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Copyright for articles used in CER (Clinical Evaluation Report)

TheMightyWife

Involved In Discussions
#1
Hi All,

I struggle to find information on how to use articles within CERs.
I'm using PubMed to search relevant articles that I list on my controlled form for 'Literature Search'. I don't download them, just hyperlink them in the document.
Next step is to read them all and decide which ones are going to be included in our CER.
They are available on the website (usually in full) but how does it work with copyright?
They will be obviously quoted in my document, can I do it providing I check that copyright allows this:
'This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited'
And is CER a non-commercial use?
Thank you all for any input you may have.
 
#2
Hi TMW,

Generally speaking, citing/referencing papers (regardless of the purpose) is not considered copyright infringement because copyright protects the actual work, not the ideas contained in the work or references to that work.

If, for example, you were directly quoting substantial amounts including quotations directly of from the papers your referenced into your CER (or substantially similar non-quotations), then the analysis would need to be undertaken about whether: (i) your use was NonCommercial and thus allowed by the Creative Commons / Open Access license (provided you properly cited); and/or (ii) your use fell under the Fair Use doctrine (or another exception) to infringement.

Disclaimer: I am not your lawyer and you are not my client. This is not legal advice and I am by no means a copyright expert.
 

TheMightyWife

Involved In Discussions
#4
Hi TMW,

Generally speaking, citing/referencing papers (regardless of the purpose) is not considered copyright infringement because copyright protects the actual work, not the ideas contained in the work or references to that work.

If, for example, you were directly quoting substantial amounts including quotations directly of from the papers your referenced into your CER (or substantially similar non-quotations), then the analysis would need to be undertaken about whether: (i) your use was NonCommercial and thus allowed by the Creative Commons / Open Access license (provided you properly cited); and/or (ii) your use fell under the Fair Use doctrine (or another exception) to infringement.

Disclaimer: I am not your lawyer and you are not my client. This is not legal advice and I am by no means a copyright expert.
Hi Supadrai,

Thank you for your input. It seems like rather complicated matter and I might suggest contacting company's lawyer to clarify this matter
 

TechnicalGuy

Research and Development
#5
Hi All,

I struggle to find information on how to use articles within CERs.
I'm using PubMed to search relevant articles that I list on my controlled form for 'Literature Search'. I don't download them, just hyperlink them in the document.
Next step is to read them all and decide which ones are going to be included in our CER.
They are available on the website (usually in full) but how does it work with copyright?
They will be obviously quoted in my document, can I do it providing I check that copyright allows this:
'This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited'
And is CER a non-commercial use?
Thank you all for any input you may have.
Hi MightyWife,

I write CERs as well as published peer reviewed work and the rule of thumb is that if the article is cited correctly in the text or in a references section you can report or use whatever you like. Doing things like taking their conclusions and implying they are your own is a no-no as is using large sections of their text. Otherwise there is plenty of freely available published and peer reviewed literature out there, I am a strong advocate for free published work, it often makes copyrighting issues easier to overcome.

Welcome to the Medical Device (and Dental) Industry!
 

TheMightyWife

Involved In Discussions
#7
Hi MightyWife,

I write CERs as well as published peer reviewed work and the rule of thumb is that if the article is cited correctly in the text or in a references section you can report or use whatever you like. Doing things like taking their conclusions and implying they are your own is a no-no as is using large sections of their text. Otherwise there is plenty of freely available published and peer reviewed literature out there, I am a strong advocate for free published work, it often makes copyrighting issues easier to overcome.

Welcome to the Medical Device (and Dental) Industry!
Thank you TechnicalGuy :)
To be perfectly honest I didn't take copyright to consideration until we received an email form one of the licensing agencies (we are in UK).
Dentistry is something completely different to my previous environment :)
 

TechnicalGuy

Research and Development
#9
Thank you TechnicalGuy :)
To be perfectly honest I didn't take copyright to consideration until we received an email form one of the licensing agencies (we are in UK).
Dentistry is something completely different to my previous environment :)
I am also in the dental industry in the UK (8 years in some Quality but mostly Design). Feel free to contact me personally if you want to network. I'm sure we can help and assist each other in any specifics going forward.
 
#10
Good morning,
here comes an awkward question :)
I am a medical devices CER writer and I am looking some (official, wishfully) guidelines on the extent of plagiarism we we "allowed" to practice when writing the State of the Art Section and when appraising clinical data on equivalent devices.
Does anyone have any examples where a Notified Body rejected a CER because plagiarism was detected in these two sections?
Do you think we should treat the CER as an original paper that will undergo peer-review, therefore all plagiarism rules apply, or we could be a bit more flexible given that this is a regulatory document that remains confidential throughout the process?
Any thoughts will be highly appreciated!
 
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