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 Ethics, Integrity, and the importance of the IRB operating as an independent body within the university. Browse the newsletter to hear from HRPP leaders and researchers on this topic, and to see the latest news from the HRPP! |
|
A Word from the Institutional Official |
|
|
|
Dear colleagues,
As the institutional official at VCU, I'd like to share with you an important message about integrity and ethics in the context of undue influence and inducement of IRB members. I cannot overstate the importance of the IRB operating as an independent body, and encourage you to read the OVPRI's compliance notice on this topic. The work of the IRB is essential to patient health and protection, and independent by law. Any efforts to impede their work or retaliate against anyone working to support the IRB process are unacceptable and constitute violations of the VCU Code of Conduct for which appropriate consequences will follow.
P. Srirama Rao, Ph.D.
Vice President for Research and Innovation
|
|
VCU HRPP on the National Stage |
Two HRPP Staff members, Elicia Preslan, MS, CIP, and Nyssa Towsley, MS, CIP, are presenting at the upcoming Association for the Accreditation of Human Research Protection Programs (AAHRPP) national conference, being held in Denver, CO from May 24-26, 2022! |
|
 |
Elicia Preslan, MS, CIP, will be presenting a session titled "Balancing Inclusion with Protection: Assessment of Capacity to Consent." |
|
|
|
Nyssa Towsley, MS, CIP, will be presenting a session titled "A(n Even) New(er) Look at an Old Problem: IRB Member Recruitment and Training." |
|
|
|
HRPP Team Volunteers at Maymont |
|
In March, the HRPP held a team building day, full of exciting activities, including a volunteer project at the historical Maymont Estate, in Richmond, VA. The team worked to help organize supplies in preparation for spring events. The team had a lot of fun, and the HRPP hopes to engage in community service activities like this one again! Check out some photos from the event below. |
|
HRPP Team Members working in a back room at Maymont, organizing supplies. |
|
HRPP team members unloading supplies from the bed of a white pickup truck on the grounds of Maymont. |
|
HRPP members on the grounds of the historic Maymont estate. Left to right: Sanjur “Sandy” Brooks (Director, HRPP), Christine Davison (Associate Director), Elizabeth Marlowe (PAMQuIP Manager), Elicia Preslan (QI/QA Manager), Stacy West (IRB Reliance Manager), and Courtney Roberts (IRB Analyst). |
|
Integrity and Ethics, Community Impact, and the HRPP
As part of the VCU Human Research Protection Program's (HRPP) commitment to continual improvement, we generate metrics to evaluate how well our program complies with regulations, engages the community, and upholds VCU's core values.
For example, did you know that almost 10% of the VCU IRB Membership is comprised of community members? Learn about this and other interesting facts about the HRPP by clicking the button below!
|
|
NEW TOOL: Human Research "Quick Start Guide"
The VCU HRPP is pleased to offer a new tool to assist investigators in preparing for IRB reivew: the Human Research Quick Start Guide!
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.
|
|
Ethics and Integrity Resources |
|
Ethics and Integrity are at the heart of everything we do at VCU, especially in the research we conduct here with human participants.
Learning and understanding the nuances of research ethics and integrity can be challenging. Fortunately, VCU offers several resources on this topic. See the sidebar to the right for helpful links!
|
|
Check out the following Ethics and Integrity resources:
|
|
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!
|
|
The Importance of Independence: HRPP and Researcher Perspectives |
|
"An IRB that is not acting independently exposes human research participants to potentially significant risks, as well as erodes public trust in not only the IRB review process and an institution, but human subject research as a whole." |
|
Perspectives from the HRPP Director |
Dr. Sanjur “Sandy” Brooks, DPS, MA, is the Director of the VCU Human Research Protection Program. In this article, she reflects on the importance of the IRB operating independently, free from undue influence or inducement. |
|
Perspectives from a Research Dean |
Dr. Michael Donnenberg is the Senior Associate Dean for Research and Research Training and Professor of Internal Medicine and of Microbiology and Immunology in the VCU School of Medicine. In this article, he shares his thoughts on the topic of ethics and integrity, with an emphasis on the importance of the independent operation of the IRB. |
|
"...researchers need independent review of their human subjects research plans for two main reasons: (1) human nature doesn’t allow us to objectively analyze the risks and benefits of our own work, and (2) the pubic needs to have confidence that human subjects research will not be conducted if the risks outweigh the benefits." |
|
"... it is imperative that IRB panel members involved in these discussions ... be allowed to make these determinations free of undue influence from other panel members, colleagues, supervisors, study sponsors, or administrators." |
|
Perspectives from the IRB Chair |
Dr. Ron Evans is an Associate Professor in the Department of Kinesiology and Health Sciences and currently serves as Chair of the VCU IRB Social Behavioral/Biomedical panel. In this article, Dr. Evans reflects on the importance of the IRB operating independently, free from undue influence or inducement. |
|
Meet the Deans: Research Dean Feature |
|
|
|
Meet Dr. Michael Donnenberg, Senior Associate Dean for Research and Research Training in the School of Medicine! |
Dr. Donnenberg came to VCU in November, 2016 after 27 years at the University of Maryland, Baltimore. He received his MD from the Columbia University College of Physicians and Surgeons and trained in Internal Medicine and Infectious Diseases at Johns Hopkins Bayview and Tufts/New England Medical Center.
Dr. Donnenberg’s active research effort is focused on the molecular pathogenesis of enteric infections, particularly those due to enteropathogenic Escherichia coli and Clostridium difficile. Despite the vast evolutionary distance separating these potentially deadly microbes, they both produce similar surface appendages called type IV pili. Such pili are used by numerous pathogens to colonize and move along host cell surfaces. Pilus assembly and retraction are powered by a multicomponent membrane-spanning molecular machine. Understanding how this machine works is a long-term goal of the lab. His publications include over 100 original manuscripts, numerous reviews, books and book chapters, with over 15,000 citations (view his NCBI library). He is a Fellow of the Infectious Diseases Society of America and the American Academy of Microbiology and a member of the American Society for Clinical Investigation. He is a recipient of the Oswald Avery Award from the Infectious Diseases Society of America.
Dr. Donnenberg also directs the VCU SOM MD-PhD program and advises the SOM Dean and the VCU Vice President for Research and Innovation on matters related to research.
If you have questions or concerns about ethics and integrity in research at the SOM, you can contact Dr. Donnenberg, in addition to the other resources highlighted in this issue.
|
|
Emergency Preparedness Tips |
|
Make Backups of Your RAMS-IRB SmartForm/Protocol to Prepare for an Emergency
In the event of an emergency, researchers may have limited access to electronic systems at VCU, including the RAMS-IRB system. As such, it is important for researchers and research teams to have access to a backup copy of their most recently-approved IRB submission/protocol, that can be accessed outside of RAMS-IRB. It will be important in an emergency situation for you to be able to reference a document that outlines precisely what is currently approved by the IRB for your study.
You can learn how to save a backup of your RAMS-IRB SmartForm/Protocol by viewing the Gif Guide on this topic, which you can access through the button below.
|
|
Student Researcher, Gus White |
Gus (far right) is joined by other members of his MD/PhD cohort, as well as MD/PhD Program Director Michael Donnenberg MD, at their white coat ceremony in June of 2018. |
|
Improving the Health of Tobacco Users with VCU Student Researcher, Gus White |
Gus White is a 4th-year MD/PhD student in the Department of Health Behavior and Policy, currently working as a graduate research assistant at the VCU Center for the Study of Tobacco Products (CSTP). At CSTP, he works in the field of tobacco regulatory science, informing policymakers on ways to decrease the public health burden of tobacco use in the United States. Specifically, his research focuses on the abuse liability of alternative tobacco products (e.g., e-cigarettes, heated tobacco products) and the factors that drive substitution with these products among combusted cigarette smokers.
Ultimately, Gus aims to combine his interests in research and medicine by pursuing a career as a physician-scientist. He hopes to conduct clinical trials within the field of addiction medicine, developing novel approaches and interventions to help those who develop drug dependencies improve their health and wellbeing.
Gus is currently in his 2nd-year in the Healthcare Policy and Research PhD program. In addition to his work in tobacco regulatory science, he also has interests in behavioral economics, health economics, and the design of online experiments.
|
|
The Office for the Vice President for Research and Innovation has recently undergone some changes in leadership. Read more about these changes below! |
|
|
|
Lisa Ballance has transitioned into her new role as associate vice president for strategy and regulatory affairs. Lisa now oversees critical aspects of the VCU research enterprise, including guiding the One VCU Research Strategic Priorities Plan and overseeing VCU’s comprehensive regulatory affairs programs, including the human research protection program, the animal care and use program, and clinical research regulatory affairs. |
|
|
|
Tina Cunningham, J.D., has transitioned into her new role as associate vice president for research administration. In addition to continuing to oversee the Division of Sponsored Programs, Tina’s new duties include responsibility for and oversight of the export compliance program, the controlled substances program, the policies and compliance notices program, and general non-compliance investigations. |
|
|
|
|
|
|
Ivelina Metcheva, Ph.D., has transitioned into her new role as assistant vice president for innovation. Ivelina will continue to manage all technology commercialization activities at Innovation Gateway, and will additionally have oversight of faculty entrepreneurship and new ventures creation (start-ups), regional economic development, and strategic relationships with industry. Ivelina’s team will support faculty and staff entrepreneurship and new ventures creation by providing mentoring to faculty and support to newly launched start-ups. |
|
|
|
Michael Newsome remains senior associate vice president for finance and operations but has taken on additional management and supervisory duties over the Division of Animal Resources and the OVPRI’s project manager, who coordinates the work of multiple university-wide committees and task forces. |
|
|
|
|
|
|
James Ward has transitioned into his new role as assistant vice president for research computing. James oversees all aspects of the Research Computing Center and Division of Research Information Systems across the VCU research enterprise. The center provides a central IT hub to support research computing needs, while the division provides oversight of all research administration systems. James provides IT strategic direction and planning for research computing, mentoring and leadership for research computing initiatives, and oversees senior research computing staff, employee growth, and diversity in IT research computing. |
|
|
|
|
|
|
|
|
