IJBMPH’s Principles of Publishing & Research Ethics
International Journal of Biomedicine and Public Health (IJBMPH) is committed to apply ethics of publication, based on the COPE’s Code of Conduct and Best Practices. Also, in medical studies, IJBMPH 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. IJBMPH’s Principles of Publishing Ethics
International Journal of Biomedicine and Public Health (IJBMPH) as a member of Negah Journals, co-published by Negah Institute for Scientific Communication, is committed to apply ethics of publication, based on the COPE’s Code of Conduct and Best Practices. You may find the journal’s code of publication ethics, here.
Introduction:
International Journal of Biomedicine and Public Health (IJBMPH) aims to be a main channel of data communication, sharing of ideas and information to the scientific researching community. It is mandatory for us to follow certain code of ethics and it is advices to adhere strictly to the following code of ethics, which will enhance the quality of the published works heavily. This currently written code of ethics is focusing to provide guidance on the proper behavior of editors, authors and reviewers in the process of scientific publication.
Authors and Co-authors
Authors
International Journal of Biomedicine and Public Health is committed to follow and apply “International Standards for Authors” of Committee on Publication Ethics in designing and leading the Journal’s reviewing and publishing process and dealing with their issues. You may find the International Standards for Authors, here. Authors should read the standard and apply it on their works, completely.
Authors submitting a paper confirm that the understanding that the manuscript have been read and approved by all authors and that all authors agree to the submission of the manuscript to the Journal. International Journal of Biomedicine and Public Healthadheres to the International Committee of Medical Journal Editors (ICMJE) recommends that authorship be based on the following 4 criteria:
It is a requirement that all authors have been accredited as appropriate upon submission of the manuscript. Contributors who do not qualify as authors should be mentioned under Acknowledgements.
In addition, authors are advised to follow the following code of ethics strictly Submit manuscripts, which are their originals works or of the work, they are associated with during their tenure.
Submitted manuscripts should contain original and new results, data, and their ideas, which are not submitted for publishing to other publications or published elsewhere. Fabrication of data and results, intellectual property theft and plagiarism are highly unacceptable, it is beyond the ethics of an author. Information obtained via various media should be provided in the manuscript only with prior permission from the owner of the source of information or data.
They should properly cite the work they are referring; authors are advised to crosscheck the reference before submission of manuscript.
They may not promote in any form via any media to get their works published. No article should have an author who is not directly involved in the work for any means or reasons.
Authors and co-authors are requested to review and ensure the accuracy and validity of all the results prior to submission. Any potential conflict of interest should be informed to the editor in advance. Authors are bound by the Creative Commons licensing policy of publication.
All authors are requested to submit the copyright transfer form without failure once they receive the acceptance of their article for publication.
Editors
International Journal of Biomedicine and Public Healthis committed to follow and apply “International Standards for Editors” of Committee on Publication Ethics in designing and leading the Journal’s reviewing and publishing process and dealing with their issues. You may find the International Standards for Editors, here. The journal's editors should read the standard and apply it in their editorial tasks and procedures, completely.
The term editor is a common terminology used to refer Chief Editor of any journal, Content editor, Section Editor (An expert who is the manager of reviewing process in a subject centered section), and Editorial board members. Editors of the IJBMPH are insisted to have full responsibility for editorial and technical decisions of the journal. Any editor or office bearer should not intervene or give comment on any editorial decisions taken on any manuscript by the concerned editor. Editors are requested to give unbiased considerations for the articles submitted. IJBMPH aims for rapid publication, editors are advised to process the manuscripts promptly and diligently.
Editors are the sole responsible persons for the acceptance or rejection of a manuscript, it may be subjected to peer review but the final decision is bound to the concerned editor.
Any decision taken or matter of concern about a submitted article should not be revealed to anyone by an editor. If one of the editor is willing to publish an article the article should be processed by another editor.
Editor should refrain from using the information, data, theories, or interpretations of any submitted manuscript in her/his own work until that manuscript is in press.
Reviewers
Reviewers are the main members contributing for the benefit of the journal being a peer reviewed (double-blind review) journal they are insisted not to disclose their identity in any form.
A reviewer should immediately decline to review an article submitted if he/she feels that the article is technically unqualified or if the timely review cannot be done by him/her or if the article has a conflict of interest.
All submissions should be treated as confidential, editorial approval might be given for any outside person’s advice received.
No reviewer should pass on the article submitted to him/her for review to another reviewer in his own concern, it should be declined immediately.
Reviewers being the base of the whole quality process should ensure that the articles published should be of high quality and original work. He may inform the editor if he finds the article submitted to him for review is under consideration in any other publication to his/her knowledge.
There are no hard and fast rules to analysis an article, this can be done on case-to-case basis considering the worthiness, quality, and originality of the article submitted.
In general, cases the following may be checked in a review
· Structure of the article submitted and its relevance to author guidelines
· Purpose and Objective of the article
· Method of using transitions in the article
· Introduction given and the conclusion/ suggestions provided
· References provided to substantiate the content
· Grammar, punctuation and spelling · Plagiarism issues
· Suitability of the article to the need
A reviewer’s comment decides the acceptance or rejection of an article and they are one major element in a peer review process. All our reviewers are requested to go through the articles submitted to them for review in detail and give the review comments without any bias, which will increase the quality of our journals.
Breach of Code
Being an association dedicated for the researcher fraternity, we all should ensure that the code of ethics formed is followed in all possible ways. Being a not-for-profit body it is the internal responsibility of a person whom should have to follow the codes, there is no enforcement to follow.
IJBMPH committee members are entitled to take action against an individual if they found to be violating the code.
COPE’s Guidelines & Flowcharts
International Journal of Biomedicine and Public Health is committed to follow and apply guidelines and flowcharts of Committee on Publication Ethics in its reviewing and publishing process and issues. For more information, please click here.
COPE’s Code of Conduct and Best Practices
1. Editors
Chief Editors is accountable for everything published in the journal. This means the editors
1.1 strive to meet the needs of readers and authors;
1.2 strive to constantly improve their journal;
1.3 have processes in place to assure the quality of the material they publish;
1.4 champion freedom of expression;
1.5 maintain the integrity of the academic record;
1.6 preclude business needs from compromising intellectual and ethical standards;
1.7 always be willing to publish corrections, clarifications, retractions and apologies when needed.
Best Practice for Editors would include
2. Readers
2.1 Readers should be informed about who has funded research or other scholarly work and whether the funders had any role in the research and its publication and, if so, what this was.
Best practice for editors would include:
3. informing readers about steps taken to ensure that submissions from members of the journal’s staff or editorial board receive an objective and unbiased evaluation
4. Relations with authors
4.1 Editors’ decisions to accept or reject a paper for publication should be based on the paper’s importance, originality and clarity, and the study’s validity and its relevance to the remit of the journal.
4.2 Editors should not reverse decisions to accept submissions unless serious problems are identified with the submission.
4.3 New editors should not overturn decisions to publish submissions made by the previous editor unless serious problems are identified.
4.4 A description of peer review processes should be published, and editors should be ready to justify any important deviation from the described processes.
4.5 Journals should have a declared mechanism for authors to appeal against editorial decisions.
4.6 Editors should publish guidance to authors on everything that is expected of them. This guidance should be regularly updated and should refer or link to this code.
4.7 Editors should provide guidance about criteria for authorship and/or who should be listed as a contributor following the standards within the relevant field.
Best practice for editors would include:
5. Relations with reviewers
5.1 Editors should provide guidance to reviewers on everything that is expected of them including the need to handle submitted material in confidence. This guidance should be regularly updated and should refer or link to this code.
5.2 Editors should require reviewers to disclose any potential competing interests before agreeing to review a submission.
5.3 Editors should have systems to ensure that peer reviewers’ identities are protected unless they use an open review system that is declared to authors and reviewers.
Best practice for editors would include:
6. Relations with editorial board members
6.1 Editors should provide new editorial board members with guidelines on everything that is expected of them and should keep existing members updated on new policies and developments.
Best practice for editors would include:
7. Relations with Negah Publisher
7.1 The relationship of editors to Negah Publisher and the owner is based firmly on the principle of editorial independence.
7.2 Editors should make decisions on which articles to publish based on quality and suitability for the journal and without interference from Negah Publisher.
7.3 Editors have a written contract(s) setting out their relationship with Negah Publisher.
7.4 The terms of this contract is in line with the COPE Code of Conduct for Journal Editors.
Best practice for editors would include:
8. Editorial and peer review processes
8.1 Editors should strive to ensure that peer review at their journal is fair, unbiased and timely.
8.2 Editors should have systems to ensure that material submitted to their journal remains confidential while under review.
Best practice for editors would include:
9. Quality assurance
9.1 Editors should take all reasonable steps to ensure the quality of the material they publish, recognizing that journals and sections within journals will have different aims and standards.
Best practice for editors would include:
10. Protecting individual data
10.1 Editors must obey laws on confidentiality in their own jurisdiction. Regardless of local statutes, however, they should always protect the confidentiality of individual information obtained in the course of research or professional interactions. It is therefore almost always necessary to obtain written informed consent for publication from people who might recognize themselves or be identified by others (e.g. from case reports or photographs). It may be possible to publish individual information without explicit consent if public interest considerations outweigh possible harms, it is impossible to obtain consent and a reasonable individual would be unlikely to object to publication.
Best practice for editors would include:
Note that consent to take part in research or undergo treatment is not the same as consent to publish personal details, images or quotations.
11. Encouraging ethical research (e.g. research involving humans or animals)
11.1 Editors should endeavor to ensure that research they publish was carried out according to the relevant internationally Declaration of Helsinki for clinical research, and the AERA and BERA guidelines for educational research.
11.2 Editors should seek assurances that all research has been approved by an appropriate body (e.g. research ethics committee, institutional review board) where one exists. However, editors should recognize that such approval does not guarantee that the research is ethical.
Best practice for editors would include:
12. Dealing with possible misconduct
12.1 Editors have a duty to act if they suspect misconduct or if an allegation of misconduct is brought to them. This duty extends to both published and unpublished papers.
12.2 Editors should not simply reject papers that raise concerns about possible misconduct. They are ethically obliged to pursue alleged cases.
12.3 Editors should follow the COPE flowcharts where applicable.
12.4 Editors should first seek a response from those suspected of misconduct. If they are not satisfied with the response, they should ask the relevant employers, or institution, or some appropriate body (perhaps a regulatory body or national research integrity organization) to investigate.
12.5 Editors should make all reasonable efforts to ensure that a proper investigation into alleged misconduct is conducted; if this does not happen, editors should make all reasonable attempts to persist in obtaining a resolution to the problem. This is an onerous but important duty.
13. Ensuring the integrity of the academic record
13.1 Errors, inaccurate or misleading statements must be corrected promptly and with due prominence.
13.2 Editors should follow the COPE guidelines on retractions.
Best practice for editors would include:
14. Intellectual property
14.1 Editors should be alert to intellectual property issues and work with Negah Publisher to handle potential breaches of intellectual property laws and conventions.
Best practice for editors would include:
15. Encouraging debate
15.1 Editors should encourage and be willing to consider cogent criticisms of work published in their journal.
15.2 Authors of criticized material should be given the opportunity to respond.
15.3 Studies reporting negative results should not be excluded.
Best practice for editors would include:
16. Complaints
16.1 Editors should respond promptly to complaints and should ensure there is a way for dissatisfied complainants to take complaints further. This mechanism should be made clear in the journal and should include information on how to refer unresolved matters to COPE.
16.2 Editors should follow the procedure set out in the COPE flowchart on complaints.
17. Commercial considerations
17.1 Journals should have policies and systems in place to ensure that commercial considerations do not affect editorial decisions (e.g. advertising departments should operate independently from editorial departments).
17.2 Editors should have declared policies on advertising in relation to the content of the journal and on processes for publishing sponsored supplements.
17.3 Reprints should be published as they appear in the journal unless a correction needs to be included in which case it should be clearly identified.
Best practice for editors would include:
18. Conflicts of interest
18.1 Editors should use IJJME form and procedure for managing the conflicts of interest issues.
18.2 Journals should have a declared process for handling submissions from the editors, employees or members of the editorial board to ensure unbiased review.
2. Plagiarism
International Journal of BioMedicine and Public Health (IJBMPH) as a member of Negah Journals, has accepted all terms and conditions of Committee on Publication Ethics (COPE) on plagiarism. So, in any case of plagiarism, which is brought to the journal’s editors attention and accompanied with convincing evidence, we act based on flowcharts and workflows determined in COPE. Meanwhile, to detect and prevent plagiarism in the journal articles, all submissions will be checked with iThenticate and Samim Noor in both stages of submission and acceptance.
3. Conflict of Interest
International Journal of Biomedicine and Public Health(IJBMPH) as a member of Negah Journals, published by Negah Institute for Scientific Communication, 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. So, 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 International Journal of Biomedicine and Public Health
(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 relation- ships 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 IJBMPH’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 credit- able 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, IJBMPH editors choose to include information in the Methods section about the sponsor’s involvement.
IJBMPH 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
IJBMPH 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.
IJBMPH 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.
IJBMPH 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.
4. IJBMPH' Ethical Codes: Medical Research
In medical studies, International Journal of Biomedicine and Public Health(IJBMPH) as a member of Negah Journals, published by Negah Institute for Scientific Communication, is committed to apply ethics of research, based on Declaration of Helsinki: Statement of Ethical Principles for Medical Research. You may find the journal’s Ethical Principles for Medical Research, here.
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