irb.vt.eduHuman Research Protection Program (HRPP) | Research & Innovation | Virginia Tech

Human Research Protection Program (HRPP) | Research & Innovation | Virginia Tech Universal Access Toggle Universal Access Close Universal Access dialog Universal Access Options Report a barrier Turn link underline On Off Accessibility portal Apply Visit Give Shop Resources for Future Students Current Students Parents and Families Faculty and Staff Alumni Industry and Partners Menu Research & Innovation Opportunities Opportunities Submenu Toggle Internal Funding Funding Institutional Limited Submissions Undergraduate Research Opportunities Training Sponsored Programs Integrity & Compliance Integrity & Compliance Submenu Toggle Scholarly Integrity & Research Compliance Conflict of Interest Human Research Protection Program (HRPP/IRB) Institutional Animal Care and Use Committee Institutional Biosafety Committee Privacy & Research Data Protection Program Research Integrity University Veterinarian & Animal Resources Export & Secure Research Compliance Required Research Trainings Procedures for Handling Confidential Information at Virginia Tech Partnerships Partnerships Submenu Toggle LINK: Center for Advancing Industry Partnerships Learn About Entrepreneurship Connect with the Virginia Tech Corporate Research Center (VTCRC) Institutes & Centers Institutes & Centers Submenu Toggle Fralin Biomedical Research Institute Fralin Life Sciences Institute Hume Center Institute for Creativity, Arts, and Technology Institute for Critical Technology and Applied Science Institute for Society, Culture and Environment Virginia Tech Transportation Institute Virginia Tech Applied Research Corporation Research Centers, Labs, and Groups About About Submenu Toggle About OVPRI Areas of Research Leadership Divisions Senior Staff Organization Careers Apply Visit Give Shop Resources for Future Students Current Students Parents and Families Faculty and Staff Alumni Industry and Partners Search Search Submit Research and Innovation / Scholarly Integrity & Research Compliance / Human Research Protection Program (HRPP/IRB) / Explore SIRC Contacts Research Integrity Officer Research Integrity and Consultation Institutional Biosafety Committee Institutional Animal Care and Use Committee Current page: Human Research Protection Program (HRPP/IRB) Protocol Management IRB Committee Review Deadlines & Meeting Dates Training (CITI) Resources Commercial IRB Contacts News Privacy & Research Data Protection Program Conflict of Interest News Human Research Protection Program (HRPP) SIRC continues to support integrity in the research community with the SIRC Investigator Series Learn More In the News Human Research Protections Program protocol coordinators support researchers HRPP Important Dates Your browser does not support iframes. Link to iframe content: https://calendar.google.com/calendar/b/1/embed?height=600&wkst=1&bgcolor=%23ffffff&ctz=America%2FNew_York&showTitle=0&showNav=1&showTz=1&mode=MONTH&src=dnQuZWR1XzU4c3RzaTR2NGV2Nm9ocXY2dDd1dW5pOXBjQGdyb3VwLmNhbGVuZGFyLmdvb2dsZS5jb20&color=%2381910B Students in class in the new Classroom Building. The Human Research Protection Program (HRPP) has been established to support researchers whose work involves human participants. The Scholarly Integrity and Research Compliance division of the Office of the Vice President for Research and Innovation (OVPRI) is implementing changes to comply with new federal Institutional Review Board (IRB) regulations. A primary goal of the revised regulations is to reduce the regulatory burden on researchers, and these changes will benefit researchers at Virginia Tech. The revisions to the Common Rule for the protection of human research participants go into effect on January 21, 2019. Some of the key regulatory changes include: Abbreviated reviews for studies with less risk A single IRB review for multi-site studies Improvements in what is required in consent forms to help participants make informed decisions about joining a study Click one of the headings below to learn more regarding a specific topic: Studies with less risk may have abbreviated reviews and/or no annual review Under the new rule, some studies may receive only a brief review of certain protections instead of a full review by the IRB. In addition, some minimal-risk studies will no longer require annual review. It is important to note that even without an annual review, researchers are still required to keep the HRPP office up-to-date on any concerns or events to ensure that research subjects are protected. Multiple Sites – One IRB Although NIH-funded multi-site studies have been required to use a single IRB review since 2018, the federal-wide requirement to have a single IRB oversee studies that are conducted at multiple sites does not go into effect until January 2020. Once implemented, a single IRB will serve as the reviewing board for all sites involved in a multi-site study. This will reduce multi-site review delays that have occurred in the past when the different sites’ IRBs attempted to reconcile the various, sometimes contradictory, requirements. HRPP Coordinators and Departmental Human Subjects Advisors Researchers will have the opportunity to work with HRPP Protocol Coordinators. To support the growing research environment, Virginia Tech is hiring several new HRPP Protocol Coordinators to augment the existing IRB support staff An HRPP coordinator will be assigned to handle each study throughout the lifecycle of the protocol—from preparation for IRB submission through study closure. Coordinators will be available to answer questions, direct researchers to resources, and provide updates on where the researcher’s study is in the process. HRPP is also enhancing the training of and strengthening its connection with Departmental Human Subjects Advisors. This corps of advisors comprises faculty and staff with expertise in their unit’s human subjects research portfolio and additional expertise in research ethics and IRB regulations. They serve as a bridge between faculty, HRPP, and the IRB and can assist fellow faculty with research ethics and IRB-related questions. In many instances, they can provide the initial determination of whether or not a protocol must undergo IRB review. Education and Training In preparation for the upcoming changes and to improve the IRB process overall, the Division of Scholarly Integrity & Research Compliance created a Human Research Protections Program (HRPP) to support researchers whose work involves human participants. HRPP has improved education and training to bring researcher training to industry standard by January 21, 2019. Virginia Tech will now use the same training required at other universities and federal research institutions. The Collaborative Institutional Training Initiative (CITI) training is transferrable and meets requirements for collaborative or multi-site studies. If a researcher has previously taken CITI human protections training either at Virginia Tech or at another institution, they can affiliate with Virginia Tech through their CITI account to transfer completed courses without retaking them. HRPP enlisted researchers and stakeholders from across campus to review the updated Human Research Protection Training Requirements Standard Operating Procedure. Input from Professors Kevin Carlson, Rosemary Blieszner, Karen Roberto, Marie Paretti, and Kathy Hosig provided helpful insights from the user perspective. CITI training is available online and is self-paced to meet the researcher’s schedule. It provides information on both the regulatory requirements and the ethical context necessary to understand human research protections. We expect that researchers who have completed the training will be able to write improved protocols and receive faster approval,” said Suzie Lee, IRB Chair. CITI human subjects research training will be available beginning January 21, 2019. The new...