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 Reportable Events! Browse the newsletter to hear perspectives from different HRPP units and professionals regarding the requirement for researchers to promptly report Unanticipated Problems (UPs) and noncompliance to the IRB. |
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A Word from the Institutional Official |
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As the institutional official at VCU, I'd like to share with you an important message about promptly reporting events like unanticipated problems and noncompliance to the IRB. Doing so is a critical aspect of creating and maintaining a culture of transparency and accountability across the research enterprise. When an investigator promptly reports an event to the IRB, they are ensuring the protection of human participants, and in turn the protection over investigators and the institution as regulatory obligations are met. If you ever have questions or concerns about these types of processes, please always feel free to connect directly with the HRPP at [email protected]. You can find additional resources and training opportunities here on our website.
P. Srirama Rao, Ph.D.
Vice President for Research and Innovation
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VCU Receives Historic Gift for Liver Research |
VCU has received a historic, transformational $104 million gift from R. Todd Stravitz, M.D., and his family’s Barbara Brunckhorst Foundation, to support the new Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, which will expand treatment options for liver and liver-related metabolic diseases. (Photo credit: Allen Jones, University Marketing)
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March: Reportable Events Training
Keep calm and report to the IRB! Sign up for one of three training sessions in March to learn all about which events must be reported to the IRB, including Unanticipated Problems (UPs) and noncompliance.
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April: Regulatory Documentation Training
Research is all about documentation, documentation, documentation! Sign up for one of three training sessions in April to learn all about regulatory documentation requirements for human research, including regulatory binders. The HRPP will also present its newly-revised Study Conduct Toolkit for researchers during these sessions.
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Reportable Events: HRPP Perspectives |
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"However, once a researcher receives their IRB approval, that does not mean that the IRB and researcher no longer engage with each other. In fact, the IRB-Researcher relationship should be solidified by keeping the IRB abreast of its progression and IRB must conduct regulatory monitoring of the study and maintain oversight..." |
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Perspectives from the IRB Director |
Dr. Sanjur (Sandy) Brooks, HRPP Director, offers her perspectives on the importance of reporting events to the IRB. |
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Perspectives from the IRB Chair |
Dr. Ron Evans, IRB Chair and Associate Professor in the Department of Kinesiology and Health Sciences, offers his perspectives on the importance of reporting events to the IRB, from the viewpoint of someone who is both a researcher and an IRB Chair. |
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"...the goal of our reporting to OHRP is not to specifically draw attention to the investigator, but instead, the goal is to demonstrate to OHRP that our HRPP is working as intended, and has the accountability and transparency structures in place to adequately manage events should they occur." |
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"We, as IRB Administrators, think of reports as all in a day’s work. Reports are expected, and are a normal part of conducting research. We think it is important to stress that reports don’t mean there will be a negative outcome for investigators..." |
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Perspectives from the IRB Administrators |
The VCU HRPP’s IRB Administrators are professionals who are tasked with ensuring submissions to the convened panel are ready for review at meetings, managing IRB meetings and providing expert regulatory advice, and working closely with investigators to help them respond to requests for changes or information from the convened panel. In this article, the IRB Administrators share their perspectives on reportable events |
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Perspectives from the IRB Analysts |
The VCU HRPP’s IRB Analysts are professionals who are tasked with reviewing and approving minimal risk research at VCU. They independently review and approve expedited research protocols, perform exempt determinations, and make determinations of “Not Human Subjects Research.” In this article, the IRB Analysts share their thoughts on reportable events. |
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"Reporting instances of noncompliance to the IRB helps investigators identify areas of the protocol that should be modified, to either be prepared for a similar situation, or to add flexibility to a protocol. This can help investigators not only avoid problems in the future, but also improve the operationalization of their research..." |
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"When you’re reporting events in the context of research that is reviewed by an external IRB, you are really responsible for reporting to two entities: the reviewing IRB and the VCU HRPP. Remember, the IRB and the HRPP are not one and the same! So, even though your study might be reviewed by another IRB, it is still the responsibility of the VCU HRPP to ensure that subjects at our institution are protected and that local policies and requirements are accounted for..." |
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Perspectives from the IRB Reliance Team |
The VCU HRPP’s IRB Reliance Team is tasked with managing studies that engage in reliance agreements that cede IRB review to another, non-VCU IRB, or which allow the VCU IRB to review for multiple, non-VCU research sites. In this article, the Reliance Team share their perspectives on reportable events |
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Perspectives from the PAMQuIP Team |
The VCU HRPP’s Post-Approval Monitoring and Quality Improvement (PAMQuIP) Team is tasked with providing ongoing oversight and monitoring of human research, following initial approval by the IRB. In this article, the PAMQuIP team shares their perspectives on reportable events. |
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"Our role is to partner with the research team to ensure IRB-approved study procedures are operationalized appropriately to ensure participant safety and make certain documentation complies with federal, state, and institutional regulations. Ideally, this partnership is established before a reportable event occurs; however, regardless of the timing, study reviews always include an educational component to equip the study team with necessary knowledge to address and/or prevent reportable events..." |
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"Reporting an event to the IRB is not necessarily a reflection of your ability to be an ethical or effective researcher. Conducting human research is complex, and while the IRB process is designed to help investigators plan for the unexpected, things like noncompliance or unanticipated events are always a possibility.." |
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Perspectives from the Education & Outreach Team |
The VCU HRPP’s Education & Outreach Team is composed of professionals who are experts in the field of human research regulations. The unit delivers education and training to IRB members, and also engages in education and outreach efforts to the VCU research community. In this article, the Education & Outreach Team offers their perspectives on reportable events. |
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Students in Caitlin Black's ARTE310 - Foundations of Art Education course discuss the Mending Walls murals during class in Fall 2021. |
Caitlin Black (far right) joins Mending Walls creator, Hamilton Glass, and Mending Walls artists, Nadd Harvin & Humble, during a community engagement day in the fall of 2020. |
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"Mending Walls" with VCU Student Researcher, Caitlin Black |
Caitlin Black is a second year Ph.D student in the Department of Art Education. Her research focuses on the transformational power of the arts in cultivating more inclusive communities. She is interested in the significance of community engagement and accessibility in creating meaningful arts opportunities that promote empathy, connection, and healing, rooted in social justice.
Caitlin currently works as an intern with Mending Walls and teaches undergraduate and graduate art education courses at VCU. Presently, she is exploring how preservice art educators perceive the impact of using a local community-engaged mural project (Mending Walls) in foundational coursework. |
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The VCU HRPP welcomes the newest additions to the HRPP Team! Say hello to ... |
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Dr. Sanjur (Sandy) Brooks, DPS, MA, joined the VCU HRPP as Director in November, 2021. Prior to joining VCU, Dr. Brooks was the Chief of Ethics Policy, GS 15, at the National Center for Ethics in HealthCare and Acting Director of Compliance at the Office of Business Integrity at the Department of Veteran Affairs. Dr. Brooks has also previously held the position of Human Protection Administrator and Program Director for the Department of Research Programs at Walter Reed National Military Medical Center. In addition, Dr. Brooks holds an Adjunct Assistant Professor appointment in the Department of Clinical Research and Leadership at George Washington University, School of Medicine.
Originally from Cleveland, OH, Dr. Brooks earned her Doctor of Professional Studies Degree in Bioethics from Albany Medical College. She also holds a Master of Arts Degree in Bioethics from Case Western Reserve University, School of Medicine, and a Bachelor of Arts Degree in Biomedical Humanities from Hiram College. Welcome, Dr. Brooks!
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Kayla Lawrence is a senior biology major at VCU with plans to become a physician assistant after graduation. As a biology major, Kayla has learned how to conduct ethical research, but she wanted to join the HRPP to apply what she’s learned, and to assist with ensuring that human research is conducted ethically here at VCU. She’s excited to join the Post-Approval Monitoring and Quality Improvement (PAMQuIP) division and to learn from all the professionals within the HRPP about how to become a great researcher! Welcome, Kayla! |
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The VCU HRPP says farewell to those who are leaving VCU and thanks them for their service. Say farewell to ... |
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The VCU HRPP says farewell to long-time Senior Associate Vice President for Research Compliance, Susan Robb. Sue has been an invaluable resource to so many around the university for the last 18 years, and in that time has provided a wealth of knowledge, experience, and leadership within the Office for the Vice President of Research and Innovation, not least of which was serving as interim Director of the HRPP from spring 2020 until November 2021.
We thank Sue Robb for her amazing work and leadership, and wish her the best in her future endeavors!
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