WHA clinical trial resolution: draft text now public

“The World Health Organization today published the draft text of the clinical trial resolution being debated at the ongoing World Health Assembly.

 

 

The resolution’s overall aim is to improve the coordination, design, conduct and reporting of clinical trials worldwide. It was partly spurred by the realisation that hundreds – maybe thousands – of Covid clinical trials have ended up as costly research waste….

 

Promoting, as appropriate, measures to facilitate the timely reporting of both positive and negative interpretable clinical trial results in alignment with the WHO joint statement on public disclosure of results from clinical trials and the WHO joint statement on transparency and data integrity, including through registering the results on a publicly available clinical trial registry within the [global trial registry network] ICTRP, and encouraging timely publication of the trial results preferably in an open-access publication.

Exploring measures during public health emergencies of international concern to encourage researchers to rapidly and responsibly share interpretable results of clinical trials, including negative results, with national regulatory bodies or other appropriate authorities, including WHO for clinical guideline development and emergency use listing (EUL), to support rapid regulatory decision-making and emergency adaptation of clinical and public health guidelines as appropriate, including through pre-print publication. …”

 

Open Access Monographs: Making Mandates Reality Tickets, Thu 23 Jun 2022 at 14:00 | Eventbrite

“This half-day webinar galvanises a much-needed sector-wide conversation on OA monographs in the context of the UK’s policy landscape. Expert panels of speakers from the library, publishing and policy worlds will outline the current state-of-play and discuss how we can move to meet the imminent OA mandates from cOAlition S/Plan S in Europe and UKRI in the UK, and potential implications of the REF.

Featuring expert speakers from UKRI (Rachel Bruce) and Jisc (Caren Milloy), the event will open with a discussion of monograph policies and mandates before moving to an academic viewpoint from Professor Martin Eve (Birkbeck, University of London) who will talk about various international OA funding models and the need to move quickly from pilot phases to business as usual.

The second half of the session will highlight the challenges of getting OA metadata into supply chains and systems often designed for closed books, and will discuss the concomitant challenges posed by metrics and reporting on OA books (speakers TBC). The afternoon will close with a view from the library perspective and expert speakers from the libraries at the Universities of York (Sarah Thompson), Aberdeen (Simon Bains) and Imperial College (Chris Banks). There will be time for Q&A after each set of speakers….”

Frequently Asked Questions, Open Science Europe

“These pages are updated with the answers to the most frequent questions that have been submitted to the Research Enquiry Service and Participant Validation, IT Helpdesk, eProcurement Helpdesk, Call Coordinators and Horizon Europe NCP correspondents….”

Seeding a Community of FORESTers | Educopia Institute

“How well do your policies and practices align with your values? And how well do your vendors’ and partners’ policies and practices align with your values?

Do you know? Would it change your investment choices if you did? 

We believe that if there were clearer ways to evidence and assess actions against values, it could.

The Next Generation Library Publishing (NGLP) team is excited to announce the release of the FOREST Framework for Values-Driven Scholarly Communication. This framework has been created to help scholarly communication organizations and communities to demonstrate, evaluate, and improve their alignment over time with six key values:  

Financial and Organizational Sustainability

Openness

Representative Governance

Equity, Accessibility, and Anti-Oppression

Sharing of Knowledge

Transparency …”

Critique of “Transformative” Reasons: “T”As and Their Discontents | Brianne Selman @ Library Publishing Forum, 18 May 2022

Presentation slides by Brianne Selman. Session description: “This session will summarize some of the major categories of the critiques of “transformative” agreements. Perspectives that critique negotiation approaches, the continued bundling of costs into large agreements, market concentrations, decline in scholarly standards, analysis of whether OA goals are even being met by TAs, as well as major equity and diversity concerns will be summarized and discussed.”

Public access policy in the United States: Impact of the Scholarly Publishing Roundtable – Plutchak – – Learned Publishing – Wiley Online Library

“Key points

 

The Scholarly Publishing Roundtable was formed in 2009 at the request of a US Congressional Committee to develop recommendations for public access policy.
Published in January 2010, the Roundtable’s recommendations had a significant impact on the guidelines for federal funding agencies issued in 2013.
The Roundtable was unique in bringing together individuals holding divergent views about open access policy.
The success of the Roundtable may provide important lessons for policymakers in addressing open access issues….”

Controlled Digital Lending for resource sharing: Law and policy since 2018. – YouTube

“For more than a decade, libraries have engaged in a variety of digital lending practices that are now described as controlled digital lending (CDL). But only more recently, in 2018, were the foundational law and policy arguments for the practice of CDL articulated in what has become the widely cited White Paper on Controlled Digital Lending of Library books.” Since that time, the law, policy, and practice of CDL have evolved considerably.

In this session, the presenters—Dave Hansen and Kyle K. Courtney, both lawyers, librarians, and authors of the original CDL white paper—explain the basic framework for CDL. They will review recent developments in CDL law and policy, including integration in library norms such as reserves and interlibrary loan. They also will review international developments and the copyright infringement lawsuit filed by the ‘Big Five’ publishers against Internet Archive for CDL. Speakers: Kyle K. Courtney, Copyright Advisor, Harvard University Dave Hansen, Associate University Librarian for Research, Collections & Scholarly Communications, and Lead Copyright & Information Policy Officer, Duke University…”

CERN moves closer to achieving full open access | CERN

“Since 2014, CERN has required that all peer-reviewed primary research articles from CERN authors are published open access (OA), i.e. freely available for anyone around the world to read and re-use with appropriate attribution. This policy reflects the moral imperative of CERN as a publicly-funded organisation – supported by contributions from its Member States – to ensure that the results of our work accrue benefits to all.

I’m pleased to report that we are close to achieving full policy compliance: in 2021, 93.7% of the 1058 publications from CERN authors were published OA. …”

L’accés obert en els centres de recerca CERCA: anàlisi de la producció científica i de les polítiques de suport a la publicació en obert

From Google’s English:  “The first part of this research begins with an overview of the situation current state of scientific communication. Subsequently, the interest in it is justified thematic focusing on research centers. The purpose is presented below of this thesis, the research techniques used, the information search strategies bibliographic material used and the structure of the manuscript. This section concludes with a statement of the issue of open access and research policies and a presentation of the centers CERCA and the I-CERCA institution in the research system of Catalonia.”

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….”

First meeting of the Working Group on Open Science Policies and Policy Instruments | 23 May 2022 | UNESCO

“To support the implementation of the 2021 UNESCO Recommendation on Open Science, UNESCO in collaboration with its partners will be developing a series of supporting tools – technical briefs, fact sheets, guidelines and training materials – that will constitute an online ‘living’ Open Science Toolkit accessible to all and easy to use, reuse, expand and update. To produce the toolkit and its different components, UNESCO will mobilize its Global Open Science Partnership and convene ad-hoc Open Science Working Groups around 5 key priority/high impact areas: Open Science policies and strategies; Open Science financing and incentives; Open Science infrastructures; Open Science capacity building; Open Science monitoring framework. Experts and interested open science entities, organizations and institutions, including the UNESCO Chairs and Centers, all of which are part of the UNESCO Global Open Science Partnership can participate in the Working Groups relevant to their field of activity and expertise. They will provide the core inputs for the following deliverables and will be involved in their development:   Working Group: Working Group on Open Science Policies and Policy Instruments. Deliverables: Global repository of open science policies and policy instruments…”

In Keeping with Academic Tradition: Copyright ownership in higher education and potential implications for Open Education | Journal of Copyright in Education & Librarianship

Abstract:  Most postsecondary institutions in the United States have a copyright and/or intellectual property (IP) ownership policy, outlining under various circumstances the ownership of copyright and IP generated by faculty, staff, and students (Patel, 1996). As awareness of open educational resources (OER) increases and both faculty and student creation of openly licensed materials builds momentum, a closer examination of copyright ownership policies and what legal and ethical implications they may have for open education is crucial. This study analyzed 109 copyright ownership policies at both public and independent two-year and four-year postsecondary institutions of higher education in the U.S. and surveyed facilitators of open education initiatives (generally librarians and related educators) at these same institutions (N = 51) to gather the perceptions and preferences of their copyright policies with respect to locally-developed OER.

The content analysis revealed that while the ownership of scholarly works overwhelmingly belongs to the person who created the work, variables such as unusual support and potential uses affect copyright ownership. These factors can be problematic for faculty who receive support through campus programs to create and share openly licensed instructional materials beyond their institution and are also problematic for students participating in OER-enabled pedagogy coursework and projects. While our survey showed that many in the open community indicate that they have great confidence in their understanding of these policies, that certainty is often pinned to a sense of shared values and unspoken assumptions, rather than clear legal rules or reliable policy.

MIT Open Access Task Force | Massachusetts Institute of Technology

“The MIT Ad Hoc Task Force on Open Access to MIT’s Research, chaired by Class of 1922 Professor of Electrical Engineering and Computer Science Hal Abelson and Director of Libraries Chris Bourg, will lead an Institute-wide discussion of ways in which current MIT open access policies and practices might be updated or revised to further the Institute’s mission of disseminating the fruits of its research and scholarship as widely as possible.”