Gearing Up for 2023 Part II: Implementing the NIH Data Management and Sharing Policy – NIH Extramural Nexus

“NIH has a long history of developing consent language and, as such, our team worked across the agency – and with you! – to develop a new resource that shares best practices for developing informed consents to facilitate data/biospecimen storage and sharing for future use.  It also provides modifiable sample language that investigators and IRBs can use to assist in the clear communication of potential risks and benefits associated with data/biospecimen storage and sharing.  In developing this resource, we engaged with key federal partners, as well as scientific societies and associations.  Importantly, we also considered the 102 comments from stakeholders in response to a RFI that we issued in 2021.

As for our second resource, we are requesting public comment on protecting the privacy of research participants when data is shared. I think I need to be upfront and acknowledge that we have issued many of these types of requests over the last several months and NIH understands the effort that folks take to thoughtfully respond.  With that said, we think the research community will greatly benefit from this resource and we want to hear your thoughts on whether it hits the mark or needs adjustment….”

Next steps for the Catalog of Open Infrastructure Services (COIs) | 2022-05-09 | Invest in Open Infrastructure

“We invite open infrastructure service providers to express interest in being added to the next release of the COIs….

We are releasing the COIs documentation. This documentation is the primary resource for understanding the background, content, and key frameworks for COIs. We define key terms, describe key inputs, and articulate our internal decision-making on what content we included and how we chose to display it in order to inform and engage users of COIs, as well as support those interested in submitting information on services not already included in COIs.

We are launching an interest survey for open infrastructure service providers who are interested in being added to the next release of COIs. In this short survey, we ask service providers to assess their information on the key areas covered in COIs, and how they would like to submit that information to and maintain it on COIs. We would like to invite a broad range of open infrastructure service providers, e.g. of different sizes, governance models, and geographical areas, to take part in this survey. This would help build a more comprehensive understanding of the diversity of data types and practices, and increase the resilience of COIs, its infrastructure and processes.

Contribute to developing COIs — We can only move COIs and this work forward with the support of open infrastructure services providers. You can help by expressing your interest in being added to the next release of COIs by filling in the Interest survey, by June 20.

We also invite everyone interested to read and comment on the COIs documentation to help improve the value, usability, scalability and overall user experience of COIs.

We are organizing two Q&A sessions on Tuesday, May 17, 2022 to further discuss these plans with the community and answer any questions you may have: Session 1: 10 am EDT (see this in your time zone) – register here. / Session 2: 7 pm EDT (see this in your time zone) – register here. The sessions will be recorded, and the recordings and a short recap will be shared here on our blog. We look forward to meeting you at one of the sessions!…”

Draft Strategic Vision for U.S. Repositories Open for Community Consultation | comments by May 13, 2022

“COAR and SPARC are seeking comment from the repository community on a draft strategic vision for U.S. repositories. The strategic vision is intended to be aspirational yet achievable over time through active community collaboration within the U.S. Repository Network. This Network is envisioned as inclusive of all U.S. repositories rather than as a membership-based organization. The process for reaching this draft vision is outlined in the U.S Repository Network Initiative Progress Report. This public comment phase is the final step before finalizing the strategic vision. Please contribute your comments by May 13, 2022….

In addition to welcoming written comments, two live consultation sessions will also be offered via Zoom. Join these sessions to discuss the draft Strategic Vision live with other community members. Click the links below to register:

Wednesday, May 4, 2022, 2:00-3:00pm Eastern

Friday, May 6, 2022, 10:00-11:00am Eastern…”

Research Data Management Framework for Australian Universities Open for Consultation – ARDC

“Institutional Underpinnings is a collaborative project between 25 of Australia’s universities to develop a shared approach to university research data management in the form of a nationally-agreed framework.

The program aims to increase Australian universities’ capability in research data management and encourage collective problem-solving and alignment across the sector.

The draft Research Data Management Framework is now open for consultation. The Framework was developed by the 25 participating universities, with more than 90 experts contributing to working groups to identify and develop the key elements that are included….”

Contract Language Working Group Model License Agreement Call for Comments – SeamlessAccess

“We are pleased to announce the second output from the Contract Language Working Group, whose job it is to build on the Entity Category work to produce a toolkit for use in contracts between libraries and service providers (and for service providers to have as a reference for library requirements). This group is working to develop a toolkit that can be used to update contracts and documentation to help libraries and providers choose the appropriate entity category for the resource and outcomes they desire. The first document from the toolkit was the Entity Category Use Case Scenarios released last year.

Today, the Contract Language Working Group is happy to release its Model License Agreement with Commentary document for comments. The Model License is presented in the form of a contract, with sections specific to Federated Authentication issues and commentary from the authors highlighted with purple text for ease of identification….”

Simplicity, flexibility, equity – IFLA submits comments on South Africa’s Copyright Amendment Bill – IFLA

“IFLA has responded to a call for comments on the South African Copyright Amendment Bill, highlighting the need to reject proposals that will have a chilling effect on the work of libraries, and deepen divisions in terms of access to education, knowledge and culture.”

Wikidata as a Tool for Mapping Investment in Open Infrastructure

“This working paper shares the results of research conducted to explore Wikidata’s current coverage of the domain of open infrastructure and investment therein. The research question investigates whether Wikidata, a collaboratively edited and multilingual knowledge graph hosted by the Wikimedia Foundation, is a viable prospect for hosting investment flow data for open infrastructure. 

 
At present, Wikidata partially describes the domain. Coordinated efforts to collectively define relevant data categories, relationships, and values, and to align distributed editing will help to improve coverage.

 
This study was conducted as part of a Research Fellowship with Invest in Open Infrastructure (IOI), and is generously supported by the Alfred P. Sloan Foundation. 

We invite feedback and comments directly in this document. Please feel free to add your thoughts via the commenting function. Have questions? Contact us. …”

Call for interest – Towards an agreement on reforming research assessment | European Commission

“The Commission is calling organisations to express their interest in being part of a coalition on reforming research assessment.

The coalition will bring together organisations funding research, research performing organisations, national/regional assessment authorities or agencies, as well as associations of the above organisations and learned societies, all willing and committed to implement reforms to the current research assessment system as described in this report, which summarises the outcomes of extensive consultations with stakeholders.

The deadline to express interest is 10 January 2022. The coalition will however remain open to new members at all times….”

NOT-OD-22-029: Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy

“Respect for and protection of the interests of research participants are central tenets of the NIH GDS Policy and are fundamental to NIH’s stewardship of large-scale genomic data. Data derived from human research participants under the GDS Policy must be de-identified and provided with a random, unique code, the key to which is held by the submitting institution. NIH acknowledges that the concept of “identifiability” is a matter of ongoing deliberation within the scientific and bioethics communities. NIH relies on robust protections beyond de-identification, such as Institutional Review Board (IRB) consideration of risks associated with data submission, designating controlled access for certain data types, use of Data Access Committees to review requests, data use agreements to prohibit data disclosure and participant re-identification, and Certificates of Confidentiality[ii] to prohibit disclosure. As outlined in the NIH GDS Policy, the criteria for establishing de-identification are:

Identities of research participants cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users (45 CFR 46.102(e) (Federal Policy for the Protection of Human Subjects); and
18 identifiers enumerated at 45 CFR 164.514(b)(2)(the HIPAA Privacy Rule) are removed.

The reliance on the 18 identifiers enumerated at 45 CFR 164.514(b)(2) (the HIPAA Privacy Rule) as the only acceptable method under the GDS Policy for de-identification has recently presented several challenges. Certain data elements considered potentially identifiable, such as date ranges shorter than a year, may have scientific utility, especially when studying disease progression (e.g., with COVID-19) or higher resolution location data than the regulatory standard (e.g., full ZIP codes or mobile location data), which may be valuable for studying the social determinants of health or environmental risk.

Challenges have also arisen recently around data linkage. It is difficult to know in advance which data sources may add scientific value when combined, so it is not always possible to tell participants about data linkage during their initial consent. Linking data refers to connecting two or more data sources (often multiple studies) to bring together information about a person, enabling researchers to learn more about a participant or small group of participants. For example, a participant might enroll in a study that uses their electronic health record as well as a separate study that uses a sample of their blood, and the data about them from those studies could later be linked in new research for more powerful analyses. This challenge in prospectively informing participants about data linkage raises questions about respecting individuals’ autonomy and what participants understand about how their data will be used. Furthermore, data from multiple sources may not have been obtained under the same consent and de-identification expectations as the GDS Policy….”

NOT-OD-22-029: Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy

“Respect for and protection of the interests of research participants are central tenets of the NIH GDS Policy and are fundamental to NIH’s stewardship of large-scale genomic data. Data derived from human research participants under the GDS Policy must be de-identified and provided with a random, unique code, the key to which is held by the submitting institution. NIH acknowledges that the concept of “identifiability” is a matter of ongoing deliberation within the scientific and bioethics communities. NIH relies on robust protections beyond de-identification, such as Institutional Review Board (IRB) consideration of risks associated with data submission, designating controlled access for certain data types, use of Data Access Committees to review requests, data use agreements to prohibit data disclosure and participant re-identification, and Certificates of Confidentiality[ii] to prohibit disclosure. As outlined in the NIH GDS Policy, the criteria for establishing de-identification are:

Identities of research participants cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users (45 CFR 46.102(e) (Federal Policy for the Protection of Human Subjects); and
18 identifiers enumerated at 45 CFR 164.514(b)(2)(the HIPAA Privacy Rule) are removed.

The reliance on the 18 identifiers enumerated at 45 CFR 164.514(b)(2) (the HIPAA Privacy Rule) as the only acceptable method under the GDS Policy for de-identification has recently presented several challenges. Certain data elements considered potentially identifiable, such as date ranges shorter than a year, may have scientific utility, especially when studying disease progression (e.g., with COVID-19) or higher resolution location data than the regulatory standard (e.g., full ZIP codes or mobile location data), which may be valuable for studying the social determinants of health or environmental risk.

Challenges have also arisen recently around data linkage. It is difficult to know in advance which data sources may add scientific value when combined, so it is not always possible to tell participants about data linkage during their initial consent. Linking data refers to connecting two or more data sources (often multiple studies) to bring together information about a person, enabling researchers to learn more about a participant or small group of participants. For example, a participant might enroll in a study that uses their electronic health record as well as a separate study that uses a sample of their blood, and the data about them from those studies could later be linked in new research for more powerful analyses. This challenge in prospectively informing participants about data linkage raises questions about respecting individuals’ autonomy and what participants understand about how their data will be used. Furthermore, data from multiple sources may not have been obtained under the same consent and de-identification expectations as the GDS Policy….”

Scientific knowledge must be protected to ensure a Europe fit for the digital age

“CESAER, COAR and LIBER welcome the strong focus of the European Commission towards a A Europe fit for the digital age as part of its priorities from 2019 to 2024. We are convinced that the importance of research and education needs a strong focus within these initiatives and call upon the EU institutions to (i) acknowledge the unique position of universities and other research performing organisations in the provision of digital services and infrastructure directed towards the common good and (ii) provide for an overarching legal framework excluding university and research related repositories and corresponding infrastructures from market-oriented EU legislation, in order to prevent any unintended collateral damage from current and future EU legislation aimed at commercial players….

While we understand that the aim of these initiatives is to modernise legislation in a digital age for the good of society, we are concerned that certain aspects of them will negatively impact the research and education sectors, as they conflict with key notions of scientific collaboration, open science, and knowledge-based societies….

It is important to ensure that the knowledge sector does not suffer unintended consequences and collateral damage in current and future market-oriented EU legislation. On the contrary, research and education sectors must be empowered to assume responsibilities in creating a Europe fit for the digital age built on scientific knowledge and learning.”

Proposals for legislative changes for clinical trials – GOV.UK

“The Medicines and Medical Devices Act 2021 provides the powers to update the legislation for clinical trials. This brings the opportunity, having left the European Union, to design a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as world leading base for life sciences, generating opportunities for skilled jobs in the UK. This consultation outlines a set of proposals, capitalising on this opportunity, to reframe the UK legislation for clinical trials, responding to the needs of the sector to deliver a more streamlined and flexible regulatory regime, whilst protecting the interests of patients and trial participants.

This consultation specifically relates to clinical trials and the medicinal products used in clinical trials (Investigational Medicinal Products, ‘IMPs’). These proposals are to update the current UK legislation that governs clinical trials, The Medicines for Human Use (Clinical Trials) Regulations 2004” (SI 2004/1031), as amended, which transposes the EU Clinical Trials Directive 2001/20 EC into UK law.

Through the legislative proposals in this consultation, we aim to enable a thriving clinical research environment in the UK, reflecting innovative trial design and delivery and supporting the wider programme of work being taken forward as part of the UK vision for the future of clinical research delivery in Saving and Improving Lives: The Future of UK Clinical Research Delivery and its implementation as well as the Life Sciences Vision. These proposals also take steps to remove bureaucracy to support an efficient and effective clinical trials environment, in line with recommendations from the Taskforce for Innovation, Growth and Regulatory Reform (TIGRR) and support faster access to new, innovative treatments for patients.

We are seeking the views of clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals, and the wider public to help shape improvements to the legislation for clinical trials….”

100+ Conversations to inspire our new Direction – Open Knowledge Foundation blog

“It has been almost two decades since OKF was founded. Back then, the open movement was navigating uncharted waters, with hope and optimism. We created new standards, engaged powerful actors and achieved change in government, science and access to knowledge and education, unleashing the power of openness, collaboration and community in the early digital days. You were a key mind in shaping the movement with your ideas and contributions.

Now, the World changed again. Digital power structures are in the hands of a few corporations, controlling not only the richest datasets but also what we see, read and interact with. The climate crisis is aggravated by our digital dependencies. Inequality is rampant and the benefits of the digital transition are once again, unevenly distributed. We transferred racism and prejudices of the past to the technologies of the future, and the permissionless openness we enabled and encouraged led in some cases to new forms of extractivism and exploitation.

What is the role of Open Knowledge Foundation to face the new challenges of “open” and the new threats to a “knowledge society and economy”? Which are the most urgent and important areas of action? Who are the partners we need to bring in to gain relevance and traction? Who are the allies we need to get closer to? Priorities? Areas of opportunity? Areas of caution?

We are meeting 100+ people to discuss the future of open knowledge, as we write our new strategy, which will be shaped by a diverse set of visions from artists, activists, academics, archivists, thinkers, policymakers, data scientists, educators and community leaders from all over the World, to update and upgrade our path of action and direction to meet the complex challenges of our times….”

100+ conversations to inspire our new direction

“We are meeting 100+ people to discuss the future of open knowledge, as we write our new strategy, which will be shaped by a diverse set of visions from artists, activists, academics, archivists, thinkers, policymakers, data scientists, educators and community leaders from all over the World, to update and upgrade our path of action and direction to meet the complex challenges of our times.

We believe you can help us understanding who could make a difference in this conversation….”

Response from TU Delft on National Programme Open Science consultation document | Open Working

“Delft University of Technology was delighted to respond to the open consultation for the Dutch National Programme for Open Science 2030. The following summary was drawn from across the university, including researchers and teachers who form part of the university’s Open Science Community, and members of staff working on the university’s Open Science Programme.

Overall, there was satisfaction that a national programme was being developed, providing funding and impetus to make systematic changes to the practice of science within the Netherlands.

However, a number of comments were made indicating where the consultation document to have greater nuance, and awareness of the systematic pressures holding Open Science back….”