In a previous edition of "Tips for Conducting Quality Pharmacy Resident Research," the role of the Institutional Review Board (IRB) was addressed.  Protection of human subjects is addressed under Title 45, Part 46, of the Code of Federal Regulations. 

One of the questions that investigators raise frequently is what type of review – expedited or full – will occur or if a study will be exempted from review.  The Code of Federal Regulations §46.101(b) contains information on those types of studies that are exempted from review. The Code of Federal Regulations also contains detailed information about expedited review.  A list of research categories that the Secretary of the Department of Health and Human Services has determined may be reviewed through an expedited review is also available.

Again, Dr. Byerly provides a thorough primer on this topic in his article, Working with the Institutional Review Board.

It is critical that the resident and his or her research advisor discuss the IRB review process with representatives of the institution’s IRB.  

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 I
• Data Collection, Display and Manipulation
• Grant Submissions, Part I
• Grant Submissions, Part II
• Grant Submissions, Part III 
• Research Presentations
• Submitting a Manuscript