Is informed consent document the same as informed consent form?

[yongqunh]

Based on many websites like:
http://research-compliance.umich.edu/informed-consent-guidelines
https://www.rit.edu/research/hsro/informed_consent_document_sample_tips
An informed consent document is the same as an informed consent form.

my question is whether there is some other document that is not an informed consent form but it is an informed consent document.

[fjmanion]

I don't think conflating the colloquial use of informed consent document with formal definitions of these artifacts is a good idea. Assent forms are certainly an example of a document that is part of an informed consent process. Without checking the existing common rule, if memory serves me right there are also requirement to record the person administering the consent in certain circumstances. This is also an "informed consent document". -- Frank

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On 4/13/2017 5:28 PM, Yongqun Oliver He wrote: Based on many websites like: http://research-compliance.umich.edu/informed-consent-guidelines https://www.rit.edu/research/hsro/informed_consent_document_sample_tips An informed consent document is the same as an informed consent form. my question is whether there is some other document that is not an informed consent form but it is an informed consent document. — You are receiving this because you are subscribed to this thread. Reply to this email directly, view it on GitHub <#7>, or mute the thread <https://github.com/notifications/unsubscribe-auth/ABGiGjmD0ohwI7Ult0urrmME7GOm_BQCks5rvpOKgaJpZM4M9Od2>.

-- *Frank J. Manion* Chief Informatics Officer Univ. of Michigan Comprehensive Cancer Center 1600 Huron Parkway, Bldg 100, Room 131 Ann Arbor, MI 48109-2800 Email: [email protected] | Web: http://cci.med.umich.edu/ Office: (734) 764-2473 | Cell: (734) 276-0111 | Fax: (734) 615-0507 Assistant: Lisa Papp ([email protected]) (734) 764-8848

[yongqunh]

I agree.
In this case, we can probably add to ICO a new term 'informed consent document', and then add under it the 'assent form' and other specific documents.
In addition, we can place current term 'informed consent form' under the new term 'informed consent document'.
We will also need to define what is 'informed consent document'.
Probably we can define an 'informed consent document' as:
A document that is used during an informed consent process.