AGENDA

REWS Genetic Discrimination
Tuesday August 30 @ 1pm PT / 4pm ET / 9pm BST / 6am AEDT

Meeting recording

Attendees:

1. Lindsay Smith
2. Beatrice Kaiser
3. Yves Moreau
4. Yann Joly
5. Gratien Dalpe
6. Nicole Palmour
7. Dianne Nicol
8. Ted Dove
9. Augusto E Valderrama
10. Shubha Chandrasekharan
11. Maili Raven-Adams
12. Rosalyn Ryan
13. Aida Falcon
14. Yvonne Bombard
15. Anya Prince

Minutes:

Human Genetics Research in the Age of Mass Surveillance

YM: Today I will really be talking about forensic genetics. Example of the golden state killer who was never identified. Technology moved forward, saw the development of the CODIS database, and later genetic sequencing. Traced the killer through the genetics of his relative. By looking at genealogical information, a limited number of suspects could be identified, and later the killer was matched.

People proposed we should developed a genetic database of the entire US population for forensic identification. The main issue is that this information and use of it can evolve into other things. In Taiwan, someone will living with roommates and someone was stealing yogurt from her fridge. Police agreed to use DNA matching to identify the culprit.

In the past couple of years, have mostly been focusing on abuses in Xinjiang against minorities. Part of the persecution involves sophisticated and high tech tools - facial tracking, QR codes next to houses. Model of total surveillance that amounts to much more - active control of an entire population. One core element of those persecution is the set up of DNA databases. DNA collection has been set up on a large scale, with all citizen aged 12-65. About 4 million samples have been collected so far, but not sure exactly where the profiles might be. The police bought 4 sequencers. The problems are not limited to Xinjiang, in the US, DNA was collected from illegal immigrants and refugees at the border. Another example is the NY database with data collected in unclear circumstances, non voluntary situations.

One key player is the suppliers of DNA profiling technologies, like TF. In the past, they were somewhat reckless about selling their products, such as selling to Xinjiang police. The level of collaboration of a company like TF with law enforcement is also of concern - developed a kit up to the standard of the Chinese police. Cannot be significant player in population genetics with direct collaboration with public security bureaus.

Problems are not limited to just research - as another example, there was a reference database in Berlin that contains 132k profiles from China, many of which come from vulnerable populations. We pushed our concerns about this to a journal, and in that publication, about ⅓ of the authors were affiliated with Chinese law enforcement related institutions. Human Genetics did retract that publication, but unclear if Charite has removed the samples/database. We have no real legal leverage to put pressure on groups that break ethical standards.

We went through the whole set of publications on characterizing ethnic groups across China, and saw that vulnerable groups are way more often studied than you would expect for a population of their size. The statement on consent is often unclear - no mention of engaging with the community or whether it is informed or free. Ethics committees were often from law enforcement agencies. Autosomal STR profiles are often just attached as supplementary material, which is in violation of the GDPR.

We do get some success with article retraction, 7 so far with another in the pipeline. Happens very slowly. We do see some positive change - Qiagen modified its policy and will not tolerate misuse of its products. Nature also released a statement, but there is no mention of community.

As we build more and more comprehensive databases, they will become more interesting for law enforcement. A key element we think protects those databases is patient-physician privilege. The core element is protection of privacy and maintaining trust between patients and physicians. To give an example of what can go wrong, DNA samples from rape cases linked a woman to a crime she had committed. We run a strong risk of backlash, there is a lawsuit coming against TF for the abuse of cells from Henrietta Lacks.

Take homes: A key element is that we need more protections from research and clinical data. A mechanism that is there are certificates of confidentiality that should be extended to all data and specimens. Consent must be truly informed and free, and involve community engagement for vulnerable groups. Ethics committees should consider whether broad consent or secondary use w/o consent is acceptable for a particular purpose. Reviews, editors and publishers must be more active in their review if they have doubts. Demand accountability from biotech suppliers.

Q&A

YJ: How can GA4GH help, where can we strike a balance between not preventing research but at the same time, not help bad research or communicate research that does not meet ethical standards?

YM: I want to stress I am a scientist working in the field of rare diseases. We need to strike a balance, and it’s not a totally solved problem. Need to share data and knowledge. Our moral duty is to share knowledge, more so than data. Maybe we can build systems but these can be attacked. My vision is to federate and leave data under the control of their natural controller, and then carry out analysis in a distributed fashion. Not perfect, but can be part of the solution. I think also demanding a fair balance between data coming in and out.

SC: Coming from the AoU project, which is building one of those large databases. I wonder if you could comment on a few thoughts. Do you feel setting up access models, where you can only come do your analysis with transparency, is sufficient protection, or do you think that’s not enough of a fool proof system.

YM: It’s not my favourite model because it’s based on centralization. You cannot control the controllers of the enclave. Technically it is currently superior to federation, we don’t have all of the tool and query tools ready. If the enclave get bigger and more interested to intelligence, there the concerns grow bigger. Depends also on what you want to do.

SC: Second thought was about the certificates of confidentiality. The NIH ones apply to research data as well. We do have the flexibility of coverage, but those not covered can apply for and seek a certificate. But these have never been tested by law. There might become state level reporting requirements. I don’t know how well the certificates will last.

YM: Agree, arbitration will go up with laws conflate with others. Someone should bring the case to test how solid it is. Can always write the law better. The big concern is that it does not protect routine clinical data as far as I’m aware. It should be strengthened to the point where it is meaningful, and it should be extended to Europe as well. Main argument is to explain that there are severe risks of interference with clinical care if databases open to other care.

CS: Agree, murky border between clinical care and research.

YJ: For research data, the people that contribute data are being altruistic. There is a researcher's privilege in Canada that involved sensitive information on an individual. Not a perfect protection, but interesting to see how it would go in the case of genetic information.

TD: Wanted to ask your view on recommendations for legal reform if any

YM: On the question of consent, you’re at the core of the research world, and it would make academic research very fragile. I think on the side of accountability and multinational business there is a lot of progress to be made. There is no legal statue by which you can go after such crimes of abuse.  France has something close, it has a duty of vigilance law, so can actually sue for things like environmental abuse in Africa. Not attacking the abuse, but the lack of vigilance. I think you can also apply this thought this publishers, they’ve been reluctant to do anything. But they have responsibilities if they publish research that is known to be connected to abuses.

Next Steps

YJ: Two topics to address, one being genetic discrimination of whole population groups. Beatrice circulated a new nature comment prior to this meeting.  Would like us to do as homework, see what people think are the most useful tools we can develop for GA4GH, tools that are going to be practically useful to our user group, tools that can meet stringent approval mechanisms. Have to come up with something that is not too theoretical. If you have suggestions, please send them to rews-coordinator@ga4gh.org. Can be as general or specific as you would like. Will collect and potentially can discuss at the next REWS General meeting.

Last item I wanted to have us discuss is that some of us have been working on a short manuscript on developing a definition of genetic discrimation. On that note, go ahead Beatrice:

BK: Currently at the stage of synthesizing all of the components from various collaborators. WIll have a draft to share by mid-september.

Chat Transcript

Rosalyn38:22

Fascinating presentation. Do you have suggestions as to how to reach out to publications and other violators?

The standard approach is to reach to the journal editor-in-chief who will escalate the matter with the publisher, and then diligently following up for as long as it takes.  Less standard is unleashing a Twitter storm and an online petition. This was done very effectively in this case:

https://medium.com/@CoalitionForCriticalTechnology/abolish-the-techtoprisonpipeline-9b5b14366b16

They obtained a retraction within a couple of weeks, but the coordination effort was substantial.

Aida Falcon40:01

Very Good presentation!!congratulation !

Nicole Palmour, Mrs40:35

Excellent presentation

Aida Falcon40:59

Excellent!

Edward Dove51:30

Great talk, Yves – thanks! You had some fabulous recommendations in your final slide regarding approaches for more ethical use of genomic data and ways in which consent processes can be improved to respect participants’ rights, interests, and welfare.Question: At some general level, what more do you think can be done, if anything, with respect to *law* (national, regional, international) to address some of the concerns you raised, which are more prophylactic rather than reactive? (You mentioned strengthening HIPAA as one example) Fewer/more data localisation laws? Stronger data protection law? Law enforcement regulations? Humans rights law (despite criticism from some corners that this is a Western construct)? You mentioned more work needed around the notion of community – might you expand on that? (e.g. what forms of community engagement do you think might be feasible for research organisations and respectable for participants in genomics research?)

Regarding community engagement, I would add CIOMS Guideline 7, which deals with community engagement:

https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

Also, the following guidelines for DNA research on human research, which is very sensitive while addressing DNA from (long ago) deceased individuals:

Ethics of DNA research on human remains: five globally applicable guidelines

https://www.nature.com/articles/s41586-021-04008-x

YJOLY56:38

I do think that TF have now stopped selling thse equpments to China.

Thermo Fisher stopped sales to Xinjiang police, but not elsewhere in China. They have for example played a key supplier role in the deployment of the national male DNA database in China. https://www.aspi.org.au/report/genomic-surveillance

Dianne Nicol58:25

Is the court of public opinion a more powerful tool - naming and shaming

Yes, this is certainly an option. As an academic, I have named for example Thermo Fisher and Promega, but I have been careful about public shaming because of potential backlash and the expectations of academic decorum.

Shubha Chandrasekharan (She/her)58:58

I am recalling how DNA companies decided to adopt self regulation due to concerns about dual-use of dna synthesis technology. Seems that type o duality of use could be a model for companies selling equipment and lab supplies related to use of DNA for purposes that could harm groups and communities or violate their dignity.

Indeed, the notion of dual use technology should be clarified/extended to cover mass surveillance and social control and more generally products that enable human rights abuses. Currently, the interpretation of dual-use is often restricted to strictly military applications. US export controls could be updated to restrict the export of such products (such controls are now in place for the Xinjiang police, but not for the Chinese police in general).

Edward Dove59:26

Thanks so much for your thoughtful reply, Yves.

Shubha Chandrasekharan (She/her)59:59

Indeed, thank you for a great talk and discussion

Dianne Nicol01:00:25

Yes - really great Yves - I learned a lot

Lindsay Smith01:00:36

Thank you, really interesting talk!

Lindsay Smith01:05:54

rews-coordinator@ga4gh.org

Lindsay Smith01:06:38

broadinstitute.swoogo.com/ga4gh-10th-plenary