In medical studies, the Journal of Advances in Environmental Health Research, affiliated with Kurdistan University of Medical Sciences and published by MUK Press, is dedicated to upholding research ethics in accordance with the Declaration of Helsinki: Ethical Principles for Medical Research and the ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The journal's ethical guidelines for medical research can be found here.
Protection of Human Subjects and Animals in Research
(According to ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals)
In the Journal of Advances in Environmental Health Research, authors reporting experiments on human subjects must specify whether the procedures adhered to the ethical standards set by the responsible institutional and national committees on human experimentation, as well as the Helsinki Declaration of 1975, revised in 2013. If there is uncertainty about whether the research complies with the Helsinki Declaration, authors are required to justify their approach and provide evidence that the institutional review board explicitly approved any questionable aspects of the study. For experiments involving animals, authors should state whether they followed the institutional and national guidelines for the care and use of laboratory animals.
Informed Consent in Patients and Study Participants
(According to ICMJE's Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals)
In the Journal of Advances in Environmental Health Research, patients' right to privacy must be respected and cannot be violated without informed consent. Identifiable information, such as names, initials, or hospital numbers, should not be published in descriptions, photographs, or family pedigrees unless it is crucial for scientific purposes, and the patient (or their parent/guardian) has given written informed consent for publication. This consent requires that the patient reviews the manuscript before publication if they can be identified. Authors should inform patients about the possibility that their identifiable information could be accessible online as well as in print after publication. Written consent must be archived with the journal, the authors, or both, depending on local laws or regulations.
Nonessential identifying details should be omitted, and informed consent must be obtained if there is any uncertainty about maintaining anonymity. For instance, masking the eye region in patient photographs does not offer sufficient anonymity. If identifiable features are modified, such as in genetic pedigrees, authors must confirm that these changes do not affect the scientific validity, and editors should note this. The article should indicate when informed consent has been obtained.
Declaration of Helsinki: Statement of Ethical Principles for Medical Research
Preamble
The World Medical Association (WMA) created the Declaration of Helsinki to establish ethical guidelines for medical research involving human subjects, including research involving identifiable human material and data. The Declaration should be understood as a comprehensive document, with each section considered in relation to the others.
While the Declaration is primarily directed at physicians, in line with the WMA’s mandate, the association also encourages other professionals involved in medical research on human subjects to follow these ethical principles.
General Principles
-The WMA’s Declaration of Geneva obliges physicians with the statement, “The health of my patient will be my first consideration,” while the International Code of Medical Ethics mandates that, “A physician shall act in the patient’s best interest when providing medical care.”
-Physicians are responsible for promoting and safeguarding the health, well-being, and rights of patients, including those involved in medical research. Their knowledge and conscience must be dedicated to fulfilling this responsibility.
-Medical progress is founded on research, which ultimately requires studies involving human subjects.
-The main goal of medical research involving human subjects is to enhance understanding of the causes, development, and effects of diseases, and to improve preventive, diagnostic, and therapeutic methods. Even the most well-established interventions must undergo continuous evaluation through research for safety, effectiveness, efficiency, accessibility, and quality.
-Medical research is bound by ethical standards designed to respect and protect the health and rights of human subjects.
-Although the primary goal of medical research is to generate new knowledge, this objective must never override the rights and interests of individual participants.
-Physicians involved in medical research must protect the life, health, dignity, integrity, self-determination, privacy, and confidentiality of research subjects. Responsibility for their protection rests with healthcare professionals, not the participants themselves, even when they provide consent.
-Physicians must adhere to ethical, legal, and regulatory standards for research involving human subjects in their own countries, as well as international norms. No requirement should diminish the protections provided to research participants in this Declaration.
-Medical research should be conducted in a way that minimizes environmental harm.
-Only individuals with the necessary ethical and scientific education, training, and qualifications should conduct medical research involving human subjects. Supervision by a competent, qualified physician or healthcare professional is required when research involves patients or healthy volunteers.
-Underrepresented groups in medical research should be given adequate opportunities to participate.
-Physicians combining medical care with research should involve patients only when the research is justified by potential preventive, diagnostic, or therapeutic benefits, ensuring it does not negatively impact the health of patient participants.
-Adequate compensation and treatment must be provided for research subjects harmed during their participation in research.
Risks, Burdens and Benefits
-In both medical practice and research, most interventions carry inherent risks and burdens. Medical research involving human subjects should only proceed if the significance of the study's objectives outweighs the potential risks and burdens to participants.
-Before conducting any medical research involving human subjects, a thorough evaluation of the anticipated risks and burdens to individuals and groups must be conducted, weighing them against the possible benefits to the participants and others affected by the condition under investigation. Researchers must implement strategies to minimize risks, and the risks should be consistently monitored, evaluated, and recorded throughout the study.
-Physicians should not participate in research involving human subjects unless they are assured that the risks have been adequately assessed and can be effectively managed. If the risks are found to exceed the potential benefits, or if definitive results are obtained, physicians must decide whether to continue, modify, or terminate the study immediately.
Vulnerable Groups and Individuals
-Certain groups and individuals are more vulnerable, making them more susceptible to being wronged or exposed to greater harm. These vulnerable groups and individuals require special protection tailored to their specific needs.
-Conducting medical research involving a vulnerable group is only justifiable if the research addresses the health needs or priorities of that group and cannot be conducted with a non-vulnerable group. Furthermore, the vulnerable group should benefit from the knowledge, practices, or interventions that result from the research.
Scientific Requirements and Research Protocols
-Medical research involving human subjects must adhere to widely accepted scientific principles and be grounded in a comprehensive understanding of the scientific literature and other pertinent sources of information. It should also include sufficient laboratory work and, when necessary, animal experimentation, ensuring respect for the welfare of the animals used.
-The design and execution of each research study involving human subjects must be thoroughly detailed and justified in a formal research protocol.
The protocol should include a statement addressing the ethical considerations involved and demonstrate how the principles outlined in this Declaration have been incorporated. Additionally, it should provide details about funding sources, sponsors, institutional affiliations, potential conflicts of interest, incentives for participants, and provisions for treating or compensating individuals who may be harmed as a result of their participation in the research study.
In the case of clinical trials, the protocol must also outline suitable arrangements for post-trial provisions.
Research Ethics Committees
-The research protocol must be presented to the relevant research ethics committee for evaluation, feedback, guidance, and approval before the study commences. This committee should operate transparently, maintain independence from the researcher, the sponsor, and any other external influences, and possess the necessary qualifications. It must consider the laws and regulations of the country or countries where the research will be conducted, as well as applicable international norms and standards; however, these should not compromise or diminish any protections for research subjects established in this Declaration.
The committee is entitled to oversee ongoing studies. Researchers are required to provide monitoring updates to the committee, particularly regarding any serious adverse events. Any modifications to the protocol must be reviewed and approved by the committee. Once the study concludes, researchers must submit a final report to the committee that includes a summary of the study’s findings and conclusions.
Privacy and Confidentiality
-All necessary measures should be implemented to safeguard the privacy of research participants and ensure the confidentiality of their personal information.
Informed Consent
-Individuals who are able to provide informed consent must voluntarily choose to participate as subjects in medical research. While consulting with family members or community leaders may be appropriate, no person capable of giving informed consent should be enrolled in a research study without their free agreement.
-In medical research involving individuals who can give informed consent, each potential participant must be thoroughly informed about the study's objectives, methodologies, sources of funding, any potential conflicts of interest, the researcher's institutional affiliations, the expected benefits, possible risks, and any discomfort that may arise from participation. Additionally, they should be made aware of post-study provisions and any other pertinent details. It is essential to inform potential subjects of their right to decline participation or withdraw their consent at any time without facing any negative consequences. Special consideration should be given to the unique informational needs of each potential participant and the methods used to convey this information.
Once it is confirmed that the potential participant has comprehended the provided information, the physician or another qualified individual should obtain the participant's informed consent, ideally in written form. If written consent is not feasible, the verbal consent must be formally recorded and witnessed.
Furthermore, all subjects involved in medical research should have the opportunity to receive information about the overall outcomes and results of the study.
-When obtaining informed consent for participation in a research study, physicians must exercise extra caution if the potential participant has a dependent relationship with them or may feel pressured to consent. In these cases, consent should be obtained by a qualified individual who is completely independent of that relationship.
For potential research subjects who are unable to provide informed consent, the physician must seek consent from a legally authorized representative. Such individuals should not be included in research that offers no potential benefit to them unless the research aims to enhance the health of the group they represent, cannot be conducted with individuals capable of providing consent, and involves only minimal risk and burden.
If a potential subject who cannot provide informed consent is capable of giving assent, the physician must obtain that assent in addition to consent from the legally authorized representative. The subject's dissent should always be respected.
Research involving individuals who are physically or mentally unable to give consent, such as unconscious patients, may only proceed if their condition is a necessary characteristic of the study group. In such cases, informed consent must be obtained from the legally authorized representative. If no representative is available and the research cannot be postponed, the study may go ahead without consent, provided that the specific rationale for including subjects unable to give consent is outlined in the research protocol and has been approved by a research ethics committee. Consent to continue participating must be sought as soon as possible from the subject or their representative.
The physician must clearly inform the patient about which aspects of their care are connected to the research. A patient's decision to refuse participation or withdraw from the study should never negatively impact the patient-physician relationship.
For medical research that involves identifiable human materials or data, such as samples from biobanks, physicians must obtain informed consent for their collection, storage, and/or reuse. There may be exceptional circumstances where obtaining consent is not feasible. In such cases, research may only proceed after consideration and approval by a research ethics committee.
Use of Placebo
-The advantages, risks, burdens, and efficacy of a new intervention must be compared with those of the most established interventions, unless the following conditions apply:
-Placebo or no intervention may be acceptable in situations where no proven intervention exists. Additionally, it may be necessary to use any intervention that is less effective than the best established one, a placebo, or no intervention for compelling and scientifically valid methodological reasons to assess the efficacy or safety of an intervention. However, patients receiving any intervention that is less effective than the best proven one, a placebo, or no intervention should not face increased risks of serious or irreversible harm due to the absence of the best proven intervention. Caution must be exercised to prevent misuse of this option.
Post-Trial Provisions
-Before starting a clinical trial, sponsors, researchers, and the governments of the host country should ensure that there are arrangements for post-trial access to any intervention that has been deemed beneficial for all participants who continue to need it. This information should also be communicated to participants during the informed consent process.
Research Registration and Publication and Dissemination of Results
-All research studies involving human subjects must be registered in a publicly accessible database prior to the recruitment of the first participant.
-Researchers, authors, sponsors, editors, and publishers share ethical responsibilities regarding the publication and dissemination of research results. Researchers are obligated to make the outcomes of their studies involving human subjects publicly available and are accountable for the completeness and accuracy of their reports. All parties should follow established guidelines for ethical reporting. Both negative and inconclusive results, as well as positive ones, must be published or otherwise made publicly accessible. Additionally, funding sources, institutional affiliations, and any conflicts of interest must be disclosed in the publication. Research reports that do not align with the principles outlined in this Declaration should not be accepted for publication.
Unproven Interventions in Clinical Practice
-In cases where proven treatments are unavailable or existing interventions have failed, a physician may, after consulting with experts and obtaining informed consent from the patient or their legally authorized representative, use an unproven treatment if they believe it could potentially save the patient's life, restore health, or relieve suffering. This intervention should then be subjected to research aimed at assessing its safety and effectiveness. Additionally, any new information obtained must be documented and, when appropriate, made publicly accessible.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