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.
April 10, 2012 12:18 pm
In one of the first studies of its kind, University of Pennsylvania School of Nursing researchers have identified what cancer patients consider the “benefits and burdens” of participating in clinical research trials. From their findings, the researchers developed a model of the five elements of decision-making (physical, psychological, economic, familial, and social) that patients with cancer use to determine whether to participate or remain in a clinical trial.
April 5, 2012 12:57 pm
The Portable Legal Consent for Common Genomics Research (PLC-CGR) is an experimental bioethics protocol that provides maximum utility to researchers who agree to its terms and protection for the de-identified personal and genomic data volunteered by informed research subjects. Data and resulting publications from this protocol are equally available to all academic, nonprofit and commercial competitors, so that intellectual property claims should arise only on new discoveries based on the data.
April 2, 2012 9:21 am
The way clinical studies inform patients about what they are getting involved with works no better in the U.S. than elsewhere in the world, one expert said. Patients from both developed and third world countries exhibited a similar lack of understanding of the medical research process, which limits their discernible rights, said Christine Grady, the chief of the department of bioethics at the National Institutes of Health Clinical Center.
March 2, 2012 2:18 pm
Christine Grady, Ph.D., was recently named chief of the Department of Bioethics of the National Institutes of Health (NIH) Clinical Center. Grady has served as deputy director of the department since 1996 and served as acting chief since September 2011. Her research focuses on clinical research subject recruitment, incentives, vulnerability, consents, and international research ethics. #bioethics #researchethics