The Virginia Tech Institutional Review Board (IRB) and Human Research Protection Program (HRPP) has announced new tools to help researchers comply with recently updated federal regulations.

Last year, the IRB created the HRPP to support researchers whose work involves human participants. The HRPP has improved education and training to bring researcher training to industry standard.

The revised Common Rule for the protection of human research participants went into effect on Jan. 21, 2019, and is intended to reduce administrative burdens for researchers while also improving protections for research participants. New protocol and consent templates along with supporting checklists and worksheets are now available to allow researchers to take advantage of those revisions.

“The new templates will allow researchers to build protocols more efficiently, and once they have developed standard language for their work, this information will be able to be used in subsequent protocols, presentations, and manuscripts,” said Robin Queen, associate professor, Department of Biomedical Engineering and Mechanics and faculty fellow in Research and Innovation.

Research Protocol Template

The new research protocol template is designed to assist investigators step-by-step through the conception, design, and implementation of human subjects research. The research protocol template includes research methods best practices and is designed to provide Virginia Tech researchers with a robust scientific protocol. The new research protocol template includes the level of detail needed to allow researchers to take advantage of the burden reducing options available under the revised Common Rule but may also:

  • Reduce turnaround times for IRB review.
  • Reduce or prevent the need for time-consuming revision requests.
  • Assist researchers in preparation for a full board review, if required.
  • Prepare investigators for publication of their results.

A revised research protocol template designed specifically for the use of existing data or biospecimens will be available soon. These templates are available on the HRPP website and the IRB Protocol Management online system.

Informed Consent Form Templates 

New informed consent templates are also available to help researchers comply with the revised Common Rule. The templates are designed to help investigators provide the newly required “concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.” The new consent templates are located on the HRPP website and the IRB Protocol Management online system.

Human Subject Research Determination

In addition to the new templates, a new process has been added to the IRB Protocol Management online system to allow researchers to request a human subjects research determination. The Virginia Tech HRPP recommends this option if a researcher is unsure if their planned activity requires IRB review or if documentation of ”Not Human Subjects Research” is needed to satisfy a sponsor or other entity.  The Human Subjects Research Determination Form is available on the HRPP website and the IRB Protocol Management online system. 

“These new resources and tools are designed to help Virginia Tech faculty infuse ethical excellence into their human subjects research from the very beginning of the project. The revised templates will guide researchers to include in the initial protocol submission all of the ethical dimensions that the IRB considers, reducing time-consuming revision requests,” said Lisa M. Lee, associate vice president for research and innovation, who leads the Division of Scholarly Integrity and Research Compliance.

New Checklists and Worksheets

New checklists and worksheets are also available on the HRPP website to support both new and seasoned investigators on research processes and the new requirements. The new tools are available on the HRPP website as of March 7, 2019. Additional tools will be added over the coming weeks as HRPP continues to roll out its new researcher toolkit. 

For more information, please contact HRPP at irb@vt.edu