Ethical Consideration

 | Post date: 2020/02/3 | 

Journal of Medicinal Plant (JMP)’s Ethical Consideration

Journal of Medicinal Plant (JMP) editorial policy is in accordance with code of conduct and best practices by COPE. RJP follows the declaration of Helsinki (2013) regarding researches involving humans.

For animal or human studies, adequate statistics must be presented and the details of approvals of the research ethical committee including the code and date of approval should be indicated in the experimental section. The letter of approval of the Ethics Committee should also be uploaded during online submission in case of human studies.

While preparing the manuscript, every related literature should be cited properly and the manuscripts must be devoid of any kind of plagiarism. The submitted manuscript will be checked for plagiarism by Plagscan.

In the cover letter, the authors should clearly mention the type of their manuscripts (original article, short communication,... ), state that the work has not been submitted elsewhere and mention if there is any conflict of interest; also any conflict of interest should be stated before the reference section in the manuscript.

The articles published in Journal of Medicinal Plant (JMP) are licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. The copyright of the articles retains to the authors and authors are free to reproduce and disseminate their work.

Journal of Medicinal Plant (JMP) ‎is committed to apply ethics of publication, based on the COPE’s Core Practices. Also in psychological studies, ethics of research, based on American Psychological Association’s Ethical ‎Principles of Psychologists and Code of Conduct. ‎In addition, in medical studies, RJP has engaged to apply ethics of research, based on Declaration of Helsinki: Statement of Ethical Principles for Medical Research. So, the research’s ethical considerations must be addressed in the Materials and Methods section.  For more information on the journal’s ethical Principles, please refer to following title:

 

  1. Ethical Principles for Medical Research
  2. APA’s Ethical Principles of Psychologists and Code of Conduct
  3. Conflict of Interest

1. Ethical Principles for Medicinal Research

In medical studies, Journal of Medicinal Plant (JMP) is committed to apply ethics of research, based on 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. You may find the journal’s Ethical Principles for Medical Research, here.

 

Protection of Human Subjects and Animals in Research

(Prepared Based on ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals)

In Journal of Medicinal Plant (JMP), 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. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

 

Informed Consent in Patients and Study Participants

(Prepared Based on ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals)

In Journal of Medicinal Plant (JMP), patients 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: Statement of Ethical Principles for Medical Research

Preamble

1.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.

2.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. 

 

General Principles

3.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.”

4.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.

5.Medical progress is based on research that ultimately must include studies involving human subjects.

6.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.

7.Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8.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.

9.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.

10.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.

11.Medical research should be conducted in a manner that minimizes possible harm to the environment.

12.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.

13.Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

14.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.

15.Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

 

Risks, Burdens and Benefits 

16.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.

17.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. 

18.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.           

 

Vulnerable Groups and Individuals

19.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.

20.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.

 

Scientific Requirements and Research Protocols 

21.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.

22.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.

 

Research Ethics Committees

23.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. 

 

Privacy and Confidentiality 

24.Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

 

Informed Consent 

25.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.

26.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.

27.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 the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28.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.

29.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.

30.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.

31.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.

32.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.

 

Use of Placebo

33.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.

 

Post-Trial Provisions

34.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.

 

Research Registration and Publication and Dissemination of Results

35.Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36.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.

 

Unproven Interventions in Clinical Practice

37.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 judgement 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 the:

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

2. APA’s Ethical Principles of Psychologists and Code of Conduct

Journal of Medicinal Plant (JMP) is committed to apply ethics of research, based on American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct, in psychological studies. You may find the journal’s Ethical Principles for Psychological Research, here.

 

3. Conflict of Interest

Journal of Medicinal Plant (JMP)‎ is committed to apply ICMJE recommendation on “Author Responsibilities-Conflicts of Interest” in authors’ conflict of interest issues.

Authors should disclose, at the time of submission, information on financial conflicts of interest or other interests that may influence the manuscript. Authors should declare sources of funding for the work undertaken, too. Therefore, completion and signing the ICMJE Form for Disclosure of Potential Conflicts of Interest is necessary for all authors and the articles submission won’t be accepted without filling this form. 

 

Conflicts of Interest Policy in Journal of Medicinal Plant (JMP)‎ 

(Prepared Based on ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals)

Public trust in the peer-review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from negligible to great potential for influencing judgment. Not all relationships represent true conflict of interest. On the other hand, the potential for conflict of interest can exist regardless of whether an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

All participants in Journal of Medicinal Plant (JMP)‎’s peer-review and publication process must disclose all relationships that could be viewed as potential conflicts of interest. Disclosure of such relationships is also important in connection with editorials and review articles, because it can be more difficult to detect bias in these types of publications than in reports of original research. Editors may use information disclosed in conflict-of-interest and financial interest statements as a basis for editorial decisions. The Journal editors should publish this information if they believe it is important in judging the manuscript.

 

1. Potential Conflicts of Interest Related to Individual Authors’ Commitments

When authors submit a manuscript, whether an article or a letter, they are responsible for disclosing all financial and personal relationships that might bias their work. To prevent ambiguity, authors must state explicitly whether potential conflicts do or do not exist. Authors should do so in the manuscript on a conflict-of-interest notification page that follows the title page, providing additional detail, if necessary, in a cover letter that accompanies the manuscript.

Authors should identify Individuals who provide writing or other assistance and disclose the funding source for this assistance. Investigators must disclose potential conflicts to study participants and should state in the manuscript whether they have done so. Editors also need to decide whether to publish information disclosed by authors about potential conflicts. If doubt exists, it is best to err on the side of publication.

 

2. Potential Conflicts of Interest Related to Project Support

Increasingly, individual studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias and otherwise discredit the research.

Scientists have an ethical obligation to submit creditable research results for publication. Moreover, as the persons directly responsible for their work, researchers should not enter into agreements that interfere with their access to the data and their ability to analyze them independently, and to prepare and publish manuscripts. Authors should describe the role of the study sponsor, if any, in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state. Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases. In such cases, therefore, Journal of Medicinal Plant (JMP) editors choose to include information in the Methods section about the sponsor’s involvement.

Journal of Medicinal Plant (JMP)‎ editors may request that authors of a study funded by an agency with a proprietary or financial interest in the outcome sign a statement, such as “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis.” The editors will review copies of the protocol and/or contracts associated with project-specific studies before accepting such studies for publication. The journal’s editors may choose not to consider an article if a sponsor has asserted control over the authors’ right to publish.

3. Potential Conflicts of Interest Related to Commitments of Editors, Journal Staff, or Reviewers

Journal of Medicinal Plant (JMP)‎ editors avoid selecting external peer reviewers with obvious potential conflicts of interest, for example, those who work in the same department or institution as any of the authors. Authors often provide editors with the names of persons they feel should not be asked to review a manuscript because of potential, usually professional, conflicts of interest. When possible, authors may be asked to explain or justify their concerns; that information is important to editors in deciding whether to honor such requests.

Journal of Medicinal Plant (JMP) reviewers must disclose to the journal editors any conflicts of interest that could bias their opinions of the manuscript, and they should recuse themselves from reviewing specific manuscripts if the potential for bias exists. As in the case of authors, silence on the part of reviewers concerning potential conflicts may mean either that conflicts exist and the reviewer has failed to disclose them or conflicts do not exist. Reviewers must therefore also be asked to state explicitly whether conflicts do or do not exist. Reviewers must not use knowledge of the work, before its publication, to further their own interests.

Journal of Medicinal Plant (JMP) editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues they might judge. Other members of the editorial staff, if they participate in editorial decisions, must provide editors with a current description of their financial interests (as they might relate to editorial judgments) and recuse themselves from any decisions in which a conflict of interest exists. Editorial staff must not use information gained through working with manuscripts for private gain. The journal editors should publish regular disclosure statements about potential conflicts of interests related to the commitments of journal staff.


Keywords: Journal of Medicinal Plant | Ethical Consideration | JMP | plagiarism | copyright | Conflict of Interest | APA | Code of Conduct |



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