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  • Track Descriptors

    1 & 2
    A Dialogue with the Feds Tracks
    These tracks will provide attendees with an opportunity to hear from and ask questions of federal agency representatives.
    Sessions: A1, A2, B2, C1, C2, D1, E1, E2
    3
    Advanced Forum for IRB Professionals Track
    This track will provide experienced IRB professionals with a series of sessions covering challenging and complex issues related to everyday aspects of their jobs.
    Sessions: A3, B3, C3, D3, E3
    4
    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: A4, B4, C4, D4, E4
    5
    Educating and Training Track
    This track will help attendees develop effective educational programs for the assorted stakeholders involved in human subjects protections, by reviewing and discussing the various resources available for education and training.
    Sessions: A5, B5, C5, D5, E5
    6
    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: A6, B6, C6, D6, E6
    7
    Ethical Issues Track
    This track will explore the underlying ethical principles of human subjects research and issues for HRPPs/IRBs as they are translated from the theoretical to the human research setting.
    Sessions: A7, B7, C7, D7
    8
    FDA Regulations Track
    This track will provide attendees with an opportunity to talk with representatives from the FDA and experts in the field about regulations and guidance pertaining to FDA-regulated clinical investigations.
    Sessions: A8, B8, C8, D8, E8
    9
    Global Research Track
    This track is designed for non-US-based research professionals and US-based professionals working outside North America, and will examine issues related to the conduct of ethical research across geographic and cultural borders.
    Sessions: A9, B9, C9, D9, E9
    10
    Hot Topics Track
    This track includes a variety of sessions on topics that are current, complex, and/or late breaking.
    Sessions: A10, C10, D10, E10
    11
    Institutional Officials and HRPP Leadership Track
    This track will provide institutional officials, IRB chairs, HRPP directors, and others with oversight responsibilities an opportunity to discuss concerns and problems, strategies and best practices, and other useful innovations related to the successful oversight of research programs.
    Sessions: A11, B11, C11, D11, E11
    12
    IRB 101 Track
    This track is designed for those new to the field of human subjects protections and will provide information on changes to the Common Rule, key elements of successful HRPPs/IRBs, and best practices in IRB operations and subjects protections.
    Sessions: A12, B12, C12, D12, E12
    13
    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 and being a successful IRB chair. The track will provide the skills and resources that can help IRB chairs excel in their role and manage an efficient and effective IRB.
    Sessions: A13, B13, C13, D13, E13
    14
    IRB Operations Advanced Track
    This track is designed to provide experienced IRB administrators, coordinators, and other professionals involved with HRPP/IRB operations an opportunity to discuss challenging issues, and will provide tools and strategies to achieve administrative efficiency and effectiveness.
    Sessions: A14, B14, C14, D14, E14
    15
    Issues for Pharma/Biotech Track
    This track will provide representatives from drug, device, and biotechnology industries an opportunity to discuss topics of mutual interest, including protocol deviations and violations, expanded access, Clinicaltrials.gov, Good Clinical Practice, and more.
    Sessions: A15, B15, C15, D15, E15
    16
    Legal Track
    This track will cover legal, legislative, and compliance issues in research with human subjects, including the role legal counsel can play within an HRPP, and how understanding and managing legal risks contributes to human subjects protections. Sessions: A16, B16, C16, D16, E16
    17
    Non-Scientist IRB Members Track
    This track will discuss the roles and responsibilities of non-scientist IRB members, as well as provide non-scientist IRB members information on basic scientific topics and foundational strategies for IRB review.
    Sessions: A17, B17, C17, D17, E17
    18
    Out-of-Body Experiences: Research Involving Tissue and Data Track
    This track will explore the complex and evolving ethical and regulatory issues for the collection and banking of biological specimens and data, including consent, limited IRB review, privacy and confidentiality, return of results, secondary research, and more.
    Sessions: A18, B18, C18, D18, E18
    19
    Populations Requiring Additional Protections Track
    This track will explore issues related to vulnerable populations, including regulations, guidance, best practices, and ethical principles, and will redefine vulnerability by looking beyond populations recognized in the federal regulations.
    Sessions: A19, B19, C19, D19, E19
    20
    QA/QI and Post-Approval Monitoring Track
    This track will address current topics and issues faced by QA/QI and post-approval monitoring programs, including investigator site reviews, audit and monitoring findings, quality improvement programs, IRB compliance, and more.
    Sessions: A20, B20, C20, D20, E20
    21
    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: A21, B21, C21, D21, E21
    22
    Responsible Conduct of Research Track
    This track will explore how responsible conduct of research (RCR) intersects with the research enterprise and HRPP/IRB responsibilities. Attendees will gain a greater understanding of the scope of RCR, as it often includes the general areas of research with human and animal subjects, research misconduct, data management, and publication practices, and a better appreciation of the complexities of RCR and issues related to IRB noncompliance (and vice versa).
    Sessions: A22, B22, C22, D22, E22
    23
    Small Research Programs Track
    This track will address the special challenges faced by small research programs at community hospitals, colleges, and research institutions. The sessions in this track recognize the designation "small" is typically self-imposed, and may be given on one or more of the following bases: protocol workload, number of FTE IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.
    Sessions: A23, B23, C23, D23, E23
    24 & 25
    SBER Tracks
    These tracks will cover issues related to the conduct and review of SBER, including the federal regulations governing SBER (including changes to the Common Rule), assessing risks and benefits, mental health and safety plans, research in K-12 settings, research with vulnerable populations and sensitive topics, SBER in international settings, and more.
    Sessions: A24, A25, B24, B25, C24, C25, D24, D25, E24, E25