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French to English translations [PRO] Medical - Medical (general) / clinical trials
French term or phrase:préjudice
From an Informed Consent Form and a Patient Information Sheet originating in Switzerland:
"J’ai été informé(e) que je suis couvert(e) par une assurance en cas de préjudice survenant dans le cadre de l’étude."
"XXX [drug company] vous indemniseront en cas de préjudice que vous pourriez subir dans le cadre de l’essai clinique."
'Injury' seems to me to be the legal translation here, but it does fit well in the context of material meant for the patient. 'Ill effect' seems a bit too wide. Any other suggestions?
Explanation: What is the NIH's policy regarding research-related injuries?
The following standard CC minimum language is part of the consent template and must be used: “The Clinical Center of the NIH will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided by the National Institutes of Health, the Clinical Center, or the Federal Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.”
-------------------------------------------------- Note added at 7 mins (2012-01-26 10:42:26 GMT) --------------------------------------------------
-------------------------------------------------- Note added at 9 mins (2012-01-26 10:44:34 GMT) --------------------------------------------------
For th UK:
]
Informed Consent Form for Participants in Research Studies www.geog.qmul.ac.uk/docs/research/Research ethics/5777.doc
File Format: Microsoft Word - Quick View
Informed Consent Form for Participants in Research Studies ... and my rights as a participant and whom to contact in the event of a research-related injury.
[DOC]
ICMR comes out strict draft norms on clinical trials www.iptu.co.uk/.../INDIA RELATED ARTICLE/...
File Format: Microsoft Word - Quick View
19 Feb 2009 – According to Indian Council of Medical Research's draft guidelines for compensation to participants for research related injury in India, ... The draft also says that the Informed Consent Document (ICD) will have to clearly state ...
[PDF]
Taking Informed Consent www.thh.nhs.uk/.../Research/sops/taking_informed_consent_v2...
File Format: PDF/Adobe Acrobat - Quick View
evidence of the consent for research is explicitly required by ICH GCP. Written documentation ... Informed consent must be obtained prior to any research related procedures being performed. .... of any injury relating to the trial. • Anticipated ...
-------------------------------------------------- Note added at 10 mins (2012-01-26 10:45:54 GMT) --------------------------------------------------
§ read the information sheet and/or the project has been explained to me orally;
§ had the opportunity to ask questions and discuss the study;
§ received satisfactory answers to all my questions or have been advised of an individual to contact for answers to pertinent questions about the research and my rights as a participant and whom to contact in the event of a research-related injury.
-------------------------------------------------- Note added at 15 mins (2012-01-26 10:51:12 GMT) --------------------------------------------------
Very detailed document here. See pp 17-18 in particular:
Compensation for any injury caused by taking part in this study will be in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). Broadly speaking the ABPI guidelines recommend that ‘the sponsor’, without legal commitment, should compensate you without you having to prove that it is at fault. This applies in cases where it is likely that such injury results from giving any new drug or any other procedure carried out in accordance with the protocol for the study. ‘The sponsor’ will not compensate you where such injury results from any procedure carried out which is not in accordance with the protocol for the study. Your right at law to claim compensation for injury where you can prove negligence is not affected. Copies of these guidelines are available on request.’
-------------------------------------------------- Note added at 40 mins (2012-01-26 11:15:35 GMT) --------------------------------------------------
This is the legalistic translation, but also apparently widely used on ICFs despite a common usage of 'injury' that is slightly different from the legal usage. This is the one I used, and the client was happy :) 4 KudoZ points were awarded for this answer
to my thinking everything may be ruled out except the two suggestions
a) personal injury and b) personal damage (Personenschaden as opposed to Sachschaden: material damage)
Silly question time from the floor... does your original provide any specific indication as to the type of prejudice. The context is specific of course and insurers are too. There are a couple of likely candidates for the term but unless and until you have precise information as to the nature of the cover provided, it might be a bit dicey supposing anything at all. That said, I suppose if you knew, you might not have posted the question! Hmm. Do you have an opportunity to put the question to the client?
Explanation: What is the NIH's policy regarding research-related injuries?
The following standard CC minimum language is part of the consent template and must be used: “The Clinical Center of the NIH will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided by the National Institutes of Health, the Clinical Center, or the Federal Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.”
-------------------------------------------------- Note added at 7 mins (2012-01-26 10:42:26 GMT) --------------------------------------------------
-------------------------------------------------- Note added at 9 mins (2012-01-26 10:44:34 GMT) --------------------------------------------------
For th UK:
]
Informed Consent Form for Participants in Research Studies www.geog.qmul.ac.uk/docs/research/Research ethics/5777.doc
File Format: Microsoft Word - Quick View
Informed Consent Form for Participants in Research Studies ... and my rights as a participant and whom to contact in the event of a research-related injury.
[DOC]
ICMR comes out strict draft norms on clinical trials www.iptu.co.uk/.../INDIA RELATED ARTICLE/...
File Format: Microsoft Word - Quick View
19 Feb 2009 – According to Indian Council of Medical Research's draft guidelines for compensation to participants for research related injury in India, ... The draft also says that the Informed Consent Document (ICD) will have to clearly state ...
[PDF]
Taking Informed Consent www.thh.nhs.uk/.../Research/sops/taking_informed_consent_v2...
File Format: PDF/Adobe Acrobat - Quick View
evidence of the consent for research is explicitly required by ICH GCP. Written documentation ... Informed consent must be obtained prior to any research related procedures being performed. .... of any injury relating to the trial. • Anticipated ...
-------------------------------------------------- Note added at 10 mins (2012-01-26 10:45:54 GMT) --------------------------------------------------
§ read the information sheet and/or the project has been explained to me orally;
§ had the opportunity to ask questions and discuss the study;
§ received satisfactory answers to all my questions or have been advised of an individual to contact for answers to pertinent questions about the research and my rights as a participant and whom to contact in the event of a research-related injury.
-------------------------------------------------- Note added at 15 mins (2012-01-26 10:51:12 GMT) --------------------------------------------------
Very detailed document here. See pp 17-18 in particular:
Compensation for any injury caused by taking part in this study will be in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). Broadly speaking the ABPI guidelines recommend that ‘the sponsor’, without legal commitment, should compensate you without you having to prove that it is at fault. This applies in cases where it is likely that such injury results from giving any new drug or any other procedure carried out in accordance with the protocol for the study. ‘The sponsor’ will not compensate you where such injury results from any procedure carried out which is not in accordance with the protocol for the study. Your right at law to claim compensation for injury where you can prove negligence is not affected. Copies of these guidelines are available on request.’
-------------------------------------------------- Note added at 40 mins (2012-01-26 11:15:35 GMT) --------------------------------------------------
SJLD Local time: 18:21 Specializes in field Native speaker of: English PRO pts in category: 1777
Grading comment
This is the legalistic translation, but also apparently widely used on ICFs despite a common usage of 'injury' that is slightly different from the legal usage. This is the one I used, and the client was happy :)
The translation workplace 
peer agreement (net): +1
