REGULAORY OVERSIGHT
This federal agency oversees human subjects protections for HHS-funded research.
What is Office for Human Research Protections (OHRP)?
This Belmont principle focuses on maximizing benefits and minimizing harms.
What is Beneficence?
This document describes the study objectives, procedures, risks, and plans for conducting the research.
What is a Protocol?
This level of IRB review is typically required for studies involving greater than minimal risk.
What is Full Board review?
This term refers to the probability and magnitude of harm or discomfort in research.
What is Risk?
This process involves identifying and inviting potential participants into a study.
What is Recruitment?
Research that falls into specific low-risk categories may qualify for this type of IRB determination and forego the need for continuing review.
What is Exemption?
This principle recognizes the autonomy of individuals and provides extra protections for vulnerable populations.
What is Respect for Persons?
This type of research prospectively assigns participants to interventions to evaluate health-related outcomes.
What is a Clinical Trial?
This type of review may be used for certain minimal risk studies and minor changes to approved research.
What is Expedited review?
This federal law helps protect identifiable health information used in research and healthcare.
What is HIPAA?
A pacemaker, insulin pump, or imaging tool used in a study may fall into this FDA-regulated category.
What is a Device?
This federal agency regulates drugs, biologics, and many medical devices used in research.
What is the U.S. Food and Drug Administration (FDA)?
Limiting access to identifiable study information and protecting participant confidentiality are key aspects of this concept.
What is Privacy?
The systematic investigation designed to develop or contribute to generalizable knowledge is called this.
What is Research?