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  • Your Guide to the Conference Tracks

    A Dialogue with the Feds
    This track will provide attendees with an opportunity to hear from and ask questions of federal agency representatives
    Sessions: A1, B1, C1, C2, D1, E1
    Boundaries and Balance Track
    This track will explore potential models for streamlining IRB processes through an examination of existing regulatory flexibility and best practices, and will explore health-related activities that are often said to occur along the imprecisely drawn borders of human subjects research.
    Sessions: A3, B3, C3, D3, E3
    Educating and Training Track
    This track will help attendees develop effective educational programs for the assorted stakeholders involved in human subjects protections. In addition, the speakers in each session will describe, and then discuss with the attendees, the various resources available for education and training.
    Sessions: A4, B4, C4, D4, E4
    Empirical Research Ethics Track
    Using current examples in empirical research ethics, this track will help attendees learn how to read and interpret empirical research ethics literature and make assessments on what counts as good research.
    Sessions: A5, B5, D5
    FDA Regulations Track
    This track will provide attendees with an opportunity to interact with and hear from representatives from the FDA, and other experts in the field, about important FDA initiatives, and pertinent topics in the world of FDA-regulated clinical investigations.
    Sessions: A6, B6, C6, D6, E6
    Global Research Track
    This track is designed for non-US-based research professionals and US-based professionals working outside North America. Sessions will examine issues related to the conduct of ethical research across geographic and cultural borders.
    Sessions: A7, B7, C7, D7, E7
    Hot Topics Track
    This track includes sessions on topics that are current, complex, and/or late breaking.
    Sessions: A8, B8, C8, D8
    Institutional Officials and HRPP Leadership Track
    This track will provide institutional officials, IRB chairs, HRPP directors, and others with oversight responsibilities with an opportunity to discuss shared concerns, problems, strategies, best practices, and other useful innovations.
    Sessions: A9, B9, C9, D9, E2, E9
    IRB 101 Track
    This track is designed for those new to the field of human subjects protections and will provide rigorous training in the elements of IRB operations that are key to successful HRPPs/IRBs and subject protections.
    Sessions: A10, b10, C10, D10, E10
    IRB Chairs Track
    This track will provide IRB chairs an opportunity to gain new insight, exchange ideas, share best practices, and discuss strategies for becoming a successful IRB chair. The track will review the skills, additional education, and resources that can help IRB chairs excel in their role as chair while managing an efficient and effective IRB.
    Sessions: A11, B11, C11, D11, E11
    IRB Operations Advanced Track
    This track is designed to provide experienced IRB administrators, coordinators, and other professionals involved with HRPP/IRB operations with an opportunity to discuss challenging issues, and will provide tools and strategies to address some of the complex issues and regulatory changes IRBs face.
    Sessions: A12, B12, C12, D12, E12
    Pharma/Biotech Perspectives Track
    This track will provide representatives from drug, device, and biotechnology industries and other HRPP professionals an opportunity to discuss topics of mutual interest, including, the European Union General Data Protection Regulation, expanded access, and more.
    Sessions: A13, B13, C13, D2, D13, E13
    Legal Track
    This track explores hot button issues in research compliance from a legal perspective, but also how to best leverage legal expertise to ensure a robust human research protection program. Although this track covers issues of interest to a legal audience, the sessions should be of interest to anyone who encounters legal questions raised in connection with human subjects research and its associated operations.
    Sessions: A14, B14, C5, C14, D14, E14
    Non-Scientist IRB Members Track
    This track will focus on IRB Members that have a unique or specialized role and perspective, in particular, the non-scientist and the non-affiliated members. This track will explore the roles, expectations, relationships, challenges, and strategies of these important IRB members. Sessions will be of interest to the IRB community in general, as well as to non-scientist and non-affiliated IRB members.
    Sessions: A15, C15, D15, E15
    Research Involving Data and Biospecimens Track
    This track explores issues that arise in the context of research on data and human specimens. Many sessions include topics relevant to an SBER audience and are not limited to biomedical research.
    Sessions: A16, B16, C16, D16, E16
    Populations Requiring Additional Protections Track
    This track will explore issues related to vulnerable populations, including regulations, guidance, best practices, ethical principles, and community engagement. In addition, this track will redefine vulnerability by looking beyond populations recognized in the federal regulations.
    Sessions: A17, B17, C17, D17, E17
    QA/QI and Post-Approval Monitoring Track
    This track is intended for those who are responsible for post approval monitoring/auditing of investigator sites and/or IRBs for their institution/organization. The sessions are intended to span across the spectrum of research, and will provide examples and approaches appropriate for those concerned with either biomedical or SBER human subjects research.
    Sessions: A18, B18, C18, D18, E5, E18
    Research Conducted in the Digital World Track
    This track will explore the risks, benefits, and challenges of using the internet, social media, and mobile health applications in research.
    Sessions: A19, B19, C19, D19, E8, E19
    Responsible Conduct of Research (RCR) Track
    This track will cover the area of RCR and how it intersects with the research enterprise and IRB/HRPP responsibilities. Participants will gain greater understanding of the scope of RCR, as it often includes the general areas of research with human and animal subjects, research misconduct (plagiarism, falsification, and fabrication), data management, publication practices, and much more. IRB and HRPP professionals will gain a better appreciation of the complexities and interest of RCR and issues related to IRB noncompliance (and vice versa).
    Sessions: A20, B20, C20, D20, E20
    Small Research Programs Track
    Running small research programs, regardless of institutions’ sizes, may pose both challenges and opportunities. This track provides guidance, advice, and room for brainstorming on how to be efficient and effective in a small IRB office.
    Sessions: A21, B21, C21, D21, E21
    SBER Track
    These tracks will cover basic and advanced issues related to the conduct and review of SBER, including assessing the risks and benefits of SBER, mandatory reporting, building an HRPP in a primarily SBER institution, scientific merit in qualitative research, student research, FDA oversight in SBER, research investigating illegal behaviors, using social media in SBER, and more.
    Sessions: A22, A23, B22, B23, C22, C23, D22, D23, E22, E23