欢迎来到丹佛州立大学机构审查委员会(IRB)

The Human Subject Protection Program (HSPP) provides professional support to 密歇根州立大学丹佛’s 院校覆核委员会.  IRB oversight is an essential component of human subjects protection.  The Review Board is composed of members of the 密歇根州立大学丹佛 faculty and 工作人员 and the community at-large.  Members of the IRB are tasked with protecting the rights and welfare of participants in research studies.

IRB reviews and makes determinations on proposed human subjects research that is conducted by or in collaboration with 密歇根州立大学丹佛 faculty, 工作人员, 和/或学生.  IRB follows regulatory requirements and the ethical principles of 尊重他人善行正义 in reviewing research that involves participants and/or identifiable private information.

If your research project is conducting a systematic investigation with human subjects and you hope to disseminate your findings to outside parties, 你应该事先咨询HSPP关于IRB过程.

请联系 (电子邮件保护) 如果您有任何与IRB相关的问题,皇冠官网网站都会支持您的研究!

人类受试者保护计划

The cornerstone of the Human Subject Protection Program (HSPP) efforts is the establishment of 密歇根州立大学丹佛’s 人体研究保护计划,由前总统约旦于2014年9月19日签署.

The University’s HRP Plan is a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research.  The protection of human subjects relies on ALL individuals at this University, 以及关键的个人和委员会, 履行本计划中所描述的角色和职责.  The 人类受试者保护计划 (HSPP) serves as the administrative unit of this institutional plan to ensure that it functions effectively.

资源 & 支持

皇冠官网网站来这里是为了帮助你在密歇根州立大学进行研究!!!

HSPP是密歇根州立大学丹佛分校研究人员(教师)的资源, 工作人员, 和学生调查员), for research participants or for individuals considering participation in research, 及院校覆核委员会(IRB)成员.  通过HSPP, individuals can learn about the ethical conduct of human subjects research, understand and implement regulatory requirements and standards in their studies, successfully navigate the IRB review process and requirements throughout the life of their study.

HSPP接收所有提交给IRB的申请, 分配研究供审查, 并为研究人员和IRB审稿人提供便利.

Researchers are encouraged to consult with the HSPP during the development of their IRB submission and to engage with the HSPP during the review process for any assistance needed.

请访问皇冠官网网站的研究员资料 & 资源 page for access to templates to help you complete your submission.

The HSPP also coordinates outreach activities and provides workshops to train and inform researchers on the ethical conduct of human subjects research and the IRB process.  请联系 us if you are interested in holding a workshop or training for your class or department!

经修订的通用规则

2019年1月,美国政府宣布.S. 卫生与公众服务部(HHS), 以及其他15个联邦机构, issued a final rule to update regulations that safeguard individuals who participate in research.

The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, 尤其是低风险研究. It also allows more flexibility in keeping with today’s dynamic research environment.

The final rule will now generally expect consent forms to include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in a particular study, 包括研究的目的, 风险和收益, appropriate alternative treatments that might be beneficial to the prospective subject.

The final rule also removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.

Metropolitan State University of 丹佛 has adopted these changes to the review of research involving human subjects. If you have any questions, please contact the HSPP Manager at 303-605-5282 or (电子邮件保护).

合规性- FWA & IRB登记

The HSPP works to ensure that the review and conduct of human subjects research is in compliance with regulations and standards.  这些任务包括, 实现, evaluating policies and procedures that meet the terms of our 联邦保险(FWA).  The FWA is the institution’s agreement with the federal government on the conduct and oversight of human subjects research.  皇冠官网网站的OSRP主任, Laneika Musalini, serves as the signatory authority on the FWA and oversees the Human Subject Protection Program and the administrative support of the IRB.

The HSPP actively consults and collaborates with University departments, 项目, offices to ensure that the IRB and researchers comply with institutional policies, 赞助商要求, federal regulations that govern the conduct of human subjects research.  The HSPP and the IRB take a collaborative approach with researchers to ensure that any concerns of noncompliance are appropriately addressed, that corrective actions are developed to protect current and future participants, that reporting requirements are met both within and outside of the institution.

联邦保险(FWA) & HHS IRB注册

通过FWA,一个机构向美国政府承诺.S. 卫生与公众服务部(HHS) that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46.

丹佛州立大学的FWA编号:FWA00010020   

到期:09/16/2027

每个FWA必须指定至少一个在OHRP注册的IRB.  密歇根州立大学丹佛分校的机构审查委员会在卫生与公众服务部注册.

iorg0004531   

03/01/2025到期

HHS IRB登记号:IRB00005388

院校检讨委员会 & 人类受试者保护计划

赞助研究办公室 & 程序(OSRP)

约旦学生成功大厦(JSSB)

人体受试者保护项目经理:

迈克Heathcote

(303) 605-5282

(电子邮件保护)

IRB椅子:

莫林·弗林博士.D.

(电子邮件保护)