The Statistical Applications and Innovations Group and the division of Scholarly Integrity and Research Compliance have collaborated to develop new research protocol writing workshops to help investigators and graduate students streamline their IRB review and approval process.

The Blacksburg workshop will be held from 2 - 5 p.m. Oct. 22 and the Roanoke workshop is scheduled from 1 – 4 p.m. Nov. 14. These trainings will highlight the essentials of protocol development, providing hands-on training on the development of protocols for research involving human particpants.

“We want to help researchers think about the protocol as a process designed to help them design ethically and methodologically sound research studies, not just as an application for IRB approval,” said Frances McCarty, IRB member and faculty in the department of statistics.

McCarty has analyzed comments sent back to researchers during IRB review process and found that often vital information is missing from initial protocol submission, which slows the review process and causes delays in the start of research. “We want to reduce the frustration of multiple iterations in the approval process by helping researchers understand why they need to submit a complete description of the research,” McCarty noted. “The IRB needs complete information on the methods in order to assess the ethics of a research plan.”  

“We hope the workshop will demonstrate to researchers that they do not have to reinvent the wheel,” added Barbara DeCausey, director of the Human Research Protection Program (HRPP). “We will show researchers ways to use what they have already written in a grant proposal or description of their research to meet the protocol requirements of the IRB submission template. A complete research protocol is an essential part of the holistic process of doing research, even if the human subjects regulations do not apply.”

The workshop’s hands-on approach is designed to provide information about what the regulations require and what the IRB is looking for in a protocol. The session will be interactive and allow researchers time to discuss specific questions and receive immediate feedback on the best ways to incorporate into their protocols the ethical dimensions that the IRB needs to see. Researchers are encouraged to bring draft research plans for discussion with HRPP staff and members of the IRB.

“An important benefit of this workshop is that researchers will meet and interact directly with IRB members — who are their faculty peers, and who are dedicated to moving research forward. We also want researchers to know that HRPP staff are there to ensure that the review process moves as smoothly and efficiently as possible,” said Mary Potter, IRB member and director of the Privacy and Research Data Protection Program.

Interested researchers and graduate students should contact fmccarty@vt.edu for more information.

— Written by Tiffany Trent