Guidelines Regarding Human Subjects Protection and Microbiome Research

With thanks to Sharon Ellison and Jody Power from the IRB and John Rawls, Lawrence David, Raphael Valdivia, Neil Surana, Naz Siddiqui, and many others from the DMC community, we are happy to share the Guidelines Regarding Human Subjects Protection and Microbiome Research. We hope this will be helpful for individuals considering collecting human samples, research with samples that have already been collected, or research with microbes cultured or isolated from human samples. These guidelines are meant to address questions of when a full IRB protocol is needed (and which may require patient consent), when research may be considered exempt (while an IRB submission may be needed, patient consent may not), or when IRB review is not needed. Of course, these are guidelines, and if there is ever a question, the IRB remains available to help.