1. Views from policy makers Dr Naomi Hawkins Lecturer, University of Exeter School of Law and Research Associate, HeLEX - Centre for Health Law and Emerging Technologies Dr Jane Kaye Director, HeLEX - Centre for Health Law and Emerging Technologies

2. Methodology Results 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 interviews Telephone and face-to-face Senior stakeholders Involved in the design and administration of data access policies for various major GWAS and cohort studies around the world

3. Purpose of Data Sharing Strikingly 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 generators Focus today on 2 aspects of divergence in views

4. Protecting Participants Nature of risks Centred on identifiability Likelihood of identification Likelihood of harm Types of harm not clearly defined ‘scaremongering’ vs real risks that should be guarded against Protection Strong and effective governance twin pillars of anonymisation and consent

5. Participants - Consent First 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)

6. Participants - Consent Well, 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)

7. Participants - Consent Respect for the letter of consent forms No good mechanisms for ascertaining the wider context of consent In some cases, regard may be had to participant information sheets or materials given to recruiting nurses Consent is a yes/no issue

8. Participants - Consent Divergence between US and UK approaches to consent US – more formalistic Respect the letter of a consent form Risk of ignoring the wider context UK – more purposive More likely to respect the ‘spirit’ and defer to the original PI Risk of samples being used in ways to which participants did not consent

9. Participants - Consent Most 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)

10. Participants - Consent Moves 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)

11. Researchers Range of views as to the degree and type of protection that is necessary or justified Low protection? High protection?

12. Researchers We 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)

13. 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)

14. Researchers - Protectionism Historical 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)

15. Researchers - Protectionism Historical 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)

16. Researchers - Protectionism Reducing 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)

17. Researchers Ways to protect researchers Publication embargo (time reserved for publication) Delayed release of data Other possibilities Different 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

18. Harmonisation International harmonisation is important International projects Recognise and minimise barriers to harmonisation Different laws in different jurisdictions (expected) Cultural differences are not always recognised

19. Katherine Littler – Wellcome Trust Dr Naomi Hawkins Research Associate, HeLEX - Centre for Health Law and Emerging Technologies and Lecturer, University of Exeter School of Law N.L.Hawkins@exeter.ac.uk Dr Jane Kaye Director, HeLEX - Centre for Health Law and Emerging Technologies