-
The Institute of Medicine has called for some major changes in IRBs and research, including suggestions that research grants and sponsors, as well as research institutions, put more money into the process of protecting human subjects.
-
Rather than treat the risk of harm and potential for benefit as two weights on opposite sides of a scale, IRBs and researchers should fully explore and express the potentials of each, say research ethics experts.
-
A key issue in determining whether IRB review is necessary is whether the program in question is, in fact, research. While at least one federal regulation has defined research, the application of the definition provided by the regulation is not always clear.
-
IRBs and investigators who would like an organized checklist of steps to take to ensure human subject protection and the highest ethical standards in designing clinical trials could look no further than the ASSERT statement.
-
Some high-profile deaths of research participants in the past decade have led to federal scrutiny of IRBs and their roles in protecting human research subjects. Heres a thumbnail sketch of some of these cases.
-
Though there are no federal laws mandating that IRBs collect and evaluate the potential impact of financial conflicts of interests, a bill introduced by Sen. Edward Kennedy and a recent Institute
of Medicine report recommend that such an evaluation become a critical element in ethics and human subject protection.
-
When Peter Moran, RN, CM, BSN, MS, CCM, was a case manager for a payer organization that was considering cutting personnel, he was able to document that case management interventions netted his organization $190,000 in hard cash savings over the course of three quarters.
-
A team approach to managing patients who are likely to be high utilizers of health care resources has paid off at HealthCare Partners, a large multispecialty medical group in Los Angeles County serving more than 450,000 patients.
-
Educating the internal staff was the first step in Highmark Blue Cross Blue Shields Advance Care Planning/End-of-Life Care program.
-
When case managers at Highmark Blue Cross and Blue Shield talk to their members, they take steps to ensure that the members have advanced care-planning documents in place.
