Institutional Review Board (IRB) review and approval is imperative to the ethical conduct of research, to the protection of human subjects and to assure compliance with federal regulations governing research. In the early stages of project planning, the investigators should incorporate IRB processes into the research timeline. This provides a good opportunity for residents and other new investigators to become acquainted with the IRB’s procedures and review requirements. The ASHP Foundation requires evidence of IRB approval before it funds research projects and a large number of scientific journals require similar evidence prior to publication. 

To listen to a review of the history of IRBs and their role in overseeing research by Wesley G. Byerly, Pharm.D., visit the ASHP 39th Midyear Clinical Meeting Synchronized Presentations and select "Quality Practice Research, Part 2." 

Dr. Byerly also provides an in-depth primer on this topic in his article, Working with the Institutional Review Board.

Access to information on federal regulations regarding IRBs can be helpful as the resident is organizing their research.  The resident should give serious consideration to attending an institutional program on conducting human subjects research. 

Also see:

• Establishing Timelines
• Evaluating the Existing Evidence
• Developing the Research Question, Part I
• Developing the Reseach Question, Part II
• Efficacy vs. Effectiveness
• Writing Specific Aims
• Hypothesis Statements
• Data Sources
• Study Design
• Survey Research
• Gaining Institutional Support
• Biostatistics
• Human Subjects Protections, Part II
• Data Collection, Display and Manipulation
• Grant Submissions, Part I
• Grant Submissions, Part II
• Grant Submissions, Part III 
• Research Presentations
• Submitting a Manuscript