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:: Ethics ::
 | Post date: 2017/03/11 | 

31 codes of research ethics

1. The main objective of the research must be the improvement of human health with respect for their dignity and rights.

 

2. In research on human subjects, individual subjects' health and safety during and after the study has priority over all other materials. Any research on human subjects should be designed and implemented by people who have the relevant expertise and the necessary clinical skills. In clinical trials on patients or healthy volunteers the supervision of a physician with appropriate medical skills and knowledge is required.

 

3. Research on humans is justified only if the potential benefits to individual subjects are greater than its risks. In non-clinical studies, the level of damage to subjects must be no more than what the ordinary people encounter in their daily lives. Ensuring this issue is responsibility of designers, implementers and research collaborations, and all councils or research supervisors, including research ethics committee.

 

4. Speed, convenience, comfort of researcher, lower cost and / or practicality in any way should not expose studied subjects at higher risk or loss or should not impose any restrictions of additional powers to him/her.

 

5. Before beginning any medical research, basic measures should be taken to minimize potential losses incurred by participants and ensuring their health should be carried out.

 

6. In double-blind clinical trials that the subjects are unaware of the nature of the prescribed drug or intervention, the researcher must take the necessary steps to help subjects if necessary to summon emergency.

 

7. If during the study it was determined that the risks to the subjects participating in this study is more than potential benefits, it must immediately be stopped.

 

8. Design and implementation of studies are conducted on human subjects must conform to generally accepted scientific principles based on knowledge and based on a thorough review of existing literature and previous research laboratory, and if necessary, animal should be appropriate. Animal studies must be according to ethical principles of work with laboratory animals.

9. In medical researches that may harm the environment, precautions need to maintain the environment.

 

10. Any research must be based on and consistent with a proposal. In clinical trials in addition to a plan, instructions (protocol) are prepared and presented. Proposal and instructions should include all necessary components including the ethical considerations, information regarding funding, sponsors, institutional affiliations, other potential cases of conflict of interest, participants incentives, provision of or compensation for the affected people in the study as written informed consent be obtained in cases where it is necessary , a consent form must be developed and attached to proposal. Before ratification or approval of proposal by the Independent Committee for Ethics in Research the study should not be initiated.

 

11. The research ethics committee in addition to review and approval of proposal and instructions has the right to monitor the projects during and after implementation for terms of moral considerations. Information and documents that are required for monitoring of research ethics committee must be provided by the researchers.

 

12. Selection of potential participants from among the patient population or any other population group should be fair, so that distribution of risks or costs and benefits of participating in research study should not be discriminatory among the population and the entire community.

13. Freely written consent in any research on human subjects is required. This consent must be in writing. In the event that written informed consent is impossible or negligible, reasons must be transferred to the Ethics Committee. In the event of ethics committee approval, consent documents will be postponed or converted into verbal consent or implied.

 

14. If the study changed or new information obtained during the execution of research, likely affecting the decision of participants to continue participating in the study, this should be reported to the ethics committee and in case of approval to continue the study, subjects must be aware and informed consent should be reallocated.

 

15. The researcher must ensure informed consent is derived. To this end, in all medical research, including therapeutic and non-therapeutic studies, the researcher is bound to notify adequately the person considered as subject from all the information that can be helpful in his decision. This information includes: title and purpose of the study, duration of study, a method that is supposed to be used (including the probability assigned to treatment or control groups), sources of funding, and any possible conflicts of interest, institutional affiliations of the researcher, and the expected benefits and losses of the study. Also, each participant must know that he can at any time be excluded from your study and must be aware and supported about the risks and potential losses arising from the premature withdrawal of research. The researcher also should be responsible of all the questions and concerns of the people, patient. The aforementioned points should be reflected in informed consent.

 

16. The researcher must ensure free consent had been obtained. All behaviors that in any way involves threats, seduction, deception or coercion lead to revocation of the consent of the subjects. The subjects must have enough time for consultation with people who want such as family members or family doctor. Also, in studies in which organizational position of researcher is higher than subjects, the reasons for this way to attract participants must be approved by the ethics committee, in these cases, third person and trustees must get consent.

 

17. Senior researcher is directly responsible for providing sufficient information in a language understandable to subjects, ensuring understand the information provided, and obtaining informed consent. In cases where for some reason, such as the large number of participants, this information is done through someone else, senior researcher is responsible to choice an informed and proper person and ensure the conditions are provided as mentioned in this paragraph.

 

 

18. In studies of physical materials (including tissues and body fluids) or data that identity of their owners is detectable, for the collection, analysis, storage and / or reuse, informed consent must be taken. In cases where consent is impossible or compromise the validity of research, may be possible the use of the body stored data or materials without obtaining informed consent after reviewing and approval of the Ethics Committee.

 

19. Refuse to participate in research or discontinue in cooperation should not affect any health care at the same institution such as hospitals. The participants must be notified in the process of obtaining informed consent.

 

20. In cases where informing the participants about the research decreases the credibility of study, incomplete information from the researcher must be approved by the ethics committee. After the removal of this restriction, should the subjects be fully informed.

 

21. Some individuals or groups of people, such as mental disability, children, babies, emergency patients, or prisoners may participate as subjects in research, informed consent, knowledge or freedom is not necessary. These individuals or groups are vulnerable and need special protection.

 

22. of vulnerable groups should never (for reasons such as ease of access) be used as favorite subjects. Medical research using vulnerable groups or communities is justified only if be designed and implemented aiming to meet the health needs and priorities of the group or community and there is a reasonable probability that the same group or community will benefit from the results of that research.

 

23. The task of obtaining informed consent must not to be neglected in research on vulnerable groups. For people who have a legal guardian, the researcher is required in addition to the informed consent of the legal guardian, according to their individual capacity, obtain informed consent. However, they must be respected if refuse to participate in research.

 

24. If during the study, participants have the capacity, lose their capacity or individuals without the capacity acquire the capacity, according to obtained changes, researcher should take informed consent from legal guardian or person to continue the research.

 

25. The researcher is responsible for observing the principle of confidentiality and privacy of subjects and to take appropriate measures to prevent its publication. Also, the researcher has a duty to ensure the privacy of subjects during the study. Publishing any data or information obtained from the patients should be based on informed consent.

26. Any injury or damage resulting from participation in research must be in accordance with the laws passed by compensation. This should be considered when designing research. This is unconditional implementation, preferably in the form of insurance coverage.

 

27. At the end of the study, each individual who is enrolled as a participant in it has the right to be informed about the results of the study and the interventions or benefit shown in the study.

 

28. Researchers are required to publish their research results as honestly, accurately and completely. The results, whether positive or negative, as well as sources of funding, institutional affiliations and conflicts of interest - if any - should be quite revealing. Researchers should not accept any condition to remove or not to publish findings that was not favorite of research supporter.

 

29. How to report research results must guarantee the rights of all persons associated with the study, including researchers, subjects and the institution sponsoring the study.

 

30. Reports and articles resulting from research that violated the provisions of this directive, should not be accepted for publication.

 

31. The study should not be in conflict with social values, cultural and religious communities.

 

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مجله علمی دانشگاه علوم پزشکی بابل Journal of Babol University of Medical Sciences
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