Showing results for IRB

Reporting Serious Adverse Events
Defines the criteria for reporting of serious adverse events (SAEs) to regulatory agencies, IRBs, and sponsors. Includes definitions for "serious" and...
Informed Consent and Incidental Findings in Research with Human Subjects
Defines incidental findings (IFs) in human subjects research and covers how IFs should be managed in the informed consent process. Provides an overvie...
New SACHRP Recommendations Available
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) provides expert advice and recommendations on issues and topics pertaining...
What Does Diversity Mean in Clinical Trials?
Overview The lack of diversity in clinical trials is a major issue that scientific research is battling today. The ethical inclusion of diverse parti...
On Tech Ethics Podcast - Impact of Recent Social Media Platform Changes
Season 1 - Episode 9 - Impact of Recent Social Media Platform Changes This episode discusses how the recent changes to the social media landscape may...
Getting People Involved in Research
This module describes recruitment, consent, and assent in research. It explains the importance of using Institutional Review Board (IRB)-approved recr...
Consent and Subject Recruitment Challenges: Therapeutic Misconception
Describes therapeutic misconception and identifies potential strategies researchers and institutional review board (IRB) members can use for reducing ...
Humanitarian Use Devices (HUDs)
Provides a basic overview of the U.S. Food and Drug (FDA) regulations and responsibilities regarding HUDs. It describes the HUD program and Humanitari...
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