & & X *>. &% !# 1 ! 6 !6 '& X + ' $ % '"% @ 1 & ! " '"% $ & ' 6 > '"% # 1 6 " ' 4 / ,6 # 6 '- '"% # 1, &4 6 '' ''> '"% # 1< ' 6 , < '' ''> '"% # 1 #. % 2542 < #'* 6 -4 # 1 # 1 # 1 " #- & ! , , ^ ' 6-4 # 16 '! 9 # * % 1. 6 " ' $ % @ 1 & ! 6 '"% # 1 2. 6 " ' 4 / ! # " " ' % # & +*1 ! & # 1 3. 6 " ' > # 1 # * # 6 '-"% " ' ' 6 # #- 4. ', 6 @4 # 1 ! ,6 [ 6 ! < ' *' /1 # 1 '! . " !'! '! % CITES (Convention International Trade in Endangered Species of Wild Fauna and Flora) 5. ! ' *6 !% 6 " '"% 53

Good Research Practice

# 1' 6-4 3 '! $ >! ''6 ' '' ''> ' "% # 1 1 ' ' #- ' !" 1. ' "% # 1 3 # 1 6 6 & +* ''6 2. 6 " ' " 6 ' # # 1 3 6 #- ' < 4 -4 #* . & !# # . & # 1

66 '8 # 3. 6 " ' " 6 ' # - <' , #9 '# 1 4. 6 " ' " 6# - 9# 1'! ' ' 6 ' 9# 1 6 !#6 ' 5. 6 " ' 4 / ' $ 6 !#6 % '

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54

Appendix

. 3 #%$ ! 1. " '> # 1, ' 3 ' ' 6# 6 '-" ' ' %

6 6 " ' ' " 6 ' '*> 0

6 + , ' ' 6' " '! # 2. " '> ,6 6 6 '!# 1 ! # 1 # #* 6 " ' 9 ' " 6 ' 9# 1 " 6 % ! 6 9 6#6 ' < ,6 . '! 1 ' #- ' # + '>! 3. " '> ! 6 ' # 1 #9+ ''6% 6 " ' '!# # & 1 6 6'9 6 # 6 '- % !'! " # 1 !<' 4. 6 " ' # 8 # ' ! '"% # 1 '# ' '!# 1 ! &6 &13 -9 '

55

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56

Bibliography

! " & The Danish Committee on Scientific Dishonesty. Guidelines for Good Scientific Practice. Copenhagen: Danish Medical Association Publishers, 1998 [cited 2005 May 15]. Available from http://forsk.dk/portal page?_pageid=407,889357&_dad=portal&_ schema=PORTAL MRC. Good research practice. London: Medical Research Council, 2000, 16 pp. [cited 2005 May 15]. Available from http://www.mrc.ac.uk/pdfgood_research_practice.pdf .. Hyva tieteellinen k,yt,nt‰ ja sen loukkausten k,sitteleminen 2002 [Good scientific practice and procedures for handling misconduct and fraud in science] [cited 2005 May 15]. Available from: http://www.pro.tsv.fi/tenk/htkoengl.pdf Steneck NH. ORI introduction to the responsible conduct of research. [cited 2005 May 15]. Available from http://ori.dhhs.gov/publications /ori_intro_text.shtml].

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58

Additional reading 4. Atsdr.cdc.gov [homepage on the internet]. US DHHS: Agency for Toxic Substances and Disease Registry [Updated 2005 May 27]. Available from http://www.atsdr.cdc.gov/atsdrhome.html Hse.gov.uk [homepage on the internet]. Great Britain: Health and Safety Executive [Updated 20.05.05; cited 2005 June 6]. Available from: http://www.hse.gov.uk/coshh/ 6.

A few steps towards responsible authorship (Editorial). J Postgrad Med. 2001;47:233-4. Abraham P. Duplicate and salami publications. J Postgrad Med. 2000;46:67-9. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS. Sponsorship, authorship, and accountability. Lancet. 2001; Sep 15;358(9285):854-6. Drenth JPH. Multiple authorship. The contribution of senior authors. JAMA. 1998;280:219-21.

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Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, Rennie D. Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998;280:222-4. Friedman PJ. A new standard for authorship. [Cited 2003 Oct 27]. Available from: http://www.councilscienceeditors.org/ services/ friedman_article.cfm International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication [home page on the Internet] [Updated October, 2004, cited 2005 March 4]. Available from: http://www.icmje.org/. Kempers RD. Ethical issues in biomedical publications. Fertil Steril. 2002;77:883-8. Lee KP, Schotland M, Bacchetti P, Bero LA. Association of journal quality indicators with methodological quality of clinical research articles. JAMA. 2002; 287:2805-8. Meakins JL, Waddell JP. Authorship. Can J Surg. 2002; 45:84-5. Sahu DR, Abraham P. Authorship: rules rights, responsibilities and recommendations. J Postgrad Med. 2000;46:205-10. ! Fine A, Kurdek LA. Reflections on Determining Authorship Credit and Authorship Order on Faculty Student Collaborations. AmericanPsychologist. 1993;48(11):1141-7. Harvard Medical School [home page on the Internet] [Adopted 1999 December 17; cited March 4, 2005]. Boston: the President and Fellows of Harvard College; c2005. Authorship Guideline. 60

[About 5 screens]. Available from: http://www.hms.harvard. edu/integrity/authorship.html Southwest Texas State University [home page on the Internet]. Texas: the College of Health Professions, Department of Physical Therapy, Research Committee; approved 2000 Jul 7. [cited 2005 Mar 4]. Policy on authorship/Data ownership. [2 pages]. Available from: http://www.health.txstate.edu/PT/ PolicyonAuthorship.pdf University of Alberta. [home page on the Internet]. Alberta: Faculty of Graduate Studies and Research; c2001 [cited 2005 Mar 4]. Guidelines for authorship;[about 4 screens]. Available from: [http://gradfile.fgsro.ualberta.ca/current/guideauthor.html] University of Pennsylvania. [home page on the Internet] [Adopted 1999 December 17; cited 2005 Mar 4]. Pensylvania: Biomedical Graduate Studies; c2005. Biomedical Graduate Studies Authorship Policy.May 14, 1998. [2 pages]. Available from: http://www.med.upenn.edu/bgs/policy/BGS_author.pdf " # $ %& (Research misconduct) Gilbert FJ, Denison AR. Research misconduct. Clin Radiol. 2003; 58: 499-504. Office of Science and Technology. Federal policy on research misconduct; preamble for research misconduct policy. Federal Register.2000;Dec 6, 65(235):76260-4. 8. !

Association of American Medical Colleges (AAMC).[home page on the Internet] Washington, DC: AAMC; c1995-2005 [cited 2005 March 61

Good Research Practice

4]. Protection subjects, preserving trust, promoting progress- Policy and guidelines for the oversight of individual financial interests for human subject research. December 2001, 25 pp. Available from: http://www.aamc.org/members/coitf/firstreport.pdf Gannon F. Money in scientist pocket. EMBO reports. 2002; 2:75. Lo B, Wolf LE, Berkely A Conflict-of-interest policies for investigators in clinical trials. N Engl J Med. 2000;343:1616-20. Office for Human Research Protection (OHRP). [home page on the Internet] [cited 2005 Mar 4]. Draft interim guidance. Financial relationship in clinical research: issues for institutions, clinical investigators, and IRBs to consider when dealing with issues of financial interests and human subject protection. January 10, 2001. Available from: http:// www.hhs.gov/ohrp/nhrpac/mtg12-00/finguid.htm " # * % + ,!

. . .2545 ! " # #" $ . ! " # $ % & &% " " '#( )* &. %& " '"*+ $ ! & % # * & & < $ ! . 2546. 54 $ = Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human, 2002. [cited 2005 May 14]. Available from: http://www.cioms.ch/ frame_guidelines_nov_ 2002.htm 62

Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Ethical Review of Epidemiological Studies, 2001. Draft of revised version March 2005. [cited 2005 May 14]. Available from: http://www. cioms.ch/epiwebdoc.pdf ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice (ICH GCP), 1997. [cited 2005 May 14]. Available from: http://www.ich.org/ MediaServer.jser?@_ID= 482& @_ MODE =GLB World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, 2000. [cited 2005 May 14]. Available from: http://www. wma.net/e/policy/ b3.htm $ % ! + - . & . . 2542 Animal welfare information center. US Department of Agriculture National Agricultural Library. [homepage on the Internet]. Available from: http://www.nal.usda.gov/awic/. AVMA. 2000 Report of the AVMA panel on Euthanasia. JAVMA. 2001;218:669-96. [cited 2005 May 14]. Available from: http: //www.avma.org/resources/ euthanasia.pdf Canadian Council on Animal Care. CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing. 1998. [cited 2005 May 14]. Available from: http://www.ccac.ca/en/CCAC_Programs/ Guidelines_Policies/GDLINES/ENDPTS/APPOPEN.HTM

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CIOMS. International Guiding principles for Biomedical Research Involving Animals, 1985. [cited 2005 May 14]. Available from: http://www.cioms.ch/frame_ 1985_texts_of_ guidelines.htm CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora) [homepage on the Internet] [cited 2005 May 14]. Available from: http://www.cites.org/. Close B, Banister K, Baumans V, Bernoth EM, Bromage N, Bunyan J, Erhardt W, Flecknell P, Gregory N, Hackbarth H, Morton D, Warwick C. Recommendations for euthanasia of experimental animals: Part 1. DGXI of the European Commission. Lab Anim. 1996;30:293-316. Close B, Banister K, Baumans V, Bernoth EM, Bromage N, Bunyan J, Erhardt W, Flecknell P, Gregory N, Hackbarth H, Morton D, Warwick C. Recommendations for euthanasia of experimental animals: Part 2. DGXT of the European Commission. Lab Anim. 1997;31:1-32. Diehl KH, Hull R, Morton D, Pfister R, Rabemampianina Y, Smith D, Vidal JM, van de Vorstenbosch C. European Federation of Pharmaceutical Industries Association and European Centre for the Validation of Alternative Methods. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J Appl Toxicol. 2001; 21:15-23. NHMRC. Australian code of practice for care and use of animals for scientific purposes. 7th ed. 2004. 84 pp. [cited 2005 May 14]. Available from: http://www7.health.gov.au/nhmrc/ publications/synopses/ea16syn.htm Nicklas W, Baneux P, Boot R, Decelle T, Deeny AA, Fumanelli M, Illgen-Wilcke B; FELASA (Federation of European Laboratory 64

Animal Science Associations Working Group on Health Monitoring of Rodent and Rabbit Colonies). Recommendations for the health monitoring of rodent and rabbit colonies in breeding and experimental units. Lab Anim. 2002;36:20-42. Office of Laboratory Animal Welfares/Applied Research Ethics National Association. Institutional Animal Care and Use Committee Guidebook. 2nd ed. 2002. 210 pp. [Available from: http://www.grants. nih. gov/ grants/ olaw/GuideBook.pdf] Reilly JS, editor. Euthanasia of Animals used for Scientific Purposes. 2nd ed. The Australian and New Zealand Council for the Care of Animals in Research and Testing (ANZCCA); 2001. Available from: http://www.adelaide.edu.au/ANZCCART/. Wood M, Smith MW. Health and safety in laboratory animals facilities. London: Royal Society of Medicine Press, 1999. 249 pp.

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