Tag Archives: Research

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

drug testing
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research conducted or supported by participating federal departments and agencies.[1]  Compliance with the revised Common Rule is expected on January … Continue reading this entry

Investigating Research Misconduct: The Legal Process

Research
The alarming news about potential research misconduct can come in a variety of ways: a negative report in Retraction Watch, an anonymous “Clare Francis” letter, or a tip on the employee hotline. Regardless of the source, every institution must take each allegation seriously, especially if it involves research funded with federal dollars. Not only can a … Continue reading this entry

Scientific Research Misconduct vs. Fraud: How to Tell the Difference

digital health
The following article was originally published in May 2018 Compliance Today and is reprinted with permission. For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services.1 After a lengthy and confidential review, an institution suspected of producing false or fraudulent … Continue reading this entry