The VCU Human Research Protection Program Newsletter is a place to learn about exciting upcoming events, hear from professionals in the field, and learn new things about the conduct of human research. This month, it's all about investigators who are newly joining VCU. Welcome new investigators! Browse the newsletter to learn important information, find useful tools, and to see the latest news from the HRPP! | |
New Guidance for Investigators Using Juul Products in their Research | |
Due to a confluence of actions by the FDA and federal appeals courts, Juul products are currently not allowed to be marketed or sold in the US. Investigators who currently use, or had planned to use, Juul products in their research studies must review the guidance document below and take appropriate action based on the guidance document. This guidance document can be found in the future on the HRPP Policies and Guidance Webpage. | |
VCU HRPP at the AAHRPP Conference | |
In May, 2022, members of the VCU HRPP, Elicia Preslan, MS, CIP, and Nyssa Towsley, MS, CIP, presented at the Association for the Accreditation of Human Research Protection Programs (AAHRPP) annual conference. Elicia presented on assessing capacity to consent in adults, and Nyssa presented on IRB member recruitment and training. Here are some pictures from the event! | |
Nyssa Towsley, MS, CIP along with co-presenter John Horigan (NIH - All of Us Research Program) at the AAHRPP Conference in May 2022 | |
Attendees in the ballroom at the AAHRPP Conference in May 2022 | |
Introducing the "Deep Dives" Blog Series
The VCU HRPP is pleased to present a new blog post series called "Deep Dives." This series of blog posts is intended to delve deeply into different regulatory topics of importance. This first post in the series explores the difference between Exempt Human Subjects Research, and projects that are Not Human Subjects Research (NHSR).
In the future, access the Deep Dives posts using the Deep Dives tag on our blog.
| | |
|
The HRPP is Seeking Students With an Interest in Research!
The VCU HRPP is seeking to hire several student workers to assist with operational tasks within various units within the HRPP. The ideal students for these roles include those who have an interest in the research enterprise, are highly motivated, and possess excellent analytical and communication skills.
Interested students can apply using Handshake. There are two positions available: general HRPP support, and support to the Protocol Development Consultants pilot program. Multiple hires may be made for the general support position. Only one hire will be made for the PDC support position.
| |
New-to-VCU Faculty Resources | |
|
Human Research "Quick Start Guide"
The IRB is not the end-all-be-all of the human research oversight reviews. There are separate but equally important processes and reviews, such as the Protocol Review and Oversight Committees (PROCs), and Conflict of Interest (COI) review, to name a couple.The Human Research Quick Start Guide is a tool to help investigators identify ancillary reviews and processes that go in tandem with IRB review.
This REDCap-based tool helps investigators explore ancillary reviews and processes that are or may be required for their research projects, prior to the project being submitted to the IRB, and points investigators in the right direction for where to get help with common research development questions.
Investigators make selections in the tool to describe aspects of their project, and the tool will generate a list of links, suggestions, and contacts to help get a research project off the ground and ready for IRB review! This list can be saved as a PDF and referenced again later.
This Quick Start Guide will be accessible from the HRPP's main page and getting started page moving forward.
| |
|
RAMS-IRB Gif Guides and Videos
Did you know that the VCU HRPP offers video walkthroughs and narrative guides on how to navigate RAMS-IRB? Whether you're new to RAMS-IRB or have been using it for years, the RAMS-IRB Gif Guides and Video Walkthroughs can help you navigate RAMS-IRB with ease!
| |
|
HRPP Consultation Program
HRPP Staff are available for consultations with investigators who are developing IRB submissions. Investigators with existing submissions should contact the person designated as IRB Coordinator for their submission in in RAMS-IRB. But, prior to submission, the consultation program is a great way to start your project off on the right track!
| |
Information for New-to-VCU Investigators | |
VCU Human Research Training Requirements
Learn more about VCU's training requirements for investigators conducting human research, including CITI training, in our New Investigator blog post series.
| |
| |
|
Transferring Active Studies to VCU
Investigators who are bringing active research studies with them from their previous institutions must arrange for VCU IRB review. Learn more about this requirement in our New Investigator blog post series.
| |
Exempt Research Requirements
VCU requires exempt research to be submitted to the IRB for review and approval. Learn more about these institution-specific requirements in our New Investigator blog post series.
| |
|
HRPP Perspectives: Effectively Interacting with the HRPP/IRB | |
Meet the Deans: Research Dean Feature | | |
|
Meet Dr. Gary Cuddeback, Ph.D., Professor and Associate Dean for Research and Interim Associate Dean for Faculty Affairs in the School of Social Work | |
Dr. Gary Cuddeback, Ph.D., joined the faculty at VCU from the University of North Carolina at Chapel Hill, where he was the Berg-Beach Distinguished Professor of Community Social Work at the School of Social Work, a faculty research fellow at the Cecil G. Sheps Center for Health Services Research, and a research professor with the Department of Psychiatry.
Dr. Cuddeback is a mental health services researcher and conducts implementation and effectiveness studies of interventions designed to improve outcomes of individuals with severe mental illnesses in criminal justice settings. He has published papers about the physical health needs of justice-involved individuals with severe mental illnesses; the role of Medicaid on mental health service use and recidivism after jail release; the characteristics of individuals with mental illnesses who are incarcerated in jails versus prisons; and adaptations of evidence-based practices for justice-involved individuals with severe mental illnesses.
Over the years, Dr. Cuddeback’s research has required complex IRB applications, specialized consent protocols and unique research considerations, as well as many, many interactions with IRB analysts and committees. Over time, he feels that these interactions greatly improved his ability to anticipate and address human subjects issues and helped him think critically about all aspects of his research. As a researcher and an IRB member, he has a great appreciation for the dedicated HRPP staff and IRB committee members who ensure high quality research and the protection of human subjects. Dr. Cuddeback recognizes the IRB as a partner and a resource, and its critical role in our research community here at VCU.
| |
VCU Student Researcher and PhD Student in the School of Social Work, Sarah Lineberry |
Sarah Lineberry presenting some of her research at the Graduate Research Symposium in 2022 | |
Improving Outcomes for People with Intellectual and Developmental Disabilities, with VCU Student Researcher Sarah Lineberry | |
Sarah Lineberry is a fourth year PhD student in the School of Social Work and is a graduate research assistant at the VCU School of Social Work and the Partnership for People with Disabilities. Her research focuses on policies and services that support people with intellectual and developmental disabilities (IDD), particularly in the area of health equity. At The Partnership, Sarah works on an interdisciplinary team using large merged administrative datasets to identify practices that improve outcomes for people with IDD living in the community.
Since the start of the COVID-19 pandemic, Sarah has increased her work on improving access to quality healthcare and improving health outcomes for people with IDD, combining her research with her on-the-ground experience as a member of the COVID-19 response team at the Richmond City Health District. In addition to The Partnership, Sarah has collaborated on projects with the Center for Dignity in Healthcare for People with Disabilities, including work on a report to the White House COVID-19 Health Equity Taskforce. Sarah’s dissertation uses the lens of epistemic injustice to understand how ableism shaped the COVID-19 response as it relates to people with IDD.
In her dissertation and in her career, Sarah hopes to draw from her work as a practitioner with people with IDD and with the health department to conduct research that promotes equitable access to healthcare and support services for people with IDD, including responsible planning for future public health emergencies.
| | | | | |
