By Lori Melichar, PhD, director, Pioneer Portfolio at Robert Wood Johnson Foundation
The systems that drive institutional review boards (IRBs) was last modified nearly a quarter century ago. That overhaul was before the internet and smartphones, and before the human genome was completed. Recently, new technologies such as ResearchKit, have emerged as game changers for patient engagement in research studies. Other studies that apply social network science, big data analysis, and personalized medical insight raise important new questions about how patient rights can and should be protected in this new [...] Read more
By Avery Avrakotos, education and policy manager
ResearchKit, an open-source software framework aimed at furthering our understanding of health and disease, provides researchers a tool to conduct research utilizing Apple's iPhone that developers hope will help revolutionize how that research is conducted.
First introduced at an industry event in March, ResearchKit consists of three modules: the first focuses on providing potential subjects with information about participation and obtaining subject consent; the second administers surveys using a pre-built user [...] Read more
by Athos Bousvaros, MD, Boston Children's Hospital
Athos Bousvaros, MD, and Susan Kornetsky, MPH, both of Boston Children's Hospital, recently created a comic book, titled Sophie's Science Project, to help teach children about medical research. Below Dr. Athos shares their motivation for creating the comic book and what they hope it will accomplish.
For children and adolescents to participate in pediatric clinical research, parental permission is needed, but the children themselves are also expected to provide assent. Assent is defined by the US Department of Health and Human Services as "a child's [...] Read more
Technology takes center stage in this week's Research Ethics Roundup. On Monday, Apple introduced a new open-source framework that could have significant implications for the research enterprise, while, on the same day, the Food and Drug Administration (FDA) released draft guidance aimed at clarifying the use of electronic processes to obtain informed consent.
Apple's ResearchKit Is a New Way to Do Medical Research: On Monday, Apple announced ResearchKit, an "open-source framework that lets medical researchers create diagnostic apps that tap into the screens and accelerometers on the iPhone." This article from Wired discusses the announcement and how the use of the framework could revolutionize research.[...] Read more
by Amy Davis, JD, MPH
Overheard, a new series here on Ampersand, is a glimpse into conversations, discussion, and debate on PRIM&R's IRB Forum. No participants or institutions are identified to preserve the mission and openness of the Forum, though IRB Forum members are welcome and encouraged to comment on these posts. To suggest a topic for Overheard, please contact us. If you are not a member of the IRB Forum and would like to join, you can do so here.
On the IRB Forum, people are [...] Read more