Stream: genomics
Topic: consent scope for genomics testing
Andrew Patterson (Jan 02 2019 at 00:11):
Hi all, happy new year. We are looking at shoe horning some consent information for our genomics testing into a FHIR consent resource (to go along with our other genomics fhir data). Understanding that the Consent resource is still at a low level of maturity and this is outside its current scope - but just looking at doing our best we can for the moment and fix/realign later.
Our consent forms are such that participants both consent for clinical testing and may opt in to research in both identifiable and anonymous modes + other details. It is a reasonably complex consent model.
(The form has evolved from here but this is a sample of what we are talking about
https://www.australiangenomics.org.au/media/1500/australian-genomics_national-clinical-genomics_consent-form_-consultation-draft.pdf)
Anyhow, in the first instance I am already stuck - I feel our form leads to multiple Consent records - some with a consent scope of 'research'. But for the pure clinical use case Consent record - I'm not sure what (mandatory) consentscope is appropriate. A genomics test is almost a consent to be diagnosed - so 'treatment' doesn't feel appropriate. Is 'patient-privacy' the right path? Or is this outside the scope of the currently thought of use cases? @John Moehrke thoughts?
Andrew Patterson (Jan 02 2019 at 00:34):
(actually I see with the latest R4 build that consentscope is extensible - but am still interested in whether our case fits in)
Lloyd McKenzie (Jan 02 2019 at 01:43):
@David Pyke ?
David Pyke (Jan 02 2019 at 02:01):
This is definitely a new scope for the Consent resource. From what I read in the linked consent form, you have a research consent requirement and a variety of other consent requirements. The big issue I would need to understand is how the consent resource should be expanded. It is possible to cover this all in one resource but I think it is better set, especially for the familial link, that it would be a bundle of Consents. I would like to talk further about this with you and bring it in front of the WorkGroup to get a better handle on the possibilities.
I don't quite understand what the consent requirements are for some of these and would need to better discuss how we could add categories and/or values to cover this use case.
Andrew Patterson (Jan 02 2019 at 02:09):
Thanks. I'll follow up with you with an email.
We are definitely envisaging a bundle of consents, not the least because as you have noted we are actually taking consent from multiple parties in the family. But even the base singleton case I think we will have multiple Consents for the different purposes rather than trying to wedge all our rules into one.
Just looking at the more 'clinical' end of the form - the consent for a specimen to be taken and acknowledging the understanding of a genomic test - does that not currently fall into any existing consent scope? I would have thought that some (not genomic) diagnostic tests would already fall into that style of consent but which don't seem to fit into a scope of 'treatment' (angiograms?)
John Moehrke (Jan 02 2019 at 13:51):
Another factor in this is what you want to get out of the Consent resource. The Consent resource can be used simply as a way to find the scanned paperwork, with no support for automating any business or privacy rules. This use-case is often overlooked, yet it is the most used system in real systems today. That said, we designed Consent resource to be able to support automating business rules and privacy enforcement rules. The design is intended to scale to these various use.
Andrew Patterson (Jan 02 2019 at 22:05):
We definitely want it for the (semi) automation of making research releases of genomic data sets. Whilst the labs who use our system might also attach the scanned paperwork - we know that they maintain their own scans in their own systems for their other business purposes (i.e. legal).
Our purpose is more like - "of the X thousand genomic samples (with accompaying BAM/VCF files), find all that are consented to reidentifiable cardiomyopathy research by a not for profit"..
John Moehrke (Jan 04 2019 at 15:06):
That automation should only need the .provisions of Consent, so that should be easy to support. The different purposeOfUse vocabulary is expected, hence why it is extensible. Very much expect all reasearch projects will have a unique research project purpose vocabulary they manage and use.
Last updated: Apr 12 2022 at 19:14 UTC
