Research and Infrastructure

NIH Reform RFI HIVMA IDSA

IDSA and HIVMA Response to NIAID Strategic Plan

IDSA and HIVMA submitted joint comments in response to NIAID's RFI on its new strategic plan, and research priorities.

NIAID Strategic Plan RFI Template - Word Document

Please find the word document for the strategic RFI.

NIAID Strategic Plan RFI Template

For those interested in submitting a response to NIAID's request for information on its new strategic plan, please refer to this template from IDSA.

IDSA Response to HELP Committee RFI on NIH

IDSA submitted a response to an RFI from Ranking Member Cassidy (R-LA) regarding NIH reform.

IDSA Letter to NIH on New International Grantee Policy

IDSA submitted comments to NIH regarding their new policy for increased documentation for international grantees of NIH funding.

IDSA Letter to NIAID on ID Paylines

IDSA submitted a letter to NIAID regarding paylines on early career awards for ID researchers and physician scientists.

IDSA and HIVMA OSTP RFI on Clinical Trials

IDSA and HIVMA submit comments to OSTP on clinical trial infrastructure and emergency trial governance.

OSTP RFI on Biomanufacturing and Biosafety/Biosecurity

IDSA submits comments to the Office of Science and Technology Policy (OSTP) regarding biomanufacturing and biotechnology, and biosafety and biosecurity at the federal level.

IDSA OSTP Equitable Data RFI

IDSA submitted comments to the Office of Science and Technology Policy (OSTP) on equitable data, and public health engagement.

IDSA Response to RFI on NIH-Wide Strategic Plan for DEIA

Comments submitted by IDSA to the NIH following a request for information regarding its Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA).

IDSA Comments on PCORI’s Proposed Research Agenda

IDSA submitted comments to the Patient-Centered Outcomes Research Institute (PCORI) outlining priority areas for its proposed Research Agenda, which offers a framework for identifying research topics for PCORI support.

IDSA Comments re: NIA Workshop on Microbial Pathogenesis of Alzheimer’s Disease

IDSA wrote a letter to the National Institute on Aging (NIA) voicing its support for the October 5-6 NIA workshop on microbial pathogenesis of Alzheimer’s Disease (AD) and highlighting research priorities at the intersection of infectious diseases and AD.

IDSA and HIVMA response to Office of Science and Technology Policy (OSTP) RFI on Scientific Integrity Practices and Processes

Recommendations from IDSA and HIVMA to the OSTP following a request for information on the current state of federal science integrity policies and promoting trust in federal science.

Joint IDSA-HIVMA Clinical Trial Infrastructure Recommendations for NIAID (PDF)

Clinical trial infrastructure recommendations for future meetings with NIAID leadership, following an initial discussion with the IDSA Board of Directors and Research Committee in March 2021.

Joint IDSA-HIVMA ID Workforce Recommendations for NIAID (PDF)

Infectious diseases workforce and research training recommendations for future meetings with NIAID leadership, following an initial discussion with the IDSA Board of Directors and Research Committee in March 2021.

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.