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implications for the research enterprise, while, on the same day, the Food and Drug Administration (FDA) released draft guidance aimed at clarifying the use of electronic processes to obtain informed consent.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
by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more
U.S. Urged to Clarify Extent of Funding Moratorium on Risky Virus Research:
Researchers are pleading with the US government to clarify the details of a recent moratorium placed on funding projects that show potential risks due to the use of certain viruses. Concerns include confusion on the specific viruses and experiments covered by the new policy. A statement released by the National [...] Read more