What does randomization mean for research volunteers?

Introduction

• Presenter: The Federal Office for Human Research Protections (OHRP)
• Purpose: To help potential research volunteers understand randomization in studies
• Key Point: Deciding to volunteer for research can have important consequences

Random Assignment

• Definition: Process where volunteers are assigned to study groups by chance
• Examples: Drawing numbers from a hat, flipping a coin
• Purpose in Research: Ensures that assignment is not influenced by researcher, doctor, or volunteer

Why Randomized Assignment?

• Reliability: Helps in getting reliable answers to research questions
• Example: Comparing a new drug to an existing one for treating an infection
  • Without Randomization: Researchers might unintentionally assign drugs based on perceived severity of illness, skewing results
  • With Randomization: Ensures groups are similar in health and other characteristics, making results more reliable
• Additional Steps: Blinding (volunteers don’t know their group) and double-blind studies (neither researchers nor volunteers know the groups)

Implications for Volunteers

• Random Assignment: Like a coin flip; neither the research team nor the doctor can choose your group
• No Choice: Volunteers cannot choose their group and may not get the preferred group
• Blinding: Researchers, doctors, and volunteers may not know the group assignments during the study
• Considerations: Research is not designed to address individual medical needs, may not benefit the volunteer, and could be harmful despite protections

Volunteer Contribution

• Purpose: Volunteers help in answering medical or behavioral questions, contributing to future treatments

Closing

• Encouragement: Volunteers should ask questions and discuss concerns with the research team
• Resources: Visit OHRP website for more information