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privacy language

French translation: formulation des clauses de confidentialité

06:15 Sep 6, 2011
English to French translations [PRO]
Medical - Medical: Health Care / Clinical study
English term or phrase: privacy language
Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures.
Jacek Sierakowski
Belgium
Local time: 04:26
French translation:formulation des clauses de confidentialité
Explanation:
Spontanément, c'est ce que je comprends. Peut-être à affiner, mais le sens devrait y être
Selected response from:

marie-christine périé
France
Local time: 04:26
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +7formulation des clauses de confidentialité
marie-christine périé
4confidentialité des éléments relatifs à la vie privée conformément aux règlementations nationales
Marion RIHANI
4déclaration
Titus Haennni
Summary of reference entries provided
SJLD

  

Answers


32 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
confidentialité des éléments relatifs à la vie privée conformément aux règlementations nationales


Explanation:
I think the meaning of "language" here is the set of elements that must be respected by health provider with regard to their patients' privacy (private, medical and social information)

Marion RIHANI
Local time: 04:26
Native speaker of: French
Notes to answerer
Asker: Thank you.

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35 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +7
formulation des clauses de confidentialité


Explanation:
Spontanément, c'est ce que je comprends. Peut-être à affiner, mais le sens devrait y être

marie-christine périé
France
Local time: 04:26
Specializes in field
Native speaker of: French
PRO pts in category: 189
Notes to answerer
Asker: Merci.


Peer comments on this answer (and responses from the answerer)
agree  GILLES MEUNIER
7 mins
  -> merci Gilles
agree  Marion RIHANI: You have named it!
29 mins
  -> merci Marion
agree  SJLD
1 hr
  -> merci !
agree  Veronique Parente: qu'y aurait-il à affiner ? très joliment dit
4 hrs
  -> merci Véronique, je rougis !
agree  FX Torrentz
10 hrs
  -> merci FX
agree  Imanol
10 hrs
  -> merci !
agree  enrico paoletti
1 day 14 hrs
  -> merci enrico
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
déclaration


Explanation:
"Déclaration (de consentement en connaissance de cause et de confidentialité)"
Je ne vois pas pourquoi ce serait au sujet ou à son représentant légal de "formuler" ces choses là.
Par contre, obtenir du sujet une déclaration attestant qu'il a bien compris ce qui va se passer et comment on traite ses données fait partie de la procédure normale pour les études.
(Peut-être que dans ce cas le sujet doit formuler lui-même les termes de son accord plutôt que de simplement apposer sa signature?)

Titus Haennni
Switzerland
Local time: 04:26
Specializes in field
Native speaker of: Native in FrenchFrench
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Reference comments


5 hrs
Reference

Reference information:
http://clinicaltrials.gov/ct2/show/NCT01163799

Inclusion Criteria:

•Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization for U.S. sites, or equivalent privacy language as per national regulations , obtained from the subject or legally authorized representative prior to study-related procedures (including withdrawal of prohibited medication, if applicable)

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Note added at 5 hrs (2011-09-06 11:25:16 GMT)
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IOW the informed consent and privacy authorisation must be worded similarly to the HIPAA requirements and conform with national regulations in countries outside the USA participating in the trial.

SJLD
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 178
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