Sep 6, 2011 06:15
12 yrs ago
2 viewers *
English term
Belgium
Medical writer, journalist, translator
Native in: French
Works in: English to French, Dutch to French
privacy language
English to French
Medical
Medical: Health Care
Clinical study
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.
Proposed translations
(French)
References
| http://clinicaltrials.gov/ct2/show/NCT01... |
SJLD
|
Proposed translations
+7
35 mins
marie-christine périé
France
France
Native in French
Specializes in field
France
Related KudoZ points
:
189
Selected
formulation des clauses de confidentialité
Spontanément, c'est ce que je comprends. Peut-être à affiner, mais le sens devrait y être
Note from asker:
| Merci. |
4 KudoZ points awarded for this answer.
32 mins
confidentialité des éléments relatifs à la vie privée conformément aux règlementations nationales
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)
Note from asker:
| Thank you. |
1 hr
Titus Haennni
Switzerland
Switzerland
Native in French
Specializes in field
Switzerland
What are we waiting for?
Native in: French 
Works in: English to French, German to French, English, and 1 more.
déclaration
"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?)
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?)
Reference comments
5 hrs
Reference:
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.
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)
--------------------------------------------------
Note added at 5 hrs (2011-09-06 11:25:16 GMT)
--------------------------------------------------
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.
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