existing term 'assent process'

[yongqunh]

We need to check what we intend to mean by this term. It may not be under 'informed consent process'.

This label appears to be a type of informed consent process where the person is not able to consent, but the person asks another one to consent.

[jonathanbona]

Right, so there seem to be two kinds of processes relevant here:

1. A true 'assent process' that is the process of a person (who is not able to consent) giving their assent as part of a consent process that involves their legally authorized representative, and
2. The specific type of consent process that has as a part a process of type 1).

The definition for 'assent process' http://purl.obolibrary.org/obo/ICO_0000084, and its position as a subclass of 'informed consent process' seem to indicate that it captures processes of type 2) above. The suggestion if that's the case is:

• to change its label to clarify that it's an informed consent process that involves assent,
• to add a class for 'assent process' as in 1), and
• to add axioms to connect these (using processual parthood)

[linikujp]

The suggestions are very good. If we are going to have class of assent process, what's the label for the current meaning of type2) then? Any suggestions?

[fjmanion]

I think it depends on if we define "informed consent process" in a narrow or broad sense. Under the Common Rule, which is the basis for requiring assent, "assent" is part of the requirements for an informed consent process. It takes place in certain, well specified as described in 45 CFR 46 Subparts B, C, and D. The question is should we model it as a "subprocess", or as a separate process that has certain constraints.

…

On 2/17/17 1:29 PM, Yongqun Oliver He wrote: We need to check what we intend to mean by this term. It may not be under 'informed consent process'. This label appears to be a type of informed consent process where the person is not able to consent, but the person asks another one to consent. — You are receiving this because you are subscribed to this thread. Reply to this email directly, view it on GitHub <#4>, or mute the thread <https://github.com/notifications/unsubscribe-auth/ABGiGsSsBDYTRWV8mR_YA8e-0YS7UIrWks5rdecDgaJpZM4MEmLt>.

-- *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

[jonathanbona]

'informed consent process' is currently defined as: "A planned process in which a person or their legal representative is informed about key facts about potential risks and benefits of a process and makes a documented decision as to whether the person in question will participate."

Frank, do I understand correctly that only some informed consent processes involve assent, namely those where the subject is either too young or otherwise incapable of giving informed consent? If so then this is a subtype of 'informed consent process', and what differentiates it from the more general type is that it has an assenting process as one of its parts. Does this make sense?

[linikujp]

We just need a term like " informed consent process that involves assent", which should be a subclass of informed consent process. I didn't see any conflicts there. Thanks, Asiyah

…

On Sat, Feb 18, 2017 at 11:41 AM, Jonathan Bona ***@***.***> wrote: 'informed consent process' is currently defined as: *"A planned process in which a person or their legal representative is informed about key facts about potential risks and benefits of a process and makes a documented decision as to whether the person in question will participate."* Frank, do I understand correctly that only *some* informed consent processes involve assent, namely those where the subject is either too young or otherwise incapable of giving informed consent? If so then this is a subtype of 'informed consent process', and what differentiates it from the more general type is that it has an assenting process as one of its parts. Does this make sense? — You are receiving this because you commented. Reply to this email directly, view it on GitHub <#4 (comment)>, or mute the thread <https://github.com/notifications/unsubscribe-auth/AITyPaRL79kHvhzjW8x4v0TWg61f1DuEks5rdx89gaJpZM4MEmLt> .

[fjmanion]

Jonathan, Yes, that is correct. I refer everyone on this thread to the US Common Rule with particular attention to Subparts B, C, and D. There are many variants to the details of the processes involved, including who must sign, attest, and what precisely must be documented. There are also differences in rights and obligations of various persons laid out in these subparts. ICO does not currently capture these nuances. The modeling question is do we represent Assent as a subclass of Informed Consent Process or as a separate process. I tend to agree with Asyiah and keep it simple, since the overarching goal is achieving "legally effective informed consent" as well as adhering to principles of beneficence, among others. -- Frank

…

On 2/18/2017 11:41 AM, Jonathan Bona wrote: 'informed consent process' is currently defined as: /"A planned process in which a person or their legal representative is informed about key facts about potential risks and benefits of a process and makes a documented decision as to whether the person in question will participate."/ Frank, do I understand correctly that only /some/ informed consent processes involve assent, namely those where the subject is either too young or otherwise incapable of giving informed consent? If so then this is a subtype of 'informed consent process', and what differentiates it from the more general type is that it has an assenting process as one of its parts. Does this make sense? — You are receiving this because you commented. Reply to this email directly, view it on GitHub <#4 (comment)>, or mute the thread <https://github.com/notifications/unsubscribe-auth/ABGiGvvVn47-pFzLiHP0ooOcOeMMTweKks5rdx89gaJpZM4MEmLt>.

-- *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

[cstoeckert]

discussed on March 16, 2017. Proposal as per Asiyah, relabel "assent process" to be more clearly "informed consent process that involves assent" and has as part an assent process to be defined.

[mbrochhausen]

We should make "informed consent process involving assent" a defined class. Hence we need a new class: "assent process"

[jobeid]

"Assent" means a child's affirmative agreement to participate in research. It is an act signifying understanding (recognizing that the minor has not reached full legal age). Mere failure to object by the child should not, absent affirmative agreement, be construed as assent.
Source: http://www.irb.vt.edu/pages/assent.htm
Note that this definition misses the incapacitated adult use case.

[yongqunh]

Based on today's ICO meeting discussion, I have changed the original 'assent process' to 'informed consent process with assenting process':
http://purl.obolibrary.org/obo/ICO_0000084
and then added a new 'assent process' in ICO:
http://purl.obolibrary.org/obo/ICO_0000143

then I used axioms to link these two terms:
'assent process' subClassOf : 'happens during' some 'informed consent process with assenting process'
'informed consent process with assenting process' subClassOf : 'encompasses some assent process'

please see if these definitions are OK. Thanks.