DRAFT AGENDA TOPICS – to be updated weekly ….
Breakfast, Lunch, Networking hour and conference materials are all included with your registration!
DAY 1 APRIL 29, 2020 9:00 AM – 4:00 PM CONFERENCE NETWORKING HOUR / FREE DRINKS & HORS D’OEUVRES 4:00 – 5:15 PM
Gene therapy studies are quickly becoming a staple of research in oncology, rare monogenic diseases and infectious disease vaccines. The FDA has begun issuing approvals for gene therapy products (e.g. CAR T cells, Imlygic and Luxturna) and is drastically scaling up their infrastructure for the surge of reviews. This presentation will go over the booming growth in the gene therapy field, summarize recent regulatory changes, elaborate on the requirements for IBC review and provide best practices for institutions to avoid IBC review from becoming a rate limiter for study activation.BREAKOUT & GENERAL SESSIONS REGULATORY Sessions
ALL I’s RESEARCH INTEGRITY, BIOSECURITY, BIOETHICS AND YOU™… a hands-on/interactive session
This session will focus on practices implemented at The Jackson Laboratory (JAX) which improved quality processes and communication for personnel working with the two IACUCs and the IBC. By standardizing practices between the regulatory committees, JAX was able to increase efficiencies and reduce burden on administrative staff, committee members, and principal investigators. We would like to share our experiences to help others that may be contemplating doing the same thing – what worked, what did not and how it helped us grow and improve our quality regulatory program.IACUC IBC RISK ASSESSMENT FOR DIFFERENT ANIMAL MODELS: THE EVER-CHANGING PUZZLE … biosafety risk assessment of different animal models STANDARDIZING PRACTICES BETWEEN IACUC AND IBC TO IMPROVE/MAINTAIN QUALITY PROGRAMS
This session will explore the foundations of the current concerns with academic-industry research affiliations and how those concerns resulted in the current federal regulations on financial COI (FCOI). The most common types of COIs will be reviewed along with how institutions generally approach disclosure and management of COIs. Differences between FCOIs and COI as it is currently defined for IACUC review, as per Animal Welfare Act Regulations and the Public Health Service Policy requirements, will be critically examined. Additionally, the impact on rigorous COI review, management, and enforcement on animal research and researchers at various institution types (academic, industry, government) will be evaluated. Several scenarios will be presented. Audience members will learn about important historical events involving research COIs, federal regulatory COI requirements, and current efforts to continue vital academic-industry partnerships in biomedical research while assuaging mounting public alarm. Most importantly, attendees will understand the significance of COI and how it impacts their research programs. AT THE INTERSECTION OF CONFLICT OF INTEREST & THE IACUC: RE-EXAMINING CONFLICTS IN ANIMAL RESEARCH OVERSIGHT
IRB USE OF AN AUTOMATED WIZARD TO PROCESS MINIMUM RISK RESEARCH
Excessive administrative burden is abundant when reviewing human subjects research with no or minimum risk. The 2015 ANPRM provided a mechanism to develop an automated tool, or wizard, to allow investigators to self-determine exempt status. The Federal Demonstration Partnership (FDP) has developed a wizard and tested its use in a blinded side-by-side comparison (demonstration). The pilot showed an 81% agreement between wizard and board determinations, which, when adjusted for institutional policies that were stricter than the regulations, would have been 94% agreement. We have revised this tool by: moving exclusion questions to the beginning of the instrument, increasing the number of exclusion questions and providing categories to aid investigators in making an appropriate decision. Results of the current blinded comparison will be presented, along with a “live” demonstration of the wizard. The wizard runs in Qualtrics and will be available to all for download at the end of the demonstration.
The Department of Justice (DOJ) recovers several billion dollars each year through its enforcement of the False Claims Act (FCA). Universities receiving federal funds for research from NIH, NSF, and other government agencies are often targeted by these actions. In March 2019, Duke University paid $112.5 million for alleged fraud in research sponsored by NIH and EPA. Other schools have likewise reached settlements with the DOJ or face ongoing investigations. RESEARCH INTEGRITY THE FALSE CLAIMS ACT’S APPLICATION TO RESEARCH INTEGRITY
Involves a multi-level, multi-discipline approach to issues facing researchers. These include foreign influences, export control challenges, responsible conduct of research, conflicts of interests, research misconduct, etc. The reason for this approach is that is focus on any influence that could impact researchers and/or academic integrity. The focus is not on any one group or country and can involve influences that are both foreign and domestic. OUTSIDE INFLUENCES ON RESEARCH AND ACADEMIC INTEGRITY
RESEARCH ADMINISTRATOR IACUC/IRB/IBC 101
COMPLIANCE TOOLS OF THE TRADE TO ENGAGE AND PROMOTE COMPLIANCE FOR CONTROLLED SUBSTANCES IN NON-HUMAN RESEARCH
Understand how to build and utilize audit tools to engage and promote compliance with internal policy and state and federal regulations
Learn to create tools for consistent documentation and tracking of controlled substances
Create checks and balances to help detect diversion and weaknesses in your controlled substances program
4:00 PM MEET & GREET … Join your colleagues for a drink and appetizers in the registration area to unwind and share your conference experiences!
DAY 2 APRIL 30, 2020 8:30 AM – 4:00 PM
BREAKOUT & GENERAL SESSIONS
ALL I’S /BIOETHICS/BIOSECURITY INTRODUCTION TO BIOETHICS ACROSS THE THREE I’s and BIOSECURITY FBI BIOSECUITY (panel) SPOT THE ISSUES©
IACUC IBC PRIMER ON BIOSECURITY REQUIREMENTS FOR SELECT AGENT RESEARCH
IACUC IACUC & CHALLEGES
IBC RISK ASSESSMEMT FOREIGN INFLUENCE
This session provides an overview of a variety of social media research methods and contexts that present challenging problems for Institutional Review Boards in the rapidly-evolving world of Internet communication, technologies, and norms of expression. As an ethnographer, a scholar of Internet research ethics, and a Research Compliance Officer with 15 years of IRB experience, I offer a broad perspective on how the field of Internet research ethics has changed over the past two decades, how IRBs and the federal regulations have attempted to keep up (with mixed success), and how the emerging platforms and types of research now coming up for review can be approached. I discuss the contradictions inherent in trying to impose ethical standards on researchers who live in a world of perpetual sharing–a world of increasing cynicism and hopelessness regarding privacy. I present a number of useful examples of cases in which the ethics of online research have been debated and re-framed by scholars from around the world, as Internet data collection so characteristically takes place in a global context. Studies that involve digital ethnography, participant observation, mobile technologies, public vs. private Internet spaces, international populations, closed communities, and gray areas of confidentiality and/or anonymity will be addressed. These concerns range from the apparently casual interactions of online research subjects to the most sensitive and personal information shared among human subjects who may believe themselves to be–or act as if they are–part of an intimate group. Guided by the Revised Common Rule, we must contemplate: What is a reasonable person, in 2020, on the Internet? And how can we determine what that person can reasonably expect as a research subject, in terms of informed consent and protection of their private information?IRB BRINGING YOUR IRB UP TO SPEED ON SOCIAL MEDIA RESEARCH CONTEXTS AND DILEMMAS
Implementing the revised Common Rule has been a challenge for many IRB’s as they struggle with how to update system, operationalize processes and make organizational decisions about how to move forward. The session will draw on recent revised Common Rule implementation and how UNC operationalized the revisions, including; systems, processes, revisions to exempt review and communication to the research community. Implementing large scale changes do not come without challenges and this session will identify both challenges, and opportunities that have presented over the last year. This session will be an interactive opportunity to self identify where your institution is with the revised Common Rule and to discuss next steps, share experiences, and ideas with a group of IRB and research peers.AN IRB DIVIDED BY THE COMMON RULE CANNOT ONLY STAND, IT CAN THRIVE
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement. AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public, AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants. Protecting participants in research is a shared commitment of organizations, researchers, sponsors, and the public. As the research environment has changed to one dominated by multi-site research, there is a need for a flexible, efficient, and effective system of protections for research participants. The concept of the “human research protection program” (HRPP) describes the elements that are involved in protecting participants in research, which can involve shared oversight by many different organizations. This presentation will look at opportunities for flexibility in human research protection programs that can facilitate research, including the notion that the resources devoted to the evaluation and management of research should be calibrated appropriately according to the risks posed by the research. This presentation will center around AAHRPP’s, highly successful global model of establishing an efficient, and effective HRPP.ESTABLISHING A HIGH QUALITY HUMAN RESEARCH PROTECTION PROGRAM (HRPP): THE AAHRPP MODEL
DATA SECURITY AND PRIVACY: A PRACTICAL APPROACH TO PROTECT CONFIDENTIALITY
DATA SECURITY AND PRIVACY: A PRACTICAL APPROACH TO PROTECT CONFIDENTIALITY
IRBs are broadly responsible for assessing risks to human research subjects and ensuring those risks are minimized. One of the principal risks is a breach of confidentiality – the possibility that personal information about subjects will be viewed by others. This risk has been exacerbated by the development of new technologies, especially those using internet-based systems to collect, store, and disseminate data. In our experience, many IRB committee members and research staff lack the expertise to identify potential data security risks and review plans to minimize these risks. At the University of Pittsburgh, a data security assessment instrument was created to assist as a proactive plan targeting the mitigation of confidentiality violations. The completed form is uploaded and reviewed as part of the IRB approval process. This development included collaboration with the University’s Chief Information Security Officer (CIO), as well as with key researchers, IRB staff, security analysts from the Computing Services and Systems Development (CSSD), staff from our federally funded Clinical and Translational Science Institute (CTSI) and security consultants from our affiliated UPMC hospital system. Those collaborations were enhanced with a series of fact-finding meetings with research faculty and staff, and IRB staff as well as educational events with local and national speakers. These meetings were held to guide the collective consciousness about the importance of an effective data management plan. Drawing on these experiences, the “Data Security Assessment Form” for Human Subjects Research was developed and included into each study submitted to the IRB. This form is included in every research study submitted to the IRB which has now been integrated as smartform questions in our electronic application. This process encourages researchers to consider appropriate data security safeguards for their studies while the CSSD review provides the IRB with the information needed to ensure that each study minimizes the risk of breach of confidentiality.
This talk will summarize the process of developing the Data Security Assessment Form and illustrate its use in addition to discussing ongoing collaborations.
At this time in the Electronic Age, technology is pervasive and part of most modern societies and cultures; technologies rapidly advance, many of them increasingly affect our lives, whether we know or care. One evolving aspect is machine learning, where technologies use historical and contemporary data to make decisions, from predicting whether an individual will default on their mortgage to training a robot how to perform surgery. Another aspect of such information processing is computational social science research, where researchers use social data and technology to analyze, model, or simulate social relationships and phenomena. In the midst of all these developments, researchers, IRBs and the public need to identify, understand and address the ethical issues that such advances present.IRB RI INFORMATION, INTEGRITY, AND IRBS (THREE IS) IN THE ERA OF SOCIAL DATA
This workshop-style presentation, presented by Dr. Anne M. Corbin, J.D., Ph.D. and Ross Hickey, J.D., CIP, CPIA., will review a foundational phenomenon of key relationships of responsible conduct of research, namely their social capital. It will pay specific attention to techniques used to nurture and maintain effective relationships (e.g., collaborations, mentorships). It will also examine the pitfalls and repercussions of failing to recognize the importance of social capital in these relationships. Finally, it will equip participants with information and tools on how to leverage social capital to protect and make the most of research relationships. RESEARCH INTEGRITY NAVIGATING NORMS
RESEARCH ADMINISTRATOR HOW TO BETTER COORDINATE BETWEEN THE SPONSORED PROGRAMS UNITS AND THE COMPLIANCE UNITS
PRE-AWARD, COMPLIANCE, TECH TRANSFER
Learn to create a framework that identifies research risk within your institution.
Utilize your risk assessment data to develop a work plan.
Share assessment results and create effective and meaningful reports to support allocation of resources.
COMPLIANCE CONDUCTING AN INSTITUTIONL RESEARCH RISK ASSESSMENT
DAY 3 MAY 1, 2020 9:00 AM – 4:00 PM
BREAKOUT & GENERAL SESSIONS
We will address foreign influence and cyber threat to universities, its research, and the protection of intellectual property rights from a North Carolina perspective. The panel would consist of special agents who specialize in Counterintelligence, Cyber Security, and Biosecurity.
o DEVELOP PROCESSES & CONTROLS
o CRITICAL ELEMENTS OF A PLAN
o INVOLVE & Communicate to ALL … the planALL I’S BIOSECURITY CHALLENGES OF FOREIGN INTEREST, DUE DILIGENCE, INTER AND CONFLICT OF INTEREST
Dependent on the nature of the stem cell research, approval may be required from the IRB, the IBC and the IACUC. In 2005, a well-known case of scientific misconduct involved stem cell research.
What should be considered when your institution conducts stem cell research? THE FOUR CORNERS OF STEM CELL RESEARCH
PUBLIC COMMUNICATION ACROSS THE I’s …
DYI BIOLOGY … Panel: Biohacker, ethics, regulatory/compliance – who understands the drug pathway animal – human
HOW INCREASED COMMUNICATIONS AND TRANSPARENCY TRANSLATE INTO IMPROVED SECURITY AND REDUCED RISK
I. The current state of transparency in animal research
II. Common transparency concerns amongst research organizations
III. How increased transparency can actually reduce risk and improve security
IV. The benefits of revisiting/revising public records protocols
This session will provide attendees with an overview of Tribal IRB processes. The speaker will address common aspects in navigating the regulatory landscape of research with Native American and Indigenous populations on tribal lands and provide examples of successful collaborations. During this session, the speaker will:
•Provide a brief overview of research misconduct with Native American and Indigenous populations in the past, both nationwide and tribally-specific examples
•Discuss specific and unique ethical and regulatory aspects to conducting research with Native American and Indigenous populations on tribal lands
•Outline the specific ethical considerations of conducting research with Indigenous populations from a Native viewpoint (versus a Western perspective) using Indigenous methodologies in order to better understand Native experiences, to educating the external researcher, and providing strength-based outcomes
•Reflect on the revised Common Rule changes addressing tribal sovereignty and Tribal IRBs
•Review some Tribal IRB tools including the rETHICS training for researchers, the Tribal IRB Toolkit for tribal nations, and two recently published manuscripts on building tribal research infrastructure (by the speaker)IRB RESEARCH WITH NATIVE AMERICAN AND INDIGENOUS POPULATIONS: ETHICAL AND REGULATORY PERSPECTIVES FROM A TRIBAL IRB
RESEARCH INTEGRITY TBA
RESEARCH ADMINISTRATOR TBA
Responsible Conduct of Research (RCR) training, mandated by the NIH, NSF and USDA/NIFA for students on funded research projects, requires instruction in ethical behavior/research integrity. While investigators largely endorse this idea, they may associate it with a compliance requirement rather than promoting desirable behavior. My research showed that when RCR is administered by Compliance or Sponsored Programs offices (which is often the case at small or mid-sized institutions), it is presented and perceived as a compliance requirement. Further, while investigators are strongly encouraged to provide “informal instruction,” they may be unaware of what resources are available on RCR topics, particularly local interpretation. At my institution, faculty do not feel equipped to start conversations with students around some RCR topics, and administrators struggle to apply broadly written university policy when addressing issues that arise within certain RCR topics. This session will discuss varying ways different campuses administer RCR training and shares best practices to encourage training based in ethical principles rather than a compliance requirement.COMPLIANCE RCR AS ETHICS, NOT COMPLIANCE
INTEGRATING AND MANAGING START-UPS IN AN ACADEMIC INSTITUTION
Research administration and compliance has become increasingly complex within academic institutions and with collaborations between academic institutions and the entrepreneurial start-ups that often arise from them. When such start-up activities as housed in space on campus what’s the role and responsibility of compliance committees? What’s the liability and who’s in control? Through case examples, I will describe how the UC Berkeley is beginning to address this dilemma and the conflicts that arise when individuals/programs advocating for and promoting these entrepreneurial activities don’t see or know about the bigger picture of research compliance, occupational health and safety, lab safety and how these start-ups integrate into the larger primary activities of academia.
BIOETHICS BIOETHICS Q & A … SEND YOUR QUESTIONS / CASE STUDIES