[Openid-specs-heart] Additional Considerations for the "Alice Consents to Clinical Research" Use Case

[Aaron Seib]

I ran two IRBs (Cancer Adult and Peds) for a while in a previous life.  As you state:

 

“The key issue is whether an "informed consent" <document> is sufficient to provide <enough> information to the patient, or whether it's necessary to ensure the patient is actually informed by it.”

 

As this has been debated since the end of WWII, I full heartedly support the notion of keeping this debate out of the scope for HEART and make the assumption that from the system perspective there is a triggering event that conveys that the consumer has satisfied the policy requirements established to demonstrate informed consent.

 

Aaron

 

Aaron Seib, CEO

@CaptBlueButton 

 (o) 301-540-2311

(m) 301-326-6843



 

From: Openid-specs-heart [mailto:openid-specs-heart-bounces at lists.openid.net] On Behalf Of Glen Marshall [SRS]
Sent: Thursday, September 24, 2015 4:01 PM
To: HEART List
Subject: [Openid-specs-heart] Additional Considerations for the "Alice Consents to Clinical Research" Use Case

 

Team,

Adding to our discussion, there are two patient PHR feedback loops in the "Alice Consents to Clinical Research" use case:    



*	The EHR-to-PHR link is only incidental to the use case, as it was covered in our first use case. However, the translation of clinical data to a consumer-understandable form is of possible interest as a precondition.  The key issue is whether in "informed consent" it is sufficient to provide information to the patient, or whether it's necessary to ensure the patient is actually informed by it.  Is there a trigger event that indicates the "informed" precondition has been met?  

I don't want to lead us all down a rabbit hole, though, so I'd like the specification of that event, other than Alice signing the consent form, to be declared out of scope.
*	The CDRN-to-PHR link is important to the complete use case.  The technical issue is how to report disclosures to a patient whose data is pseudonymized in the CDRN.  I don't think HEART will solve it, we need to include a a "black box" that re-identifies patients for communication to the patients and their care providers.  For this use case we need to have an UMA permission in the AS, probably from the IRB, that allows the "black box" to reidentify an incoming transaction for the purpose of disclosure, but not for any other purpose.

Your thoughts?

Best,
Glen  




-- 

Glen F. Marshall
Consultant
Security Risk Solutions, Inc.
698 Fishermans Bend
Mount Pleasant, SC 29464
Tel: (610) 644-2452
Mobile: (610) 613-3084
gfm at securityrs.com
www.SecurityRiskSolutions.com

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