SBER Track

2019 AER Conference

B18 - A Comparison of Human Subjects Protections Auditing Between Biomedical and Social-Behavioral Human Subjects Research

Speaker(s)

• 

  Narayan A. Escolin, MBS, CCRP
  

  Human Subjects Protection Analyst, Rutgers University
  Co-Instructor, Rutgers University
• 

  Kate Sasamoto, JD
  

  Senior Research Compliance Associate, Office of Research Compliance Review, University of Michigan
  

While there are some similarities in the conduct of biomedical and SBE human subjects research, there are many differences: applicable regulations and guidelines, institutional policies, standard research practices, background/makeup of research teams, etc. As such, the approach to auditing these protocols must be distinct and depends on the type of research being conducted. Auditors must take into account subject populations, types of interventions, levels of research experience, and common research tools, among other things. A nuanced approach tailored by the appropriate considerations can affect factors such as principal investigator cooperation, comprehensiveness of the audit review, and duration of the audit process. During this session, speakers and attendees will:

Learning Objectives:

• Compare and contrast the obstacles in each step of the auditing process for the two types of human subjects research
• Provide the reasons for these differences
• Share examples that highlight current practices and considerations