Authorship.

Peer Review and the PJOHNS: Principles, Problems, and Promise

Information for authors and editorial policies

Background: The Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) are two internationally recognised organisations in the field of publication ethics. Guidelines from these two organisations were updated in 2018. Objectives: To assess the extent to which the journal Pharmactuel is compliant with the guidelines on publication ethics updated by ICMJE and COPE in 2018 and, where the journal is found  wanting, to take the necessary steps to make it compliant. Methods:  A list of updated criteria – 56 by ICMJE and 22 by COPE – was compiled. In January 2020, compliance with each of these criteria was evaluated by the editor-in-chief and validated by all six associate editors. The evaluation was followed by an action plan to improve compliance, and the evaluation was repeated in November 2020. Results: Of the 56 ICMJE criteria, Pharmactuel was fully compliant with 31 and partly compliant with 10 criteria (a compliance rate of 73%, taking the two together). The corresponding figures for the 22 COPE criteria were 17, 3, and 91%. By modifying its editorial policies, training its associate editors, and creating appropriate guidelines for its editorial board and editors, Pharmactuel achieved almost 100% compliance by the end of 2020. Conclusions: Pharmactuel has been fully compliant with ICMJE and COPE recommendations since January 2021. Minor modifications to Pharmactuel’s publication process have enabled the editorial team to ensure that the journal continues to be almost totally compliant with COPE and ICMJE guidelines and to uphold its high ethical standards.

Uniform Format for Disclosure of Competing Interests in ICMJE Journals

This article is a documentary of the history of the American College of Clinical Pharmacology (ACCP) and the Journal of Clinical Pharmacology. The history of the college and of the journal is presented as summarized by a few of the many leaders who played key roles in the growth of the profession of Clinical Pharmacology. Together, the college, the journal, and all clinical pharmacologists working in academia, industry, CROs, or government in many different subspecialty areas of the discipline contribute to the advancement of clinical pharmacology, the development of new drugs, and to an improved quality of life for mankind. Achieving leadership in health care in an era of change requires actions to be dynamic and flexible. Leaders must be capable of self-development and self-education. Leaders must examine challenges from top to bottom and build on the leadership foundations of vision, courage, and knowledge. Strong leaders are needed for the future of clinical pharmacology to address the rapidly changing environment for health care givers and the challenges faced by those working in drug development or training new leaders. One lesson from the past, from the professional life of Harry Gold, is that it is very important to convey the excitement of the field of clinical pharmacology and to pass on this excitement and knowledge base to those currently leading the educational process necessary to keep clinical pharmacologists in the forefront of the medical arena of today and tomorrow. The college became an instrument for change in the field of clinical pharmacology. Forward thinking efforts of the college did not allow stagnation. All founding leaders of the college were possessed of a dream of "what could be and what should be." Two points should be emphasized: the importance of teaching teachers how to teach and the importance of forming national networks, such as the college, to concentrate on the role of teaching students. Today's students are the leaders of tomorrow. The training of any given student in the field of clinical pharmacology continues over many years and requires the effort of many qualified mentors. The ACCP continues to prepare for the changing demands of a new millennium. The college responded to three challenges: (1) utilization of new technologies consistent with contemporary trends; (2) identification of new member services; and (3) dissemination of a position paper defining the philosophical foundations of the college. The basic tenant of the college remains the same today as it has been over the years: provide a multidisciplinary educational environment to have a broad appeal to the membership interested in clinical pharmacology.

The great variability in the processes that different journals use to ask about and report authors' potential conflicts of interest creates confusion for authors, readers, and the public. To help lessen this confusion, the International Committee of Medical Journal Editors (ICMJE) developed an electronic uniform disclosure form and placed it in the public domain in October 2009. The ICMJE member journals piloted the form, encouraged other journals to use it, and invited feedback. We recognized that the reporting of competing interests is complex and nuanced and sometimes contentious and thus anticipated modifying the form on the basis of feedback received. . . .

Plagiarism, Self-Plagiarism, and Text Recycling.

Committee on Publication Ethics 1997–2000

The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM).Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements.

A the concept of integrity in human actions is universal and inherent to any relationship in a civilized society, some guidance should be given to specific situations to set standards of good practice. In times of great academic pressure to publish, double care is necessary to preserve the integrity of research and to prevent publication misconduct. The Revista Odonto Ciencia (Journal of Dental Science) strongly recommends that our authors, reviewers and editors follow the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publications” by the International Committee of Medical Journal Editors (ICMJE) and the guidelines by the Committee on Publication Ethics (COPE). Furthermore, our journal is affiliated with the Brazilian Association of Scientific Editors (ABEC) and the BVS Virtual Community of Scientific Editors, which provide additional discussion on editorial policies. Our journal also supports the Singapore Statement on Research Integrity, an international initiative that discloses fundamental principles and professional responsibilities related to research and publication integrity. During the 2nd World Conference on Research Integrity, July 2010, in Singapore, scholars, researchers, funders, representatives of research institutions and publishers from all over the world developed this global guide to the responsible conduct of research. In synergy with this scenario, the Revista Odonto Ciencia (Journal of Dental Science) attended the First Brazilian Meeting on Research Integrity, Science and Publication Ethics (I BRISPE), in December 2010. One of the goals of the meeting was “to stimulate the involvement of the country’s academic community in the development of policies and in decision making concerning ethics and research integrity at the international level”. The Revista Odonto Ciencia (Journal of Dental Science) is committed to help to disseminate this important information and the good practices in research and publication. Further information can be found at:

Academic institutes are breeding grounds of innovation and the cradle of future clinical pharmacologists and pharmacometricians. However, there is a crisis looming over academic institutions; funding for research in clinical pharmacology is at an all-time low. This crisis of academic funding is no longer a well-kept secret. This crisis is at a national level and has far-reaching consequences. Federal funding for biomedical research in the United States doubled between 1998 and 2003 and fueled academic research nationally.This funding was considered key to maintaining the edge of the United States in the pharmaceutical and biotechnology industries. However, federal funding for biomedical research has been in decline since that time. Federal funding for biomedical research is estimated to be at least 25% less in inflation-adjusted dollars than it was in 2003, whereas demand for research dollars has skyrocketed.1-3 The increased demand for research money in the face of dwindling federal support may be attributed to several factors. Universities were able to expand their facilities and hire more faculty during the years of surplus funding and now must maintain those facilities and retain key faculty in the face of ever-shrinking federal dollars. Adding to the problem, public universities face decreased funding at the state level, as state governments attempt to balance their budgets. Other sources of funding, such as the pharmaceutical industry, have also dried up, as the industry itself comes under pressure to control costs and faces close scrutiny of its funding of academic research. Finally, the rising cost of conducting biomedical research (both as actual costs and the ever-increasing regulatory burden to conduct those studies) contributes to the problem, as even phase 1 clinical studies may now cost upwards of $4 million.4 As dire as things are for the biomedical research community as a whole, the situation is even worse when it comes to attracting major federal funding for research in the field of clinical pharmacology and pharmacometrics. The key characteristic of being a universally applicable field of research has a considerable downside; clinical pharmacology is a field without the face of a disease that the public cares about. There is no 5K race for “getting the dose right,” in contrast to diseases like breast cancer, diabetes, and AIDS. The public in general does not know what clinical pharmacology is and does not understand its role in the development of new medicines for the diseases that affect loved ones in their families and communities. This is even reflected in federal funding, where the National Institutes of Health (NIH) has traditionally funded basic research while being slow in funding clinical pharmacology–based research. The funding crisis may affect what kind of research is performed in academic institutions, as “fundability” takes precedence over good science. More time is now spent by researchers worrying about how to bring in funds rather than generating truly innovative ideas. The time that used to be spent brainstorming on the whiteboard that fueled and inspired great innovations and mentored and shaped future leaders in the field of clinical pharmacology and pharmacometrics is now spent on decorating, refining, and rewriting research proposals to make them “fundable.” As academic researchers compete for the same small share of grant money, they are realizing that they often need to abandon ambitious innovative ideas for more predictable, less innovative ones, which have higher chances of securing funding. This “risk aversion” has become a serious threat to the innovation engine of academic research in the field of clinical pharmacology and pharmacometrics. The dwindling chances to secure funding, less freedom for bold innovative research, and diminishing returns as the funding gets tighter is resulting in a mass exodus of clinical pharmacologists and pharmacometricians leaders and mentors from academia. Over the last decade as the academic funding crisis has increased in its severity, the faculty members, postdoctoral fellows, staff scientists, and graduate students engaged in innovative clinical pharmacology research in academia have drastically decreased in number. In discussing this funding crisis with respected academic researchers in the field of clinical pharmacology and pharmacometrics, I saw a common theme emerge: “It is a great time to do science, but a terrible time to be an academic researcher.” Unless the situation improves, we may lose key mentors and leaders in academia, resulting not only in lost innovative research in clinical pharmacology and pharmacometrics, but also in the dire consequences of losing an entire generation of future clinical pharmacologists and pharmacometricians. The American College of Clinical Pharmacology believes that it is time for the national clinical pharmacology and pharmacometrics societies to come together to highlight the seriousness of this issue. A quick solution is not forthcoming. First and foremost, these scientific societies need to work collaboratively to generate awareness regarding the field of clinical pharmacology in public and within the federal funding agencies such as the NIH, whether this is through public media social events, 5K races, or other platforms to bring together science and the general public and to create a face for the field. Collaborative partnerships between the pharmaceutical industry, national funding agencies, and academia for continued innovative research and education of future clinical pharmacologists and pharmacometricians will be an effective approach, but will require more than lip service—a true commitment to the field of clinical pharmacology is needed by funding agencies and academic institutions. An effective solution to keep innovative clinical pharmacology and pharmacometrics research flourishing in academia could be funding through development of consortia and cooperative arrangements, particularly precompetitive consortia comprising, for example, the pharmaceutical industry, federal funding agencies, and academia. The consortium model best fosters collaboration among stakeholders with common goals by sharing resources, knowledge, and expertise as well as sharing risk in the most effective way. Several successful examples of cooperative arrangements via consortium already exist, including the Biomarkers Consortium, the Predictive Safety and Toxicology Consortium, and the Patient Reported Outcomes Consortium.5 Innovation in clinical pharmacology and pharmacometrics for the advancement of optimal drug development is a common goal for academia, federal funding agencies, the pharmaceutical industry, and the public—precompetitive consortia could bring these together in an effective way to rescue clinical pharmacology and pharmacometrics from this existential funding crisis in academia. Acknowledged for valuable discussions are Jeffrey S. Barrett, PhD, FCP, Michael J. Fossler, PharmD, PhD, FCP, Mathangi Gopalakrishnan, PhD, Peter Wiernik, MD, Raimund Peter, PhD, Lorraine Rusch, PhD, and Krista Levy.

Although popular, I argue that the International Committee of Medical Journal Editors (ICMJE) account of authorship is flawed. It inadvertently allows for practices that it was designed to prevent. In addition, it creates a new category of authorless papers—orphan papers. The original World Association of Medical Editors (WAME) criterion is preferable.

Challenges for modern scientific writing and editorship: have we lost our moral compass?

BackgroundThe number of coauthors in the medical literature has increased over the past 50 years as authorship continues to have important academic, social and financial implications.Aim and methodThe study aim...

The great enemy of communication, we find, is the illusion of it. William Hollingsworth Whyte, 19501 On September 6, 2022, a combined investigation by research integrity experts, data and analytics experts, publishing and operational teams, and legal counsels from Hindawi and its parent company Wiley, led to the initial recommendation to retract 511 articles that were compromised based on reviewer activity alone.2 That same month, the physics publisher Institute of Physics (IOP) announced the retraction of 494 papers after investigation indicated they “may have been created, manipulated, and/or sold by a commercial entity” (or paper mill).3 This October, the Elsevier journal Thinking Skills and Creativity retracted 47 papers that appear to have been generated by a paper mill because they were each accepted on the “positive advice of one illegitimate reviewer report.”4 Paper mills and phony peer reviews5 undermine the soundness of science, because it is based on illusion rather than truth. Truth (veritas) is only verifiable if it is transparent. The Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishing Association (OASPA), and the World Association of Medical Editors (WAME) have been collaborating to identify principles of transparency and best practice for scholarly publications.6 The fourth version of this work in progress was published on September 15, 2022 and is available from: https://publicationethics.org/files/principles-transparency-best-practice-scholarly-publishing.pdf The Philippine Journal of Otolaryngology Head and Neck Surgery upholds these principles of transparency and continues to strive to implement these best practices. In a related development, the International Association of Scientific, Technical and Medical Publishers (STM) has proposed a standard taxonomy for peer review,7 recognizing a need to identify and standardize definitions and terminology in peer review practices to help align nomenclature as more publishers use open peer review models. This peer review taxonomy will help make the peer review process for articles and journals more transparent and will enable the community to better assess and compare peer review practices between different journals. According to STM, peer review should be described using four components:7 identity transparency: all identities visible: reviewers, authors, decision-making editor [editor] all visible to each other single anonymized: reviewer identity is not visible to the author, author and editor identities are visible to everyone (also known as single masked, formerly single blinded, review) double anonymized: reviewer identity is not visible to the author, author identity is not visible to the reviewer, editor identity is known to both (also known as double masked, formerly double blinded, review) triple anonymized: reviewer identity is not visible to the author or editor, author identity is not visible to the reviewer or editor, editor identity is not visible to reviewer or author (also known as triple masked, formerly triple blinded, review) who the reviewer interacts with: the editor only (traditional review), direct interaction with the other reviewers (with or without their identities visible), and/or directly with the authors (with or without identities visible) what information about the review process is published: options include no information, review summaries, review reports, review reports if the reviewer opts to have review published, review reports if the author opts to have review published, the submitted manuscript (can be posted as a preprint), the submitted manuscript if the author opts in, the editor’s correspondence with the author, the authors’ response (rebuttal) letter, reviewer identities, reviewer identities if the review opts in, editor identities 4. whether post-publication commenting takes place: online comments may be either open (commenters may be anonymous or required to sign comments; could also include whether comments are moderated) or invited only; this item does not include letters to the editor. This item is not mentioned if no commenting is allowed. Using STM terminology, the Philippine Journal of Otolaryngology Head and Neck Surgery may be described as follows: Identity transparency: Double anonymized Reviewer interacts with: Editor Review information published: None We are updating our Instructions to Authors and About the Journal to reflect these developments. On another front, the Philippine Journal of Otolaryngology Head and Neck Surgery has agreed to co-publish an editorial calling on wealthy countries to do more to support Africa and other vulnerable nations in mitigating the impact of climate change on health.8 The guest editorial in this issue is authored by the editors of 16 African health journals, and is co-published by 259 international journals, including The Lancet, British Medical Journal, New England Journal of Medicine, National Medical Journal of India, and Medical Journal of Australia and the Philippine Journal of Otolaryngology Head and Neck Surgery (see http://press.psprings.co.uk/bmj/october/Journals.pdf). Never have so many journals come together to make the same call, reflecting the severity of the climate change emergency now facing the world. The authors say Africa has suffered disproportionately although it has done little to cause the crisis and urges wealthy nations to step up support for Africa and vulnerable countries in addressing past, present and future impacts of climate change.8 They explain that the climate crisis has had an impact on the environmental and social determinants of health across Africa, leading to devastating health effects. In West and Central Africa, for example, severe flooding resulted in mortality and forced migration from loss of shelter, cultivated land, and livestock, while extreme weather damages water and food supply, increasing food insecurity and malnutrition, which causes 1.7 million deaths annually in Africa.8 Changes in vector ecology brought about by floods and damage to environmental hygiene has also led to increases in malaria, dengue fever, Ebola virus, and other infectious diseases across sub-Saharan Africa.8 In all, it is estimated that the climate crisis has destroyed a fifth of the gross domestic product (GDP) of the countries most vulnerable to climate shocks.8 The damage to Africa should be of supreme concern to all nations, they write, because in an interconnected world, leaving countries to the mercy of environmental shocks creates instability that has severe consequences for all nations.8 We call on participants of the 2022 United Nations Climate Change Conference (COP27) to take concrete steps towards achieving our collective climate goals by turning their commitments under the Paris Agreement into action, without falling short as they did in COP26 Glasgow.9 Without compromise; in truth, transparently.