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Concerns over timing of opt-out 'publicity campaign' for genomics research

Researchers are worried that affected patients and families will not see notices for commercially linked study.

PEOPLE ARE NOT being given enough notice to opt out of research that will use brain tumour samples of living and dead patients, experts fear.

A study, to be conducted by Beaumont Hospital in partnership with Genomics Medicine Ireland (GMI), intends to conduct whole genome sequencing on archived brain tumour samples from adult patients who have previously undergone treatment at the hospital.  

This involves taking samples of part of the tissue on file in order to extract DNA from it. This is then sequenced and entered into an interactive database along with other health information such as survival data.

Beaumont Hospital said “the research and establishment of a Brain Tumour Information System will improve diagnosis and treatments for newly diagnosed patients”.

Two notices about this opt-out process for “adult patients and family members of deceased adult patients” were put in three national newspapers by Beaumont and GMI. The first on 13 March, the day the schools closed due to the pandemic with the second and “final” notice appearing last Saturday. 

  • (Read more here on how you can support a major Noteworthy project delving into why a private rather than public initiative was funded to sequence Irish genomes.)

“The general public’s attention is focused on Covid-19,” said Dr Ciara Staunton, senior lecturer in law at Middlesex University in London. She previously wrote about the €73.5 million government investment in Genomics Medicine Ireland (GMI) which she said “has serious legal and ethical concerns that are likely to negatively impact genomic research in Ireland”.

GMI, a private company owned by WuXi NextCODE which is based in Europe, China and the United States, aims to collect the DNA of 400,000 volunteers and are involved in a large number of research projects with both Irish hospitals and universities. Concerns have been raised by scientists about this investment in a private genome sequencing programme rather than a publicly funded initiative, as has been done in the UK and US. 

“There are a number of reasons this is the wrong time,” added Staunton. “Papers are not being bought, people are worried about Covid-19 and experts in the area are focused on [the crisis].”  

GMI stated that “the notices were published in three national newspapers in line with the requirements and timing set out in the HRCDC Appeal Panel Decision”. 

Beaumont Hospital said in a statement that “the study is due to commence in June 2020 and in line with common practice, plans were made to place notices in a number of national publications well in advance of the commencement date”.

The notice was published in the Irish Times daily and weekend edition, the Irish Independent, the Irish Daily Mail, and the Sunday Independent. These notices were booked in February, the hospital said, before the extent of Government restrictions to Covid-19 were announced. It said that a second notice ran six weeks later in the same publications.

“All notices contained detailed information on how to opt out of the study before it begins,” stated the hospital.

‘Low level of transparency’

The researchers had to apply to be exempt from having to seek informed consent from brain tumour patients, before sequencing their DNA from archived tissue samples.

The Health Research Consent Declaration Committee (HRCDC) initially rejected the research application stating “a ‘for-profit’ organisation processing personal data introduces a higher risk that data subjects may have a deeper concern for their privacy rights”.

In their minutes, they also noted “there is no transparent public notice detailing GMI’s subsequent use and provision of access of BTIS [Brain Tumour Information System] data to third parties” and “the low level of transparency potentially creates a high risk to data subject confidence and trust”.

The committee concluded that it “was not satisfied that the public interest significantly outweighed the requirement for explicit consent of data subjects”.

However, on appeal the committee stated that a “publicity campaign drawing attention to the proposed research and affording data subjects the possibility of withdrawing their samples from the research will improve somewhat the protection afforded to the privacy of the data subjects”. They granted approval on condition of this publicity campaign. 

On the Brain Tumour Research Study website, it states “a 90-day publicity campaign is required to be conducted which provides information to relevant members of the public on the purpose of the project and how to opt out”. This 90-days started on the day of the first notice, 13 March, and affected patient and families have until 12 June 2020 to “request that their samples are not included”.

If they do not contact the team by this date, “it will not be possible to be excluded from the research”, according to the research website. This was not explicitly stated on the recent public notice but it said “research will commence on 15 June” beneath the opt-out deadline.

‘Public trust is important’

“I don’t think many people will have this foremost in their minds at the moment,” said Dr Ricardo Segurado, associate professor in public health biostatistics at UCD.  “The intention should be to try and reach as many [people] as possible.” 

Seguarado was also concerned that the link to commercial interests and what GMI is doing “is not clear” in the notice.  

“Public trust is important in any genomic medicine study and then when you involve a commercial entity, empirical data shows us that people have concerns about this,” according to Staunton. She adds the key to maintaining public trust is “accountability and transparency”.

A spokesperson for the Irish Cancer Society said they believe “that data protection, patient welfare and informed consent are all essential pillars of good research”.

Appropriate and meaningful communication between the researcher and the patient is critical.

Brain Tumour Ireland said while it “has no involvement in this particular study, we generally understand and support the need to use archived tissue in research, in order to provide better therapies and outcomes for people diagnosed with brain tumours. We understand this study allows for the continuation of research on over 9,000 human brain tumour tissues which are archived in the neuropathology department at Beaumont Hospital.”

The organisation continued: “Brain Tumour Ireland does not speak for any individual brain tumour patients or family members and we fully support the right of anyone to opt out of this research should they so wish. To that end we have informed the brain tumour community about this research via our website and social media platforms.”

SELLING OUR GENES Investigation 

Do you want to know if the Government should be funding a private company to collect 400,000 Irish people’s DNA?

The Noteworthy team want to do an in-depth investigation into why a private rather than public initiative was funded to sequence Irish genomes and find out what is being done to protect Irish genomes and data privacy in terms of genetic material.

Here’s how to help support this proposal>

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About the author:

Maria Delaney

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