Lawyer Xiaorong Chen (center, in white) spoke to a capacity crowd in Kresge G-3 on March 12 as part of a presentation and panel discussion on consent monitoring and research integrity. Pictured above, from left to right, are Xiping Xu, associate professor of occupational epidemiology, Department of Environmental Health; Sarah Putney, director of the Human Subjects Administration at HSPH; Daniel Wikler (in back), professor of ethics and population health, Department of Population and International Health; Chen; James Ware, Dean for Academic Affairs; and Binyan Wang, research associate in the Department of Environmental Health, who served as Chen’s interpreter.

Chen leads an independent consent monitoring team for collaborative studies between HSPH and Anhui Medical University in China. Currently, researchers from the two institutions are collaborating on epidemiologic research related to studying osteoporosis and to investigating the reproductive health effects of pesticide exposure.

Use of the team was embraced by HSPH and Anhui Medical University officials when both institutions reviewed and invigorated their human subjects committees’ activities. The team surveils the collaborative studies’ protocols step by step, assessing a variety of criteria that include recordkeeping of consent forms, training of researchers in human subjects protections, and compliance with the studies’ protocols. They travel to study sites, directly observing interactions and providing feedback to researchers in real time. They also conduct interviews with a sampling of subjects to assess their understanding of the studies, the voluntary nature of their consent, and their satisfaction. The work of Chen’s team–in the breadth and depth of its activities–is the most comprehensive model for real-time monitoring of human research in current practice.

The event was sponsored by the Office for Academic Affairs, Department of Environmental Health, and the Human Subjects Committee.