5 min

Introductions

Quick tour around the table for introductions.

20 min

Framing of the project and work to date

• Framing of the project and its milestones/expected deliverables:

• Inventory

• Online research of consent forms based on a National Initiatives List 
  

• Genomic clinical consent clauses

• Research for clinical genomics forms online and paper copies
• Research in the literature for consent guidelines in clinical genomics (additional results in the research setting to draw comparisons when necessary)
  

• Familial consent clauses (clinical, research settings, international norms)

• Documents produced: lit review + familial consent clauses typology including the international documents with all the references to familial RoR guidelines

Presentation of the goals and work to date from Bartha Knoppers.

Meg Doerr emphasizes how urgent this work is. There are countries with particular needs that have to be addressed.

10 min

Germany and the Nordic Countries

• Familiarization with the national initiatives of:

• Germany (Dr. Eva Winkler): national effort to develop a clinical broad consent
• The Nordic Countries (Bobbie Nicole Ray): see the Nordic Alliance for Clinical Genomics which has similar ambitions than the GA4GH as the former considers launching a work stream developing a consent framework and toolkit for cross border sharing of genetic data within the Nordic countries.

Christoph presents work to date in Germany. The creation of data integration centres is central to the work of informed consent documents which are supposed to apply to all of Germany. As of now, it is unsure if there are any English versions available and there are still no official versions, even in German, as they are still discussing access to clinical data with experts in data protection. The goal would be that every researcher can access the targeted data once the broad clinical consent is integrated. The idea is to submit a research query to one person (coordinator) to get access to health data. It is still unsure if efforts are enough for interoperability outside of Germany since it is already very difficult within Germany. A second step would be to use data for a specific process, such as the IRB process. The goal is also to share data with researchers outside or inside the EU.

Nordic Alliance: there is a white paper that can be consulted (do we have a link or access to the document? Is it in English?). The Alliance is an independent foundation and the partners of the Alliance appear on their website. NAGG is expanding to include a Nordic legal network in the future. The framework of the project is a living consent form and there is a lot of mapping to be done even though the Nordic countries share similar values. The Alliance meets twice a year in an interactive working meeting to resolve these issues.

10 min

Next steps

• Invitation to the collaborators to solicit their network for consent forms to complete the inventory, that is:

• Genomic consent forms for clinical care/health care (no ethics committees involved)
• Genomic research consent forms for population studies (focus on cross border data sharing)
• Genomic research consent forms for biobanks (focus on cross border data sharing)
  

• Analysis of the inventory and drafting of academic papers

• Team clinical
• Team family

There is an addition of the ‘deceased’ as part of the family members and thus, familial clauses.
We will have a follow-up call in March.