CURRENT MEDICAL AND DRUG RESEARCH
Publication Ethics and Publication Malpractice Statement
GENERAL GUIDELINES
The publisher “Global SciTech Ocean” (GLOSTO) is committed to strictly following ethical guidelines for all of its published contents. The manuscripts received for publication in “Current Medical and Drug Research” (CMDR) will be only considered if they follow the guidelines of International Standards for authors. All the authors who are interested to publish in CMDR must read the guidelines of Standards for Reporting Qualitative Research. GLOSTO conducts a peer-reviewing process as per the COPE Ethical Guidelines for Peer-Reviewers and the invited reviewers are suggested to read the above guidelines before reviewing a manuscript.
PUBLICATION MODEL
All the manuscripts in CMDR are published as “Open Access” and freely available for all. The contents are published by following terms and conditions as framed for Creative Commons Attribution-Noncommercial 4.0 International License. The copyright of the manuscripts retains by the publisher and also by the authors where an author is free to reproduce and disseminate the contents.
GUIDELINES FOR ANIMAL STUDIES
The studies based on animal research will be only considered if these are conducted as per the standard guidelines framed by different internationally recognized agencies institutions for this purpose. One can read Ethical Guidelines for the Use of Animals in Research given by the National Committee for Research Ethics in Science and Technology or the guidelines of The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Govt. of India. For animal studies, adequate statistics must be presented and the details of approvals of the animal ethical committee including the date of approval must be mentioned in the experimental section.
GUIDELINES FOR HUMAN STUDIES
CMDR is committed to following ethics of publication, based on the COPE’s Core Practices and follows the declaration of Helsinki regarding research involving humans. The name and license/ approval number of the “Institutional Ethics Committee” with the date of approval must be mentioned in the experimental section. However, in the case of psychological studies, ethics of research, based on the American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct must be followed. Researchers have a moral obligation towards the animals and human subjects they use for their research goals and are appealed to treat them with all compassion and consider their well-being as a priority while designing the projects. The detailed information on the ethical guidelines followed by the journal is given below.
ETHICAL GUIDELINES FOR MEDICAL RESEARCH
CMDR is committed to following ethics of medical research, based on the Declaration of Helsinki: Statement of Ethical Principles for Medical Research and ICMJE’s Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals.
Protection of Human Subjects
When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2013.
Informed Consent of Participants
The human participants have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived either with the journal, the authors, or both, as dictated by local regulations or laws. Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance, and editors should so note, that such alterations do not distort scientific meaning. When informed consent has been obtained, it should be indicated in the published article.
Declaration of Helsinki
- The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
- Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.
- The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.”
- It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.
- Medical progress is based on research that ultimately must include studies involving human subjects.
- The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best-proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
- Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
- While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
- It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
- Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
- Medical research should be conducted in a manner that minimizes possible harm to the environment.
- Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
- Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
- Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
- Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
- In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
- All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
- Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
- Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.
- Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
- Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
- The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
- The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.
- Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
- Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
- In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.
- When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations, informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
- For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
- When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject’s dissent should be respected.
- Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances, the physician must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorized representative.
- The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
- For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a research ethics committee.
- The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best-proven intervention(s), except in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best-proven intervention. Extreme care must be taken to avoid abuse of this option.
- In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.
- Every research study involving human subjects must be registered in a publicly accessible database before the recruitment of the first subject.
- Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
- In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by:
- 29th WMA General Assembly, Tokyo, Japan, October 1975
- 35th WMA General Assembly, Venice, Italy, October 1983
- 41st WMA General Assembly, Hong Kong, September 1989
- 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
- 52nd WMA General Assembly, Edinburgh, Scotland, October 2000
- 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
- 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
- 59th WMA General Assembly, Seoul, Republic of Korea, October 2008
- 64th WMA General Assembly, Fortaleza, Brazil, October 2013
CONFLICT OF INTEREST
For publication in CMDR, authors must include a statement declaring all relevant competing interests in relation to their research. A “Conflict of Interests” section should be included at the end of all submitted manuscripts listing all competing interests (financial and non-financial). Where authors have no competing interests, authors should mention: “The authors declare no conflicts of interest” Editors may ask for further information concerning this section. Reviewers are also required to declare, if any, competing interests and will be then excluded from the manuscript’s peer review process.
PUBLICATION CHARGES
CMDR is an Open Access journal and its contents are freely available to all. The publisher manages its expenses for publication, editing, website maintenance and other costs from nominal publication charges received from authors. Presently, the publisher charges INR 2500 or USD 35 per accepted article. However, the manuscript submission is free of cost and the charges are only asked once a manuscript is accepted for publication. The publication charges are partially or fully waived off on request which is dependent on the quality of manuscript contents and also on the economic status of the authors’ country as per the World Bank classification.
PEER-REVIEW MODEL
All the manuscripts are initially checked for their quality, journal’s requirements and status of copyright agreement by the editorial office. Once all formalities are done, the manuscript is sent to one of the editors to complete reviewing process and make a final decision on the manuscript. The Editor is responsible for deciding which of the articles submitted to the journal should be published. The authors must follow the instructions of the journal and be constrained by such legal requirements as shall then be in force regarding libel, copyright infringement and plagiarism. The journal follows the “Single Blind Reviewing Model” where the reviewer is aware of the names and other information about the authors. Each manuscript is sent to two independent reviewers and based on their opinions, the Editor takes a final decision on the manuscript. In some cases where the reviewers are not unanimous, the Editor may consult other Editors or Reviewers in making this decision.
ORIGINALITY OF CONTENTS
It is the authors’ responsibility to assure that the contents to be submitted for publication in CMDR are original. The statement about the originality of contents in the manuscript is also given in the copyright form that an author has to be signed. The editorial office also checked the originality of the contents using Plagiarism Software. If the similarity index is found high, the manuscript does not send to the Editor and is rejected immediately.
RESPONSIBILITIES OF EDITOR, REVIEWER, AUTHOR AND PUBLISHER
CMDR follows the Code of Conduct and Best Practice Guidelines for Journal Editors and the Code of Conduct for Journal Publishers. Hence, we are requested to editors, reviewers and authors to read the COPE guidelines before serving/ writing for CMDR. Following are the key roles of editors, reviewers, authors and publisher.
Responsibility of Editors
- To evaluate every received manuscript (MS) based on its scientific and academic merits which include the importance of the work, originality of the contents, clarity and validation of the data. In addition, the examination for the scope of the work for the journal is also the part of Editors’ duty. The decision will be strictly taken without considering the race, religion, ethnicity or affiliation of the author. The Editor-in-Chief (EiC) has full authority over the entire editorial content of CMDR and the timing of publication.
- Editors will maintain confidentiality, and not disclose any information about a submitted manuscript to anyone other than the corresponding author(s), reviewers and the publisher.
- Editors will not use any unpublished information of submitted manuscripts for their own research purposes without the authors’ consent. Key information and ideas obtained by editors from such manuscripts will be kept confidential; they cannot even use these ideas for their personal advantage. Editors will recuse themselves from considering manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships/connections with any of the authors, companies or institutions connected to the papers; instead, they will ask another member of the editorial board to handle the manuscript.
- The editors ensure that all submitted manuscripts being considered for publication undergo peer-review by at least two reviewers who are experts in the field. The EiC is responsible for deciding which of the manuscripts submitted to the journal will be published, based on the validation of the work in question, its importance to researchers and readers, the reviewers’ comments, and such legal requirements as are currently in force regarding libel, copyright infringement and plagiarism. The EiC may confer with other editors or reviewers in making this decision.
- Editors (together with the publisher) will take responsive measures when ethical concerns are raised with regard to a submitted manuscript or published paper. Every reported act of unethical publishing behaviour will be looked into, even if it is discovered years after publication. Editors will follow the COPE Flowcharts when dealing with cases of suspected misconduct.
Responsibility of Reviewers
- Peer review assists editors in making editorial decisions and, through editorial communications with authors, may assist authors in improving their manuscripts. Peer review is an essential component of formal scholarly communication and lies at the heart of the scientific endeavour. CMDR shares the view of many that all scholars who wish to contribute to the scientific process have an obligation to do a fair share of reviewing.
- Any invited referee who feels unqualified to review the research reported in a manuscript or knows that its prompt review will be impossible should immediately notify the editors and decline the invitation to review so that alternative reviewers can be contacted.
- Any manuscript received for review is a confidential document and must be treated as such; it must not be shown to or discussed with others except if authorized by the EiC. This applies also to invited reviewers who decline the review invitation.
- Reviews should be conducted objectively and observations formulated clearly with supporting arguments so that authors can use them for improving the manuscript.
- Reviewers should identify relevant published work that has not been cited by the authors. Any statement that is an observation, derivation or argument that has been reported in previous publications should be accompanied by the relevant citation. A reviewer should also notify the editors of any substantial similarity or overlap between the manuscript under consideration and any other manuscript (published or unpublished) of which they have personal knowledge.
- Any invited referee who has conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies or institutions connected to the manuscript and the work described therein should immediately notify the editors to declare their conflicts of interest and decline the invitation to review so that alternative reviewers can be contacted.
- Unpublished material disclosed in a submitted manuscript must not be used in a reviewer’s own research without the express written consent of the authors. Privileged information or ideas obtained through peer review must be kept confidential and not used for the reviewer’s personal advantage. This applies also to invited reviewers who decline the review invitation.
Responsibility of Authors
- Authors of original research should present an accurate account of the work performed and the results, followed by an objective discussion of the significance of the work. The manuscript should contain sufficient detail and references to permit others to replicate the work. Review articles should be accurate, objective and comprehensive, while editorial opinion or perspective pieces should be clearly identified as such. Fraudulent or knowingly inaccurate statements constitute unethical behaviour and are unacceptable.
- Authors may be asked to provide the raw data of their study together with the manuscript for editorial review and should be prepared to make the data publicly available if practicable. In any event, authors should ensure accessibility of such data to other competent professionals for at least 10 years after publication (preferably via an institutional or subject-based data repository or other data centre), provided that the confidentiality of the participants can be protected and legal rights concerning proprietary data do not preclude their release.
- Authors should ensure that they have written and submit only entirely original works, and if they have used the work and/or words of others, that this has been appropriately cited. Publications that have been influential in determining the nature of the work reported in the manuscript should also be cited. Plagiarism takes many forms, from "passing off" another's paper as the author's own, to copying or paraphrasing substantial parts of another's paper (without attribution), to claiming results from research conducted by others. Plagiarism in all its forms constitutes unethical publishing behaviour and is unacceptable.
- Papers describing essentially the same research should not be published in more than one journal or primary publication. Hence, authors should not submit for consideration a manuscript that has already been published in another journal. Submission of a manuscript concurrently to more than one journal is unethical publishing behaviour and unacceptable.
- The publication of some kinds of articles (such as clinical guidelines, translations) in more than one journal is sometimes justifiable, provided that certain conditions are met. The authors and editors of the journals concerned must agree to the secondary publication, which must reflect the same data and interpretation of the primary document. The primary reference must be cited in the secondary publication.
- Only persons who meet these authorship criteria should be listed as authors in the manuscript as they must be able to take public responsibility for the content: (i) made significant contributions to the conception, design, execution, data acquisition, or analysis/interpretation of the study; and (ii) drafted the manuscript or revised it critically for important intellectual content; and (iii) have seen and approved the final version of the paper and agreed to its submission for publication. All persons who made substantial contributions to the work reported in the manuscript (such as technical help, writing and editing assistance, general support) but who do not meet the criteria for authorship must not be listed as an author, but should be acknowledged in the "Acknowledgements" section after their written permission to be named as been obtained. The corresponding author should ensure that all appropriate coauthors (according to the above definition) and no inappropriate co-authors are included in the author list and verify that all co-authors have seen and approved the final version of the manuscript and agreed to its submission for publication.
- Authors should, at the earliest stage possible, disclose any conflicts of interest that might be construed to influence the results or their interpretation in the manuscript. Examples of potential conflicts of interest that should be disclosed include financial ones such as honoraria, educational grants or other funding, participation in speakers’ bureaus, membership, employment, consultancies, stock ownership, or other equity interest, and paid expert testimony or patent-licensing arrangements, as well as non-financial ones such as personal or professional relationships, affiliations, knowledge or beliefs in the subject matter or materials discussed in the manuscript. All sources of financial support for the work should be disclosed (including the grant number or other reference numbers if any).
- Authors should ensure that they have properly acknowledged the work of others, and should also cite publications that have been influential in determining the nature of the reported work. Information obtained privately (from the conversation, correspondence or discussion with third parties) must not be used or reported without explicit, written permission from the source. Authors should not use information obtained in the course of providing confidential services, such as refereeing manuscripts or grant applications unless they have obtained the explicit written permission of the author(s) of the work involved in these services.
- If the work involves chemicals, procedures or equipment that have any unusual hazards inherent in their use, the authors must clearly identify these in the manuscript. If the work involves the use of animals or human participants, the authors should ensure that all procedures were performed in compliance with relevant laws and institutional guidelines and that the appropriate institutional committee(s) has approved them; the manuscript should contain a statement to this effect. Authors should also include a statement in the manuscript that informed consent was obtained for experimentation with human participants. The privacy rights of human participants must always be observed.
- Authors are obliged to participate in the peer-review process and cooperate fully by responding promptly to editors’ requests for raw data, clarifications, proof of ethics approval, patient consents and copyright permissions. In the case of a first decision of "revisions necessary", authors should respond to the reviewers’ comments systematically, point by point, and in a timely manner, revising and re-submitting their manuscript to the journal by the deadline given.
- When authors discover significant errors or inaccuracies in their own published work, it is their obligation to promptly notify the journal’s editors or publisher and cooperate with them to either correct the paper in the form of an erratum or to retract the paper. If the editors or publisher learns from a third party that a published work contains a significant error or inaccuracy, then it is the authors’ obligation to promptly correct or retract the paper or provide evidence to the journal editors of the correctness of the paper.
Responsibility of the Publisher
- In cases of alleged or proven scientific misconduct, fraudulent publication or plagiarism, the publisher, in close collaboration with the editors, will take all appropriate measures to clarify the situation and to amend the article in question. This includes the prompt publication of an erratum, clarification or, in the most severe case, the retraction of the affected work. The publisher, together with the editors, shall take reasonable steps to identify and prevent the publication of papers where research misconduct has occurred, and under no circumstances encourage such misconduct or knowingly allow such misconduct to take place.
- The publisher will be committed to the permanent availability and preservation of scholarly research and ensure the accessibility of published articles.