Views from policy makers
Dr Naomi HawkinsLecturer, University of Exeter School of LawandResearch Associate, HeLEX - Centre for Health Law and Emerging Technologies
Dr Jane KayeDirector, HeLEX - Centre for Health Law and Emerging Technologies
MethodologyResults of a study commissioned by the
Wellcome Trust Policy Unit to feed in to assessment of data access policies for GWAS and cohort studies
Semi-structured qualitative interviewsTelephone and face-to-face
Senior stakeholdersInvolved in the design and administration of
data access policies for various major GWAS and cohort studies around the world
Purpose of Data SharingStrikingly uniform in all interviews
Data sharing benefits science BUT it must be done in such a way that participants and data generators are protected
Divergence in views about how to protect participants and data generatorsFocus today on 2 aspects of divergence in
views
Protecting ParticipantsNature of risks
Centred on identifiabilityLikelihood of identificationLikelihood of harmTypes of harm not clearly defined
‘scaremongering’ vs real risks that should be guarded against
Protection Strong and effective governancetwin pillars of anonymisation and consent
Participants - ConsentFirst would be the requirement really that any of their users use the data consistent with the informed consent and the data use limitations. Most users don’t have access to the informed consent but we make sure that they know what the data use limitations are so that they adhere to them. (Interview 10)
Participants - ConsentWell, I do feel that once people have given consent for something, that consent should be respected. So if they’ve consented to autism or autism and related diseases, whatever, those conditions really should be respected. I think it’s too bad that they did that, or not that they did that, but that form was restrictive enough. But what people have agreed to I believe should be respected. (Interview 12)
Participants - ConsentRespect for the letter of consent forms
No good mechanisms for ascertaining the wider context of consentIn some cases, regard may be had to
participant information sheets or materials given to recruiting nurses
Consent is a yes/no issue
Participants - ConsentDivergence between US and UK approaches
to consentUS – more formalistic
Respect the letter of a consent form Risk of ignoring the wider context
UK – more purposiveMore likely to respect the ‘spirit’ and defer to
the original PI Risk of samples being used in ways to which
participants did not consent
Participants - ConsentMost consent forms make no reference to the
sharing of data outside the research group which collected it
Our view has tended to be that, you know, if the consent didn’t specifically say your data will only remain at a specific place that probably there’s nothing against data sharing in the consent and you could go ahead, but that’s only our view and obviously you know the ethics committees have to deal with their community norms and what they feel their participants would want. I think that’s been the biggest real challenge for them. (Interview 10)
Participants - ConsentMoves to make consent forms consistent with future
data sharing:[I]t would be particularly valuable if when people
were consented, they gave consent to any study, rather than just saying, “My samples can be used for autism,” you know, most people who are willing to have their data and samples be used for research are not terribly concerned that even though they or their family member has autism, they don’t want it used to study schizophrenia or cancer or something. I think people don’t realize how valuable it is that data sets on one study or one disease may actually be very, very useful for diseases in general. (Interview 12)
ResearchersRange of views as to the degree and type of
protection that is necessary or justified
Low protection?
High protection?
ResearchersWe do want PIs to have good careers, but
we’re spending millions of dollars investing in these datasets. The public really has a right to benefit from those. But if they really don’t want to play ball, I don’t have to fund you, you know, I think it’s that simple. ... there are other datasets on these diseases and researchers who are willing to put the field first are going to get my funding. (Interview 12)
Researchers - Protectionism[W]e do feel that there could in some
instances be investigators who have other reasons than protection of their participants for not sharing their data, you know, particularly not wanting competitors to scoop them etc, that could go on for quite some time, in some cases we have seen that, that kind of protectionism, it’s rare but it does happen. (Interview 10)
Researchers - ProtectionismHistorical collections:[T]he fundamental problem with all this is that
people work so hard for years and years to recruit subjects, participants, you know, do their interviews, get consent, document everything, take blood samples, urine, whatever they do, work and work, clean the data and years later they have this wonderful database and it’s at the point that everybody around the world says “Hey, nice database, we’d like to use your data” so there are all these poor graduate students and technicians and post-docs and others who worked very hard to build this treasure and then suddenly other people want to use it, and that’s really… it’s very difficult. (Interview 3)
Researchers - ProtectionismHistorical collections:It’s just the people who have spent the last 25
years sweating their gut out, amassing a group of consented patients and samples for disease X believe very strongly that they have proprietary rights, and in a sense that’s the deal that was done when they collected the samples. Nobody told them from the beginning that there was a different deal on the table. So I think one has to be sensitive to the problem and work with the people to overcome it. (Interview 13)
Researchers - ProtectionismReducing over time:[I]n the future I don’t think there’s any problem because
in the future it’ll be made clear to people getting awarded grants that they’re expected to make their data available. The problems are the people who’ve collected stuff over the last twenty or thirty years and they’ve not signed anything, and I think there has to be some level of understanding that they should be treated fairly. But equally I think that we have to move away from the... you know they don’t own their data and they have to be persuaded gradually to release things on it. And the way that’s actually happening and is working is, first of all the people can see that if you do share data that it isn’t to your disadvantage … then the other thing is that they know that if they’re seen as being un-helpful that that is going to reduce their prospects for funding like other projects in the future. (Interview 17)
Researchers Ways to protect researchers
Publication embargo (time reserved for publication)Delayed release of data
Other possibilitiesDifferent ways of assigning credit (eg for data
generation) Moves away from traditional academic credit through
authorship Look to other academic disciplines eg physics Better recognition of collaboration
Concern that the current system works well for senior researchers, but perhaps doesn’t protect junior researchers as well
HarmonisationInternational harmonisation is importantInternational projectsRecognise and minimise barriers to
harmonisationDifferent laws in different jurisdictions
(expected)Cultural differences are not always
recognised
Katherine Littler – Wellcome Trust
Dr Naomi HawkinsResearch Associate, HeLEX - Centre for Health Law and Emerging TechnologiesandLecturer, University of Exeter School of [email protected]
Dr Jane KayeDirector, HeLEX - Centre for Health Law and Emerging Technologies
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