Research in Global Health Emergencies: Ethical issues - p. 1 - p. 75

Q1: Give a brief description of what has been outlined in this item.

• Focusses on global health emergencies (disease outbreaks, natural disasters, human made disasters).
• Did research to identify ethical issues that occur during GHE and offers recommendations on how to address these issues.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

• Ethical challenges faced during GHE and provides a framework (“ethical compass”) to assist in addressing ethical issues that come up during GHE. Also provides a lot of recommendations.

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

• N/A (in general this question won’t apply to protocols)

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Restrictions:

• Very broad – applies to several types of GHE; applicable to all research disciplines; broad target audience (researchers, institutions, funders, governments, journals, etc).
• This was researched, compiled, and published before Covid, therefore there are certain ethical issues (which occurred during the pandemic) that were not considered.
• Very, very long

Benefits

• The document was based on the information they gained from speaking to a wide range of researchers.
• Well written; easy to read

Q5. How might this item affect the working group?

• We can review their recommendations and adapt and incorporate those that are applicable
• Their “ethical compass” can assist us with identifying solutions for ethics problems we identify.

Q6. What, if anything else, about/from this item do you want to mention?

• Notes the importance of collaboration between researchers and those (people and organizations) directly responsible for emergency response
•  Emphasizes importance of meaningful research collaborations
• Chapter 9 – Data and samples

Nagoya Protocol^[d]

Q1: Give a brief description of what has been outlined in this item.

The Nagoya Protocol to the Convention on Biological Diversity (CBD) deals with access to, and benefit sharing of, genetic resources. The CBD provides that each state has sovereign rights over its genetic resources, meaning that each state can decide how its genetic resources will be governed, including how rights will be vested in its genetic resources. This principle is often referred to as ‘genetic sovereignty’. The CBD defines ‘genetic resources’ as ‘genetic material of actual or potential value’; ‘genetic material’ in turn is defined as ‘any material of plant, animal, microbial or other origin containing functional units of heredity’. Since the word ‘animal’ can be interpreted as including humans, the Conference of the Parties to the CBD clarified that the CBD does not apply to human genetic material. When adopting the Nagoya Protocol, the Conference of the Parties to the CBD again recorded that the Nagoya Protocol does not apply to human genetic material. Accordingly, the Nagoya Protocol does not apply to human genetic material or data that are shared.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

The Nagoya Protocol aims to ensure access by actors from any state to the genetic resources in any other state in return for benefit sharing by the state that provides access. In this way, the Nagoya Protocol aims to break down barriers to access while at the same time ensuring fairness between states that provide access and states that receive access.

The problem is that this system is designed for non-human resources, and cannot easily be applied to the human context. For example, a state can legitimately put in place statutory measures to stop its endemic fauna and flora from being exported to stop unlawful bioprospecting. However, it would be a human rights violation for a state to put in place statutory measures to stop its own people from visiting other states, and participating in research in such other states.

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

I suggest that we could develop good practice guidelines, but we should keep in mind states have different national priorities and histories, and therefore also different laws that relate to the cross-border sharing of human bio samples and data. We should embrace this diversity, while looking for areas of commonality.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Because the Nagoya Protocol deals with the concepts of access and benefit sharing, advocates of each of these concepts in the human context have used the Nagoya Protocol to lend (moral) support for access and/or benefit sharing in the human context. However, both of these concepts–access and benefit sharing–are considerably more complex in the human context. As such, I suggest that (moral) reliance on the Nagoya Protocol does not take the case for access and benefit sharing in the human context forward.

Q5. How might this item affect the working group?

I suggest we refer to it only to explain why we are not placing any reliance on it.

Q6. What, if anything else, about/from this item do you want to mention?

The working group might find it interesting to compare the Nagoya Protocol with UNESCO’s Universal Declaration on the Human Genome and Human Rights. Whereas the Nagoya Protocol promotes national interests (think “genomic sovereignty”), the Declaration talks of the “heritage of humanity”.

WHO Pandemic Accord/treaty^[e][f][g][h]

Q1: Give a brief description of what has been outlined in this item.

The zero draft aims to establish international collaboration in the pandemic prevention, preparedness, response and health systems recovery         

To achieve the objective of the WHO CA+ and to implement its provisions, the Parties will be guided by the principles and rights, such as, Sovereignty; Equity; Solidarity; Inclusiveness; Transparency, etc                                                                   

Q2. What challenges does this item describe? What challenge is the item aiming to address?

The draft attempts to acknowledge the need for an equitable and collaborative approach in pandemic prevention, response, and recovery while simultaneously acknowledging the sovereign rights of countries.

It highlights the importance of publicly funded research. It also acknowledges that intellectual property protection is important in developing medecine but that IP can create barriers to equitable access to health.

Open and timely sharing, access to and disclosure of accurate information, data and other relevant elements that may come to light.

Science, evidence, and findable, accessible, interoperable and reusable data should inform all public health decisions.

The WHO CA+ draft acknowledges the failures identified by the community over the course of the COVID-19 pandemic, and aims to develop a framework to prevent these failures in the future.

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Develop guidelines that promote early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens.

Provide recommendations to increase harmonization of regulatory requirements at the international level.                                

Develop mechanisms to strengthen knowledge translation and evidence-based communication tools and strategies relating to pandemic prevention, preparedness, response and recovery, at local, national, regional and international levels.

Framework for ensuring benefits arising from facilitating access to pathogens with pandemic potential are shared fairly and equitably.

Framework to establish global, regional, and national collaborative genomics networks that are dedicated to epidemiological genomic surveillance and the global sharing of emerging pathogens with pandemic potential.

The aim for “Increasing research and development capacities” aligns most closely with the goals of the GA4GH

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

The draft focuses on guiding principles and commitments for conduct with little guidance on meeting those commitments.

The notes in Q3 refer to areas where the draft calls for actions that could benefit from greater clarity before there is an urgent need to implement and execute due to emerging pandemic.

The draft refers to an agreement to establish a WHO Pathogen Access and Benefit-Sharing System (the “PABS System”). That system has not yet been developed.

The draft does not acknowledge informed consent as a requirement

Q5. How might this item affect the working group?

The working group could provide complimentary resources that support the calls to action in the document.

Q6. What, if anything else, about/from this item do you want to mention?

We could specifically address the aims for transparency and Increasing research and development capacities

International Ethical Guidelines for Health-related Research Involving Humans - focus on guideline 20^[i][j]

Q1: Give a brief description of what has been outlined in this item.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Q5. How might this item affect the working group?

Q6. What, if anything else, about/from this item do you want to mention?

Research in Global Health Emergencies: Ethical issues - p. 76 - p. 163^[k][l]

Q1: Give a brief description of what has been outlined in this item.

•        Focusses on global health emergencies (disease outbreaks, natural disasters, human made disasters).

•        Did research to identify ethical issues that occur during GHE and offers recommendations on how to address these issues.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

•        Ethical challenges faced during GHE and provides a framework (“ethical compass”) to assist in addressing ethical issues that come up during GHE. Also provides a lot of recommendations

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

N/A

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Restrictions:

•        Very broad – applies to several types of GHE; applicable to all research disciplines; broad target audience (researchers, institutions, funders, governments, journals, etc).

•        This was researched, compiled, and published before Covid, therefore there are certain ethical issues (which occurred during the pandemic) that were not considered.

•        Very, very long

Benefits

•        The document was based on the information they gained from speaking to a wide range of researchers.

•        Well written; easy to read

Q5. How might this item affect the working group?

•        We can review their recommendations and adapt and incorporate those that are applicable

•        Their “ethical compass” can assist us with identifying solutions for ethics problems we identify.

Q6. What, if anything else, about/from this item do you want to mention?

•        Notes the importance of collaboration between researchers and those (people and organisations) directly responsible for emergency response

•        Emphasises importance of meaningful research collaborations

•        Chapter 9 – Data and samples can offer a lot of guidance

Research in Global Health Emergencies: Ethical issues - p. 164 - p. 254^[m][n]

Q1: Give a brief description of what has been outlined in this item.

Chapter 8 (collaborations/partnerships): Summarizes the ethical value of collaboration in research during emergencies, and details a number of practical steps to foster such collaboration, both between researchers themselves and between researchers and responders. Several frameworks and examples of good practice are summarized, but firm recommendations focus on funders and governments to provide material support and resources to encourage collaborations, including a requirement for researchers to include clear partnership plans involving all stakeholders in funding applications and ensure equitable partnerships and capacity building.

Chapter 9 (data and sample sharing) focuses on the how, rather than whether, of sharing. Particular emphasis is put on consent and governance processes, but the report does not make firm recommendations regarding appropriateness of broad consent; this appropriateness is meant to be determined contextually based on engagement with local stakeholders and policymakers. Some guidance is offered, but the firmest recommendations are directed at funders (to support engagement and publicity around data), institutions (sharing of info) and journals (to expand authorship criteria to include original data contributors). Particular focus on legacy samples, where scope of consent unclear: recommendation that inventories and registers of such collections should be created and made openly available.

Chapter 10 (practical issues for research workers) is, compared with the other chapters, relatively under-covered in broader discussions. Most pertinently, they give a soft suggestion to expand REC remit to include worker welfare. The firmest recommendation, though, is directed at employers and is somewhat anodyne in its standard fair employment criteria, recommending highest standard of care and support, safeguarding and safety for front line workers. Similarly, the recommendation to support ethics training for workers is welcome, but somewhat overlapping with the preceding of the report.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

These chapters address discrete, well-defined challenges as indicated by the subject matter summarized in Q1: collaborations and stakeholder engagement in shaping research, data/sample sharing and research, and frontline health worker welfare.

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

The chapters themselves are fairly thorough and very well-researched, but there are some notable gaps.

1) This was drafted pre-COVID; some reflection would be needed on how well it held up, and how its recommendations intersect with developments. E.g., the pandemic treaty may instantiate some of the sample and benefit-sharing suggestions.

2) Recommendations are primarily aimed at funders or institutions, rather than researchers, research bodies, DACs, RECs, etc. Softer guidance provided in the report is more applicable to those broader groups of stakeholders, but the report is reluctant to take strong stances for such a wider audience.

3) The chapter on data/sample sharing puts a great deal of emphasis on consent, and comparatively little on ensuring data/samples are used appropriately and in line with the public interest. Likewise, it does not directly cover the technical and legal challenges of data access and sharing and how these impact on ethics and governance

4) The chapters cover a broad array of research contexts, and as such recommendations are fairly generic. GA4GH may be able to offer more concrete guidance through more domain-specific guidance.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

See Q3

Q5. How might this item affect the working group?

The Nuffield Report is one of the most thorough and well-researched of the documents we are surveying. The soft guidance it contains will be a very useful touchstone for our own work. And, the very thorough literature reviews and summaries (conveniently in boxes) can save us considerable labor in understanding the state of the literature.

Q6. What, if anything else, about/from this item do you want to mention?

I only looked at three of the chapters, so can’t speak to overall gaps in the report that might come to light with a more comprehensive reading.

Also, one of the appendices has a useful summary of the Nuffield Council’s processes, which emphasize transparency and engagement. Some reflection on the extent to which our own processes live up to such standards may be due. In the very least, we should be documenting the very processes we are undertaking now, for publicly reporting on later, as well as incorporating learnings from the COVID-19 pandemic.

Equitable Data Sharing in Epidemics and Pandemics^[o][p]

Q1: Give a brief description of what has been outlined in this item.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Q5. How might this item affect the working group?

Q6. What, if anything else, about/from this item do you want to mention?

Covington Report on Global Disease Surveillance and Pathogen Sharing

Q1: Give a brief description of what has been outlined in this item.

The scope of the report is to assess the current surveillance and pathogen sharing practices and actors, for both physical samples and sequence data.

The report aims to help better understand (i) what are the needs for physical pathogens and genetic sequence data (“GSD”) from industry; (ii) what are the existing surveillance and pathogen sharing mechanisms and (iii) what is the status regarding access provisions for physical pathogens and GSD.

It evaluates limitations, shortcomings, areas of strength in the rules.

The report considers:

(1) rules on international shipping by air of physical samples;

(2) rules on biosecurity;

(3) rules on biosafety;

(4) rules on dual use of goods;

(5) rules regarding trade in endangered species;

(6) access and benefit-sharing (“ABS”) rules implementing CBD and Nagoya Protocol;

(7) rules on the sharing of pathogen genetic sequence data; and

(8) contractual rules on the sharing of physical materials, bilaterally or through networks of biorepositories.

But focuses mostly on 6, and does not cover points 1-5 at all.  

Q2. What challenges does this item describe? What challenge is the item aiming to address?

It explores the issues related to not having a consistent set of rules for sharing, and how they might be addressed. There is discussion on how access and benefit sharing rules can conflict with the Nagoya Protocol.

It discusses the need for a central database (similar to GenBank/GISAID, but more universally usable)

That there are often ‘siloed’ disease networks that work differently, would be better to have a global network that work according to a standard set of practices. It details the main players in this area.

It discusses the difficulties in sharing physical samples. It discusses in particular the contracture hurdles e.g.

‘First, sometimes the materials held by the networks come with prior strings attached that will restrict the ways a pathogen can be accessed or used by the requesting entity. ’

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Yes, there are lots of challenges identified here and proposals from the community on how to potentially go about fixing them. I think that the main thing that GA4GH could do would be to condense the suggestions here and use this document as a basis for what the global community should do. For example, this report could be used for GA4GH to be able to enforce the global set of standards that it talks about for communities.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

The main limitation of this report (whilst not a protocol) is that it’s extremely long. So, whilst the material is good, it is perhaps unlikely that many will read. Therefore the likelihood of the suggestions being taken forward as a whole is unlikely. In it’s current form, it seems more likely that people will ‘pick and choose’, which means that nothing will really get any better.

Q5. How might this item affect the working group?

It could really be used as a checklist of what we should include in a framework. We might have to consider any advancements since the report was written, but it’s not too old (so hopefully relatively up to date).

Q6. What, if anything else, about/from this item do you want to mention?

I (Liane) have made a shortened summary of the important points for myself. It’s not very structured/well formatted, but I’m happy to share it if it might be beneficial.

Covid-19 and Ethical Preparedness^[q][r]

Q1: Give a brief description of what has been outlined in this item.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Q5. How might this item affect the working group?

Q6. What, if anything else, about/from this item do you want to mention?

Discussing the Drawbacks of the Implementation of Access and benefit Sharing of the nagoya Protocol following the Covid-19 Pandemic^[s][t]

Q1: Give a brief description of what has been outlined in this item.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Q5. How might this item affect the working group?

Q6. What, if anything else, about/from this item do you want to mention?

GLOPID-R: Principles of data sharing in public health emergencies^[u][v]

Q1: Give a brief description of what has been outlined in this item.

Q2. What challenges does this item describe? What challenge is the item aiming to address?

Q3. Are these challenges that could be addressed through the development of a policy/framework from GA4GH? If yes, name the specific challenge(s) that could be addressed.

Q4. If this is already a protocol, what are its benefits and what are its failings/restrictions that make way for improvement?

Q5. How might this item affect the working group?

Q6. What, if anything else, about/from this item do you want to mention?