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    02/18/2014

    IDSA Letter to NIH on Informed Consent for Research Use of Clinical Specimens (PDF)

    IDSA strongly supports improved patient protections but is concerned about certain proposed informed consent reforms in the Advance Notice of Proposed Rule-Making that would negatively impact patients and public health by inhibiting clinical and epidemiological research that is critical for new medical breakthroughs and public health surveillance.
    04/23/2013

    IDSA Comments on Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF)

    IDSA Supports the principles underlying the draft U.S. Government (USG) policy, but urges the USG to re-define the scope of oversight and provide much more specific guidance, analytical tools and other resources to assist institutions in implementation.
    12/14/2012

    IDSA Comments on HHS H5N1 Select Agent Proposal (PDF)

    IDSA advocates balancing the public health risk of impeding the conduct of H5N1 research against the public health risk of an accidental laboratory release or act of bioterrorism.  IDSA recommends that naturally occurring H5N1 viruses and vaccine strains be regulated as HHS select agents with current biosafety and biosecurity regulations, while H5N1 viruses that have been engineered for greater transmissibility or pathogenicity be regulated as Tier 1 select agents, and with increased biosafety and biosecurity restrictions.
    03/15/2012

    IDSA Comments on Patient-Centered Outcomes Research Institute (PCORI) Draft Research Priorities and Agenda (PDF)

    IDSA applauded PCORI for developing the first Draft National Priorities for Research and Research Agenda that will serve as the framework for building the emerging field of patient-centered outcomes research (PCOR).  IDSA urged PCORI to consider infectious disease areas that align significantly with PCORI's priorities and where there are gaps in the current evidence base that would benefit from PCOR.  Critical ID areas include diagnosis and treatment of hepatitis C, reduction of health care-associated infections and improvement of antimicrobial stewardship.
    12/21/2011

    IDSA Comments on FDA Development of Multiplexed Diagnostics (PDF)

    FDA sought comments on options being considered for the performance validation of highly multiplexed microbiology/medical countermeasure (MCM) diagnostic devices.  In responding to the FDA concept paper, IDSA addressed the clinical and public health need for better infectious diseases diagnostic devices, clinical considerations for device design, and key issues for device validation.
    12/02/2011

    IDSA Comments on Select Agents and Toxins Proposed Rule (PDF)

    IDSA conveyed its appreciation to CDC/HHS for aspects of the Proposed Rule that provide greater clarification for managing select agents and toxins.  However, IDSA offered five overarching recommendations that improve biosecurity while taking into account the impact of regulations on research essential to public health and national security.
    10/26/2011

    IDSA/Others Say FDA Must Have Access to Knowledgeable Subject Matter Experts (PDF)

    IDSA joined over 75 provider and patient advocacy organizations in urging Senate leaders to eliminate over-the-top conflict of interest requirements that apply only to Food and Drug Administration advisory committees.  These requirements tie FDA's hands preventing the agency from hearing opinions from the most knowledgeable experts prior to approving new drugs, vaccines, diagnostics, etc.
    10/26/2011

    IDSA Comments on HHS Common Rule Advance Notice of Proposed Rulemaking (PDF)

    IDSA submitted comments to HHS on the proposed changes to human subjects research protections.  IDSA applauded a majority of the proposals, including mandating a single IRB for multi-site studies.  However, IDSA cautioned strongly against new informed consent requirements for biospecimens and importing HIPAA privacy definitions into the Common Rule.
    07/19/2011

    IDSA Submits Comments to HHS on HIPAA and Research (PDF)

    IDSA responded to an HHS proposed rulemaking urging that research be exempted from the HIPAA Privacy Rule and that a new privacy protection framework be created for research.  Until that can be accomplished, IDSA urged HHS to take intermediate steps to mitigate the negative impact of HIPAA on research.
    06/08/2011

    IDSA Letter to NIAID on Clinical Trials Network and Repository (PDF)

    IDSA sent a letter supporting the new NIAID clinical trials network primarily focused on bacterial antibiotic resistance. IDSA also proposed the establishment of an ID clinical specimen repository, which could be housed at NIAID and linked to clinical trials conducted through the network and other sites.
    08/19/2010

    IDSA Suggests Changes to NIAID Clinical Trials Infrastructure (PDF)

    In a letter to NIAID Director Fauci, IDSA provided its input on the future structure and objectives of NIAID’s clinical trials infrastructure.

    10/19/2009

    IDSA Urges NIAID Clinical Trial Networks Expansion into Key Areas (PDF)

    NIAID officials are examining the possibility of expanding the Institute’s clinical trials networks to cover tuberculosis, hepatitis C, and influenza research. IDSA supports this proposal and has requested that resistant bacterial infections also be considered.
    09/10/2009

    IDSA Requests FDA to Issue Revised Guidance on Adverse Event Reporting (PDF)

    In a letter to FDA Commissioner Dr. Margaret Hamburg, IDSA stated its concerns about the current adverse event (AE) reporting system for clinical research. IDSA supports the Office of Human Research Protection's (OHRP) guidance on AE reporting and urges FDA to align its guidance with OHRP.
    07/28/2009

    IDSA Proposes Clinical Trials to NIAID that Aim to Improve Antimicrobial Stewardship (PDF)

    IDSA proposes three, randomized, multi-centered controlled trials to the National Institute of Allergy and Infectious Diseases (NIAID) that seek to optimize antimicrobial prescribing practices.
    06/30/2009

    IDSA Urges NIAID to Create a Centralized Institutional Review Board (IRB) (PDF)

    In a letter to NIAID Director Anthony Fauci, IDSA shared its concerns about the regulatory burdens that clinical researchers face in the U.S. IDSA suggests that a centralized IRB for multicenter infectious disease studies housed within NIAID would reduce redundancies in research oversight.
    12/28/2007

    IDSA Comments on List of Research Categories Qualifying for Expedited Institutional Review Board (PDF)

    IDSA applauds the efforts of the Office for Human Research Protections to clarify the criteria for expedited IRB review.  The expedited review mechanism is an important means for bringing efficiency to the review process for low-risk research while preserving a rigorous independent review.
    08/20/2007

    IDSA Responds to NIH's Request for Information Regarding NIH Support of Biomedical Research and the Peer Review System (PDF)

    IDSA views the recruitment and retention of infectious disease researchers, especially clinical investigators, as a key priority. In the infectious disease arena, the apparent shortfall and reported attrition of researchers may relate primarily to low paylines and limited new R01 resources for physician-scientists.
    07/16/2007

    IDSA Proposes Clinical Trials to NIAID for Three Common Infectious Diseases (PDF)

    IDSA proposes three, randomized, multi-centered controlled trials to NIAID that would help clarify the optimal antimicrobial therapy for common infectious diseases.
    04/25/2005

    HIVMA and IDSA Challenge NIH Conflict of Interest Rules (PDF)

    HIVMA and IDSA wrote to the U.S. Department of Health and Human Services’ Office of the General Counsel expressing concern about key components of the interim final rule on conflicts of interested promulgated on February 3.

 

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