24
Apr2019

The Research Compliance Network (RCN) is a national consortium of representatives from academic medical centers, universities, and hospitals who are interested in postapproval monitoring and quality assurance and quality improvement activities (QA/QI). The group serves as a communication forum that allows members to exchange best practices, share strategies and resources, and collaborate to develop new tools. The RCN continues to grow and welcomes new members. Read more

23
Apr2019

I am a researcher working in an inner-city neighborhood serving a disadvantaged population. As such, I found the session “Navigating uncertainty: Research with Undocumented Immigrants” at the 2018 Advancing Ethical Research Conference quite relevant to my practice. This presentation helped me to understand the vulnerability of undocumented individuals involved in research. A person's documentation status may be a risk factor for health disparities; however, undocumented individuals should not be automatically excluded from research. Read more

22
Apr2019

Twenty years ago in 1999 I attended my first annual PRIM&R conference. I did so in the aftermath of then OPRR (now OHRP)’s shutdown of human subjects research that year of three federally funded institutions. At the time, there was a feeling of “there go I but for the grace of god;” if it could happen at these institutions, it could happen anywhere. Here we are in 2019, and there are once again scandals grabbing the research compliance headlines—this time involving scientific misconduct and questions of research integrity. And I cannot help but step back 20 years to that pivotal moment for IRBs and human subjects protections programs across the United States and ask again, what does a strong and robust Research Integrity program look like? Read more

19
Apr2019

Past disregard for human rights in studies such as the Tuskegee experiment, has left some individuals (rightly so) with an inherit distrust of the clinical research process. Over time, increased regulatory oversight of the clinical research environment was put into effect to protect those who participate in research, particularly those who might be more vulnerable. But sometimes the regulations don’t keep up with developments in the modern research enterprise. Read more