Glossary entry

English term or phrase:

consent x assent x permission

English answer:

consent - assent - permission (please see explanation)

Added to glossary by Marga Shaw
Apr 25, 2012 06:39
12 yrs ago
8 viewers *
English term

consent x asset x permission

English Medical Medical: Pharmaceuticals
My question is whether there is an internationally accepted (or official) distinction between consent, assent and permission, in client-facing clinical trial materials. In other words, can the three words be used interchangeably, or is there a defined difference in meaning between then that would make e.g. "informed permission" somehow different from "informed consent"?
Change log

May 2, 2012 08:19: Marga Shaw Created KOG entry

Discussion

Charles Davis Apr 25, 2012:
@Andrew Great reference, which complements and confirms Marga's answer.
BrigitteHilgner Apr 25, 2012:
With Helen I haven't come across "informed permission" yet - and I've been translating relevant material from English into German for more than a decade.
Helen Genevier Apr 25, 2012:
not interchangeable Informed consent is the only term I've seen used for an adult agreeing to take part in a trial. Informed assent is for a child agreeing to take part in a trial. These terms appear in ICH's Clinical investigation of medicinal products in the pediatric population document E11, so as official as you can get :-)
Bashiqa Apr 25, 2012:
Good question. This should start some head scratching.

Responses

+3
3 hrs
Selected

consent - assent - permission

The informed consent given by an adult confirms his/her willingness to participate in clinical reasearch.

However, consent cannot be given if another person. Therefore, this resulted in the use of informed permission and assent in paediatric clinical research. Hence parents would grant informed permission for their child to participate in clinical research/in a clinical trial.

Lastly, also children are approached to indicate their willingness to participate called assent after receiving information appropriate to their age.

https://docs.google.com/viewer?a=v&q=cache:8-JdBPtudksJ:www....
(Please see table 1, p.17)

http://www.cancer.gov/clinicaltrials/patientsafety/childrens...

http://www.seattlechildrens.org/research/support-services/re...


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Note added at 7 days (2012-05-02 08:16:43 GMT) Post-grading
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In para. two above "given if another person" should read "given by another person". Apologies for the oversight.
Peer comment(s):

agree Melanie Nassar
11 mins
Many thanks, Melanie!
agree Charles Davis : Good answer and excellent references
2 hrs
Many thanks, Charles!
agree lorenab23
8 hrs
Many thanks, Loren!
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4 KudoZ points awarded for this answer.
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