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  • Virtual Meeting


     Technical Requirements

    PRIM&R's 2016 AER Conference is happening now, and thousands of your colleagues are joining us in Anaheim, CA. For those unable to attend the conference in person, PRIM&R is once again offering a Virtual Meeting package!

    The Virtual Meeting package offers the live feel of the conference, with the added convenience of on-demand access to certain conference sessions. 

    Virtual Meeting registrants can access the Virtual Meeting login page here. The password to access this page was included in the confirmation email you received upon registering. 

     

    Thank you to our AER16 Virtual Meeting Supporter
    IRBManager


    The 2016 package includes: 

    1. Live streaming sessions on November 14-16 (all times listed in Pacific Time):

    Monday, November 14
    8:00-8:20 AMWelcome from the Conference Co-Chairs
    P. Pearl O'Rourke, MD, Director, Human Research Affairs, Partners HealthCare System, Inc., and Laura Odwazny, JD, MA, Senior Attorney, Office of the General Counsel, Department of Health and Human Services
    8:20-8:35 AMWelcome from PRIM&R’s Executive Director
    Elisa A. Hurley, PhD
    8:35-8:50 AM

    Presentation of the Research on Medical Practice Study Results
    Benjamin S. Wilfond, MD, Director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute; Professor and Chief, Division of Bioethics; Professor, Pulmonary and Sleep Medicine, Department of Pediatrics; Adjunct Professor, Department of Bioethics and Humanities, University of Washington School of Medicine

    8:55-9:40 AM

    Keynote Address: When Human Subjects, Science, and Consumer Rights Collide
    Mary L. Gray, PhD, Senior Researcher, Microsoft Research; Fellow, Harvard University’s Berkman Center for Internet and Society; Associate Professor of the Media School, with affiliations in American Studies, Anthropology, and Gender Studies, Indiana University

    9:45-11:00 AMA New Framework for Human Subjects Research? An Update from the National Academies of Sciences, Engineering, and Medicine
    Moderator: Alexander M. Capron
    Panelists: Barbara E. Bierer, Steven Joffe, Heather K. Pierce
    On June 29, 2016, NAS released the second part of their report, Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report examines the impact of regulations and policies governing federally funded academic research in the United States, and makes a number of recommendations for achieving a “more sensible regulatory structure that harmonizes and streamlines, where appropriate, federal regulation and policies.” Among them is a recommendation that Congress create a Research Policy Board (RPB), a “self-funded, government-linked entity serving as the primary policy forum for discussions related to the regulation of federally funded research programs in academic research institutions.” And, a second recommendation of particular relevance to the research protections community is that “Congress authorize, and the President appoint, an independent, free-standing national commission modeled on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,” the body that created the Belmont Report in 1978. During this plenary session, speakers will provide background about the impetus for and creation of the report, review the report’s recommendations for a RPB and a “Belmont 2.0,” and discuss the potential implications of the report’s recommendations for the field.  
    11:30 AM-12:45 PMPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned? 
    Moderator: Alexander M. Capron, LLB
    Panelists: Barbara E. Bierer, MD, Susan E. Lederer, PhD, David H. Strauss, MD
    Henry K. Beecher’s “Ethics and Clinical Research,” published in the New England Journal of Medicine in 1966, described 22 studies conducted by prominent physicians and medical researchers that reflected serious ethical lapses, including lack of informed consent and apparent disregard for subjects’ rights and welfare. The paper’s extraordinary and enduring influence was a major contributor to the field of human research ethics and the evolution of human subjects regulations. How did Beecher come to examine unethical research and what did he find? How should we understand the complicated historical circumstances that led physician-researchers to embark on projects that seemed so unethical? Can we explain past transgressions without exonerating those involved? Beecher chaired a committee to review research, but did not think highly of committees. Was his skepticism justified? What would he think of today's research ethics? Both Beecher and medical ethics advocate Jay Katz argued strongly for ethical reform, but their views of how it should be accomplished differed in many ways. Whose views were more influential in shaping the system that was adopted? Are contemporary researchers susceptible to the same types of pressures, misguided thinking, and conflicts of interest that sometimes led their predecessors astray? This panel will examine aspects of the continuing legacy of Beecher’s paper, a half century later.
    Tuesday, November 15
    8:00-8:15 AMWelcome from the Conference Co-Chairs
    P. Pearl O'Rourke, MD, Director, Human Research Affairs, Partners HealthCare System, Inc., and Laura Odwazny, JD, MA, Senior Attorney, Office of the General Counsel, Department of Health and Human Services
    8:15-8:25 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Patricia A. MacCubbin, MS, President and CEO, Research Ethics Group 
    Presented by Susan Z. Kornetsky, MPH, Director, Clinical Research Compliance, Boston Children's Hospital; Board Chair,  PRIM&R
    8:30-9:15 AMKeynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials 
    Patricia Furlong, Founding President and CEO, Parent Project Muscular Dystrophy
    9:45-11:00 AM

    Innovations A: Innovations in Public Perceptions of Research and Risks
    Moderator: Warren Capell, MD
    Understanding public perceptions of research and its risks can serve to enhance our knowledge on how best to protect human subjects. Many questions remain about what human subjects think about certain aspects of research, as well as how these views inform their decision to participate. In this panel, three poster authors will discuss their work related to human subjects’ perspectives of research and risks, including the return of incidental findings in a way that is accessible to human subjects; why human subjects enroll in multiple studies and how that affects both their health and the research as a whole; and perspectives on the use of personal data by the public versus private sector.

     
    2:00-3:15 PM

    Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
    Moderator: Christine Grady, RN, PhD
    Panelists:  Michelle H. Biros, MD, Neal Dickert, Jr., MD, PhD, Robert Silbergleit, MD 
    This panel will explore a proposal to re-frame informed consent in a manner that promotes underlying ethical mandates. The research enrollment process serves several morally meaningful roles, including: (1) demonstrating respect for participant autonomy; (2) enhancing communication; (3) promoting engagement in the research; and (4) providing transparency about research aims. These functions are particularly important for research in situations where barriers to traditional consent exist, such as research with semi-conscious or deeply stressed individuals, research involving participants with diminished decision-making capacity, or comparative effectiveness research. Considering the underlying ethical foundations of informed consent is especially timely given the NPRM's focus on revising the enrollment process.  During this session, speakers will describe a function-based approach to informed consent derived from ethical principles; discuss the application of this framework to specific research contexts, with particular emphasis on the acute care setting; and explore how this approach addresses human subjects regulatory requirements.

    Wednesday, November 16
    8:00-8:15 AMWelcome from the Conference Co-Chairs
    P. Pearl O'Rourke, MD, Director, Human Research Affairs, Partners HealthCare System, Inc., and Laura Odwazny, JD, MA, Senior Attorney, Office of the General Counsel, Department of Health and Human Services
    8:15-8:25 AMPRIM&R Membership Update
    Kelly O'Keefe, MPH, Research Ethics Board Manager, Population Services International; Member, Membership Committee, PRIM&R 
    8:30-9:15 AMKeynote Address
    Joseph Garner, DPhil, Associate Professor, Department of Comparative Medicine; Courtesy Associate Professor, Department of Psychiatry and Behavioral Sciences; Member, Child Health Research Institute, Stanford University
    9:45-11:00 AMPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
    Moderator: Laura Odwazny, JD, MA
    Panelists: Christine Grady, RN, PhD, Anne Drapkin Lyerly, MD, MA, Robert M. Nelson, MD, PhD
    Women across the lifespan – women of childbearing potential, pregnant women, and lactating women – historically have been excluded to a greater or lesser extent from research participation. There is a tension between the Belmont Report, which advises the community to be cognizant of principles involving equitable selection of subjects, autonomy, and inclusion in research, and the federal human subjects research regulations that categorize pregnant women as a vulnerable subject population. These additional protections that the federal regulations provide to pregnant women may lead to the under-representation of women in research, and the subsequent scarcity of scientific data on conditions that impact pregnant women, lactating women, and fetuses. These “protections” are more reminiscent of “paternalism,” since they may work against two overarching ethical principles: equal inclusion in research, and recognition that the informed consent process provides capable individuals with sufficient information to make voluntary decisions about participation in research. Furthermore, lactating women, pregnant women, and fetuses have unique biological considerations and react differently to medical treatments and vaccines than the general population. The intended protective effect of considering pregnant and lactating women as “vulnerable” is negated if insufficient research is conducted on preventive care or medical treatment best suited to their particular condition, thus placing when these populations at additional risk in their daily lives. This panel will explore the idea that, based on the above considerations and a focus on the “'forgotten'” Belmont principle of justice, there is an ethical imperative to include fertile, pregnant and lactating women in research.
    2:00-3:15 PMClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
    Moderator: Leonard Glantz, JD
    Panelists: Karen Kaplan, Vinay Prasad, MD, MPH, Gary Schwitzer, Lisa M. Lee, PhD, MA, MS
    A critical part of conducting research is the responsible and accurate communication of results. Given that research is meant to add to generalizable knowledge, communication is the tool by which that is accomplished. While the scientific community usually thinks of “communication” as the publication of results in peer-reviewed journals, there are numerous other channels of communication. One such important form is media coverage of “exciting” research which, at times, is invited by researchers themselves. Even if a peer-reviewed journal reported on research in an accurate and nonbiased way (which is not always the case), downstream communication, such as press releases to the media, can exaggerate the findings so the true results are misrepresented (usually by overstating positive outcomes or potential benefits). This, in turn, has the potential to mislead the general public, political decision-makers, potential funders, and others. This panel will present examples of research results hyperbole and its impact, and discuss ways to address this problem and encourage the honest and accurate communication of results.

    2. Continuing education and CIP recertification credit

    Attendees of the Virtual Meeting can earn up to 9.75 hours of continuing education credit, and up to 9.75 hours may be used as accredited hours by CIPs who are eligible to recertify by continuing education.

    3. Access to audio, video, and slide presentations from the Virtual Meeting for 30 days after the meeting

    Unable to watch the Virtual Meeting in real time? Virtual Meeting attendees will have access to the audio, video, and slide presentations from the aforementioned sessions for up to 30 days after the conference.

    4. Audio, video, and slide presentations from 16 sessions via the conference proceedings

    Watch the video and slide presentations from all the AER16 keynote addresses and panels through PRIM&R's conference proceedings. These proceedings will be available after the meeting via the PRIM&R website (password protected). Notification of when this content is online will be sent by December 16

    5. Conference handouts from the breakout sessions 

    Review conference handouts and resource articles and documents from the AER16 breakout sessions. Registrants will receive a link to the handouts by November 10. (Please note not all breakout sessions will have handouts.)

    6. Access to an online conference bibliography

    Review a list of excellent resource articles that accompany AER16’s keynote and panels. Registrants will receive a link to the bibliography by November 10.  

     

    FAQs and Technical Requirements

    Q: When will I get Virtual Meeting log-in information?
    A:
    The link and password to access the Virtual Meeting will be included in a confirmation email you’ll receive upon registering. The Virtual Meeting webpage will be available starting at 12:00 PM PT on November 10. If you have registered for the Virtual Meeting and did not receive a confirmation email, email registration@primr.org

    Q: What computer software  is required computer view the Virtual Meeting and what do I need to know in advance about viewing the Virtual Meeting on my computer?
    A:
    For the best viewing experience, PRIM&R recommends the following software:

    For Windows

    • Microsoft Windows XP SP3 or later (including Microsoft® Windows 7, 8 & 8.1)
    • Internet Explorer 7.0 or later, Firefox® 3.0 or later, or Google™ Chrome 9.0 or later
    • Adobe Flash Player 11.0 or later
    • Broadband Internet connection (512Kbps or more; 1Mbps is recommended for optimum viewing)

    For Macs

    • Mac OS X 10.4.8 or later
    • Safari™ 3.0 or later, Firefox 3.0 or later, or Google™ Chrome 9.0 or later
    • Adobe Flash Player 11.0 or later
    • Broadband Internet connection (512Kbps or more; 1Mbps is recommended for optimum viewing)

    For Linux

    • SUSE Linux Enterprise Desktop 10 or later, openSUSE 11.0 or later, Ubuntu 8.04 or later, or Fedora Core 9 or later
    • Firefox 3.0 or later,  or Google™ Chrome 9.0 or later
    • Adobe Flash Player 11.0 or later
    • Broadband Internet connection (512Kbps or more; 1Mbps is recommended for optimum viewing)

    For Mobile

    • Apple iOS version 6.0 or higher
    • Google Android version 2.3 (Gingerbread) or higher
    • Broadband internet connection with 768 Kbps downstream bandwidth (for best experience)

     

    In addition, we recommend users check the following before logging into the Virtual Meeting:

    • Check and update your version of Adobe Flash Player.
    • Talk to your organization’s IT department in advance to ensure that no institutional firewalls are in place that would prohibit you from viewing the Virtual Meeting on your computer.
    • Check your computer’s  audio settings to ensure sound is streaming properly from the computer. 
    • Log onto the Virtual Meeting at least 15 minutes in advance to ensure the presentation is viewing properly and the audio is working.

     

    Q: Who do I contact if I have trouble accessing the Virtual Meeting the day of the meeting?
    A: 
    If you experience technical difficulties on the days of the Virtual Meeting, please use the chat feature on the page. If you don’t receive a response and/or you need to speak to an individual, please call BAV Services at 716.261.4700 or email tech support
    If you are having trouble accessing the conference proceedings, handouts, and/or bibliography, contact PRIM&R at info@primr.org

    Q: How do I obtain the certificate of attendance for the Virtual Meeting?
    A:
    The certificate of attendance will be included at the end of the Virtual Meeting evaluation attendees will receive upon conclusion of the program. You do not have to watch the Virtual Meeting in real time in order to obtain the credit hours. If you need a link to the evaluation, please email info@primr.org.