Responsible data sharing in international health research: a systematic review of principles and norms

Authors : Shona Kalkman, Menno Mostert, Christoph Gerlinger, Johannes J. M. van Delden, Ghislaine J. M. W. van Thiel

Background

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development.

Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing.

Despite the recent adoption of the EU General Data Protection Regulation (GDPR), the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we set out to explore relevant ethical principles and norms.

Methods

We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research.

Results

We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement.

However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used.

Conclusions

While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust.

URL : Responsible data sharing in international health research: a systematic review of principles and norms

DOI : https://doi.org/10.1186/s12910-019-0359-9

Assessing Data Management Support Needs of Bioengineering and Biomedical Research Faculty

Authors : Christie A. Wiley, Margaret H. Burnette

Objectives

This study explores data management knowledge, attitudes, and practices of bioengineering and biomedical researchers in the context of the National Institutes of Health-funded research projects. Specifically, this study seeks to answer the following questions:

  1. What is the nature of biomedical and bioengineering research on the Illinois campus and what kinds of data are being generated?
  2. To what degree are biomedical and bioengineering researchers aware of best practices for data management and what are the actual data management behaviors?
  3. What aspects of data management present the greatest challenges and frustrations?
  4. To what degree are biomedical and bioengineering researchers aware of data sharing opportunities and data repositories, and what are their attitudes towards data sharing?
  5. To what degree are researchers aware of campus services and support for data management planning, data sharing, and data deposit, and what is the level of interest in instruction in these areas?

Methods

Librarians on the University of Illinois at Urbana Champaign campus conducted semi-structured interviews with bioengineering and biomedical researchers to explore researchers’ knowledge of data management best practices, awareness of library campus services, data management behavior and challenges managing research data.

The topics covered during the interviews were current research projects, data types, format, description, campus repository usage, data-sharing, awareness of library campus services, data reuse, the anticipated impact of health on public and challenges (interview questions are provided in the Appendix).

Results

This study revealed the majority of researchers explore broad research topics, various file storage solutions, generate numerous amounts of data and adhere to differing discipline-specific practices. Researchers expressed both familiarity and unfamiliarity with DMP Tool.

Roughly half of the researchers interviewed reported having documented protocols for file names, file backup, and file storage. Findings also suggest that there is ambiguity about what it means to share research data and confusion about terminology such as “repository” and “data deposit”. Many researchers equate publication to data sharing.

Conclusions

The interviews reveal significant data literacy gaps that present opportunities for library instruction in the areas of file organization, project workflow and documentation, metadata standards, and data deposit options.

The interviews also provide invaluable insight into biomedical and bioengineering research in general and contribute to the authors’ understanding of the challenges facing the researchers we strive to support.

URL : Assessing Data Management Support Needs of Bioengineering and Biomedical Research Faculty

Alternative location  : https://escholarship.umassmed.edu/jeslib/vol8/iss1/1/

 

Data objects and documenting scientific processes: An analysis of data events in biodiversity data papers

Authors : Kai Li, Jane Greenberg, Jillian Dunic

The data paper, an emerging scholarly genre, describes research datasets and is intended to bridge the gap between the publication of research data and scientific articles. Research examining how data papers report data events, such as data transactions and manipulations, is limited.

The research reported on in this paper addresses this limitation and investigated how data events are inscribed in data papers. A content analysis was conducted examining the full texts of 82 data papers, drawn from the curated list of data papers connected to the Global Biodiversity Information Facility (GBIF).

Data events recorded for each paper were organized into a set of 17 categories. Many of these categories are described together in the same sentence, which indicates the messiness of data events in the laboratory space.

The findings challenge the degrees to which data papers are a distinct genre compared to research papers and they describe data-centric research processes in a through way.

This paper also discusses how our results could inform a better data publication ecosystem in the future.

URL : Data objects and documenting scientific processes: An analysis of data events in biodiversity data papers

Alternative location : https://arxiv.org/abs/1903.06215

Potential predatory journals are colonizing the ICMJE recommendations list of followers

Authors : Dal-Ré R., Marušić A.

BACKGROUND

The International Committee of Medical Journal Editors (ICMJE) has expressed its concerns about predatory journals using the list of ICMJE Recommendations (ICMJE-R) followers to “gain the appearance of legitimacy.”

We assessed the presence of potential predatory journals on the ICMJE-R list and their adherence to ICMJE recommendations.

METHODS

A random sample of 350 journals from the estimated 3,100-3,200 biomedical journals listed as ICMJE-R followers was chosen. Data collected from the ICMJE and journal webpages in English were: adherence to six ICMJE-R policies/requirements, year of journal’s listing as ICMJE-R follower, discipline covered, publisher and its country of origin and existence of article processing charge.

Potential predatory journal was considered as one open access journal not being a member of a recognized listing in COPE, DOAJ, OASPA, AJOL and/or INASP.

RESULTS

Thirty-one percent of journals were considered to be potentially predatory; 94% of them were included in the ICMJE-R list in 2014-2018. Half were published in the United States and 62% were devoted to medicine.

Adherence to five of the six policies/requirements was infrequent, ranging from 51% (plagiarism) to 7% (trial registration). Seventy-two percent of journals mentioned a policy on authors’ conflicts of interest. Information on article processing charge was available for 76% journals and could not be found for 22%.

Authorship policy/ instructions were significantly more present in journals with publishers from India than from the USA (53% vs 30%; p = 0.047), with no differences in the other five policies.

CONCLUSION

Predatory journals should be deleted from the ICMJE-R list of followers to prevent misleading authors. ICMJE-R following journals need to be reevaluated with pre-defined published criteria.

URL : http://www.njmonline.nl/getpdf.php?id=2093

The impact of the open-access status on journal indices: a review of medical journals

Authors : Saif Aldeen AlRyalat, Mohammad Saleh, Mohammad Alaqraa, Alaa Alfukaha, Yara Alkayed, Maryann Abaza, Hadeel Abu Saa, Mohamed Alshamiry

Background

Over the past few decades, there has been an increase in the number of open access (OA) journals in almost all disciplines. This increase in OA journals was accompanied an increase in funding to support such movements.

Medical fields are among the highest funded fields, which further promoted its journals to move toward OA publishing. Here, we aim to compare OA and non-OA journals in terms of citation metrics and other indices.

Methods

We collected data on the included journals from Scopus Source List on 1st November 2018.  We filtered the list for medical journals only. For each journal, we extracted data regarding citation metrics, scholarly output, and wither the journal is OA or non-OA.

Results

On the 2017 Scopus list of journals, there was 5835 medical journals. Upon analyzing the difference between medical OA and non-OA journals, we found that OA journals had a significantly higher CiteScore (p< 0.001), percent cited (p< 0.001), and source normalized impact per paper (SNIP) (p< 0.001), whereas non-OA journals had higher scholarly output (p< 0.001).

Among the five largest journal publishers, Springer Nature published the highest frequency of OA articles (31.5%), while Wiley-Blackwell had the lowest frequency among its medical journals (4.4%).

Conclusion

Among medical journals, although non-OA journals still have higher output in terms of articles per year, OA journals have higher citation metrics.

URL : The impact of the open-access status on journal indices: a review of medical journals

Production and uptake of Open Access publications involving the private sector: the case of big pharma

Authors : Afredo Yegros-Yegros, Thed van Leeuwen

Over the last years Open Access has been ranked very high on science policy agenda’s both internationally as well as nationally. This resulted in many national mandates and international guidelines on OA publishing of scientific results.

One of the reasons OA has been pushed so strongly by science policy is found in the argument that what is financed publicly, should be publicly available. This argument, also known as the ‘tax payers argument’ is used to support and legitimize the push for open accessibility, not only of scientific publications, but also of the underlying research data, in order to guarantee the nonacademic sector, with lower degrees of accessibility to otherwise ‘behind-the-paywall’ information, access to outcomes of scientific research in the public sector.

In this study we will focus on the developments in the OA publishing in one particular institutional sector, the private sector. Business enterprises represent the main sector in terms of R&D investments.

According to Eurostat, in the year 2016 this sector represented 65% of the total R&D expenditures within the EU28. While objectives and incentives in the private sector might not always been aligned with the disclosure of research results in the open scientific literature, there is no doubt that this is the main actor when it comes to R&D performance.

Within the business sector, we will focus our study in the pharmaceutical sector, by selecting a number of large pharmaceutical companies. Pharmaceutical companies represent an interesting case of study, given that is it one of the most R&D intensive industries, while it si also known for its shift in R&D orientation, from an in-house focus in the development of R&D towards a model much more open and collaborative, with more interactions with academic partners and other companies.

Despite the importance of industrial R&D, until now it remains relatively understudied how private sector institutions which are active in R&D have embraced the OA movement, hence it remains relatively unknown how the private sector adapts to and can benefit from the new paradigm of open scholarship.

Our objective is to shed more light on the extent to which big pharma both has been publishing in OA and also has been benefiting from OA publications to build their own research.

URL : Production and uptake of Open Access publications involving the private sector: the case of big pharma

DOI : https://doi.org/10.31235/osf.io/zt6kc

Peer Review Bias: A Critical Review

Authors : Samir Haffar, Fateh Bazerbachi, M. Hassan Murad

Various types of bias and confounding have been described in the biomedical literature that can affect a study before, during, or after the intervention has been delivered.

The peer review process can also introduce bias. A compelling ethical and moral rationale necessitates improving the peer review process. A double-blind peer review system is supported on equipoise and fair-play principles.

Triple- and quadruple-blind systems have also been described but are not commonly used. The open peer review system introduces “Skin in the Game” heuristic principles for both authors and reviewers and has a small favorable effect on the quality of published reports.

In this exposition, we present, on the basis of a comprehensive literature search of PubMed from its inception until October 20, 2017, various possible mechanisms by which the peer review process can distort research results, and we discuss the evidence supporting different strategies that may mitigate this bias.

It is time to improve the quality, transparency, and accountability of the peer review system.

DOI : https://doi.org/10.1016/j.mayocp.2018.09.004