September 27, 2013 2:22 pm
The Pennsylvania’s Medical Care Availability and Reduction of Error Act specifically gives patients the right to ask questions of physicians, not just physician assistants or nurses.
August 27, 2013 1:03 pm
Two UC Davis neurosurgeons who intentionally infected three brain-cancer patients with bowel bacteria have resigned their posts after the university found they had “deliberately circumvented” internal policies. The surgeons maintain they were acting in the best interests of their desperately ill patients, whose prognoses for survival were poor.
August 14, 2013 6:32 pm
As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
July 2, 2013 1:41 pm
Informed consent and a change in privacy rules are what most people seem to be concerned about. However, data by itself is not intelligent. There are equal-parts rules and tools for data to become actionable information.
June 5, 2013 5:16 pm
A group of scholars and leaders in bioethics and pediatrics with extensive experience in ethical and regulatory issues in pediatrics and human subjects research urged the OHRP to withdraw its research violation notification to the institutions involved in SUPPORT.
May 21, 2013 2:37 pm
In a landmark move in the sphere of clinical trials, informed consent of patients participating in clinical trials will soon be recorded on camera.
February 28, 2013 12:49 pm
Would you eat horsemeat? A lot of people would not. Should you have the right to know if the meat you are eating contains horsemeat? The answer to that question is a resounding yes…
June 21, 2012 1:19 pm
The example points to a broad problem in research on humans — that informed consent is often not very well informed (see ‘Reading between the lines’). Protections for participants have been cobbled together in the wake of past controversies and have always been difficult to uphold. But they are proving even more problematic in the ‘big data’ era, in which biomedical scientists are gathering more information about more individuals than ever before. Many studies now include the collection of genetic data, and researchers can interrogate those data in a growing number of ways. Several US states, including California, are considering laws that would curtail the way in which researchers, law-enforcement officials and private companies can use a person’s DNA.
June 18, 2012 7:06 pm
The Welsh Government wants to introduce a system of organ donation called ‘presumed consent’, in which it is presumed individuals are happy to become donors in death, unless they opt out or family members strenuously object. It has published a draft bill today setting out the legal framework. If approved, Wales will become the first part of the UK to instigate the controversial system, in 2015.
May 4, 2012 1:34 pm
A growing number of health research programs are collaborating with community groups to conduct research. The groups help recruit study participants, obtain informed consent, collect data and provide input on study design and procedures. But existing programs that educate researchers, community groups and institutional review boards about research ethics “fail to meet the needs of all groups that have a role in community-engaged research,” according to an article in the Journal of Empirical Research on Human Research Ethics.