ethical consideration

 | Post date: 2018/04/29 | 
Ethical Guidelines for Research Publication
The increasing growth of medical knowledge is the result of constant efforts of researchers of the field in conducting various studies in order to answer the relevant questions and bridge the health problems. Therefore, consideration of ethical standards in all stages of the research from design to implementation and publication of the results of biomedical research is the main concern of all the beneficiaries, including the journal editors and researchers in different fields and disciplines of medical sciences. In this regard, many activities have been carried out at international and national levels aiming to assure increased implementation of ethical standards in publication.  Consequently, researchers are required to comply with the ethical standards in research publication, in accordance with the following criteria available on the website of the National Ethics Committee for Biomedical Research, available on: http://hbi.ir/part6/Default.aspx?hbsId=377&category=6&templateid=2&hdlId=0.In addition, in the case of specific topics, investigators are required to consider ethical standards availableon the above-mentioned website.
Ethics in Research Publication: General Guideline:
1. The main purpose of any research should be to promote human health with respect to its dignity and rights.
2. In researches conducted on human subjects, the health and safety of the individual, during and in post research period, shall be prioritized to all other affaires. Any research conducted on human subjects should be designed and implemented by individuals with necessary and relevant clinical expertise. Clinical trials on patients or healthy volunteers require to be supervised by physicians with adequate medical knowledge and expertise.
3. Research on human being is justified only if its potential benefits for each subject are greater than its risks. In research with non-therapeutic nature, the level of harm subjects are exposed to should not exceed what ordinary people face in their daily life. This should be guaranteed by research designers executives and other partners as well as all councils reviewing and monitoring the study including the Ethics Committee for Research.
4. Items such as speed, ease of work, comfort of the researcher, lower cost and/or merely its practicality shall by no means put the subject at risk or increased harm or impose any additional restrictions on his liberty.
5. Before initiating any medical research, primary measurements must be taken to minimize the probable harm to the subjects and to guaranty their health.
6. In double-blind clinical trials in which the subject is unaware of the nature of the medication or the intervention prescribed for him, the researcher should provide the necessary measurements to assist to the subject when necessary such as in emergency conditions.
7. If during a research process it is determined that the risks of participation for subjects are greater than the potential benefits, the research should be stopped immediately.
8. The design and implementation of research conducted on a human subject should be in accordance with scientific principles adopted on the basis of current knowledge acquired through complete overview of available scientific resources and previous laboratory studies, which, if necessary, include appropriate animal models. Animal studies must be carried out in full compliance with the ethical principles animal experiments.
9. In medical researches potentially harmful to the environment, the precautionary actions should be taken to preserve and not to damage the environment.
10. Any research should be based on and consistent with a proposal. In clinical trials, in addition to the proposal, protocols should be provided and presented. Such proposals and protocols must include all the essential components including ethical considerations, budget information, sponsors, organizational affiliations, potential conflicts of interests, participant incentives and anticipation treatments or compensations for individuals hurt during the research. In cases where written informed consent is required, the consent form must be drafted and attached to the proposal. The research should not begin prior to the approval of the plan by an independent committee of research ethics.
11. The ethics committee in the research, in addition to reviewing and approving the plan and the instruction, has the right to monitor the plans during and after implementation in terms of ethical considerations. The information and documents requested by the Ethics Committee for monitoring should be provided by the researchers.
12. Selection of potential subjects from the population of patients or any other population group should be fair, insofar as the distribution of burdens (risks or costs) and the benefits of participating in research, in the population and in the community as a whole, would not be discriminatory.
13. Obtaining informed consent in any research on a human subject is required. This consent should be in written form. Where it is impossible or unavoidable to obtain written informed consent, the matter must be notified to the Ethics Committee with the reasons given. If approved by the Ethics Committee, written consent will be canceled or converted into oral or implied consent.
14. If a change is made in the implementation of the research or new information is obtained that is likely to affect the decision of the subject to continue the participation in the research, the matter shall be notified to the Ethics Committee and, if agreed, the committee should inform the subject of the study, and make informed consent again.
15. The researcher must ensure that the consent is obtained consciously. To this end, in all medical research, both therapeutic and non-therapeutic, the researchers are required apprise the subject of all the information that can affect his decisions. This information includes: the title and objectives of the research, the duration of the research, the implemented method (including the possibility of random allocation to the group or witness), funding sources, and any potential conflicts of interest researcher's affiliation, and the benefits which is expected to be studied. Also, each subject should know that he / she can withdraw the study at any time and should be informed and supported about the potential risks and consequences of early research abandonment. The researcher must also care for all the concerns and questions of studied individuals with patience and accuracy. These should be reflected in the consent form.
16. The researcher should ensure that the consent is obtained freely. Behaviors that in any way entail threats, seditions, deceit or compulsion will invalidate the consent of the subject. The person should have enough time to consult with people who are willing - such as family members or family physicians. Also, in researches where a researcher has a higher organizational level than the subject, the reasons for this method of absorbing the subject must be confirmed by the ethics committee, in this case, the third party and the trustee must obtain satisfaction.
17. The senior researcher is responsible for providing sufficient information in an understandable language for the subject, and ensures understanding of the provided information, and obtaining informed consent. In cases where, for reasons such as the high number of subjects, this information is provided through someone else, it is the senior researcher who is responsible for selecting a person who is knowledgeable and appropriate for this task and to ensure that the conditions are met in this clause.
18. In researches that involve physical substances (including tissues and fluids of the human body) or data whose identities are exposed or discoverable, informed consent must be taken to collect, analyze, store and or reuse the information. In cases where it is impossible to obtain satisfaction or to discriminate the validity of the research, it is possible to use data or physical materials stored without the consent of the informed body upon examination and approval of the ethics committee.
19. A refusal to participate in the research or not to continue the participation must not have any effect on the treatment provided for the person who is under treatment in the same institute, such as hospital. This subject should be informed in the process of obtaining informed consent.
20. In cases where informing the subject about a part of the research reduces the validity of the research, the need for inadequate information from the researcher should be confirmed by the Ethics Committee. After eliminating the cause of this limitation, full information should be provided to the subject.
21. Some individuals or groups of people, such as mentally disabled, children, fetuses and newborns, emergency patients, or prisoners who may be participating as a subject in the study, who cannot be provided with necessary information, or freedom are considered vulnerable and should be subject to special protection.
22. No vulnerable groups should ever be used (for reasons such as ease of access) as preferred subjects. Medical research using vulnerable groups or communities is justified only if it is designed and implemented to meet the health needs and priorities of the same group or community and there is a reasonable likelihood that the same group or community will benefit from the results of that research.
23. In research on vulnerable groups, the task of obtaining informed consent must not be overlooked. If there are legal guardians, the researcher is obliged to obtain informed consent, in addition to obtaining informed consent from the subject, according to his or her capacity. In any case, the refusal of these people in participating in the research should be respected.
24. If during the research, the subject who has the ability to lose his ability, or the subject lacking ability, gain the ability, according to the change, informed consent should be obtained from the legal guardian or the person himself for the continuation of the research.
25. The researcher is responsible for confidentiality and protecting the subjects and taking appropriate actions to prevent its revelation. Also, the researcher is required to ensure that the subjects' privacy is respected throughout the research. Any revealing of information obtained from patients should be based on informed consent.
26. Any kind of injury or damage caused by the participation in the research should be compensated in accordance with the approved laws. This should be considered when designing the research. The way this is done is preferably an unconditional insurance coverage.
27. At the end of the research, any person who entered the study as a subject has the right to be informed about the results of the study and to benefit from the interventions or practices shown to be beneficial in that study.
28. Researchers are required to publish the results of their research honestly, accurately, and completely. The results, whether negative or positive, as well as sources of funding, organizational affiliation, and conflict of interests - if any - should be fully disclosed. Researchers should not accept any condition for the removal or non-publication of findings that are unsuitable for research support when concluding a research contract.
29. The method of reporting the results of the research should be the guarantor of the material and spiritual rights of all persons related to the research, including the researcher or researchers, subjects and research support institutes.
30. Reports and articles exploited from a research that violates the provisions of these guidelines should not be accepted for publication.
31. The research methodology should not contradict the social, cultural and religious values ​​of the society.

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