In response to recently expanded clinical trial requirements for behavior and social interventions, National Institutes of Health (NIH) has released a new resource for behavioral and social science researchers. The Clinical e-Protocol Writing Tool includes a template that leads the writer through the process of preparing a research protocol involving human subjects.
The Writing Tool requires the user to set up a new log in. Once in the system, the user can find a link to instructions for each subsection of a protocol. Newer investigators may find the examples linked to the subsections to be particularly helpful, although examples are not currently provided for all subsections.
According to William Riley, Director of the NIH Office of Behavioral and Social Sciences Research, the Writing Tool “allows users to seamlessly send and edit protocol information directly to clinicaltrials.gov.” It can also help with developing IRB applications.
Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Office for the Advancement of Research and Scholarship, Miami University.
Photos by Miami University Photo Services.