PeerJ Preprints: Legal Issueshttps://peerj.com/preprints/index.atom?journal=peerj&subject=7600Legal Issues articles published in PeerJ PreprintsA guide to applying the Good Publication Practice 3 Guidelines in the Asia-Pacific regionhttps://peerj.com/preprints/278922019-08-192019-08-19Blair HespKatsuhisa AraiMagdalene ChuStefanie ChuahJose Miguel CuramengSandeep KamatZhigang MaAndrew SakkoHazel Fernandez
Numerous recommendations and guidelines aim to improve the quality, timeliness and transparency of medical publications. However, these guidelines use ambiguous language that can be challenging to interpret, particularly for speakers of English as a second language. Cultural expectations within the Asia-Pacific region raise additional challenges. Several studies have suggested that awareness and application of ethical publication practices in the Asia-Pacific region is relatively low compared with other regions. However, guidance on applying ethical publication practice guidelines in the Asia-Pacific region is lacking. This review aims to improve publication practices in the Asia-Pacific region by providing guidance on applying the 10 principles of the Good Publication Practice 3 (GPP3) guidelines and the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Recommendations are provided for encore presentations, applying the ICMJE authorship criteria in the context of regional cultural expectations, and the role of study sponsors and professional medical writers. Ongoing barriers to compliance with guidelines are also highlighted, and additional guidance is provided to support authors submitting manuscripts for publication. The roles of regional journals, regulatory authorities and professional bodies in improving practices are also discussed.
Numerous recommendations and guidelines aim to improve the quality, timeliness and transparency of medical publications. However, these guidelines use ambiguous language that can be challenging to interpret, particularly for speakers of English as a second language. Cultural expectations within the Asia-Pacific region raise additional challenges. Several studies have suggested that awareness and application of ethical publication practices in the Asia-Pacific region is relatively low compared with other regions. However, guidance on applying ethical publication practice guidelines in the Asia-Pacific region is lacking. This review aims to improve publication practices in the Asia-Pacific region by providing guidance on applying the 10 principles of the Good Publication Practice 3 (GPP3) guidelines and the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Recommendations are provided for encore presentations, applying the ICMJE authorship criteria in the context of regional cultural expectations, and the role of study sponsors and professional medical writers. Ongoing barriers to compliance with guidelines are also highlighted, and additional guidance is provided to support authors submitting manuscripts for publication. The roles of regional journals, regulatory authorities and professional bodies in improving practices are also discussed.Plan S in Latin America: A precautionary notehttps://peerj.com/preprints/278342019-07-112019-07-11Humberto DebatDominique Babini
Latin America has historically led a firm and rising Open Access movement and represents the worldwide region with larger adoption of Open Access practices. Argentina has recently expressed its commitment to join Plan S, an initiative from a European consortium of research funders oriented to mandate Open Access publishing of scientific outputs. Here we suggest that the potential adhesion of Argentina or other Latin American nations to Plan S, even in its recently revised version, ignores the reality and tradition of Latin American Open Access publishing, and has still to demonstrate that it will encourage at a regional and global level the advancement of non-commercial Open Access initiatives.
Latin America has historically led a firm and rising Open Access movement and represents the worldwide region with larger adoption of Open Access practices. Argentina has recently expressed its commitment to join Plan S, an initiative from a European consortium of research funders oriented to mandate Open Access publishing of scientific outputs. Here we suggest that the potential adhesion of Argentina or other Latin American nations to Plan S, even in its recently revised version, ignores the reality and tradition of Latin American Open Access publishing, and has still to demonstrate that it will encourage at a regional and global level the advancement of non-commercial Open Access initiatives.Practical considerations for collaborative research between the pharmaceutical industry and external investigatorshttps://peerj.com/preprints/277852019-06-052019-06-05Maureen LloydCynthia K BarbitschMary Voehl HirschAntonia PanayiEric Southam
Traditionally, clinical research has been conducted via either industry sponsored studies or non-industry investigator sponsored studies. Collaborative Research provides a relatively new mechanism for industry and non-industry partners to work together in the pursuit of effective and safe treatments for the patient. The aims of this article are to provide both industry and non-industry investigators with a greater insight into the complex processes that are currently employed by industry when entering into Collaborative Research agreements, and to encourage consistency and transparency in approach across companies.
In Collaborative Research, instead of being limited to providing funding and/or product, the industry partner contributes expertise complementary to that of the non-industry partner, who is the sponsor of the study. Collaborative Research may be conducted before, during or after regulatory approval of a drug or medical device, and may be interventional, observational or preclinical.
A collaboration requires appropriate process and governance frameworks to be established in order to be successful. Important considerations include the routes for submitting a request, the review and approval process, due diligence criteria, budgeting and contracting processes, permissible interactions during the execution of the research, the closing out of the research, and dispute resolution. It is also necessary to have in place an agreed communication strategy and a risk control framework. Clear and specific contract language around roles and responsibilities, intellectual property, rights to data, registration and disclosure of publications, and an understanding of adverse event reporting procedures are other critical facets of Collaborative Research that are essential to avoid delays and disputes.
With no global standards for Collaborative Research, it is important that partners establish practical procedures, good ongoing communication, alignment of goals, and transparent interactions and disclosure to jointly advance the science of new, safe and effective therapies.
Traditionally, clinical research has been conducted via either industry sponsored studies or non-industry investigator sponsored studies. Collaborative Research provides a relatively new mechanism for industry and non-industry partners to work together in the pursuit of effective and safe treatments for the patient. The aims of this article are to provide both industry and non-industry investigators with a greater insight into the complex processes that are currently employed by industry when entering into Collaborative Research agreements, and to encourage consistency and transparency in approach across companies.In Collaborative Research, instead of being limited to providing funding and/or product, the industry partner contributes expertise complementary to that of the non-industry partner, who is the sponsor of the study. Collaborative Research may be conducted before, during or after regulatory approval of a drug or medical device, and may be interventional, observational or preclinical.A collaboration requires appropriate process and governance frameworks to be established in order to be successful. Important considerations include the routes for submitting a request, the review and approval process, due diligence criteria, budgeting and contracting processes, permissible interactions during the execution of the research, the closing out of the research, and dispute resolution. It is also necessary to have in place an agreed communication strategy and a risk control framework. Clear and specific contract language around roles and responsibilities, intellectual property, rights to data, registration and disclosure of publications, and an understanding of adverse event reporting procedures are other critical facets of Collaborative Research that are essential to avoid delays and disputes.With no global standards for Collaborative Research, it is important that partners establish practical procedures, good ongoing communication, alignment of goals, and transparent interactions and disclosure to jointly advance the science of new, safe and effective therapies.UK universities compliance with the Concordat to Support Research Integrity: findings from cross-sectional time-serieshttps://peerj.com/preprints/276222019-03-302019-03-30Elizabeth Wager
Background. The Concordat to Support Research Integrity published in 2012 recommends that UK research institutions should provide a named point of contact to receive concerns about research integrity (RI). The Concordat also requires institutions to publish annual RI statements.
Objective. To see whether contact information for a staff member responsible for RI was readily available from UK university websites and to see how many universities published annual RI statements.
Methods. UK university websites were searched in mid-2012, mid-2014 and mid-2018. The availability of contact details for RI inquiries, other information about RI and, specifically, an annual RI statement, was recorded.
Results. The proportion of UK universities publishing an email address for RI inquiries rose from 23% in 2012 (31/134) to 55% in 2018. The same proportion (55%) published at least one annual RI statement in 2018, but only 3 provided statements for all years from 2012/13. There was great variation in the titles used for the staff member with responsibility from RI which made searching difficult.
Conclusion. Over 6 years after the publication of the Concordat to Support Research Integrity, nearly half of UK universities are not complying with all its recommendations and do not provide contact details for a staff member with responsibility for RI or an annual statement.
Background. The Concordat to Support Research Integrity published in 2012 recommends that UK research institutions should provide a named point of contact to receive concerns about research integrity (RI). The Concordat also requires institutions to publish annual RI statements.Objective. To see whether contact information for a staff member responsible for RI was readily available from UK university websites and to see how many universities published annual RI statements.Methods. UK university websites were searched in mid-2012, mid-2014 and mid-2018. The availability of contact details for RI inquiries, other information about RI and, specifically, an annual RI statement, was recorded.Results. The proportion of UK universities publishing an email address for RI inquiries rose from 23% in 2012 (31/134) to 55% in 2018. The same proportion (55%) published at least one annual RI statement in 2018, but only 3 provided statements for all years from 2012/13. There was great variation in the titles used for the staff member with responsibility from RI which made searching difficult.Conclusion. Over 6 years after the publication of the Concordat to Support Research Integrity, nearly half of UK universities are not complying with all its recommendations and do not provide contact details for a staff member with responsibility for RI or an annual statement.#Pay4Reviews: Academic publishers should pay scientists for peer-reviewhttps://peerj.com/preprints/275732019-03-082019-03-08Rodolfo Jaffé
The exploitation of scientists by traditional academic publishers is widespread, as they monopolize the right to distribute scientific papers, strip authors of their own article’s copyrights, and charge them if they wish to read papers from their peers. It is then up to scientists to free themselves (and their papers) from the tyranny of academic publishers by refusing to perform free peer-reviews for them and by publishing open-access when possible. Starved of peer-reviewers, academic publishers would have nothing to publish, while subscription fees are doomed to disappear in an age of open-science. This system would also create incentives to perform peer-review: #Pay4Reviews
The exploitation of scientists by traditional academic publishers is widespread, as they monopolize the right to distribute scientific papers, strip authors of their own article’s copyrights, and charge them if they wish to read papers from their peers. It is then up to scientists to free themselves (and their papers) from the tyranny of academic publishers by refusing to perform free peer-reviews for them and by publishing open-access when possible. Starved of peer-reviewers, academic publishers would have nothing to publish, while subscription fees are doomed to disappear in an age of open-science. This system would also create incentives to perform peer-review: #Pay4ReviewsBiosafety considerations of open air genetic engineering. An analysis of the New Zealand Environmental Protection Authority’s reasons for not classifying organisms treated with double-stranded RNA as genetically modified or new organismshttps://peerj.com/preprints/275452019-02-202019-02-20Jack A Heinemann
The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. The Decision rests on the EPA’s conclusion that dsRNA is not heritable and therefore treatments using dsRNA do not modify genes or other genetic material. I found from an independent review of the literature on the topic that each of the major scientific justifications relied upon by the EPA to conclude that exposures to exogenous sources of dsRNA were out of legislative scope was based on either an inaccurate interpretation or failure to consult the research literature on all types of eukaryotes. The Decision also has not taken into account the unique eukaryotic biodiversity of the country. The safe use of RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation. However, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes by failing to restrict the source or means of modifying the dsRNA.
The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. The Decision rests on the EPA’s conclusion that dsRNA is not heritable and therefore treatments using dsRNA do not modify genes or other genetic material. I found from an independent review of the literature on the topic that each of the major scientific justifications relied upon by the EPA to conclude that exposures to exogenous sources of dsRNA were out of legislative scope was based on either an inaccurate interpretation or failure to consult the research literature on all types of eukaryotes. The Decision also has not taken into account the unique eukaryotic biodiversity of the country. The safe use of RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation. However, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes by failing to restrict the source or means of modifying the dsRNA.Mitochondrial DNA in human identification: a reviewhttps://peerj.com/preprints/275002019-01-242019-01-24António AmorimTeresa FernandesNuno Taveira
Mitochondrial DNA (mtDNA) presents several characteristics useful for forensic studies, especially related to the lack of recombination, to a high copy number, and to matrilineal inheritance. mtDNA typing based on sequences of the control region or full genomic sequences analysis is used to analyze a variety of forensicsamples such as old bones, teeth and hair, as well as other biological samples where the DNA content is low. Evaluation and reporting of the results requires careful consideration of biological issues as well as other issues such as nomenclature and reference population databases. In this work we review mitochondrial DNA profiling methods used for human identification and present their use in the main cases of human identification focusing on the most relevant issues for the forensic and medico-legal areas.
Mitochondrial DNA (mtDNA) presents several characteristics useful for forensic studies, especially related to the lack of recombination, to a high copy number, and to matrilineal inheritance. mtDNA typing based on sequences of the control region or full genomic sequences analysis is used to analyze a variety of forensicsamples such as old bones, teeth and hair, as well as other biological samples where the DNA content is low. Evaluation and reporting of the results requires careful consideration of biological issues as well as other issues such as nomenclature and reference population databases. In this work we review mitochondrial DNA profiling methods used for human identification and present their use in the main cases of human identification focusing on the most relevant issues for the forensic and medico-legal areas.Ten Simple Rules for Scientific Fraud & Misconducthttps://peerj.com/preprints/273952018-11-292018-11-29Nicolas P RougierJohn Timmer
We obviously do not encourage scientific fraud nor misconduct. The goal of this article is to alert the reader to problems that have arisen in part due to the Publish or Perish imperative, which has driven a number of researchers to cross the Rubicon without the full appreciation of the consequences. Choosing fraud will hurt science, end careers, and could have impacts on life outside of the lab. If you’re tempted (even slightly) to beautify your results, keep in mind that the benefits are probably not worth the risks.
We obviously do not encourage scientific fraud nor misconduct. The goal of this article is to alert the reader to problems that have arisen in part due to the Publish or Perish imperative, which has driven a number of researchers to cross the Rubicon without the full appreciation of the consequences. Choosing fraud will hurt science, end careers, and could have impacts on life outside of the lab. If you’re tempted (even slightly) to beautify your results, keep in mind that the benefits are probably not worth the risks.A brief introduction to Open Data, Open Source Software and Collective Intelligence for environmental data creators and usershttps://peerj.com/preprints/271272018-10-192018-10-19Tomislav HenglIchsani WheelerRobert A MacMillan
Using the term "Open data" has become a bit of a fashion, but using it without clear specifications is misleading i.e. it can be considered just an empty phrase. Probably even worse is the term "Open Science" — can science be NOT open at all? Are we reinventing something that should be obvious from start? This guide tries to clarify some key aspects of Open Data, Open Source Software and Crowdsourcing using examples of projects and business. It aims at helping you understand and appreciate complexity of Open Data, Open Source software and Open Access publications. It was specifically written for producers and users of environmental data, however, the guide will likely be useful to any data producers and user.
Using the term "Open data" has become a bit of a fashion, but using it without clear specifications is misleading i.e. it can be considered just an empty phrase. Probably even worse is the term "Open Science" — can science be NOT open at all? Are we reinventing something that should be obvious from start? This guide tries to clarify some key aspects of Open Data, Open Source Software and Crowdsourcing using examples of projects and business. It aims at helping you understand and appreciate complexity of Open Data, Open Source software and Open Access publications. It was specifically written for producers and users of environmental data, however, the guide will likely be useful to any data producers and user.Biosafety by definition: an analysis of the New Zealand Environmental Protection Authority’s reasons for not classifying organisms treated with double-stranded RNA as genetically modified or new organismshttps://peerj.com/preprints/271082018-08-112018-08-11Jack A Heinemann
The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. dsRNA molecules can be potent gene regulators in eukaryotes, causing what is known as RNA interference. RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation but also raises the threat of unintended consequences. The Decision rests on their conclusion that dsRNA treatments do not modify genes or other genetic material and are therefore not heritable. The EPA conclusion is not consistent with the totality of peer-reviewed research on dsRNA or industry claims. The Decision applies to nearly all eukaryotes, however, the EPA relied upon knowledge of relatively few eukaryotes and its analysis neglected known exceptions. The Decision also has not taken into account the unique eukaryotic biodiversity of the country, much of which is still to be described. The regulator has potentially created precedent-setting definitions of previously undefined or alternatively defined key terms that trigger obligations under binding international agreements, in addition to domestic legislation. Finally, by placing no restriction on the source or means of modifying the dsRNA, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes. This article examines the scientific evidence, conclusions and recommendations of the EPA and also presents some additional options.
The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. dsRNA molecules can be potent gene regulators in eukaryotes, causing what is known as RNA interference. RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation but also raises the threat of unintended consequences. The Decision rests on their conclusion that dsRNA treatments do not modify genes or other genetic material and are therefore not heritable. The EPA conclusion is not consistent with the totality of peer-reviewed research on dsRNA or industry claims. The Decision applies to nearly all eukaryotes, however, the EPA relied upon knowledge of relatively few eukaryotes and its analysis neglected known exceptions. The Decision also has not taken into account the unique eukaryotic biodiversity of the country, much of which is still to be described. The regulator has potentially created precedent-setting definitions of previously undefined or alternatively defined key terms that trigger obligations under binding international agreements, in addition to domestic legislation. Finally, by placing no restriction on the source or means of modifying the dsRNA, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes. This article examines the scientific evidence, conclusions and recommendations of the EPA and also presents some additional options.