Glossary entry

French term or phrase:

avis du comité de protection de personnes

English translation:

approval of the institutional review board (IRB)

Added to glossary by Joanne Archambault
Nov 9, 2009 11:49
14 yrs ago
17 viewers *
French term

avis du comité de protection de personnes

French to English Medical Biology (-tech,-chem,micro-) Biomedical research ethics
I've translated as the approval of the CPP (for biomedical research) as opposed to opinion. Any thoughts?
Thanks!
Change log

Nov 9, 2009 12:53: Stéphanie Soudais changed "Term asked" from "avis du comite de protection de personnes" to "avis du comité de protection de personnes"

Nov 13, 2009 14:51: Joanne Archambault Created KOG entry

Discussion

Joanne Archambault Nov 9, 2009:
CPHS vs IRB From the websites of a few university medical centers in the USA:
<p/>
- The Institutional Review Board (IRB), alternately referred to as The Committee for the Protection of Human Subjects (CPHS), is a standing institutional review board established in compliance with federal policy for the protection of human subjects of research.
<p/>
- The Committee for the Protection of Human Subjects (CPHS) is the Institutional Review Board (IRB) for the University of Texas Health Science Center at Houston.
<p/>
- The CPHS, acting as the Institutional Review Board (IRB) for SFSU, is responsible for ensuring that human subjects are informed about and protected from any unnecessary risks that may be associated with participating in research.
<p/>
Gabrielle Leyden Nov 9, 2009:
opinion vs approval Jo - context is needed. The committee is asked for its opinion. It can then give an "avis affirmatif" (approval, green light) or "avis négatif", or something in between. (It may approve the overall protocol but have issues with certain details.)

Proposed translations

+2
37 mins
French term (edited): avis du comite de protection de personnes
Selected

approval of the institutional review board (IRB)

IRB is used in the US, so it depends who your client is...

"An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects."

avis = "approval" or "opinion" depending on the context, as was pointed out in the discussion...
Peer comment(s):

agree Caroline Vignard (X) : This is the translation approved by one of my (European) clients
5 hrs
Good to know, thanks.
neutral liz askew : http://209.85.229.132/search?q=cache:0cRLi8Qx7WoJ:wapedia.mo...
6 hrs
I think we're on the same page... I'm just providing the US-centric view!
agree Michael Lotz
11 hrs
thanks Michael
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4 KudoZ points awarded for this answer. Comment: "Many thanks, Jo!"
+2
5 mins
French term (edited): avis du comite de protection de personnes

approval (or not) of the Committee for the Protection of Human Subjects (CPHS)

6 May 2008 ... The Committee for the Protection of Human Subjects operates in compliance ... Protection of Human Subjects in Medical Experimentation Act. ...
www.oshpd.ca.gov/Boards/.../laws_regs.html -
Peer comment(s):

agree FrenchPhD : yep
1 hr
Thank you.
agree Chris Hall
2 hrs
Thank you Chris.
neutral Gabrielle Leyden : See Liz Askew's reference - would put "equivalent to Ethical Research Committee" in parentheses
10 hrs
Not sure it is exactly the same thing Gabrielle, we also have this committee.
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+2
2 hrs

opinion of the Comité de Protection de Personnes [the Committee for the Protection of Persons]

#
Committee for the protection of persons.
Committee for the protection of persons. [Article in English, French] ... that concern the protection of persons participating in biomedical research, ... the prior opinion of a Committee for the Protection of Persons (CPP) must be ...
www.ncbi.nlm.nih.gov/pubmed/16268433 - Similar
by N Brion - Related articles - All 4 versions
#
France - Privireal: Research Ethics Committees - Countries
30 Jun 2005 ... The Committees for the Protection of Persons (CPPs): the committee issues an opinion to the investigator of the biomedical research for the protection of the person and for ... The National Consultative Committee for the processing of ... While the research protocol is considered by a CPP and then ...
www.privireal.org/content/rec/france.php - Cached - Similar

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Note added at 2 hrs (2009-11-09 13:53:55 GMT)
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[PDF]
Microsoft PowerPoint - Ethics-G2P--Cambon-Hinxton-EBI0609
File Format: PDF/Adobe Acrobat - View as HTML
CPP (Committee for protection of persons, equivalent REC) ... Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues, ...
www.ebi.ac.uk/.../Ethical_issues_in_genotype_to_phenotype_d... - Similar

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Note added at 2 hrs (2009-11-09 13:54:36 GMT)
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General framework in France
• Legal measures for:
– Protection of persons participating in medical research
• CPP (Committee for protection of persons, equivalent REC)
• Insurance
• Informed consent (for secondary use, information + possibility of opting
out = non opposition; but if full sequencing?)
– Data protection authorities : Committee for approval of data
treatment +specific committee for health related research –
same level of protection in country of data origin/destination

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Note added at 6 hrs (2009-11-09 18:24:28 GMT)
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http://209.85.229.132/search?q=cache:0YwmfeJj7g8J:www.ephln....


Project partner

Anne-Marie Duguet holds an MD and a PhD in law. She is Senior Lecturer in the Medicine Faculty, Toulouse, Purpan (Paul Sabatier University), and works with INSERM Unit 558 Epidemiology and Public Health Analysis: risks, chronic diseases and handicap. She is president of the Ethics Committee for Biomedical Research (CPP) Sud Ouest et outre mer 2, and coordinates the Research Ethics programme in the International Institute on Research in Bioethics (IIREB). As president of ARFDM (Association for Research and Training in Medical Law) she has organised an international network of young researchers in law and medicine. She coordinates research projects supported by Ministry of Health funding, including the REMEDHOS project (Data-base on Medical Liability), the LEGIBIO project on the consequences for French legislation of biomedical research in France, and ABROVAC, which looks at the legal obligation of vaccination in France. She also participates in European and International projects, including the EURONIC Project on Parents’ information and ethical decision making in neonatal intensive care: staff attitudes and opinions , the FP5 MADO project on optimization of Haematopoietic stem cell donor Registries for transplantation, the COVEF Project Against Violence on Women, the DG Sanco project POSEIDON, dealing with quality issues and recruitment strategies in Haematopoietic stem cell transplantation, and the Epicore project on a comparative France-Quebec study on the participation of elderly patients in biomedical research.


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Note added at 6 hrs (2009-11-09 18:25:56 GMT)
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BTW
I do not know why I have "Does not meet criteria" under my name! Seems bizarre as I am forever translating medical texts from French into English:)

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te » Réglementation » Par instance » Les Instances Européennes (DG-SANCO, AESA, Conseil de l'Europe) » Avis du Comité Scientifique de l'Alimentation Humaine
Les Instances Européennes (DG-SANCO, AESA, Conseil de l'Europe)

Les Instances Françaises (DGCCRF, AFSSA)



Opinion of the Scientific Committee on Food on the irradiation of eight foodstuffs (expressed on 17.09.1998)



Revision of the opinion of the Scientific Committee on Food on the irradiation of food (expressed on 4 April 2003)



Opinion of the Scientific Committee on Food on the applicability of the ADI (Acceptable Daily Intake) for food additives to infants (expressed on 17.09.1998



Opinion on propane, butane and iso-butane as propellant gases for vegetable oil-based aerosol cooking sprays and water-based emulsion cooking sprays (expressed on 24 March 1999)



Statement of the Scientific Committee on Food on the recent report on primary aromatic amines in food and packaging samples in a Danish magazine (expressed on 26 September 2001)



Opinion of the Scientific Committee on Food on the use of carbon monoxide as component of packaging gases in modified atmosphere packaging for fresh meat (adopted on 13 December 2001)



Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials (updated on 13 December 2001)



Opinion of the Scientific Committee on Food on the introduction of a Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials (expressed on 4 December 2002)



Opinion of the Scientific Committee on Food on Potential risks from organotin compounds used as catalysts in silicone-coated baking papers (expressed on 5 March 2003)

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Note added at 21 hrs (2009-11-10 09:00:41 GMT)
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Avis = opinion

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Note added at 23 hrs (2009-11-10 11:49:52 GMT)
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* «Applications
* Approval requirements
* Before you apply to a REC
* Integrated Research Application System (IRAS)
* Booking your application
* Submitting your application
* After submission
* Attending a REC meeting
* After ethical review
* Re-submission / appeal
* Annual progress reports
* Notification of amendments
* Safety reports
* End of study and final report
* Providing feedback
* Guidance
* Frequently asked questions
* Glossary

.
After ethical review

A research ethics committee (REC) can give two possible opinions following the review of an application; an unfavourable ethical opinion or a favourable ethical opinion.


For studies receiving an unfavourable ethical opinion

*

Re-submission / appeal
How to resubmit your application or appeal against the decision.


For studies with favourable ethical opinions

*

Annual progress reports
You will need to provide a progress report to the main REC each year of the study's duration.
*

Notification of substantial amendments
When and how you should notify the main REC of any changes to your study.
Peer comment(s):

agree ACOZ (X) : I don't actually like this translation (approval is much more English - and correct) but my translation was rejected by a client a few months back, an "English-speaking" Frenchman who insisted on using opinion.
9 hrs
Good to know. I would automatically put "opinion", FWIW.
agree Scott de Lesseps
2540 days
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