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Posted by John Lehmann on Wed, Aug 19, 2015

Back Translations

On a recent monitoring visit, the coordinator asked an IMARC monitor if the study sponsor could have their consent translated into Spanish. However, the site had one caveat – their IRB also required a “back translation” of the translated consent. Why would the IRB require this back translation?

Topics: Consent, Back Translation, Section 50.20

Posted by Danielle Sas on Wed, Mar 04, 2015

Do You Know the Difference Between a Consent for Research and a Standard Consent for Treatment?

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

Topics: FDA, Clinical Research, IRB, Consent, 21 CRF 50.25

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