Ethical Preparedness for Pandemics and Epidemics Study Group Agenda and Minutes (2023)

Group Structure & Meeting Format

Groups Involved

Resources and Links

Asynchronous Platforms

Meeting Agendas and Minutes

2023-12-01

2023-09-07

2023-08-02

2023-06-30

2023-05-30

Group Structure & Meeting Format

Meetings will be held monthly.

Groups Involved

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Resources and Links

20230421 - Connect 2023 -Infectious Disease Community

Asynchronous Platforms

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Meeting Agendas and Minutes

2023-12-01

Meeting Recording

Chair: Anja Bedeker

Attendees: Neerjah Skantharajah (NS), Aida Falcon, Anja Bedeker (AB), Claire Wegel, Gemma Brown, Radhika Mahajan, Rebekah Butterfield (RB), Shu ‘Sue’ Hui Chen (SC), Donrich Thaldar, Ashley Hobb (AH), Owen Schaefer (OS), Jessica Seegobin

Regrets: Diya Uberoi

Minutes

New Members:

• Rebekah Butterfield and Jessica Seegobin provided an introduction.

Leads updates:

• Currently looking for 2 new leads; an expert in infectious disease and another in international law

Group graphic: 

•  If you have ideas for what this graphic could look like, members are invited to share input. This is a promotional thing. It’s to allow everyone to know what the framework will look like.
• SC: Should have the goals of what the group wants to do; a rough roadmap showing what we’re trying to accomplish. It should be a high-level descriptive so that people can know what the group is about and would want to tap into. It should map the charge for the group. It should have some sort of visual of what the group is trying to accomplish.
• Neerjah will create a document for collecting input for this.

Plan for 2024:

AB: It should cover:

• What the framework should look like
• How do we get to our ultimate goal?
• Next steps

AB: Reminder from last meeting since the Plenary:

• The product is going to focus specifically on researchers and scientists.
• It’s going to look at pathogen genomics
• We want to create a practical framework that can be used during pandemics and epidemics so researchers can follow ethical standards but still be able to work at a faster pace.

What should the framework look like/ useful to build the framework:

• AB: look at what is the normal protocol within pathogen genomics research, and you can then see when it’s adapted for pandemics
• RB: Relationships between research and pharma during clinical trials during pandemic response. Data sharing between public and private isn’t that big, but especially during pandemics, it’s going to be so crucial to look at partnership between public and private.
• AH, AB: To make it practical and something we can implement, we can utilize use cases or case studies of what people did and what the lessons were, and after nailing down the scope, we can do outreach and identify key people to see what was useful.
• AB: This should involve looking at different case studies and papers specifically within pathogen research. It can be an actual case study or commentaries within academic journals.

• E.g.: lots of commentary specific to how COVID-19 was handled, but also looking at things like the outbreak in West Africa and Ebola might be useful. Because a lot of epidemics are focused in low- and middle- income countries, which can allow us to find information about the difference between developed countries and then developing countries.
• E.g.: the monkeypox outbreak – the way that it spread will be interesting because it had cases in high-, low-, and middle- income countries, and the information sharing between those and even the resources the lower and middle- income countries must gather is going to be limited so proactively preparing for that would be fantastic.
• E.g.: There was an African country that didn’t do a full genome sequence after a cholera or malaria outbreak because they thought that after a few months, it would go away. Once it got to a year, they knew it was different and it was a late response to sequence it, which was also because resources were limited.

How do we get to our ultimate goal?

• AB: We want a practical framework. This will require that we reach out to people within infectious disease community, look at papers/case studies and commentaries, and some of the items that we identified during the analysis because some of those had good guidelines and we can amend them for use during pandemics and epidemics, or just make them more practical depending on what was written.
• AB: Do others in the group know of other documents that can be looked at, and who is most likely to make recommendations?
• AB, NS: Scope and target audience should also be discussed, but it will likely be a practical framework for researchers and scientists, but it can also become something that’s a standard for research institutions or public health laboratory. It can be adopted by different organizations, but there are also so many different pieces of legislation and policies, and it’ll be nice to have something to guide people as they go forward. Yann might be useful to consult on this.

Scope document (Charter), recommendations to refine scope:

• AB: Within the scope, we’re going to design a framework, focus on pathogen genomic research during pandemics and epidemics, and promote greater ethical conduct. There’ll be focus on data sharing. We will consider making a living document with case studies.
• Incorporate the partnership between public and private from the stance of the public, researchers, nonprofits, etc. Suggests we look at the relationship as well.
• NS: What are the overarching themes coming out of this related to data sharing? There are branches in data sharing that can be narrowed down and could be headings within this framework. It should establish what we are specifically trying to address and how it is helping researchers with this document. x
• AB: Suggests looking at the different types of data sharing with pathogen genomics, whether it's within/between institutions, the different kinds of public repositories and the issues with those.

Next Steps:

• AB, OS: Look at different case studies, papers that were published, so that we can look at criticisms, recommendations or mistakes that have come up and can get an idea of where to go. Try to get examples with good or bad practices in regards to the scope.
• Discussion around creating a template for how these documents should be reviewed and what kinds of questions we’re going to answer
• OS: Conduct a broader literature survey on equitable data sharing, pathogen data sharing. Having a summary of some of those key papers, which might not be official policy documents, to integrate some of those terms in the framework and the principles
• AB: As we identify different documents, we also add specifically what the templates are that we should include.
• For our next meeting in January, we can set up specifically what the template is going to look like and give out who’s going to do what with which articles. Everyone comes to the table with a list of case studies and documents. We will discuss ideas for how we should review these documents and create a template that people will then build out.
•  Finalize the country contributor list:  if members could add their names to this if they’d like to continue receiving invitations to this meeting. If you haven’t been receiving emails, it’s probably because your name isn’t added.

Actions:

• Add ideas for graphics to this document
• To this document, add case studies (within pathogen research) or a general report/commentary within academic journals on how the pandemic was handled
• Next meeting

• Here is a list of documents we want to look at and here are some ideas for the template that we will use to review those documents

Information we need to build the framework

• First step, looking at what is the standard protocol? Then comparing and contrasting with covid protocols
• Interaction between research and pharma?
• Partnership between public and private institutions
• Narrow down scope so we can reach out to key contacts that we can learn from
• Looking at case studies
• Potential topics that could be included in scope

• Relationship between public and private

• Continue to narrow scope as we review the landscape
• A summary of those key papers that can later be integrated into the document we create

2023-09-07

Meeting Recording

Chair: Anja Bedeker

Attendees: 

Regrets:

Minutes

Focusing on restrictions/challenges from landscape analysis items

Nagoya Protocol

• Doesn’t cover human genomics which are significantly more problematic

WHO Accord/Treaty

• Little guidance on meeting outlined principles
• Does not acknowledge informed consent
• Covers a lot and is very inclusive, but because of the broadness it doesn’t make a huge impact on any specific space

Research in Global Health Emergencies: Ethical Issues

• Very broad
• Not informed by covid
• Extremely long, and although it’s easy to read, the length may make it less accessible
• Lacks specific recommendations, specifically around data and sample sharing - could be because of how wide an audience it is catering to (funders, institutions etc.)
• Little emphasis on ensuring data samples and sharing are done appropriately and in line with public interest - would be difficult for us to cover as well because of different, and sometimes contradictory, laws around the world
• GA4GH could provide something more concrete through more domain-specific guidance

Covington Report

• Doesn’t exclude human samples, but didn’t speak about them specifically
• Extremely long

Common Challenges Amongst Landscape Analysis Items

• Very broad
• Some items are very long which can negatively impact their accessibility/likeliness of being used
• Do not make strong recommendations
• Not all are informed by our experiences with COVID
• Not many items cover issues related to human genomics
• Gaps in practical frameworks and guidelines for researchers

Who are we targeting? (researchers, institutions, governments, funders, regulatory bodies, etc)

• There are gaps in practical frameworks and guidelines for researchers and their institutions (+1 OS, AW, AB, SC, SB, AF)

Is the focus specifically on pathogen genomics?

• Would be nice to have it cover both pathogen and human, however we’ve learned from the landscape analysis that making it too broad can reduce the impact
• On one hand there’s a gap on human side, but there’s also a lot of areas to support the pathogen side based on existing documents
• There’s a lot of information we can use on the pathogen side - seems more feasible
• We could take two paths - the pathogen stuff can be easier and done quickly, but thinking about everything that is happening with data sharing and information that you can get from longitudinal studies (e.g. acute onset info sharing) that info was key for Covid. Perhaps it can be a points to consider document for human data sharing.
• Pathogen genomics - a double edged sword? There might be less value add if we do something here

Do we want to make it guidelines, or something that is more practically applicable?

• This needs to be some kind of living document because there’s always a changing landscape with data sharing related to human data
• Something that this practically applicable so people can use it
• Top line summary of existing docs and case study illustrations would be useful - could draw on experiences from this group for some those use cases
• Probably want to weigh pros and cons for each option to see what’s most feasible - caution against putting something in that you don’t want to do
• Having a clear framework approach that sets out different stages and different considerations can be powerful and practical

Actions

• Complete scope statement and send out for review to group

2023-08-02

Meeting Recording

Chair: Anja Bedeker

Attendees: Liane Hughes, Aime Lumaka, Anne Wozencraft, Beatrice Kaiser, Diya Uberoi, Elettra Ronchi, Francis P. Crawley, Hanshi Liu, Jasmine McKinnon, Navneet Aujla, Owen Schaefer, Radhika Mahajan, Shu ‘Sue’ Hui Chen

Regrets:

Next Steps

• Anja and Neerjah to meet next week to define guiding questions for review
• Volunteers to receive email at the end of next week with instructions to add to charter (CC whole group)
• Next meeting early September to finalize the specific problem area that this group will be addressing

Minutes

Volunteers: Diya Uberoi, Aime Lumaka, Owen Schaefer, Anne Wozencraft,

2023-06-30

Meeting Recording

s

Chair: Anja Bedeker

Attendees: Hanshi Liu, Yann Joly, Calvin Ho, Francis P. Crawley, Michelle Nichols, Liane Hughes, Donrich Thaldar, Ashley Hobb

Regrets:

Actions:

• Add ideas to scope section
• Continue adding to landscape analysis and review 2-3 existing docs

• Look at articles about how genetic research and data exchanges took place during these periods

• Add to outreach document
• Schedule scoping session with DP & PHA4GE members - Neerjah

Minutes

• Last iteration of #9 in landscape analysis was published before Covid
• Could we approach this issue from a different angle
• There are some publications around gaps specifically around Ethics Committees and IRBs - this could be a focus
• The way forward

• Review the landscape analysis
• A good specific topic is genetic data and sharing of specific that
• Genetics/Genome sharing preparedness
• Now a case of narrowing down what’s of interest ot GA4GH

• CH: Is the group contributing to ongoing discussion on the pandemic preparedness treaty / agreement? when you say genomics, is it only humans? How about pathogens?
• This topic is quite different from the focus of our driver projects
• Let’s focus on data sharing, and also the genetic materials - critical to match the data to the materials, along with access, interoperability etc.
• What is required to do data sharing of genetic materials in an efficient manner during the pandemic
• Next step: set up next meeting as a working meeting where we review landscape together, everyone prepares two-three articles that are reviewed, and then we have a document where people add ideas for scope,

2023-05-30

Meeting Recording

Chair: Anja Bedeker

Attendees: Liane Hughes (UU)

Regrets: Dianne Nicol

Minutes

Conference summary

• Need for this project not limited to pandemics and epidemics
• Several policies and declarations that can help us as a framework for moving forward
• Topics covered

• Loss of trust for both scientists and government was a main topic
• Communication of results to government and society at large
• Inclusivity
• Need to understand why things happened in the pandemic the way that they did
• We should identify what is the baseline or foundation for strong ethical research conduct, and what causes researchers to vary from that standard during pandemic times
• Working with local scientists in their communities
• Nagoya protocol - understanding where the samples comes from and ownership
• Need greater clarity on the views and feelings of participants
• What causes people’s perceptions, both positive and negative, of scientists
• Problems with current treaties/declarations, is that there are no consequences for not following them - requires buy-in from countries
• Need to learn from previous pandemics and epidemics

Landscape Analysis

• Identifying similar or useful documents/protocols to understand the landscape
• Groups to check in with

• International Pathogen Surveillance Network
• WHO COVID-19 ethics and governance working group