Best Practice

Practical advance for conducting research ethically and efficiently

Five Questions with Meliha Rahmani: Post-Approval Monitoring

magnifying glass atop laptop keyboardYou open your email one morning to find a message from ORRP’s quality improvement staff that says your study has been selected for a post-approval monitoring check. What does that mean? Did you do something wrong?

Never fear! In this edition of Five Questions, Quality Improvement Specialist Meliha Rahmani breaks down post-approval monitoring: what it is, why we do it, and what it means for your research.

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Re-post: How should a “reasonable” person approach key information?

The Revised Common Rule requires informed consent documents to begin with a concise summary of information that a “reasonable” person would want to know when deciding to participate or not participant in a research study. At the 2018 Advancing Ethical Research conference, panelists from the Office of Human Research Protections (OHRP), National Institutes of Health (NIH), and two research institutions discussed considerations for implementing the key information requirement.
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