Menu Search Account

LegiStorm

Get LegiStorm App Visit Product Demo Website
» Get LegiStorm App
» Get LegiStorm Pro Free Demo

Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain

  Premium   Download PDF Now (14 pages)
Report Type Reports and Testimonies
Report Date May 23, 2001
Report No. GAO-01-775T
Subject
Summary:

At the federal level the Department of Health and Human Services (HHS) is seeking to better protect human subjects in biomedical research by enhancing the visibility of its human subjects protection activities, improving its monitoring of compliance with relevant regulations by institutions and investigators, and strengthening enforcement of those regulations. HHS has also issued new guidance and is collecting information to improve oversight and monitoring at the institutional level. HHS activities directed at the investigator level consist largely of educational efforts to heighten investigators' awareness of and compliance with ethical policies and practices in conducting research. Overall, HHS' actions appear promising, but GAO has some concerns about the pace and scope of HHS' efforts to ensure the safety and protection of participants in clinical trials.

« Return to search Government Accountability Office reports