Flexibility and Innovation in IRB Processes Track

2019 AER Conference

Advanced

B20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)

Speaker(s)

• 

  Irene E. Stith-Coleman, PhD
  

  Director, Division of Policy and Assurances, Office for Human Research Protections
  
• 

  Laura Youngblood, MPH, CIP
  

  Health Scientist, Centers for Disease Control and Prevention
  

As the nation's health protection agency, the CDC conducts critical science, provides health information that protects the nation against health threats, and responds when health threats arise. The CDC has a vital role in ensuring the highest quality of scientific products originating from the agency are used as a foundation for putting public health research into much needed practice. As noted in the revised Common Rule, some public health activities involve research and others do not; this presents many grey areas. Statutory authority of state and local health departments to conduct public health activities using methods similar to those used by researchers may add to the complexity (although the revised Common Rule now defines public health authority). Appropriate protections applicable for activities occurring at the boundary between public health surveillance and public health research are not readily interpretable from the regulations. Before attending this session, attendees should be knowledgeable about public health practice activities and the revised Common Rule’s definition for "research," as well as have familiarity with the revised Common Rule definitions for "human subject," "public health authority," and "research." During this session, speakers and attendees will:

Learning Objectives:

• Describe the CDC's process and criteria for determining whether an activity is research, according to the revised Common Rule
• Discuss key considerations and decision points unique to public health practice activities (e.g., surveillance, public health response investigations, program evaluation)
• Review real-world examples to demonstrate the decision-making process to assist the audience in determining when something is public health surveillance vs. public health research