第十章-研究
Previous Publication Date: June 15, 1998
Publication Date: May 5, 2022
Policy Reviewed Date: June 6, 2024
Policy Owner: VP for Research
10.10人类研究
I. POLICY STATEMENT
德克萨斯大学圣安东尼奥分校 (UTSA) is committed to protecting the rights and welfare of Human Subjects in Research by adopting ethical principles and ensuring compliance with applicable federal and state laws and university regulations.
二世。 基本原理
Ethical principles for the use of Human Subjects in Research are embodied in federal regulations and administered by the United States Department of Health and Human Service’s Office of Human Research Protections. Research conducted on behalf of UTSA must comply with the applicable federal and state laws and regulations and any additional protections imposed by oversight and/or sponsoring agencies. This policy also requires compliance with UTSA’s Federalwide Assurance (FWA 00003861) for any Human Subjects Research.
三世。 范围
这项政策适用于所有UTSA员工和学生，访问研究人员，调查员和个人谁进行人类受试者研究。 它适用于研究活动，无论研究发生在哪里。
IV. WEBSITE ADDRESS FOR THIS POLICY
V. RELATED STATUTES, POLICIES, REQUIREMENTS OR STANDARDS
- 卫生与公众服务部 人体受试者的保护 45联邦法规第46部分
- 卫生与公众服务部 促进研究的客观性 42 CFR第50部分F子部分
- 美国食品药品监督管理局， 人体受试者的保护 21 CFR第50部分
- 美国食品药品监督管理局， 院校检讨委员会 21 CFR 56
- Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 贝尔蒙特报告。
- UTSA人类研究保护计划 政策及指引
- UTSA操作程序手册（跳） Policy 10.04, Conflicts of Interest in Research & Intellectual Property
VI. CONTACTS
If you have any questions about research with human subjects, contact the following office(s):
的 Office of Research Integrity
IRB@utsa.edu
七世。 定义
- 人类被试:
- 的 Department of Health and Human Services (DHHS) defines a Human Subject as a living individual about whom an 调查员 (whether an employee, student, or affiliated individual) conducting 研究:
1.1 obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
1.2 obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. - 的 Food and Drug Administration (FDA) defines a Human Subject as:
2.1 an individual who is or becomes a participant in Research, either as a recipient of a test article (investigational drug, biologic, or device) or as a control and may be either a healthy human or a patient;
2.2 an individual on whose specimen a device is used; or
2.3 unidentified tissue specimens when medical device Research involves in vitro diagnostics.
- 的 Department of Health and Human Services (DHHS) defines a Human Subject as a living individual about whom an 调查员 (whether an employee, student, or affiliated individual) conducting 研究:
- 调查员:
- An individual performing various tasks related to the conduct of Human Subject Research activities such as:
1.1 Obtaining information about living individuals by intervening or interacting with them for Research purposes.
1.2 Obtaining identifiable private information about living individuals or biospecimens for Research purposes.
1.3 Obtaining voluntary informed consent of individuals to be Subjects in Research.
1.4 Studying, interpreting, or analyzing identifiable private information, data, or biospecimens for Research purposes.
- An individual performing various tasks related to the conduct of Human Subject Research activities such as:
- 研究:
- DHHS defines Research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This is the default definition for UTSA activities unless the FDA definition applies as described in item 2.
- FDA defines Research as an activity that involves a drug or device, other than use of a marketed drug in the course of medical practice, or the use of a device to evaluate safety and effectiveness of that device, and data from the activity will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product.
- See additional definitions listed in the Institutional Review Board (IRB) office policy, 合- 001:定义.
八世。 责任
- 机构官员
- 任命和移除内部审查委员会成员、主席和副主席。
- 确定UTSA将依赖的IRBs。
- 不批准、暂停或终止人体研究。
- 限制或限制进行人类研究的特权。
- 监督人类研究项目。
- 院校覆核委员会
- 制定和实施程序，以确保UTSA遵守联邦，州和机构法规，以保障参与研究的人类受试者的福利和福祉。
- 每年审查和批准所有人类受试者研究提案。
- 审核和批准对已批准协议的修改建议。
- 对调查人员、员工、学生和附属研究人员进行有关人类受试者研究的教育，并促进此类活动的最佳道德行为实践。
- 决定与研究相关的经济利益和管理层是否允许批准人体研究。
- 暂停或终止对发现不合规或与人类受试者意外严重伤害相关的人类研究的批准。
- 调查员
- 在进行人体受试者研究之前获得所有必要的批准。
- 配合每年的协议审查。
- 向内部审核委员会提交任何对已批准协议的修改建议。
- 如果任何人类受试者受到伤害（身体上或心理上），通知IRB。
- 通知IRB和研究诚信办公室任何不当披露私人信息、经济损失、财产损失或损害或其他有害或潜在有害的事件。
- See further responsibilities described in the IRB office policies posted to the 税务局办公室网站, including:
第九。 程序
- 的 involvement of Human Subjects in Research will be permitted to begin only after the IRB has approved the Research protocol, the informed consent document, the testing instruments, and other requirements of the IRB.
- Standard Operating Procedures for the Human Research Protection Program are posted to the 税务局办公室网站. 的se procedures describe requirements for researchers, IRB members, and designated staff responsible for supporting the Human Research Protection Program. Changes to Standard Operating Procedures that affect Human Subjects 调查员s will be developed in consultation with the UTSA faculty senate research subcommittee and IRB members.
十、实施的特殊说明
没有一个
XI. 表单和工具/在线流程
Forms, checklists, and guidance for new and continuing research are found on IRB办公室网站. To submit a new IRB application or a modification to a previously approved study, visit the online submission system, 小马 IRB.
十二。 附录
没有一个