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    Joint IDSA HIVMA PIDS Letter to NIH Re Opioids and ID Research (PDF)

    IDSA, HIVMA, and PIDS wrote a letter to NIH Director Dr. Francis Collins highlighting priority research questions at the intersection of opioids and ID, and offered recommendations for the NIH Institutes and Centers to address those challenges.

    IDSA Comments to NIAID Re All of Us Research Program (PDF)

    IDSA urges NIAID to promote infectious diseases research considerations as a critical component of the NIH All of Us Research Program.

    IDSA Introduction to HHS Secretary Azar on ID Priorities (PDF)

    IDSA congratulates new HHS Secretary Alex Azar on his appointment and highlights key issues facing patients and public health, including antimicrobial resistance, ID implications of the opioid epidemic, global health security, public health infrastructure and immunizations, research investments, and the ID physician workforce.

    IDSA Comments RE HHS FY2018 - 2022 Strategic Plan (PDF)

    IDSA comments on the Department of Health and Human Services (HHS) FY2018 - 2022 Strategic Plan.

    IDSA Highlights Pressing ID Policy Issues for New HHS Secretary (PDF)

    IDSA outlines a number of pressing ID policy priorities for new HHS Secretary Dr. Tom Price, including antimicrobial resistance, domestic and global public health programs, infrastructure, and preparedness, biomedical research and innovation, and ID physician workforce issues.

    IDSA, PIDS, and HIVMA Joint letter to NIH and OHRP on Informed Consent for Use of De-identified Clinical Specimens (PDF)

    IDSA, PIDS, and HIVMA strongly support improving patient protections.  However, our societies are deeply concerned that the Notice of Proposed Rule-Making’s changes to informed consent for de-identified biospecimens will adversely impact the critical clinical and epidemiology research that enables new medical breakthroughs as well as our ability to respond to public health threats such as the ongoing Zika virus outbreak.

    IDSA Submits Priority ID Research Topics to PCORI (PDF)

    IDSA submitted five recommended infectious disease comparative effectiveness research topics to the Patient Centered Outcomes Research Institute (PCORI).  IDSA believes that PCORI is well suited to initiate research to address these topics.  PCORI has indicated it will review IDSA’s recommendations for possible prioritization in future funding announcements.


    IDSA Comments on NSABB Draft Recommendations to Oversee Gain of Function Research of Concern (PDF)

    At a January meeting, the National Science Advisory Board for Biosecurity (NSABB) unveiled its draft recommendations to the US Government on how to develop regulations for gain of function (GOF) research of concern.  In its comments, IDSA applauded the NSABB’s efforts, and offered practical considerations for the NSABB to ensure a flexible, transparent regulatory framework is developed to oversee GOF research of concern.

    IDSA, HIVMA, and PIDS Comments on HHS Notice of Proposed Rule Making to Revise the Common Rule (PDF)

    IDSA, HIVMA, and PIDS submitted comments to HHS on its 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, citing its negative impact patients and public health by inhibiting clinical and epidemiological research that is critical for new medical breakthroughs and public health surveillance.

    IDSA Comments on NIH Strategic Plan (PDF)

    IDSA responded to an NIH request for information regarding its NIH-wide strategic plan.  IDSA applauded the NIH efforts to develop a unified set of guiding principles for its research, and listed several recommendations for the NIH to consider as it finalizes the plan.

    IDSA Comments to NSABB on Gain-of-Function Risk-Benefit Assessment (PDF)

    IDSA submitted comments to the National Science Advisory Board for Biosecurity (NSABB) to highlight key questions to consider while it works with a contractor to conduct a risk-benefit analysis of gain-of-function research with pandemic potential.

    IDSA, PIDS, and HIVMA Comments to NIH to Improve the Impact and Sustainability of Biomedical Research (PDF)

    IDSA, PIDS, and HIVMA jointly commented on an NIH request for information on ways to optimize funding policies or other strategies that improve the impact and sustainability of biomedical research. The societies' listed areas of concern in administrative burden, workforce sustainability, and prioritization of research funding, and offered specific recommendations to improve them.

    IDSA Comments on the Impact of Select Agent Regulations (PDF)

    IDSA advocates for balancing the risk of impeding select agent research against the risk to the public from accidental or intentional release.  However, IDSA expresses concern that the select agent regulations, in their current state, hinders the discoveries needed to improve our biodefense and public health preparedness, and provides four recommendations to improve the regulations.

    IDSA Comments to NIH on the Use of a Single IRB for Multi-Site Research Trials (PDF)

    IDSA submitted comments to NIH on its proposed draft policy that would require all domestic NIH-funded multi-site trials to use a single IRB.  While IDSA applauded the NIH's efforts to streamline multi-site trials, it also raised several questions for the NIH to consider as it moves forward with finalizing the policy.

    IDSA Comments to PCORI (PDF)

    IDSA applauds the pioneering work done by the Patient Centered Outcomes Research Institute (PCORI), and highlighted the serious complications that can arise from acute infections in patients suffering from chronic illnesses.  IDSA urged PCORI to consider acute infection patient issues and provided several specific examples that align with PCORIs research priorities and review criteria.  IDSA also expresses interest in engaging PCORI in the future on infectious disease-related patient centered outcomes research.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.


    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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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