IRB资源
的 贝尔蒙特的报告 和 联邦法规 are the two most important federal documents that Institutional Review Boards must follow.
的 two most important federal documents that Institutional Review Boards must follow are the 贝尔蒙特的报告 和 联邦法规.
In 1974, the United States Government passed the National 研究 Act, which set up the National Commission for the Protection of Human Subjects of Behavioral and Biomedical 研究 and lead to the development of the Intuitional Review Board system 和 codes of rules related to their structure and function and to some extent the general requirements of ethical concerns of informed consent, risk to benefit ratio and documentation issues. Ethicists from various research files on the commission reviewed historically relevant ethical codes and statements like the Helsinki Declaration and modern day cases of abuses like the Tuskegee Syphilis Study. 委员会的报告, named after the conference center where they met, came to be known as “贝尔蒙特报告.”
贝尔蒙特报告
这份报告 outlines three basic ethical principles that underlie the United States regulations. 这些原则是: 尊重他人, 善行 and 正义.
尊重他人 concerns protecting a person’s autonomy and treating people with respect. It provides the basis for the requirement of obtaining informed consent from research participants.
善行 requires maximizing benefits for the research project while minimizing risks to the research subjects.
正义 确保合理的, non-exploitative and well-considered procedures are administered fairly (the fair distribution of costs and benefits).
联邦法规
Federal regulations for the protection of human participants in research have been adopted by several federal agencies and have thus come to be known as the “Common Rule.” 贝尔蒙特报告 is the basis for the regulations. 的 Department of Health and Human Services (DHHS) regulations are found at 45 CFR 46.
OHRP
的 Office for Human 研究 Protections (OHRP) provides leadership in the protection of the rights, 福利, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research. This link will take you to more resources http://www.美国卫生and the公众服务部.gov/ohrp/index.html
国家卫生研究院培训
1月1日开始, 2013, applications for approval by the bet365中文大学 Institutional Review Board (IRB) require the inclusion of certificates of completion for the National Institute of Health Training. Principal and co-investigators listed on the IRB application must complete the training in human subjects protections at http://9606j.lubosh.net/services/research/research_compliance/institutional_review/training-education.html or http://phrp.nihtraining.com/users/login.php and upon completion you will be able to secure your certificate. For applications submitted by student researchers, a certificate of completion for the faculty research advisor should also be included.
Formation en éthique de la recherche (FER): Course on research ethics in French. International Development Program cohort students who speak French can take their training here. Only students meeting the said criteria are allowed to take the training in French.
教学活动2:学习
ledidactiel EPTC 2. Formation en éthique de la recherche (FER) http://www.ger.ethique.gc.ca/fra/education/tutorial-didacticiel/
视频:
的se following videos are educational and cover a variety of topics from the protection of human subjects to avoiding research misconduct. We recommend that you watch as many as you can.
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Is an interactive movie about integrity in research that can have long-term consequences. It addresses avoiding research misconduct, mentorship responsibilities, 数据处理, 负责任的作者, and questionable research practices.
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的 interactive video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct.
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的 video educates researchers on obtaining legally effective informed consent, determining capacity to consent, using legally authorized representative, and meeting the regulatory requirements for the process of informed consent.
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Additional protections for certain vulnerable subjects, 包括孕妇, 孩子们, 和囚犯
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