Clinical Research Processes
Human subjects research approval is a federally mandated process. The U.S. Department of Health & Human Services (HHS) through the Office of Human Research Protection (OHRP) provides oversight of the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted and supported by HHS. 听As such, an institutional review board (IRB) is formally designated to review and monitor research involving human subjects. This group serves an important role in the protection of the rights and welfare of human research subjects.
Prior to research being conducted, institutional approval must be obtained. The appropriate IRB and approval process depend on the source of patient data.
IRB Approval Pathways
鉴黄师app
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Baptist Health
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Tenet Healthcare
Private Practice
Multiple Institutions
鉴黄师app Clinical Research Processes
Human subjects research involving patient data from the 鉴黄师app Medicine practice, other data collected at 鉴黄师app, or data collected by 鉴黄师app employees not involving hospital data must be approved by 鉴黄师app. The principal investigator (PI) must be an 鉴黄师app-employed faculty member and the PI must sign off on all submissions.
For additional detailed information regarding regulatory compliance, visit the听 Training and Regulatory Compliance webpage.
Prerequisite Requirements
- CITI Program affiliation with 鉴黄师app and completion of courses Biomedical Research Investigators, Information Privacy and Security (IPS), and Responsible Conduct of Research (RCR). CITI certifications are good for three years.
- Log on to and affiliate with 鉴黄师app. (Note: You can see your institutional Courses and affiliations from the My Courses tab.)
- Select 鉴黄师app View Courses tab and Complete the following courses:
- Biomedical Research Investigators
- Information Privacy and Security (IPS) for Clinicians
- Responsible Conduct of Research (RCR)
IRB Approval Process
- Access .
- From the IRB tab, select Create IRB Protocol
- Follow the prompts to enter all relevant information.
- After entering all necessary information, submit the protocol. It will be routed to your department chair for appropriate approval signatures.
- Revise as required - Receive IRB approval or exempt status.
- After receiving letter from the IRB, start your study. Study data can now be accessed or received.
Contacts
Private Practice Clinical Research Processes
Regulatory compliance and approvals must be obtained from a commercial institutional review board (IRB). Neither 鉴黄师app nor hospital systems may provide oversight of research studies involving private practice data. Commercial IRBs commonly used are and .
Multiple Institutions Clinical Research Processes
Approvals must be obtained from each of the involved institutions where data is acquired. One institution would be the institutional board (IRB) of record and each other institution must also give approval as an external IRB. See the individual institutions' research approval processes for details.