The National Institutes of Health (NIH) recently issued two policies that impact the conduct of clinical trials that the NIH funds, either partially or in full. They are as follows:
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials
The first policy requires that all...
UNH Sponsored Programs Administration (SPA) recently released guidance on Payment of Incentives/Compensation to Research Participants (Human Subjects). According to Louise Griffin, Senior Director of Research and Sponsored Programs Administration, the guidance was developed to “…meet the increasing needs of the research community, minimize the administrative burden, and comply with federal...
June 16, 1966 was the date that the New England Journal of Medicine (NEJM) published Dr. Henry Beecher’s ground-breaking Special Article on ethics in clinical research. At the time, Dr. Beecher had been the world’s leading anesthesiologist for 30 years. The Special Article was aptly titled, “Ethics and Clinical Research.” In his article, Dr. Beecher, chief anesthesiologist at Massachusetts...
On May 23, 2016, the Council for Big Data, Ethics, and Society issued a comprehensive white paper entitled, Perspectives on Big Data, Ethics, and Society. This white paper is the result of two years of meetings and discussions about the ethical, social, legal, and policy challenges associated with the rise of big data, and resultant research and initiatives.
Recent research projects in the news...
If you like being in-the-know about the latest compliance happenings, regulatory updates and related news, then this is for you.
Research Integrity Services has added several new pages to collect news items and noteworthy events in various compliance arenas:
Conflict of Interest (COI);
Export Controls and Sanctions;
Health Information Privacy (HIPAA);
Human Subjects and IRB...