CONSENT

[Debra Turnbull]

Hi all!

I am working on a project around Consent in healthcare. Consent in the commercial realm is out of scope.

Based on the above image, I have identified the main "buckets" of consent. My main question is: what's missing? What have I forgotten?

Thanks everyone.

[Kim Locke]

@Debra-Turnbull Patient consent for their data to be used in a clinical trial or patient consent for their tissue/cells/blood to be used in clinical trials? I know that researchers will collect heart or brain tissue, but I'm not sure about what is collected from limbs to be put into a biobank? That would need consent too.

[Kim Locke]

@Kim-Locke Oh! Also usage of any of the patient data to be used to "train" AI or even used to analyze images or other patient data with AI.
ie. If you want to compare all my liver CT scans with AI for trending growth with adenomas, you have to ask me if it's ok to use the liver CT scans from x date to x date. If you want to fetch them from OTHER health systems, you're welcome to do that...just let me know first.

[Debra Turnbull]

@Kim-Locke

Hi Kim!

So, Clinical Trials follow exact processes and procedures. These rules are defined in TCPS2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), found here:

• https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html

In a nutshell - it defines the rules of engagement of clinical trials / studies.

One such rule is that the trial subject (patient/volunteer) must be informed of all activities that directly impacts them - via informed consent. This information is contained in the Informed Consent Form (ICF); which the patient-participant signs; acknowledging their awareness of study activities. Study activities must be included in the ICF and may include:

• sample collection: tissues, biofluids

• responses to surveys, EEG, ECG, observations...

If samples are collected, the ICF stipulates where the samples are stored (biobank), analysed and where the analysis results are stored. All 3 locations - if not the same - must be listed individually; with their associated activity/role. There may be 2 locations listed for sample storage: prior and post analysis.

If samples are being shipped outside of Canada (or even to another province) this must be specified with an address in the ICF.

With regards to patient data to be included in the trial data set, this only happens after signing the ICF. lf something from your health record is being collected - this too must be clearly stated in ICF. Usually, a study doctor (principle Investigator or PI) will scan your health record to identify you as a potential candidate. Only if you meet their criteria - and you have consented to be approached for study - will they contact you to offer an initial meeting.

All to say: ICF and clinical trials are precise things and activities.

[Debra Turnbull]

@Kim-Locke
Yeah, training AI is a commercial activity by AI software vendors. Legally they are not permitted to access healthcare data from Canadian patients. Privacy laws block that.

Now, as for as what data went into the AI-CDSS or Radiology AI... my understanding was that was US data. You would need to do a deeper dive for those answers.