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Neighborhood consensus on core open science practices to observe in biomedicine


Introduction

In November 2021, UNESCO adopted its Advice on Open Science, defining open science “as an inclusive assemble that mixes numerous actions and practices aiming to make multilingual scientific information overtly out there, accessible and reusable for everybody, to extend scientific collaborations and sharing of knowledge for the advantages of science and society, and to open the processes of scientific information creation, analysis and communication to societal actors past the normal scientific neighborhood” [1]. UNESCO recommends that its 193 member states take motion in the direction of attaining open science globally. The advice emphasizes the significance of monitoring insurance policies and practices in attaining this objective [1]. Open science offers a way to enhance the standard and reproducibility of analysis [2,3], and a mechanism to foster innovation and discovery [4,5]. The UNESCO Advice has cemented open science’s place as a worldwide science coverage precedence. It follows different initiatives from main analysis funders, such because the Open Analysis Funders Group, in addition to nationwide efforts to implement open science by way of federal open science plans [6,7].

Regardless of these commitments from policymakers and funders, adopting and implementing open science has not been easy. There stays debate about the best way to inspire and incentivize particular person researchers to undertake open science practices [810], and the best way to finest observe open science practices throughout the neighborhood. A key concern is the necessity for funding to cowl the extra charges and time prices wanted to stick to some open science finest practices, when the tutorial reward system and profession development nonetheless incentivize conventional, closed analysis practices. What “counts” within the tenure course of is often the outwardly observable variety of publications in prestigious—sometimes excessive impression issue and sometimes paywalled—journals, moderately than efforts in the direction of making analysis extra accessible, shareable, clear, and reusable. Monitoring open science practices is important if the analysis neighborhood intends to guage the impression of insurance policies and different interventions to drive enhancements, and perceive the present adoption of open science practices in a analysis neighborhood. To enhance their open science practices, establishments must measure their efficiency; nonetheless, there’s presently no efficient system for environment friendly and large-scale monitoring with out vital effort.

Contemplate the instance of open entry publishing. A researcher-led massive evaluation of researchers’ compliance with funder mandates for open entry publishing confirmed that the speed of adherence various significantly by funder [11]. In Canada, the Canadian Institutes of Well being Analysis (CIHR) had an open entry requirement for depositing articles between 2008 and 2015. This residue requirement was modified when CIHR and the opposite two main Canadian funding businesses harmonized their insurance policies. The end result was a drop in overtly out there CIHR-funded analysis from roughly 60% in 2014 to roughly 40% in 2017 [11]. Within the absence of monitoring, it’s not potential to guage the impression of introducing a brand new coverage or to measure how different modifications within the scholarly panorama impression open science practices.

The Coronavirus Illness 2019 (COVID-19) pandemic has created elevated impetus for, and a spotlight to, open science, which has contributed to the event of recent discipline-specific practices for openness [1214]. The present venture aimed to determine a core set of open science practices inside biomedicine to implement and monitor on the institutional degree (Field 1). Our imaginative and prescient to determine a core set of open science practices stems from the work of Core Consequence Measures in Effectiveness Trials (COMET) [15]. If trialists agree on just a few core outcomes to evaluate throughout trials, it strengthens the totality of proof, permits extra significant use in systematic opinions, promotes meta-research, and will subsequently scale back waste in analysis. We sought to use this idea of community-agreed standardization to open science particularly in biomedical analysis, which at the moment lacks consensus on finest practices, and work to operationalize completely different open science practices.

Field 1. Abstract of key factors

  • Funders and different stakeholders within the worldwide analysis ecosystem are more and more introducing mandates and pointers to encourage open science practices.
  • Analysis establishments can not at the moment monitor compliance with open science practices with out participating in time-consuming guide processes that many lack the experience to undertake.
  • We carried out a world Delphi examine to agree which open science practices could be priceless for analysis establishments to observe, with a view to creating an automatic dashboard to help monitoring.
  • We report 19 open science practices that reached consensus for institutional monitoring in an open science dashboard and describe how we intend to implement these.
  • The open science practices recognized could also be of broader worth for growing coverage, schooling, and interventions.

The core set of open science practices recognized right here will serve the neighborhood in some ways, together with in growing coverage, schooling, or different interventions to help the implementation of those practices. Most instantly, the practices can inform the event of an automatic open science dashboard that may be deployed by biomedical establishments to effectively monitor adoption of (and supply suggestions on) these practices. By establishing what ought to be reported in an institutional open science dashboard by way of a consensus constructing course of with related stakeholders, we purpose to make sure the software is suitable to the wants of the neighborhood.

Methodology

Ethics assertion

This examine acquired moral approval from the Ottawa Well being Science Community Analysis Ethics Board (20210515-01H). Members had been offered with an internet consent type previous to viewing spherical 1 of the Delphi, their completion of the survey was thought of implied consent.

For full examine strategies, please see S1 Textual content. We carried out a 3-round modified Delphi survey examine. Delphi research construction communication between members to determine consensus [16]. Usually, Delphi research use a number of rounds of surveys by which members, consultants within the subject space, vote on particular points. Between rounds, votes are aggregated and anonymized after which offered again to members together with their very own particular person scores, and suggestions on others’ anonymized voting selections [17,18]. This offers members the chance to contemplate the group’s ideas and to check and alter their very own evaluation within the subsequent spherical. A power of this technique of communication is that it permits all people in a gaggle to speak their views. Nameless voting additionally limits direct confrontation amongst people and the affect of energy dynamics and hierarchies on the group’s choice.

Members in our Delphi had been from a comfort pattern obtained by way of snowball sampling of educational establishments occupied with open science. The people from the establishments represented any/all the following teams:

  1. Library or scholarly communication employees (e.g., liable for buying journal content material, liable for facilitating information sharing or administration).
  2. Analysis directors or leaders (e.g., head of division, CEO, senior administration).
  3. Employees concerned in researcher evaluation (e.g., appointment and tenure committee members).
  4. People concerned in institutional metrics evaluation or reporting (e.g., efficiency administration roles).

As a result of titles and roles differ from establishment to establishment, we left it to the discretion of the establishment to establish members. Broadly, we aimed to incorporate individuals who both knew about scholarly metrics or made selections concerning researcher evaluation or hiring. We additionally explicitly inspired the establishments to contemplate range of their representing members (together with gender and race) when inviting folks to contribute. Nonetheless, there are a number of stakeholders that will affect institutional monitoring of open science practices. A limitation of the present work is that we included completely members instantly employed by educational establishments. Whereas our intention is to implement the proposed dashboard at biomedical establishments, it’s potential we missed nuance or richness, for instance, by failing to incorporate representatives from scholarly publishers, educational societies, or funding businesses.

The primary two rounds of the Delphi had been on-line surveys administered utilizing Surveylet. Surveylet is a purpose-built platform for growing and administering Delphi surveys [19]. To start out with, the Delphi members had been offered with an preliminary set of 17 potential open science practices to contemplate that had been generated by the venture staff primarily based on a dialogue. Spherical 3 took the type of two half-day conferences hosted on Zoom [20]. Internet hosting spherical 3 within the type of an internet assembly is a modification of the normal Delphi strategy. This was performed to offer a possibility for extra nuanced dialogue amongst members in regards to the potential open science practices whereas nonetheless retaining anonymized on-line voting. We opted for a digital assembly given the COVID-19 pandemic restrictions on the time and the associated fee effectiveness for enabling worldwide participation. Nonetheless, whereas our use of a modified Delphi by which spherical 3 came about on-line offered the chance for extra nuanced dialogue previous to voting, it additionally meant that we finally decreased the general variety of members collaborating in that spherical with a view to host a manageable sized group for the net assembly. This methodological strategy could have decreased a few of the range in potential response regardless of offering larger richness in responses.

Whereas the structured, nameless, and democratic strategy of the Delphi course of affords many benefits to reaching consensus, it’s not with out limitations. The strategies used right here could have impacted our consequence. For instance, the usage of a compelled selection merchandise moderately than a scale in rounds 2 and three could have contributed to a larger chance for objects to achieve consensus in these rounds. Whereas we endeavored to draw a various and consultant pattern of establishments to contribute, finally given our sampling strategy, it’s seemingly that the members and establishments that agreed to participate might not be as consultant of the worldwide biomedical analysis tradition as we desired, and will have a stronger curiosity in or dedication to open science than is typical. Whereas the pattern might not be generalizable, these establishments seemingly signify early adopters or prepared leaders in open science. Additional, our Delphi surveys and consensus conferences had been carried out in English solely, and the assembly was not conducive for attendance throughout all time zones. These elements may have created boundaries to participation for some establishments or members. Defining who’s an “knowledgeable” to offer their views in any Delphi train offers an inherent problem [21]. We confronted this problem right here, particularly contemplating the range of open science practices and the nuances of making use of these practices in distinct biomedical subdisciplines. For instance, our imaginative and prescient to create a single biomedical dashboard to deploy on the institutional degree could imply now we have missed nuances in open science practices in preclinical as in comparison with medical analysis.

Spherical 1

Members: We excluded members who didn’t full 80% or extra of the survey on this spherical. A complete of 80 members from 20 establishments in 13 nations accomplished spherical 1. Full demographics are described in Desk 1. A complete of 44 (55.0%) members recognized as males, 35 (43.8%) as girls, and 1 (1.3%) as one other gender. Of the 32 analysis establishments that had been invited to contribute to the examine, 20 (62.5%) ended up contributing, and 1 to 7 members from every group responded to our survey. Researchers (N = 31, 38.8%) and analysis directors (N = 18, 22.5%) comprised many of the pattern.

Voting: Of the 17 potential core open science practices offered in spherical 1, two reached consensus. Members agreed that “registering medical trials on a registry previous to recruitment” and “reporting writer conflicts of curiosity in revealed articles” had been important to incorporate. See full ends in Desk 2.

Members prompt 10 novel potential core open science practices to incorporate in spherical 2 for voting; they had been as follows: use of Analysis Useful resource Identifiers (RRIDs) the place related organic sources are utilized in a examine; inclusion of funder statements; data on whether or not a printed paper has open peer opinions out there (definitions differ for open peer assessment [22], however we outline this as having clear peer opinions out there); sharing a knowledge administration plan; use of open licenses when sharing information/code/supplies; use of nonproprietary software program when sharing information/code/supplies; use of persistent identifiers when sharing information/code/supplies; sharing analysis workflows in computational environments; reporting on the gender composition of the authorship staff; and reporting outcomes of trials in a manuscript-style publication (peer reviewed or preprint) inside 2 years of examine completion.

Spherical 2

Members: Fifty-six (70% of spherical 1) members accomplished the spherical 2 survey (see Desk 1). Of the 20 analysis establishments that accomplished spherical 1, 19 (95%) establishments continued their contributions in spherical 2, with as much as 5 members from every group responding to our survey. Researchers (N = 23, 41.1%) and analysis directors (N = 11, 19.6%) once more comprised many of the pattern, as in spherical 1.

Voting: Of the 15 potential core open science practices that members had not reached consensus on in spherical 1, 6 reached consensus in spherical 2. Members agreed that the next practices had been important to reporting within the dashboard: whether or not information had been shared overtly on the time of publication (with restricted exceptions); whether or not code was shared overtly on the time of publication (with restricted exceptions); whether or not reporting guideline checklists had been used; whether or not writer contributions had been described; whether or not ORCID identifiers had been used; and whether or not registered medical trials had been reported within the registry inside 2 years of examine completion.

Members then ranked the ten novel potential core open science practices prompt by members in spherical 1 for the primary time. None of those 10 new practices reached consensus in spherical 2. There have been no different explicitly described practices prompt by members in spherical 2 to contemplate for the dashboard in spherical 3.

Spherical 3

Members: Twenty-one members had been current on day 1 and 17 on day 2 of the consensus assembly. Full demographics are described in Desk 1. One participant on every day didn’t present any demographic data.

Voting: There have been 19 objects that had not reached consensus in spherical 2. After discussing every merchandise, some had been reworded barely, expanded into two objects, or collapsed right into a single merchandise (see notes on modifications made in Desk 2). Finally, members voted on 22 potential open science practices in spherical 3. One among these things requested members to vote on “reporting whether or not registered medical trials had been reported within the registry inside 1 yr of examine completion.” An merchandise describing “reporting that registered medical trials had been reported within the registry inside 2 years of examine completion” reached consensus in spherical 2; nonetheless, a number of members commented that the timeframe was inconsistent with necessities of funders which have signed the World Well being Group joint assertion on public disclosure of outcomes from medical trials, which specified 12 months. Primarily based on this, members had been requested to revote on this merchandise utilizing the 1-year cutoff.

Of the 22 potential objects voted on in spherical 3, 12 reached consensus for inclusion: whether or not systematic opinions have been registered; whether or not there was a press release about examine supplies sharing with publications; the usage of persistent identifiers when sharing information/code/supplies; whether or not information/code/supplies are shared with a transparent license; whether or not the information/code/supplies license is open or not; citations to information; what quantity of articles are revealed open entry with a breakdown of time delay; the variety of preprints; that registered medical trials had been reported within the registry inside 1 yr of examine completion; trial ends in a manuscript-style publication (peer reviewed or preprint); systematic assessment ends in a manuscript-style publication (peer reviewed or preprint); and whether or not analysis articles embrace funding statements. One merchandise reached consensus for exclusion from the dashboard: Reporting whether or not workflows in computational environments had been shared. Members agreed this merchandise ought to be a part of the present merchandise, “reporting whether or not code was shared overtly on the time of publication (with restricted exceptions).”

Members mentioned how a few of the objects that reached consensus for inclusion represented important practices extra broadly associated to transparency or reporting than practices typically thought of conventional open science procedures. Following spherical 3, objects that reached consensus had been grouped primarily based on these broad classes (conventional open science versus broader transparency practices for reporting) and members had been requested to rank the practices primarily based on how they need to be prioritized for programming for inclusion in our proposed dashboard (Desk 3). Gadgets with larger scores signify people who got the next precedence. The highest two conventional open science practices by precedence had been reporting whether or not medical trials had been registered earlier than they began recruitment, and reporting whether or not examine information had been shared overtly on the time of publication (with restricted exceptions). The highest two broader transparency practices by precedence had been reporting whether or not writer contributions had been described, and reporting whether or not writer conflicts of curiosity had been described.

Conventional open science practices

  1. Reporting whether or not medical trials had been registered earlier than they began recruitment. This apply is required by a number of organizations and funders internationally. Regardless of clear mandates for registration, we all know this apply just isn’t optimum [23]. Standardized reporting of trial registration will permit for linkage of trial outputs to the registry and assist contribute to the discount of selective consequence reporting and non-reporting.
  2. Reporting whether or not examine information had been shared overtly on the time of publication (with restricted exceptions). Insurance policies encouraging and mandating open information are rising. This apply considers whether or not there’s a assertion about open information in a publication. It doesn’t require that this assertion point out that information are in truth publicly out there. As tradition round information sharing turns into extra normative, it could be of worth to reevaluate whether or not monitoring the proportion of overtly out there information is of worth. To take action successfully would require modifications within the tradition round and use of DOIs. Data on the information out there and its useability could be important to offer high quality management and for a person to find out not simply if information can be utilized, however whether or not it ought to be used for the meant function. Exceptions would come with nonempirical items (e.g., a examine protocol).
  3. Reporting what quantity of articles are revealed open entry with a breakdown of time delay. This apply studies on the proportion of articles revealed open entry (i.e., publicly out there with out restriction). A part of this reporting will embrace the timing of the open entry from first publication (e.g., quick open entry versus delayed open entry publication).
  4. Reporting whether or not examine code was shared overtly on the time of publication (with restricted exceptions). Much like apply 2, this apply considers whether or not there’s a assertion about open code sharing within the publication. It doesn’t require that this assertion point out that code is in truth publicly out there. As tradition round code sharing turns into extra normative, details about the standard and sort of code shared and compliance to finest practices (e.g., FAIR ideas) could also be priceless to observe. Exceptions would come with nonempirical items.
  5. Reporting whether or not systematic opinions have been registered. This apply is required by some journals and is frequent inside information synthesis tasks. Standardized reporting of systematic assessment registration will permit for linkage of assessment outputs to the registry and assist contribute to scale back pointless duplication in opinions.
  6. Reporting that registered medical trials had been reported within the registry inside 1 yr of examine completion. The apply of reporting trial ends in the registry they had been first registered in is required by a number of organizations and funders. This apply would observe the proportion of trials in compliance with reporting outcomes inside 1 yr or examine completion.
  7. Reporting whether or not there was a press release about examine supplies sharing with publications. This apply considers whether or not there’s a assertion about supplies sharing with a publication. It doesn’t take into account whether or not or not supplies are certainly shared overtly. As with information and code sharing, supplies sharing just isn’t but widespread throughout biomedicine. As a place to begin, statements about supplies sharing shall be monitored, however in time, it could be of worth to trace the frequency of supplies sharing at an establishment. This might inform infrastructure wants.
  8. Reporting whether or not examine reporting guideline checklists had been used. Reporting pointers are checklists of important data to incorporate in a manuscript; these are broadly endorsed by medical journals and have been proven to enhance the standard of reporting of publications [24]. This merchandise would observe whether or not reporting pointers had been cited in a publication. Sooner or later, monitoring precise compliance to reporting guideline objects could also be extra related.
  9. Reporting citations to information. This apply displays whether or not a given dataset shared from researchers at an establishment has acquired citations in different works. That is an assay to information reuse and could also be a related metric to contemplate alongside others when contemplating examine impression.
  10. Reporting trial ends in a manuscript-style publication (peer reviewed or preprint). This apply would report whether or not a trial registered on a trial registry had an related manuscript-style publication inside 1 yr of examine completion. It will embrace reporting within the type of preprints.
  11. Reporting the variety of preprints. This apply studies the frequency of preprints produced on the establishment over a given timeframe.
  12. Reporting systematic assessment ends in a manuscript-style publication (peer reviewed or preprint). This apply would report whether or not a registered systematic assessment had an related manuscript-style publication inside 1 yr of examine completion. It will embrace reporting within the type of preprints.

Broader transparency practices

  1. Reporting whether or not writer contributions had been reported. Journals are more and more requiring or allowing authors to make statements (e.g., utilizing the CREDIT Taxonomy) about their position within the publication. This helps to make clear the range of contributions every writer has made. This apply would observe the presence of those statements in publications. Monitoring the usage of writer contribution statements could assist establishments to plot methods to acknowledge particular person’s abilities when hiring and selling researcher.
  2. Reporting whether or not writer conflicts of curiosity had been reported. Reporting of conflicts of curiosity is a typical apply at many journals, however this apply just isn’t uniform, with some publications missing statements altogether. Monitoring conflicts of curiosity reporting helps to make sure transparency. Within the absence of a press release of conflicts of curiosity, the reader can not assume none exist. For that reason, we reached consensus that every one papers ought to have such a press release regardless of whether or not conflicts exist.
  3. Reporting the usage of persistent identifiers when sharing information/code/supplies. Persistent identifiers akin to DOIs are digital codes for on-line objects that stay constant over time. Use of persistent identifiers of analysis outputs akin to information, code, and supplies foster collation and linkage.
  4. Reporting whether or not ORCID identifiers had been reported. ORCID identifiers are persistent researcher identifiers. This apply would observe whether or not publications report these. Information about use of ORCID will assist inform iterations of our open science dashboard. Whereas our dashboard will focus on the analysis establishment degree, ORCIDs could also be related to make use of to collate establishment publications, or to supply researcher-level outputs.
  5. Reporting whether or not information/code/supplies are shared with a transparent license. This apply displays whether or not licenses are used when analysis outputs like information, code, and supplies are shared (e.g., use of artistic commons licenses).
  6. Reporting whether or not analysis articles embrace funding statements. Reporting on funding is a typical apply at many journals and required by some funders, however this apply just isn’t uniform, with some publications missing statements altogether. Monitoring funding statements helps to make sure transparency and supply linkage between funding and analysis outputs. For that reason, we reached consensus that every one papers ought to have funder statements regardless of whether or not funding was acquired. Sooner or later, information of what forms of funding a publication acquired could foster meta-research on funding allocation and analysis outputs.
  7. Reporting whether or not the information/code/supplies license is open or not. Amongst analysis outputs shared with a license, this apply displays the proportion of those which might be “open” (i.e., publicly out there with no restrictions to entry when acceptable to the information).

Future instructions

The following section of this analysis program will contain growing the open science dashboard interface and its programming. Whereas we purpose to create a completely automated software, some core open science practices that reached consensus for inclusion within the dashboard could not lend themselves to dependable, automated evaluation. For instance, the truth that digital identifiers aren’t broadly used on some analysis outputs (e.g., when sharing code or examine supplies) could create challenges in correct measurement. If we discover this to be the case, in these cases, we’ll exclude the open science apply from monitoring. We selected to not prohibit the neighborhood of Delphi members when it comes to the benefit of automation of what they wished within the software—we inspired members to “suppose massive.” Finally, some objects might not be potential to incorporate as a consequence of feasibility. We anticipate iterative session with the neighborhood as we work to develop a dashboard that finest meets their wants. As infrastructure and the usage of identifiers evolve throughout the biomedical neighborhood, there shall be a must refresh consensus and rethink processes used to finest automate the core open science practices.

We anticipate that the open science dashboard will function a software for establishments to trace their progress in adopting the agreed open science practices, but additionally to evaluate their efficiency related to current mandates. For instance, the dashboard will allow establishments to observe their adherence to mandates associated to open entry publishing, medical trial registration and reporting, and information sharing, all of that are generally mandated by funders globally and associated stakeholders within the analysis ecosystem [2527]. We additionally anticipate that a number of of the open science practices included within the dashboard won’t mirror practices which might be broadly carried out or mandated. Some objects could subsequently mirror aspirational practices for the neighborhood. The dashboard can be utilized to benchmark for enhancements in these areas.

The proposed dashboard is a crucial precursor for offering institutional suggestions on the efficiency of the agreed open science practices. As we pilot implementation of the dashboard, we’ll take into account how the software can present tailor-made suggestions to particular person establishments, or distinct settings. The central objective of the dashboard is to not facilitate comparability between establishments (i.e., the place adherence to practices might be instantly in contrast throughout the dashboard throughout completely different establishments). This kind of rating is counter to our community-driven initiative that seeks to offer a software for institutional-level enchancment in open science moderately than to pit organizations, who usually are located fairly otherwise, towards each other. Our imaginative and prescient is that the software won’t develop to be punitive, aggressive, or a status indicator, as that is prone to additional contribute to the systematic enablement of high-resource establishments. Nonetheless, a core set of agreed practices is useful for comparative meta-research round open science.

We intend for the dashboard to be carried out on the particular person establishment degree. Understanding a given establishment’s setting, present norms, and useful resource circumstances shall be important to deciding the best way to finest implement the dashboard in that surroundings. A key step in this system to develop the proposed dashboard shall be to rigorously take into account the appropriateness of the dashboard being publicly out there versus hosted internally by biomedical establishments. Choice is prone to differ throughout establishments primarily based on their circumstances. As we implement the proposed open science dashboard, it’s going to even be necessary to measure how nuances in language, geographic location, self-discipline, and different institutional variations impression optimum native adoption. Even refined variations in understanding of, and experiences with, open science at completely different establishments could have an necessary impression on how an eventual dashboard might be carried out to finest meet institutional wants whereas nonetheless retaining a core set of practices to observe.

Over time, we can even want to observe the dashboard itself. As open science turns into more and more embedded within the analysis ecosystem, the core practices of at present could differ from these of the longer term. Throughout implementation, we’ll consider how the software is impacted by subtleties and sensible constraints differing between establishments, nations, and geographical areas (for instance, how acceptable the software is in a World North versus World South setting). Addressing the distinct challenges will assist to foster harmonization in measuring open science practices within the biomedical neighborhood. We might want to monitor and keep abreast of the worldwide communities wants and practices to make sure the dashboard is sustainable and related over time.

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