The Virginia IRB Consortium provides opportunities for IRB staff, IRB members, and researchers throughout the Commonwealth of Virginia to collaborate on issues related to human research protections and IRBs. The group has held an annual conference since 2007.
The 12th Annual Virginia IRB Consortium Conference took place on Friday, October 19, 2018 at the University of Virginia. More than 130 individuals from 17 institutions attended the conference. The presentations focused on the theme “Science, Ethics, and Regulations of Research Involving Big Data” and featured eight presenters. Topics covered included Precision Medicine, Real World Evidence (RWE) Challenges, Use of Big Data in different research contexts (including mobile applications, clinical data registries, and cross-border data transfer), Large Health Data Sets, the New Benign Behavioral Interventions Exemption, and Reliance Agreements.
The 11th Annual Virginia IRB Consortium Conference took place on Friday, October 6, 2017 at INOVA. More than 130 individuals from research institutions in Virginia, the District of Columbia, and Maryland attended the conference. The presentations focused on the theme: Final Rule Dissected: Moving toward Implementation and featured nine speakers with full presentations as well as a panel discussion with three panelists.
The Tenth Annual Virginia IRB Consortium Conference, "All Aboard: Single IRB Review and Other Proposed Rule Changes", was held at the University of Virginia on September 30, 2016. Financial support was generously provided in part by Public Responsibility in Medicine and Research (PRIM&R). A total of 169 people from 37 institutions and many different professional backgrounds-researchers, study coordinators, IRB administrators, IRB members, institutional officials-came together to participate. The focus was to better understand issues involved in having a single IRB oversee multi-site research, as well as review and process changes under the proposed Final Rule from DHHS. The keynote, "A National Model Reliant Agreement For Single IRB Review, was delivered by Nichelle Cobb, Director of the Health Sciences Institutional Review Boards Office at the University of Wisconsin-Madison, and Kathy Lawry, Director of Reliant Review at Metro Health Medical Center in Cleveland, Ohio. They then participated in a panel discussion, along with VCU Office of Human Research Subjects Protection Director Michelle Stickler and UVA Law Professor Lois Shepherd, on IRB reliance agreements and their standard operating procedures. A second panel discussion focused on review and process changes under the proposed Final Rule. This included discussions of the Excluded and Exempt categories for non-HIPAA research by UVA IRB for Social and Behavioral Research Director Bronwyn Blackwood and ODU Assistant Vice-President for Research Compliance Adam Rubenstein and for HIPAA-regulated research by UVA IRB for Health Sciences Research Director Susie Hoffman, as well as of Broad Consent by VCU Office of Research Integrity and Ethics Director Monika Markowitz. The conference culminated with the initiation of working groups on the topics of single IRB review and broad consent with the goal of fostering collaboration outside of the conference, as well as small group discussions on aspects of single IRB review and proposed Final Rule changes.
Virginia Commonwealth University hosted this year's Virginia IRB Consortium, titled "Adapting to Evolving Research and Regulatory Environments." Attendees with a variety of backgrounds including IRB members, IRB staff, research coordinators, research subject protection directors, etc. attended the Consortium. We had very informative presentations which were themed around change happening in the field. Dr. Jeffrey Cooper discussed flexibility for reducing regulatory burden, Dr. Nichelle Cobb discussed Single IRB review models, and gave insight into how University of Wisconsin Madison does reviews. Dr. Jerry Menikoff from the Office for Human Research Protections presented on the Notice of Proposed Rulemaking, and lastly, faculty from VCU presented on challenges of new research models and community engaged research. Attendees ended the day with a discussion on the effects of the NPRM on large and small IRBs. The feedback was great, and everyone seemed to find the presentations informative, relevant, and useful. CME and CEU credit were also offered.
The Eighth Annual Virginia IRB Consortium, "Lifting the Fog: Issues of Informed Consent, Data Protection and Oversight in QI/Institutional Assessments and Research", was held at the University of Virginia on November 14, 2014 and was sponsored by Public Responsibility in Medicine and Research (PRIM&R), the University of Virginia (UVA), and Virginia Union University (VUU). A total of 179 people from 30 institutions and many different professional backgrounds-researchers, study coordinators, IRB administrators, IRB members, scholars, institutional officials-came together to participate. The focus was to better understand issues in quality initiatives/institutional assessments and research.
The conference opened with welcoming remarks by UVA Associate Vice-President for Research Dr. David Hudson and Institutional Review Board for Health Sciences Research (IRB-HSR) Director Susie Hoffman. Dr. Tracey Hoke, Chief of Quality and Performance Improvement at UVA, Professor Margaret Foster Riley of UVA Law School, and Dr. Danielle Whicher of the Patient-Centered Outcomes Research Institute (PCORI) participated in a panel discussion, moderated by UVA IRB-HSR Chair Dr. Richard Stevenson, on deciphering quality improvement from research and the implications for informed consent. The keynote was delivered by Dr. Danielle Whicher and focused on informed consent requirements for pragmatic comparative effectiveness trials.
The afternoon began with Dr. Ivor Pritchard of the Office for Human Research Protections (OHRP) discussing healthcare operations, quality improvement, comparative effectiveness, and experimental research in the context of the learning health system. Michelle Feige of OHRP and Dr. Michelle Stickler of Virginia Commonwealth University (VCU) then presented on flexibilities in the regulations. The conference ended with two breakout sessions. Brian Davis and Susie Hoffman led a session on UVA procedures to foster collaboration between the IRB and Security Office during protocol review. Elicia Preslan and Dawn Anderson presented a research project on VCU's experience with transitioning to an electronic submission system.
On September 27, 2013, the 7th Annual Meeting of the Virginia IRB Consortium was held in Norfolk, VA. One hundred IRB professionals from Virginia and two other states attended the meeting that was held on the campus of Eastern Virginia Medical School (EVMS) and co-hosted by EVMS and Old Dominion University. The theme for this year’s meeting was “Data Protection Challenges: Keeping it Safe and Secure.”
The morning workshops focused on the meeting theme with two very well-received keynote addresses. The first talk was given by Andrea Di Fabio, security and networks director at Norfolk State University. Ms. Di Fabio provided a stark illustration of the threats to data security that come with increasing use of internet resources. The second talk was given by Sean Owen, director of the Client Cybersecurity Center at Abt Associates. Mr. Owen built upon the first talk by showing how IRBs can enhance data security through well-considered standards, policies, and procedures.
The afternoon was spent in smaller breakout sessions that allowed attendees to explore topics of specific interest. Sessions included information about certificates of confidentiality, work with special populations, HIPAA/HITECH, management of data repositories, and a case study in handling a breach of subject privacy.
Thanks to the sponsorship of the host institutions, Virginia Union University, and PRIM&R, and the generosity of the speakers, the event was a big success. The Virginia IRB Consortium looks forward to seeing this series of meetings continue next year.
The University of Virginia in Charlottesville, Virginia was the host of the sixth annual Virginia IRB Consortium Conference entitled "Research Review Challenges: From the Small IRB to the Age of Technology.” The conference was held on October 12, 2012 with over 100 people participating. The program, sponsored by Public Responsibility in Medicine and Research (PRIM&R), the University of Virginia (UVA), and Virginia Union University (VUU), featured speakers from University of Wisconsin-Milwaukee, the Department of Health and Human Services, University of Wisconsin-Stout, Virginia Union University, University of Virginia, Carilion Clinic, University of Richmond, Virginia Commonwealth University, and James Madison University.
Virginia Union University oversaw the fifth annual Virginia IRB Consortium Conference entitled "Advancing the Culture of Subject Protections in Social and Behavioral Research". The conference, with funding from Public Responsibility in Medicine and Research (PRIM&R), was held on October 14, 2011 in Richmond, Virginia and featured topics included The “Nuts and Bolts” of Establishing an IRB, Creating a “Culture of Compliance” with IRB Regulations, Conducting Internet Research and Related Issues, Using Deception in Research, Working with Student Researchers, Conducting Research with Vulnerable Populations, Options for Protecting Confidentiality, and Applicability of IRBs across Disciplines.
Carilion Clinic in Roanoke, Virginia was the host of the fourth annual Virginia IRB Consortium Conference entitled "After Research is Approved: What's Next?".
The conference was held on November 16, 2010 with 120 participants from 20 different institutions from across the state of Virginia. The program, with funding from Public Responsibility in Medicine and Research (PRIM&R) featured speakers from OHRP, Duke, VCU and WIRB.
The Third Annual Virginia IRB Consortium, “Genetics, GWAS, GINA: “G” How Do We Keep Up?”, was held at the University of Virginia on September 29 and 30 and was a truly collaborative event sponsored by Eastern Virginia Medical School (EVMS), Public Responsibility in Medicine and Research (PRIM&R), and the University of Virginia (UVA). Over 70 people from 12 institutions and many different professional backgrounds-researchers, study coordinators, IRB administrators, IRB members, scholars, institutional officials-came together to participate. The focus was to better understand the science and ethical and legal implications of genetic research involving human subjects.
Two Learning Shots developed for the Consortium (see links below):
- Science of Genetic Research Involving Human Subjects (10 min) Updated 09/24/09
- Ethical, Legal, and Social Implications of Genetic Research Involving Human Subjects (7 min) Update 09/24/09
The Edward Via Virginia College of Osteopathic Medicine in Blacksburg hosted the Virginia IRB Consortium meeting on Friday, April 25, 2008. Topics covered included gene therapy, social and behavioral science, international health, clinical perils and pitfalls, and new federal regulations. There were about 75 people in attendance representing 8 different IRBs in Virginia.
The first meeting of the Virginia IRB Consortium was held on Monday September 24, 2007, at the University of Virginia. The topics discussed were Personalized Medicine and IRB Review of Genetic Research. There were about 60 people in attendance representing 14 different IRBs in Virginia.
If you’d like additional information about the VA IRB Consortium or to be added to the VA IRB Consortium email list, please contact Jean Gaare Eby at firstname.lastname@example.org.