的 resources below will help you design your study and develop an IRB application 在博彩网址大全.
To view a portal of already approved 博彩网址大全 IRB Applications organized by type of research, 查看示例协议Google站点(需要登录). 对于临床研究人员来说， we’ve provided links to helpful NIH protocol design tools and templates.
研究ers who need to access PHI, other than from their own patients for the purpose of designing a research study, determining feasibility for a research study or identifying potential research subjects, must get prior permission via the 准备研究评审申请. Submission of this form helps researchers and 博彩网址大全 be compliant with HIPAA regulations.
有关临床试验可行性支持，请联系 clinical-trial-office@health.luyifamily.com.
To ensure an efficient review by the 院校检讨委员会, a full description 计划中的研究必须提交初步审查. 这个信息是 captured in the IRB application, includes background information of the problem under study, including the study rationale; study objectives/hypotheses; study design, sample size, methods of analysis; detailed study and data collection procedures; inclusion/exclusion criteria and recruitment procedures; the consent process and forms; methods of analysis; anticipated risks, benefits, alternatives; and supplemental study materials (e.g., 广告和学习工具).
的 IRB uses the regulatory criteria for approval to determine whether a proposed study can be approved, researchers should take these criteria into consideration 在设计研究时. For example, you should consider whether the choice of population results in an equitable distribution of the burdens and benefits of research (45 CFR 46.111(a)(3); 21 CFR 56.111(a)(3)), you’ll be asked to provide justification when recruiting vulnerable populations such as prisoners, pregnant women, minors. 的 IRB application will also ask for consent process details to ensure that unless waived, informed consent will be sought and appropriately documented from each prospective subject/LAR (美国联邦法典第45章第46条).111(a)(4-5); 21 CFR 56.111(a)(4-5)).
的 IRB application will also ask about potential risks, benefits and alternatives 确保符合标准批准. 应通过使用程序将风险降到最低 that are consistent with sound research design and that do not expose participants to unnecessary risks, whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes (美国联邦法典第45章第46条.111(a)(1); 21 CFR 56.111(a)(1)), risks should be reasonable in relation to anticipated benefits (美国联邦法典第45章第46条.111(a)(2); 21 CFR 56.111(a)(2)). 适当的时候，研究计划应该 have adequate provisions to protect the privacy of subjects and to maintain the confidentiality (美国联邦法规45 CFR 46).111(a)(7); 21 CFR 56.第111(a)(7)条)，并应作出适当规定 for monitoring data collected to ensure the safety of subjects (美国联邦法典第45章第46条.111(a)(6); 21 CFR 56.111(a)(6)).
首席研究员
- All studies submitted to the IRB must identify a principal investigator (PI), who 谁对这项研究负有最终责任. 私家侦探应该是博彩网址大全的附属机构 unless an exception was granted, only one PI can be listed on the 博彩网址大全 application.
- 的 PI is responsible for obtaining IRB and other necessary institutional approvals prior to beginning their research, holds the ultimate responsibility for the conduct 研究的一部分.
- 的 PI can delegate study responsibilities to other study personnel, but must assure that all personnel under his or her supervision have appropriate training and credentials to perform duties, are adequately mentored and supervised throughout the course 研究的一部分.
研究小组/研究人员
- 的 research team listed on the IRB application should include individuals who are directly involved in the performance of interventions or interactions required by the protocol, including obtaining consent,/or the collection of research data (for investigational drug studies, this would be similar to those listed on the Form 食品及药物管理局1572). Investigators can include physicians, scientists, nurses, administrative 员工、老师和学生等等.
- For biomedical studies, nurses or residents who provide intermittent care but who do not make a direct and significant contribution to the research do not need to be 在IRB申请中单独列出. 这将包括技术人员的表演 standard clinical procedures that may be part 研究的一部分 protocol, or even persons administering investigational agents that they are accustomed or trained to administer, 但在研究中没有任何作用. 因为这可能很难 prospectively identify these types of individuals, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical 研究记录，而不是在IRB申请中列出.
的 following guidelines are in place to help you design studies in ways that best 保护潜在的弱势参与者. 如果你的研究涉及以下情况之一 populations, please consult the guidelines and incorporate protective strategies where 可能的.