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Supporting Equitable and Responsible Access:
Preliminary Observations and Principles for Data Access Committees

Friday, 24 July 2020

Research Team

  • University of Glasgow: Prof Madeleine Murtagh
  • Newcastle University: Dr Joel Minion, Dr James Cummings, Dr Stephanie Roberts (METADAC Secretariat), Dr Mavis Machirori, Ms Samantha Aceto

METDAC and EUCAN-connect will shortly be publishing full results from a review appraising data access committees (DACs) responsible for oversight of access to repositories of human genomic and phenotypic data and/or biological samples. In this blog, we outline some preliminary observations and principles emerging from this work.

DACs play a key role in realising the promise of public investment in science through enabling access to repositories for secondary research. Such committees help ensure that data and biosamples are used responsibly: that is, that they are used in accordance with the ethical commitments made to participants prior to collection and to the expectations participants may reasonably hold in how their data/biosamples are used. As Dame Fiona Caldicott, the UK’s Data Guardian, has observed, there should be ‘no surprises’.

DACs also have responsibility for facilitating equitable access – equitable in the sense of providing access fairly to all eligible researchers but equally supporting research and researchers equitably, especially in resource-poor regions of the world.

Review of International DAC Policy and Practice

Statement of research

The DAC Policy Review sought to identify and appraise data access committees (DACs) responsible for oversight of access to repositories of human genomic and phenotypic data and/or biological samples for secondary research. The term DAC was used as shorthand to refer to access governance infrastructures for samples and data. The resources associated with such repositories included longitudinal population studies, cohorts and biobanks (tissue banks were not included as a matter of course). The aim was to identify which DACs of this nature existed internationally, the form of their operation, and how their governance structures compared. The purpose of the review was to share good practice and the rationales for these practices and to thereby improve the equitable and responsible governance of the extensive genomic, phenotypic and biosample resources worldwide.

This review did not include review of policies for DACs managing genotype only data access (e.g. GWAS) or phenotype only data access (e.g. demographic and other characteristics) as the governance arrangements for these data are generally more straightforward. Instead we examined access governance for complex composite phenotypic and genotypic data and/or biological samples.

This summary report does not detail the analysis undertaken. Rather, it presents the emerging recommendations based on characteristics of those DACs for which we were able to access documentation online. Indeed, the research team welcomes contributions (which will be appropriately recognised) to this review. Please contact madeleine.murtagh@glasglow.ac.uk.

We identified 12 DACs which fit the criteria:

Eight principles were identified during our review, representing key values guiding the work of DACs (research questions, methods and bibliography follow):

  1. Independence and accountability
  • Independence of DAC members is key to facilitating responsible and equitable access to the data and biosamples which enable scientific research internationally. Traditional DACs comprising members of a study’s research team are more likely to face conflicts of interest and be susceptible to accusations (warranted or otherwise) of constraining access to a resource and limiting its scientific potential. This practice has variously been called ‘data hoarding’, ‘data hugging’ or ‘data hogging’.
  • The practice of ‘gift authorship’ – routinely including study research members in the authorship of outputs arising from any analysis of study data and biosamples – is no longer supported by the authorship guidance/policies of scientific journals. Genuine collaboration, rather than a gatekeeper function, should be the basis for authorship recognition.
  • DACs nonetheless require the expertise and knowledge of those who know the studies well: to advise on the affordances of the resource; to provide information about the data or biosamples available; and to address any technical conditions and constraints on their use. Such study advisors may hold non-voting roles in DACs, though decision making is increasingly consensual in nature anyway.
  • Independent DACs are not themselves inviolable. Appeals processes must be available. Often this will be to a study’s independent Scientific Advisory Board or to an independent DAC Advisory Board providing oversight and policy development support.
  1. Supporting capacity building
  • As much as responsible and equitable access to data and biosample resources support international scientific endeavours, access processes should support, not hinder, capacity building for early career researchers and researchers from resource-poor regions.
  • Embargoes that protect research-time for researchers from resource-poor regions are already common practice and serve as important mechanisms to support such researchers and scientific resources.
  • Cross-national analytic collaborations, especially those including researchers associated with scientific resources in resource-poor regions, should be encouraged. Genuine inclusion – not ‘gift authorship’ – will build networks and support capacity-building and early career researchers.
  1. Protecting the participant
  • DACs routinely protect the privacy and confidentiality of their participants, but these are not the only issues of importance. Participant expectations of data use must be respected either through consent commitments or the reasonable expectation of responsible and equitable data and biosample use (e.g. analyses should not be stigmatising or otherwise harmful to participants or their communities).
  • A key question for any proposed analysis is: “Will this research/analysis upset or alienate participants?” This question goes to both ethical issues (does this analysis respect participants?) as well as pragmatic ones (participants may remove their data and samples from studies which breach their expectations).
  • Studies will only know what participants expect by asking them, either through the direct or distributed (in varied forms of public engagement) inclusion of participants in DAC decision making.
  • Part of meeting participant expectations requires that data use to be communicated through plain language summaries. While this is already an expectation of many DACs, few provide guidance for a form of writing many researchers find difficult.
  1. Protecting and enhancing the study
  • DACs perform an important role in enabling studies to continue providing a resource to the scientific community. DACs can protect studies from reputational risk by vetting applications for controversial, stigmatising or otherwise socially unacceptable uses of data and biosamples. Reputational damage also risks alienating participants.
  • DACs play a role in preventing patenting or intellectual property claims on a study’s resource.
  • They also support enhancement of a study’s resources by requiring the return of novel data to enrich the resource.
  • DACs can require successful applicants to report their findings, outputs or incidental findings on an annual or end-of-project basis.
  • DACs may originate security practices (e.g. releasing datasets with unique identifiers) and require that data be destroyed upon study completion and/or unused samples returned.
  • While many studies include ethical approval for onward use of data and biosamples, in certain jurisdictions DACs may require additional ethical approval. In all cases, DACs uphold the commitments made to participants in consent documentation, thereby protecting both participants and the study.
  1. Transparency
  • Transparency of DAC decision making is key to providing equitable and responsible access to study resources. Questions requiring positive responses include:
    • Is the application process clearly described and criteria stated?
    • Is guidance to applicants readily available, preferably online and openly accessible?
    • Are the criteria by which applications are judged clearly stated?
    • Are deadlines and timelines clearly stated?
  1. Judging the science
  • Where resources are finite (e.g. most uses of biosamples necessarily deplete the resource), scientific review of applications plays an important role in maximising use of a study resource. Independent external expert review may be needed.
  • Where resources are infinite (e.g. most data resources), the requirement to ‘judge the science’ of applications is often unwarranted and an expectation based more on the culture of scientific practice than ethical requirement. Objections to ‘judging the science’ include those levelled at early research ethics committees (REC), which assumed all research should conform to scientific precepts of a specific discipline or practice. Properly judging the science would require expertise from an impracticable number of specialisms. Arguably, where research meets the ethical requirements of a DAC, scientific scrutiny should come from the wider scientific community through the usual processes of peer reviewed publication.
  1. Proportionate governance
  • Not all data and/or biosample access requires the same level of scrutiny. Ethical and regulatory issues for some forms of data (e.g. GWAS) are now relatively straightforward and may even be open access. Other forms of data, however, are still intrinsically sensitive or complex and therefore require managed or controlled access and oversight. Uses of composite data in particular can be become disclosive as more data points are made available, thus risking the re-identification of participants.
  • DACs need different policies, processes and guidelines for data or biosamples of different complexity and/or sensitivity. More stringent governance may be required for:
    • composite genotype/phenotype requests
    • biosamples
    • sensitive or potentially disclosive data
  1. Legitimate applicants
  • Almost all DACs require applicants to be sufficiently senior, employed at or formally associated with well-established institutions, and on contracts of employment that outlive the access request. Such conditions hold bone fide researchers accountable for the responsibilities entrusted to them in access approvals, responsibilities that are in turn often integrated into Data Transfer Agreements.
  • Where commercial access is allowed, bone fide researcher criteria may be translated as a sufficiently senior officer of the company applying for access. Such an arrangement ensures that an applicant comes from a recognised institution, though judging whether this is well-established or responsible must be taken on trust.

Research Questions and Key Objective

Research questions

  1. Which DACs are operating nationally and internationally to oversee access to complex and composite human genomic and phenotypic data and/or biosamples for secondary research?
  2. What policies and practices have these DACs implemented to govern the access process?

Key objective

  • To compile a single resource collating key information about DACs for complex composite phenotypic and genotypic data and/or biological samples and comparing their governance structures.

Methods

The DAC Policy Review project used a descriptive, exploratory design to identify and compare relevant data access committees nationally and internationally. The approach worked through the following steps:

  1. Identification and agreement among project team members of key search terminology
  2. Phase 1: Identification of relevant DAC websites using search terms developed in Step 1
  3. Phase 2: Literature searches in PubMed using the search terms to identify reports, reviews and other publications about relevant DACs
  4. Phase 3: Review of existing catalogues of longitudinal population studies, cohorts and biobanks (e.g. those of EGA and BBMRI) to identify relevant DACs
  5. Documentation of relevant DACs’ policies
  6. Extraction of key policy domains for comparison
  7. Comparison of key policies

Inclusion criteria

  • DACs governing access to complex and composite human genomic and phenotypic data and/or biosamples for secondary research
  • Policy materials available online in English or accessible from the DAC managers

Exclusion criteria

  • DACs governing access to genotype only or phenotype only data or tissue bank DACs providing access to biosamples only

Bibliography

Budin-Ljøsne, I., Isaeva, J., Knoppers, B.M., Tassé, A.M., Shen, H.Y., et al 2014. Data sharing in large research consortia: experiences and recommendations from ENGAGE. European Journal of Human Genetics, 22(3), pp.317-321.

Burton, P.R., Murtagh, M.J., Boyd, A., Williams, J.B., Dove, E.S., et al., 2015. Data Safe Havens in health research and healthcare. Bioinformatics, 31(20), pp.3241-3248.

Cheah, P.Y. and Piasecki, J., 2020. Data Access Committees. BMC Medical Ethics, 21(1), Article 12.

Fortin, S., Pathmasiri, S., Grintuch, R. and Deschênes, M., 2011. ‘Access arrangements’ for biobanks: a fine line between facilitating and hindering collaboration. Public Health Genomics, 14(2), pp.104-114.

Heeney, C. and Kerr, S.M., 2017. Balancing the local and the universal in maintaining ethical access to a genomics biobank. BMC Medical Ethics, 18(1), Article 80.

Joly, Y., Dove, E.S., Knoppers, B.M., Bobrow, M. and Chalmers, D., 2012. Data sharing in the post-genomic world: the experience of the International Cancer Genome Consortium (ICGC) Data Access Compliance Office (DACO). PLoS Computational Biology, 8(7), e1002549.

Kaye, J., Briceño Moraia, L., Mitchell, C., Bell, J., Bovenberg, J.A., et al., 2016. Access governance for biobanks: the case of the bioshare-eu cohorts. Biopreservation and Biobanking, 14(3), pp.201-206.

Kaye, J., Terry, S.F., Juengst, E., Coy, S., Harris, J.R., et al. 2018. Including all voices in international data-sharing governance. Human Genomics, 12(1), Article 13.

Murtagh, M.J., Blell, M.T., Butters, O.W., Cowley, L., Dove, E.S., et al., 2018. Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure. Human Genomics, 12(1), Article 24.

Murtagh, M.J., Thorisson, G.A., Wallace, S.E., Kaye, J., Demir, I., et al., 2012. Navigating the perfect [data] storm. Norsk epidemiologi, 21(2), pp.203-209.

Murtagh, M.J., Turner, A., Minion, J.T., Fay, M. and Burton, P.R., 2016. International data sharing in practice: new technologies meet old governance. Biopreservation and Biobanking, 14(3), pp.231-240.

Paltoo, D.N., Rodriguez, L.L., Feolo, M., Gillanders, E., Ramos, E.M., et al., 2014. Data use under the NIH GWAS data sharing policy and future directions. Nature Genetics, 46(9), p.934-938.

Saulnier, K.M., Bujold, D., Dyke, S.O., Dupras, C., Beck, S., Bourque, G. and Joly, Y., 2019. Benefits and barriers in the design of harmonized access agreements for international data sharing. Scientific Data, 6(1), Article 297.

Shabani, M. and Borry, P., 2016. “You want the right amount of oversight”: interviews with data access committee members and experts on genomic data access. Genetics in Medicine, 18(9), pp.892-897.

Shabani, M., Dove, E.S., Murtagh, M., Knoppers, B.M. and Borry, P., 2017. Oversight of genomic data sharing: what roles for ethics and data access committees? Biopreservation and Biobanking, 15(5), pp.469-474.

Shabani, M., Dyke, S.O., Joly, Y. and Borry, P., 2015. Controlled access under review: improving the governance of genomic data access. PLoS Biology, 13(12), e1002339.

Shabani, M., Knoppers, B.M. and Borry, P., 2015. From the principles of genomic data sharing to the practices of data access committees. EMBO Molecular Medicine, 7(5), pp.507-509.

Shabani, M., Thorogood, A. and Borry, P., 2016. Who should have access to genomic data and how should they be held accountable? Perspectives of Data Access Committee members and experts. European Journal of Human Genetics, 24(12), p.1671-1675.

Simell, B.A., Törnwall, O.M., Hämäläinen, I., Wichmann, H.E., Anton, G., et al. 2019. Transnational access to large prospective cohorts in Europe: current trends and unmet needs. New Biotechnology, 49, pp.98-103.

Staunton, C. and de Vries, J., 2020. The governance of genomic biobank research in Africa: reframing the regulatory tilt. Journal of Law and Biosciences, Isz018.

Sudlow, C., Gallacher, J., Allen, N., Beral, V., Burton, P., et al., 2015. UK Biobank: an open access resource for identifying the causes of a wide range of complex diseases of middle and old age. PLoS Medicine, 12(3), e1001779.

Applicant Workshop Cancelled, Thurs 2 April 2020 London

Unfortunately, we have had to postpone the workshop due to the current advice against all but necessary travel, and the uncertainty about how Covid-19 may affect our ability to deliver the workshop.

We have carefully assessed whether we could instead offer the workshop as a Webinar but with the speakers being based in different cities, and potential considerations of self-isolation, it has not been practical to do so.

Our sincere apologies for any inconvenience this may have caused.

Please register your interest to obtain relevant updates on this workshop
For more details, please contact: samantha.aceto@newcastle.ac.uk

Making data and sample access easier!
A METADAC workshop for current and future applicants

Thursday, 2 April 2020 at the Wellcome Trust London

Join us for a FREE full-day workshop delivered by METADAC, CLOSER and UKDS.

This workshop will explore best practice for researchers requesting genotypic and phenotypic data and samples through METADAC.

You will learn the key elements that make for a successful application:
• justification of data/samples requested
• assessment of risks to the study participants and studies
• writing a clear plain language summary the first time
• meeting all criteria needed to gain approval

When: Thursday, 2 April 2020 from 10:00 to 4:00 p.m.
Where: Darwin Room, 7th Floor, Wellcome Trust, 215 Euston Road, London NW1 2BE
Register here to secure your spot
For more details, please contact: samantha.aceto@newcastle.ac.uk

Data Access Made Easy: METADAC at the London Festival of Genomics

We were delighted to present METADAC to the bustling crowd of vendors, academics and scientists attending the 2020 Festival of Genomics in London at the end of January. The multidisciplinary audience was a perfect match for the research opportunities in METADAC’s affiliated UK longitudinal studies.

Samantha Aceto represented METADAC on both days of the festival, while on the second day we presented a panel discussion entitled, Data Access Made Easy: How to Access Genotypic Data and Phenotypic Data from UK Longitudinal Studies.

The presentation drew upon the expertise of four different members: the Chair, Deputy Chair and two study representatives. Because METADAC’s remit is to maximise responsible use of data, the content emphasised what is available and how to apply successfully.

Neil Walker (Deputy Chair) explained both the role of METADAC and how its access committee d assesses risks to participants, researchers or the studies when data are shared.
Professor Meena Kumari highlighted data collected by the Understanding Society study. Meena is the topic champion for biomarkers, genetics and epigenetics at Understanding Society as well as its representative to METADAC. Based on 39,805 households completing data surveys, around 10,000 Understanding Society participants have now provided genetic data, of which DNA-methylation data is available for about 1,200.

Professor Alissa Goodman, Director of the Centre for Longitudinal Studies (CLS), introduced three of their studies: the 1958 National Child Development Study, the 1970 British Birth Cohort, and the Millennium Cohort Study. METADAC oversees access to their biosamples and genetic and epigenetic data where they are combined with the phenotypic information provided by participants in repeat waves in all three studies.

Professor Madeleine Murtagh (Chair) rounded off the presentation by explaining the access criteria used by METADAC to assess applications. She also led an interactive session based around the key requirement for applicants to provide a the plain language summary, or PLS, explaining their research in accessible terms.

Because a successful PLS can be a challenge to write, we were delighted when the audience took our interactive “PLS Challenge”. Small groups were invited to rewrite a complex, technical abstract using language a 12-year-old would understand. The session was informative and a lot of fun, with prizes given to everyone who participated!

Thank you to our amazing speakers and our terrific audience who made METADAC’s participation in the 2020 Festival of Genomics such a success.

Making Data and Sample Access Easier! Workshop for METADAC applicants, in conjunction with CLOSER and UKDS will be on Thursday 2 April 2020 at Wellcome Trust, London.

METADAC at the Festival of Genomics 2020

METADAC will be at the Festival of Genomics on Thursday, January 30th at 1:40pm on the Secret Stage.

METADAC will be discussing the role of data access committees in health data governance of genomics-based research alongside three UK longitudinal studies: Understanding Society(UKHLS),
Centre for longitudinal Studies (CLS) and The English Longitudinal Study of Ageing (ELSA).

METADAC will also present the governance structure behind its data access committee and the main things that slip applicants up when applying for epigenetic, phenotypic or genomic data through METADAC from our affiliated studies.

If you have not already signed up to the Festival, you can do so here.

We look forward to seeing you there.

21/01/2020

Becoming a METADAC Access Committee Member: everything you need to know

METADAC is recruiting new members with socio-legal, clinical or genetic/medical expertise in Longitudinal Population Studies, for their Data Access Committee.

The METADAC Access Committee uses a multidisciplinary approach to evaluate applications for access to samples and data from UK longitudinal studies. Social scientists and study-facing (participant) members complete the decision- making panel, and are advised by many other individuals:

“Committee meetings also include, as observers, study PIs or study representatives, funder representatives and members of the Technical Review Team (TRT) who support the decision-making… METADAC supports a rounded approach that takes account of a plurality of perspectives in coming to consensual decisions…This rich mix of participants brings to bear perspectives and understandings which support independent and transparent decision-making” (Murtagh et.al, 2018, p. 6-7).

Synopsis of the Access Committees roles:
Each member shares their specialist assessment with the Committee. Often in lively discussions. A consensus decision is reached after considering nine standards that every application must meet: three relate to the study and its participants, three relate to formal ethics approval, and three check the project is well-defined and likely to be achievable. Applications for finite samples are also independently reviewed against the METADAC sample policy.

• Social Science: ethical or public concerns; historical & social contexts; avoiding paternalistic assumptions metholology
• Biomedical: incidental findings; risk factors; methodology; epidemiology; unlooked for findings; statistics
• Clinical: genetic illnesses (serious and treatable); unlooked for findings patients’understandings; interpreting genetic variants;
• Socio-legal: ethical norms; participants’ interests; transparency and equity; process documentation laws, regulations, good practice
• Study facing: reasonable expectations of participants; checking plain language; no disciplinary preconceptions; subjective experience
• Technical & Observers: affordances of the data; study-specific restrictions; disclosure risk in the data; additional data available; incidental finding risks

The Committee assesses some 30-40 applications each year, in about eight meetings. You can see the approved projects here.

Please find more details about METADAC here:
Murtagh, MJ et. al, “Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure”, Human Genomics (2018) 12:24 https://doi.org/10.1186/s40246-018-0154-6

HAPPY HOLIDAYS FROM THE METADAC TEAM!

17/12/2019

METADAC seeking new expert members

The METADAC Data Access Committee is currently accepting applications for Committee members with relevant experience in:
• Genetic/medical science
• Clinical expertise
• Socio-legal expertise
The METADAC is a multi-agency multi-study data access structure providing an independent mechanism for the efficient and effective governance of access to biosamples and health-related data from several leading UK longitudinal studies. The Committee meets every six to eight weeks by teleconference, and two face-to-face meetings are held annually (typically in London). Please email a 2-page CV and covering letter demonstrating suitability for the role to the Head of METADAC Secretariat, Dr Stephanie Roberts, at metadac@newcastle.ac.uk. The deadline for application is Friday 31 January 2019. Please note members’ expenses are paid but the role is not remunerated.

04/11/2019

METADAC in London: Development Workshop September 2019

This September the METADAC had their annual face-to-face workshop with colleagues from across the UK in attendance at the Wellcome Collection in London. We welcomed the Imagine ID study and Natsal for the first time. The data access committee worked industriously throughout the day to develop and produce strategies and policies that the METADAC will be introducing in 2020: communications and promotion of responsible data use, a new online application form and associated guidance, the criteria for variable selection, and improved plain-language criteria for applications.

The committee considered how best to help applicants write strong applications that clearly meet the assessment criteria. The discussions will be written up as new transparent guidelines to be honed and launched in 2020.

We reviewed the communications strategy of the METADAC for the next 12 months, to include joint workshops with partners such as UKDA, CLOSER and the affiliated cohort studies, and information outlets such as Twitter, a monthly blog post, and a quarterly newsletter. The METADAC website will be going through a brand new makeover to become more user friendly, providing a new Frequently Asked Questions page and respective links to our blog and newsletter.

We assessed the progress of the online application form for METADAC and how it can best support applicants through the application process. We evaluated how emerging technologies will affect application styles in future.

We expect our next face-to-face workshop in April 2020 to be just as engaging and successful as it was this September. Thank you to everyone who joined us in London for your time and expert engagement with the day’s discussions.

17/10/2019

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