Human Research Protections Program protocol coordinators support researchers
April 16, 2019
The Scholarly Integrity and Research Compliance division of the Office of the Vice President for Research and Innovation has undergone a transformation.
The Human Research Protections Program (HRPP) at Virginia Tech is designed to support researchers in meeting their ethical and regulatory responsibilities to human research participants. The HRPP protocol coordinators are highly trained subject matter experts in the regulatory requirements for research that involves people.
Federal regulations require that all research involving human participants undergo review by a board of scientific and faculty peers, called an Institutional Review Board, or IRB. An HRPP protocol coordinator is assigned to support the principal investigator and the research team for each new research submission to help see the protocol through the regulatory requirements across the lifecycle of the project.
A protocol must be reviewed before initiation of the study, before changes are implemented throughout the conduct of the study, and in the event of adverse events. For higher risk studies, an annual review is also required. To support its growing research environment, Virginia Tech has brought together a team of five HRPP protocol coordinators to assist investigators through the review and approval process.
“Having a highly trained and dedicated team of HRPP coordinators is an industry best practice. HRPP teams serve an important role in assisting researchers to meet their ethical and regulatory obligations. They also help improve the quality of protocol submissions and decrease the time required for regulatory review,” said Lisa M. Lee, associate vice president for research and innovation, who leads the Division of Scholarly Integrity and Research Compliance.
The HRPP coordinator will facilitate each study throughout the lifecycle of the protocol — from preparation for IRB submission through study closure. Coordinators will be available to answer questions, provide guidance on regulations, direct researchers to resources, and provide updates on where the researcher’s study is in the process.
“I’m excited to help guide this campus-wide initiative with the HRPP protocol coordinators," said Suzie Lee, interim administrator of the Virginia Tech IRB. "The collaborative nature of our team and their combined expertise will benefit all researchers involved in human subjects research at Virginia Tech.”
Lee brings her own expertise to leading the new HRPP team. Lee has been at Virginia Tech for more than 20 years, primarily at the Virginia Tech Transportation Institute (VTTI), where her research focused on young drivers and naturalistic driving studies. While at VTTI she served as the departmental human subjects advisor advising researchers on the regulatory requirements and IRB review processes. She has been a member of the Virginia Tech IRB since 2013. She first served as vice chair of the IRB before being appointed as chair in 2017.
The HRPP protocol coordinators are a diverse group of employees with complementary strengths and backgrounds. Andrea Nash, Kathleen Cicora Smith, Jennifer Farmer, Eric Newton, and Sarah Henderson are all passionate about collaborating with researchers and providing consistent protocol support.
— Nash joined the IRB staff in 2007. She has 11 years of experience working with human researchers, protocol review, and federal regulations. Nash specializes in auditing, training, and data security and protection. Along with her compliance experience, Nash has conducted IRB-reviewed domestic and international research. She graduated from Virginia Tech with a bachelor’s and master’s degree in sociology, with minors in psychology, natural resource recreation, and history.
— Smith joined the IRB staff in 2011. She came to Virginia Tech after working in human subject research as an investigator in social psychology (self-handicapping, self-regulation, and jealousy), market research, religion, institutional research, and auto safety. Smith specializes in social-behavioral research protocols and is the HRPP coordinator for most protocols approved prior to 2019. Smith served as the IRB administrative specialist from 2011 to 2013 and has been an IRB protocol reviewer for the IRB since 2013. She has also transitioned her role from IRB protocol reviewer to serve as an HRPP protocol coordinator. She has a master’s degree in experimental social psychology from Case Western Reserve University and graduated from the College of William and Mary with a bachelor’s degree in psychology.
— Farmer joined the IRB staff in August 2017. She has nearly nine years of experience in IRB regulatory requirements, seven of which were with the IRB at the University of North Carolina at Chapel Hill. Farmer specializes in multisite research agreements, external IRB reviews, and federal regulatory requirements for the IRB. She has research experience in public health, giving her valuable insight as she works with Virginia Tech researchers. She holds Regents bachelor of arts and master’s degree in public health from West Virginia University, with graduate certificates in gerontology and health care administration. Farmer is also a Mayo Clinic-certified tobacco treatment specialist.
— Newton joined the Human Research Protection Program in June 2018. He came to Virginia Tech after serving as clinical trials research manager and clinical research coordinator for numerous surgical specialties, including orthopedic surgery, vascular surgery, urology, and others within an academic medical environment. Newton specializes in informed consent and compensation in clinical research. He holds a bachelor’s degree in athletic training from Bridgewater College and a master’s degree in education from Old Dominion University.
— Henderson joined the Human Research Protections Program in February 2019. She came to Virginia Tech from Carilion Clinic with eight years of experience working in human subject research both as clinical research coordinator and regulatory affairs specialist. Her specialty is clinical trial research and FDA regulations. Henderson earned a bachelor’s degree in biology from Radford University and a master’s degree in regulatory affairs for drugs, medical devices, and biologics with a concentration in medical research from Northeastern University.
In addition to the HRRP protocol coordinators, the HRPP is strengthening its connection with departments that do a high volume of human subjects research through collaboration 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 training and expertise in research ethics and IRB regulations. Human subjects advisors 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.
To support departmental human subjects advisors, researchers, and IRB members, HRPP updated its protocol and consent form templates with a nationally vetted toolkit from Huron Consulting. The toolkit includes investigator guidance, pre-submission checklists, and other job aids to ensure that investigators are aware of the information the IRB needs in order to review and approve their research studies. These tools will lead researchers through the key ethical and regulatory considerations, improving transparency of the review process. These tools are now a part of the updated HRPP/IRB website.
For more information, please contact HRPP at firstname.lastname@example.org.