Compliance
RSSArticles
-
Ethics of Genetic Research on Alcohol Addiction
Genetic testing is not yet ready for use in the prediction of alcohol dependence, according to a recent ethical guidance.
-
Law Enforcement Requests Conflict With Nurses’ Ethical Obligations
Nurses around the country are noticing a disturbing trend: Some patients suspected of violent crimes are admitted for medical care but are not arrested.
-
Complex Research Ethics Question? Consultants Offer Their Expertise
The research ethics consultation works independently from the IRBs, although the IRBs occasionally reach out for help with challenging cases. Researchers typically seek help early in the process when thinking about recruitment or what populations to include.
-
Earning the Trust of Research Subjects
Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.
-
Research Program Closely Monitors ClinicalTrials.gov Compliance
Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.
-
FDA Unveils Real-World Data Initiative
The FDA recently opened a promising path to capture real-world data and evidence to complement traditional clinical trials and open new avenues of research.
-
Court Denies New Trial After Jury Exempts Doctor in Retained Object Case
Lessons from this case reveal the importance of proving or disproving causation, a critical element in any medical malpractice case.
-
Obstetrician Liable For $1.75 Million Due to Permanent Brain Injuries to Infant During Delivery
This case focused on the use, or misuse, of a medical device: the vacuum extractor.
-
Developing a Culture of Healthcare Safety Requires Multifaceted Approach
Improving the safety culture of a hospital or health system will require tackling challenges on several levels of the organizational structure.
-
Electronic Discovery Can Be Costly, Time-Consuming
Discovery requests for electronic data can be especially burdensome in healthcare because of the vast amount of data involved.