IRB Review

A researcher is considered engaged in human subjects research when they are actively involved in conducting research activities that directly involve human participants or the collection and use of identifiable private information or biological specimens from individual with research proposed. Some procedures and activities that suggest a researcher is engaged in human subjects research include: 

• active data collection, 
• conducting experiments or studies that involve interventions, treatments, drugs, devices, or therapeutic procedures that are administered to human participants,  

• the analysis of data collected from human participants or use identifiable private information in their analysis for research purposes 
• the review of private information, such as medical records, employment records, or educational records, for research purposes 
• involved in biospecimen collection 
• have direct communication or contact with study participants for research-related purposes 
• through collaboration with others on the design, conduct, analysis or interpretation of research studies 

• engage with stakeholders in research activities or decision-making processes related to research  
• observe human participants as part of the research 

We understand that researchers engage in a wide range of activities, and their understanding of research may vary depending on your field and the specific research project. However, a common definition of research is the systematic and organized process of gathering, analyzing, and interpreting information or data to answer a specific question or test a hypothesis. Research aims to advance knowledge, discover new facts, or enhance understanding in a particular field or discipline.    

• Research involves a structured and methodological approach to gathering and analyzing data or information. Research follows a plan or protocol. 
• Research is conducted with the intention of generating findings or insights that have broader applicability beyond the specific context of the study. Research seeks to advance knowledge in a particular field or discipline and involves the dissemination of results to a wider academic or scientific community. 

• Research is purpose-driven and aims to address a specific research question, hypothesis or problem. 
• Research often involves the collection of data, followed by data analysis to draw conclusions.    

If a study does not meet the definition of research, you do not need ORSP oversight.    

If you are unsure whether your project meets the definition, contact irb_chair@utpb.edu.

Although this is not a comprehensive list of the activities that may meet the definition of human subjects research, the list below includes several examples of what may constitute human subjects research.   

1. Clinical Trials: Clinical trials involving human participants to test the safety and efficacy of new drugs, medical treatments, or interventions.  
2. Surveys and Questionnaires: Research that collects data from individuals through surveys, questionnaires, or interviews to study attitudes, behaviors, opinions, or experiences.  
3. Observational Studies: Research that involves the systematic observation of human behavior or activities, such as ethnographic field studies, to gain insights into social or cultural phenomena.  
4. Psychological Experiments: Studies in psychology that involve human participants to investigate cognitive processes, behavior, or emotional responses.  
5. Epidemiological Research: Studies that analyze data related to the incidence, prevalence, and causes of diseases in human populations.  
6. Educational Research: Research conducted in educational settings that involves students, teachers, or educational administrators and aims to improve teaching and learning.  
7. Behavioral Interventions: Research that tests the impact of behavioral interventions, such as counseling, therapy, or behavior modification, on human subjects.  
8. Genetic Studies: Research that collects biological specimens (e.g., DNA samples) from individuals to study genetic traits, hereditary conditions, or genetic variations.  
9. Social Science Research: Studies in sociology, anthropology, political science, or economics that involve human participants to explore social, cultural, or economic phenomena.  
10. Public Health Studies: Research conducted to assess public health issues, such as disease prevention, health disparities, or the effectiveness of public health campaigns, involving human subjects  

1. Quality Improvement Initiatives: Activities aimed at improving the quality, efficiency, or safety of healthcare of institutional practices within an organization, where the primary goal is not research, but rather improving the delivery of services.  
2. Program Evaluation: Evaluations of programs or interventions within an organization to assess their effectiveness, typically for the purpose of making programmatic improvements, rather than generating generalizable knowledge.  
3. Teaching Activities: Educational activities and assignments conducted in a classroom or academic setting that do not involve research and are solely for instructional purposes.  
4. Case Studies for Educational Purposes: In-depth examinations of individuals cases, or events used for educational purposes, where the goal is not to generate generalizable knowledge but to facilitate learning.  
5. Personal Reflection or Opinion Articles: Writing personal reflections, opinions, or essays based on personal experiences or observations, without systematic data collection or analysis for research purposes.  
6. Creative Works: Activities related to artistic or creative expression, such as creating art, music, literature, or performances that do not involve systematic data collection or analysis for research purposes.  
7. Data Aggregation for Non-Research Purposes: Collecting and aggregating data for administrative, operational, or non-research purposes, where the goal is not to generate generalizable knowledge.  
8. Routine Clinical Care: Standard medical or clinical care provided to patients as part of their healthcare without any systematic data collection or research component.  
9. Quality Assurance or Compliance Monitoring: Activities conducted to ensure compliance with institutional policies, regulations, or industry standards, where the primary aim ins not research but compliance.  
10. Publicly Available Data Analysis: Analyzing publicly available data sets that do not contain personally identifiable information and were collected for non-research purposes, such as government statistics or public records