Proving informed consent in studies done in the community

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IdaBauer
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Proving informed consent in studies done in the community

Post by IdaBauer » Tue Sep 01, 2020 1:52 pm

Can anyone confirm/link me to any resources that clarify the guidelines around obtaining informed consent for use of data in community settings? In other words, where research participation is not the main reason for the participants providing the data we wish to analyse. I'm particularly interested in whether we need to store a scanned or paper copy of the consent forms (and if so, for how long), or can just record that consent was given and provide a copy of the form. We are looking to publish in journals so need to ensure we meet the level of ethics board scrutiny that comes along with that.

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miriam
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Re: Proving informed consent in studies done in the community

Post by miriam » Fri Sep 04, 2020 2:47 pm

You haven't given the information that is needed to answer the question, I'm afraid.

Who is conducting the research? A university, an NHS trust, a charity, a private provider, an independent researcher?
What data is being collected and from whom? Does it include "personal data" under the data protection act definition (eg name, date of birth, address, ethnicity, diagnoses etc)?
Is all the data being collected data that would be collected with or without the research?
Is there any randomisation or change to treatment or staff practice involved in the research?
Who is designing/supervising the research, and why do they not know about the relevant guidance for ethics/consent etc?
Miriam

See my blog at http://clinpsyeye.wordpress.com

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