poursuite destinée au patient

English translation: (consent forms) for continued participation, addressed to the patient

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:poursuite destinée au patient
English translation:(consent forms) for continued participation, addressed to the patient
Entered by: Charles Davis

11:37 Mar 23, 2018
French to English translations [PRO]
Medical - Medical (general) / Modifications to clinical trial documentation
French term or phrase: poursuite destinée au patient
Hello,

I am not sure what they are getting at here? Does it mean "litigation"??

Here is the context:

De même, les coordonnées de l’investigateur principal pourront être insérées dans les tableaux créés à cet effet au début des notices d'information et des consentements (destinés au patient, destinés aux représentants légaux et/ou parents, poursuite destinés au patient).

Pour finir, le titre de médecin a été remplacé par médecin-investigateur tout le long des notices d’information et des consentements (destinés au patient, destinés aux représentants légaux et/ou parents, poursuite destinés au patient)

Thank you!
liz askew
United Kingdom
Local time: 04:32
(consent forms) for continued participation, addressed to the patient
Explanation:
"Continued participation" is the usual term for "poursuite" in English.

To take the last part first, I take "destinés su patient" to mean addressed to the patient and to refer to "consentements" (possibly also "notices d'information"). These are clearly documents, because the text refers to the obligation to include the principal investigator's details in a table at the beginning of them. So the "consentements" are presumably consent forms. So I think "destinés à" means addressed to or directed to, or possibly "intended for".

Be that as it may, "poursuite" has a quite specific meaning here. This must be about the "consentement de poursuite" in the Loi Jarré of 2012 (the law governing clinical trials in France), as revised in 2016. It refers to a situation in which a patient is involuntarily enrolled in a study without informed consent where there is pressing need but the patient was unconscious or otherwise medically unable to give consent. Provisional consent can be given by a family member by proxy. When the patient wakes up or becomes capable of consenting, a "consentement de poursuite" is sought. If it is given, it validates the uninformed participation retrospectively. It doesn't have to be given, and if it isn't, participation obviously ceases. In those circumstances, none of the data on that patient may be used. This is different from when valid consent is withdrawn (which it may be). Data obtained with valid informed consent before withdrawal may be used.

Here's some backup in French:

"L’encadrement de la recherche en 2017 La loi Jardé révisée (Ordonnance de 2016)
1. consentement
[...]
La personne « hors d’état de consentir » (art L1122-2) et en situation d’urgence (art L1122-1-3) Le consentement de poursuite est requis dans tous les cas, lorsque le patient redevient capable de consentir (idem RE 356/2014) ou que la famille se manifeste secondairement"
(See also Retrait du consentement, p. 8)
http://www.fcrin.org/sites/default/files/u1713/ehesp_2017-11...

This situation is not unique to France, actually. The same seems to be true in Germany (admittedly, the following refers to treatment rather than research, but I think the terminology is applicable):

"if, in an emergency situation, consent cannot be obtained, treatment which is necessary without delay to save the life of the person concerned, restore good health or alleviate suffering can be started immediately. Consent for continued participation must be obtained as soon as it is possible and reasonable.” (Section 41, subsection 1 [of the German Act on Medicinal Products)
http://satoriproject.eu/media/SATORI-Deliverable-3.1-.pdf

Well, that expression is used in several EN sources:

"Persons participating in the emergency research project or, if applicable, their representatives shall be provided with all the relevant information concerning their participation in the research project as soon as possible. Consent or authorisation for continued participation shall be requested as soon as reasonably possible."
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005), Council of Europe
https://www.coe.int/en/web/conventions/full-list/-/conventio...

"Research in an emergency setting is challenging because there may not be sufficient opportunity or time to obtain informed consent from the patient or their legally authorized representative. Such research can be conducted without prior consent if specific criteria are met. However consent is sometimes required for continued participation and may bias the results of the study."
http://www.resuscitationjournal.com/article/S0300-9572(06)00...

And here it is in relation to France:

"Emergency medical consent is obtained from family members. An informed consent for continued participation is also obtained from patients when they wake."
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1528-1167...

So I think this is the appropriate expression to use.
Selected response from:

Charles Davis
Spain
Local time: 05:32
Grading comment
Thank you! This is new to me as I usually translate strictly "medical" texts.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3(consent forms) for continued participation, addressed to the patient
Charles Davis
4follow-up (documents) intended for the patient
B D Finch
4other patient documentation
Wendy Cummings
3 +1patient's study continuation
Lorraine Dubuc
4continuing the clinical trial or further investigations
Drmanu49


Discussion entries: 1





  

Answers


2 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
poursuite destinés au patient
continuing the clinical trial or further investigations


Explanation:
IMO

Drmanu49
France
Local time: 05:32
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 4391
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38 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
poursuite destinés au patient
patient's study continuation


Explanation:
Ce sont les notices d'informations et les consentements qui sont «destinés» au patient pour la poursuite de l'étude. Le patient participe à une étude et on l'informe des risques et bienfaits et il donne son consentement de poursuivre l'étude. Il peut également, le cas échéant, retirer son consentement à poursuivre l'étude. C'est ce que j'en comprends d'après le lien de référence.


    https://www.recherchecliniquepariscentre.fr/wp-content/uploads/2012/02/Chappuy_M2pharmaco2012.pdf
Lorraine Dubuc
Canada
Local time: 23:32
Works in field
Native speaker of: Native in FrenchFrench

Peer comments on this answer (and responses from the answerer)
agree  philgoddard: Charles answered in more detail, but I think you had it first.
4 hrs
  -> Thank you! Yes, I just gave my agreement to his suggestion because this is exactly what this is about.
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44 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
poursuite destinés au patient
other patient documentation


Explanation:
It seems a little oddly worded, but I understand it as this info should be included/replaced on all PIL, ICFs, for the patient and for the patient's reps/parents, as well as on all other patient documentation.

Wendy Cummings
United Kingdom
Local time: 04:32
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 16
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
poursuite destinés au patient
follow-up (documents) intended for the patient


Explanation:
The text preceding the list that is in brackets, "Pour finir, le titre de médecin a été remplacé par médecin-investigateur tout le long des notices d’information et des consentements" seems to me to be saying that for the list of printed materials in brackets "le titre de médecin a été remplacé par médecin-investigateur". So, this is just administrative information about how these various documents should be drafted. No litigation involved.

B D Finch
France
Local time: 05:32
Native speaker of: Native in EnglishEnglish
PRO pts in category: 96
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
poursuite destinés au patient
(consent forms) for continued participation, addressed to the patient


Explanation:
"Continued participation" is the usual term for "poursuite" in English.

To take the last part first, I take "destinés su patient" to mean addressed to the patient and to refer to "consentements" (possibly also "notices d'information"). These are clearly documents, because the text refers to the obligation to include the principal investigator's details in a table at the beginning of them. So the "consentements" are presumably consent forms. So I think "destinés à" means addressed to or directed to, or possibly "intended for".

Be that as it may, "poursuite" has a quite specific meaning here. This must be about the "consentement de poursuite" in the Loi Jarré of 2012 (the law governing clinical trials in France), as revised in 2016. It refers to a situation in which a patient is involuntarily enrolled in a study without informed consent where there is pressing need but the patient was unconscious or otherwise medically unable to give consent. Provisional consent can be given by a family member by proxy. When the patient wakes up or becomes capable of consenting, a "consentement de poursuite" is sought. If it is given, it validates the uninformed participation retrospectively. It doesn't have to be given, and if it isn't, participation obviously ceases. In those circumstances, none of the data on that patient may be used. This is different from when valid consent is withdrawn (which it may be). Data obtained with valid informed consent before withdrawal may be used.

Here's some backup in French:

"L’encadrement de la recherche en 2017 La loi Jardé révisée (Ordonnance de 2016)
1. consentement
[...]
La personne « hors d’état de consentir » (art L1122-2) et en situation d’urgence (art L1122-1-3) Le consentement de poursuite est requis dans tous les cas, lorsque le patient redevient capable de consentir (idem RE 356/2014) ou que la famille se manifeste secondairement"
(See also Retrait du consentement, p. 8)
http://www.fcrin.org/sites/default/files/u1713/ehesp_2017-11...

This situation is not unique to France, actually. The same seems to be true in Germany (admittedly, the following refers to treatment rather than research, but I think the terminology is applicable):

"if, in an emergency situation, consent cannot be obtained, treatment which is necessary without delay to save the life of the person concerned, restore good health or alleviate suffering can be started immediately. Consent for continued participation must be obtained as soon as it is possible and reasonable.” (Section 41, subsection 1 [of the German Act on Medicinal Products)
http://satoriproject.eu/media/SATORI-Deliverable-3.1-.pdf

Well, that expression is used in several EN sources:

"Persons participating in the emergency research project or, if applicable, their representatives shall be provided with all the relevant information concerning their participation in the research project as soon as possible. Consent or authorisation for continued participation shall be requested as soon as reasonably possible."
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005), Council of Europe
https://www.coe.int/en/web/conventions/full-list/-/conventio...

"Research in an emergency setting is challenging because there may not be sufficient opportunity or time to obtain informed consent from the patient or their legally authorized representative. Such research can be conducted without prior consent if specific criteria are met. However consent is sometimes required for continued participation and may bias the results of the study."
http://www.resuscitationjournal.com/article/S0300-9572(06)00...

And here it is in relation to France:

"Emergency medical consent is obtained from family members. An informed consent for continued participation is also obtained from patients when they wake."
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1528-1167...

So I think this is the appropriate expression to use.

Charles Davis
Spain
Local time: 05:32
Native speaker of: Native in EnglishEnglish
PRO pts in category: 112
Grading comment
Thank you! This is new to me as I usually translate strictly "medical" texts.

Peer comments on this answer (and responses from the answerer)
agree  Lorraine Dubuc: This is exactly what it is according to my research. Well this is about best interest of all, and accuracy of the wording, and not a personal competition. Thank you, Charles!
2 hrs
  -> Thank you, Lorraine! Very generous of you to agree. I hope you don't mind me posting another answer; I decided to, on balance, because I though it would be useful to explain the details, and I wanted to propose another way of expressing it.

agree  B D Finch: Well researched!
22 hrs
  -> Thanks very much, Barbara!

agree  Sue Davis
3 days 3 hrs
  -> Many thanks, Sue :-)
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