If you’ve ever struggled with deciding whether your project qualifies as human subjects research, you’re not alone. Compliance veterans Kim Dicciani (PHRP Online Training Board Member) and Christine Wallace break down the definitions, edge cases, and institutional policies that shape IRB determinations—and share practical guidance every researcher can use. 

Show Notes: 

Kim Dicciani and Christine Wallace break down key definitions, intent, and misconceptions on IRB review and non-human subjects determinations. Their key points include the following:

• Understanding Intent is Critical: The intent behind your research—whether to contribute to generalizable knowledge or for internal use only—is a primary factor in determining if IRB oversight is required. 
• Definitions Matter: A project qualifies as human subjects research if it involves a systematic investigation and either interaction/intervention with individuals or access to identifiable private data. 
• Anonymous does not equal De-identified: Anonymous data cannot be traced back to individuals, while de-identified data can be linked if a key exists. Misunderstanding this distinction often leads to incorrect IRB submissions. 
• Check User Agreements and Public Access: When using online tools such as applications, chat rooms accessed by logins may require IRB review and approval. Be sure to review restrictive user agreements as there could be language that may restrict the use of the site for research purposes. 
• Early Communication with the IRB is Essential: Researchers should consult with their IRB early—especially for ambiguous or borderline projects—to avoid delays, ensure compliance, and meet journal requirements for documentation. 

Read more about PHRP Online Training Advisory Board Member Kim Diccianni

PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com.