Ethical Codes: Medical Research

 

In medical studies, the Arab Journal of Forensic Sciences & Forensic Medicine (AJFSFM) is an open access (CC BY-NC), peer-reviewed and free of charge journal, published by Naif Arab University for Security Sciences (NAUSS). It is committed to apply research ethics, 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. 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 the Arab Journal of Forensic Sciences & Forensic Medicine (AJFSFM), when reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the committee responsible for human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). 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 the Arab Journal of Forensic Sciences & Forensic Medicine (AJFSFM), patients have a right to privacy that should not be breached without informed consent. Personal identification information, including names, initials, or hospital numbers, as well as photographs, or pedigrees should not be published in written descriptions, unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for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 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 over whether anonymity can be maintained. For example, masking the eyes of patients in photographs is an 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.