-
For years, federal regulations have deemed the research use of deidentified blood and tissue samples collected in clinical procedures to be non-human subjects research, and therefore has not required informed consent from the patients from whom they were taken.
-
Therapeutic misconception in clinical trials continues to be a significant concern for researchers and IRBs. Studies have shown that misunderstandings persist about the therapeutic value of research interventions among participants and even among research staff.
-
IRB offices might improve their staff and IRB members' training and education if they provide an occasional refresher course on the National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects, also known as the Rules of Review.
-
Practice-based researchers have long complained that IRBs don't understand their work, which is based in physicians' practices and often consists of low-risk activities such as chart reviews and surveys.
-
[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
-
When IRBs and research organizations' quality improvement offices work together, the net effect is a more thorough and efficient human subjects research process, experts say.
-
IRB directors who think their areas are safe from natural disasters should think again. Some U.S. IRBs learned the hard way that even in non-coastal cities and areas they can find their IRB offices underwater. Or they could experience earthquakes, tornadoes, hurricanes, and fires. And any research institution and IRB is at risk of an epidemic that leaves them short-staffed.
-
Applying community engagement to mental health research can help researchers about design studies that incorporate the priorities of people with mental illness and arrive at the best strategies for working with them.
-
All IRBs and IRB offices need to set up succession plans to ensure continuity in the event the IRB director or chair leave abruptly.
-
Researchers say there need to be more clinical trials examining the safety and effectiveness of pain medications used with children, which are too often administered based on information from adult trials.