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 age.
Maybe it’s time to redesign the IRB.
That’s exactly what my colleague Deborah Bae and I set out to do—explore what a redesigned IRB might look like. We gathered a group of people who care a lot about research—and a lot about research subjects. We applied design thinking to the IRB process to come up with new ways to help human research subjects understand their privacy rights and to protect them in the age of personal and big data.
It was a potent gathering. Professor Scott Klemmer facilitated the design session that included those with expertise in many fields: public health, ethics, psychology, economics, mHealth, quality improvement, medicine, (big breath), bioethics, privacy law, information science, qualitative data analysis, big data, social networks, and genetics. Also included were professionals with experience managing IRBs that oversee human subjects research.
Here are three ideas the group generated—tell us what you think of them:
Idea 1: Redesign the Consent Form and Process
How do we ensure human subjects truly understand the risks and opportunities associated with their participation in a research study—regardless of race, culture, or cognitive ability?
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.