This month’s Research Ethics Roundup covers the reportage of the PHS Study of Untreated Syphilis, considering the ethics of research on insects, multiple perspectives on patient engagement in clinical trials, and the challenges of developing drugs for ultrarare diseases. Read more
In 2010, a little-known research institute, the Patient Centered Outcomes Research Institute (PCORI), began funding hundreds of clinical studies with the aim of increasing the value of medical innovation. These studies included patients and family members in every step of the research process. This approach, called patient-centered outcomes research, has become a novel tool for conducting health care investigations; but, it raises ethical issues, which have largely been pushed to the background. Read more
One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more
