Conference Theme - Thinking outside the box: Addressing the challenges of human subject research in 2008

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Agenda

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“THINKING OUTSIDE THE BOX:
ADDRESSING THE CHALLENGES OF HUMAN SUBJECT RESEARCH IN 2008”

7:00 – 8:00 REGISTRATION AND CONTINENTAL BREAKFAST

8:00 – 8:15 WELCOME & INTRODUCTIONS
Barry Klein, Vice Chancellor for Research, University of California Davis
Anthony Perez, J.D., Chief Compliance Officer, University of California Davis Health System

8:15 – 8:45 KEYNOTE ADDRESS

  • Roxane Cohen Silver, PhD

8:45 – 9:15 PLENARY PRESENTATION

  • Gigi McMillan, BA

9:15 – 10:45 PANEL DISCUSSION – What’s new from the Feds?
Regulatory updates on human subject protections will be provided by the U.S. Food and Drug Administration, Office for Human Research Protections, and the Department of Defense.

10:45 – 11:00 BREAK

11:00 – 12:15 BREAKOUT SESSIONS (these sessions will run concurrently)

    1. Student Research - The speakers will discuss the various facets of student research, among them separating and defining “classroom activities” from “research conducted by students,” and the IRB’s role in student research projects, including oversight and guidance. Additionally, the faculty member’s role as mentor/researcher/observer will be considered, together with the issues, goals, and processes involved with student research protocols.
    2. Stem Cell Research - A discussion, the ethics of stem research and its relationship to IRBs, SCROs, and the regulations and legalities of the California Institute for Regenerative Medicine.
    3. Human Subject Protections: Regulations and Guidance - The speakers will provide an overview of the Department of Health and Human Service regulations at 45 CFR 46 for the protection of human subjects involved in research. The overview will include the process for determining applicability of the regulations, the basic protections afforded by the regulations, and OHRP guidance pertaining to some of the challenging human subject protection issues facing IRBs, investigators and research staff.
    4. Data Security
    5. Alternative Models of IRB Review An exploration in alternative approaches to IRB review. Topics will include the challenges faced in implementing inter-institutional agreements, as well as atypical local IRB committee structures.

12:15 – 1:30 LUNCH & MINGLING

1:30 – 2:30 BREAKOUT SESSIONS (these sessions will run concurrently)

    1. Research in School Settings
    2. IRB Review in CTSA Sites
    3. Nuts and Bolts of IRB This session will address various practical aspects of IRB submission, review, and processing. Drawing on the experiences of a research scientist and a senior IRB official, it will bring complimentary perspectives to topics such as negotiating multiple-site reviews. The session will take a conversational approach and will welcome questions and contributions from the audience.
    4. Research vs Program Evaluation - This session will encourage discussion of how to separate research from non-research activities.
    5. Research in Community Setting - The following two aspects will be presented and perspectives from participants in the session discussed: (1) The needs of the "community" as they engage in the research process either as participants in clinical trials or their families, and the needs of lay people who participate on IRB committees as Community Representatives. (2) The community broadly defined – the global nature of research. Community-based participatory research, cultural humility, and global health issues will be discussed.

2:30 – 2:45 BREAK

2:45 – 3:45 BREAKOUT SESSIONS (these sessions will run concurrently)

    1. California Information Security, Privacy Protection and Access and Information Privacy Act Changes (SB 13) - This session will present the State and federal mandates for information/data security, researcher responsibilities and changes in the State Information Security Office. Also included are purview of the State IRB, including implementation of SB 13 along with proposed federal changes to engagement in research definitions. A briefing of how the Univeristy of California is complying with research-related data security and privacy requirements will also be included.
    2. Reviewing & Reporting Adverse Events/Unanticipated Problems: FDA & OHRP Guidance - This session will provide a comprehensive overview of the HHS and FDA regulations and guidance for reporting and reviewing unanticipated problems and adverse events. The session will focus on investigator reporting to the IRB in a manner that enhances the protection of human subjects.
    3. Clarifying the Role of IRB Members and Admin Staff - This panel will discuss, compare and contrast the obligations of IRB members per federal regulations; whether IRB staff should be IRB members; and, the practical aspects of the daily work of the IRB Chair or Members and the IRB staff as it pertains to who does what and how. Institutions have developed a variety of procedures and processes to meet the federal requirements and this session should help you think of what you might change, improve and/or implement to improve IRB operations.
    4. Education of Researchers
    5. Michigan Initiative - FWA: "Unchecking the Box" - The session will discuss HRPP innovations and demonstrations for non-federally funded research underway at the University of Michigan. The planning process and roll-out of two demonstration projects will be discussed, as well as early working plans for additional demonstrations.

3:45 – 4:30 PANEL DISCUSSION – Q&A SESSION

4:30 CONFERENCE ADJOURNMENT