ethical qualms about a study
Thread poster: Marjolein Snippe

Marjolein Snippe  Identity Verified
Netherlands
Local time: 23:29
Member (2012)
English to Dutch
+ ...
Nov 23, 2017

I have recently translated some documents for a clinical study and realised only afterwards that I was somewhat disturbed by one of the documents.
If I had realised this immediately, I might have attached a comment to the translation, so that my client could decide whether or not to forward this to the end client. As it is, I would need to contact my client separately about something which is actually way out of scope (I am the translator - not a member of an ethics committee).

My concern is the following:
One of the documents was about the experience of two participants in a previous, small-scale study.
One of them indicated explicitly that he would recommend not talking to many people about participating, because people who did not have sufficient understanding of the experimental therapy might be prejudiced and their comments would only make you feel more nervous. He had almost not participated because of this (he said) and was very glad he did participate after all.

This was material for patient recruitment; obviously, it is not part of the ICF.
Presumably, the ICF will contain the normal clause indicating that "you may discuss this information with your GP, friends or family members".

As far as I know, it is not considered ethical to discourage people from discussing the study with their GP, friends and family.
Should I contact my client about this? It is not remotely part of my job, but does make me feel uneasy.
Or should I let it go, and trust that anything unethical will be picked up by the ethical committee when the study is submitted for approval?
Any other options?


 

Nikki Scott-Despaigne  Identity Verified
Local time: 23:29
French to English
yes and no Nov 23, 2017

I can understand your feeling ill at ease about this. I also agree with you that it is not your job to contest or question any of the content per se. If to settle your conscience, you feel the matter needs to be raised, then you could do so by mail when delivering the document to your client. It is then up to your client to consider whether your remark is worth passing on or not. I admit that I have pointed out one or two quirks in similar circumstances, and the agent has inevitably decided not to pass the comment on. The basic principle is that we are paid to translate what we are given to tra,slate and that yes, we are paid to think too. However, if the study raises some ethical points, that would mean critcising the content and it really is beyond the scope of what we are paid to do. It is the job of the research team to respect procedure/ethics. If they have not, then it is the job of the review committee receiving the publication to raise the matter.

 

Lingua 5B  Identity Verified
Bosnia and Herzegovina
Local time: 23:29
English to Croatian
+ ...
Exactely. Nov 23, 2017

Marjolein Snippe wrote:
anything unethical will be picked up by the ethical committee when the study is submitted for approval?


Yes, exactly.


 

Chris S  Identity Verified
United Kingdom
Swedish to English
+ ...
Follow your heart... Nov 23, 2017

... while covering your back...

 

Marjolein Snippe  Identity Verified
Netherlands
Local time: 23:29
Member (2012)
English to Dutch
+ ...
TOPIC STARTER
Thank you! Nov 23, 2017

Thanks for your reactions!

 

Nikki Scott-Despaigne  Identity Verified
Local time: 23:29
French to English
Like Nov 23, 2017

Chris S wrote:

... while covering your back...


 

conniebrathen  Identity Verified
Local time: 22:29
English to Norwegian
+ ...
Genuine advice from a real participant, not to be sneezed at Nov 24, 2017

TBH, I think the advice of this participant is fairly sound... Of course, participants should be encouraged to speak to their GP and close family who understand their particular health issues and medical concerns. But in my experience, it can be very unhelpful to discuss medical treatment with more peripheral acquaintances, neighbors, colleagues etc. I have worked in hospitals and clinical trials in a variety of settings for 20 years, and it never seizes to amaze me the amount of irrelevant anecdotes and unlikely horror stories some people feel the need to impart on someone coming in for particular procedures...

It is the responsibility of the medical and research team to give the full and honest information regarding any treatment, including any potential hazards. And they do, believe me, no one wants their licence revoked! And as others have pointed out, the study and any materials given out as part of the study are the subject of approval of the ethics committee, who arguably are better placed than the translator to make these calls.


 


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ethical qualms about a study

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