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  • Reducing Unnecessary Regulatory Burdens on Research

    IDSA advocates for the reform of federal regulations that have created impediments to the conduct of critical infectious diseases research and ensuing improvements in patient care. In our 2009 "Grinding to a Halt" policy statement, IDSA highlighted unnecessary regulations that ultimately slow the pace of research, increase costs, and impact research training. Like the Institute of Medicine, we are particularly concerned about regulations that do not enhance patient protections, but instead create obstacles, including the unnecessary application of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to research.

    IDSA encourages recent and ongoing efforts by the Department of Health and Human Services (HHS) to make significant changes to the Common Rule, the set of federal regulations governing human subjects research protections and the functioning of institutional review boards (IRBs). IDSA also works with other research and patient-oriented organizations to achieve changes in the HIPAA Privacy Rule and appropriate harmonization between the Privacy Rule and the Common Rule while also maintaining appropriate patient privacy safeguards.

    See elsewhere, IDSA’s related efforts: 

    Research and Infrastructure 



    IDSA's Efforts in Reducing Unnecessary Regulatory Burdens on Research


    Preventing HIV and other STIs: A Call for Science-Based Government Policies (PDF)

    An HIVMA and IDSA Joint Policy Statement states that in the absence of preventative vaccines or cures for HIV and a number of other sexually transmitted infections (STI), it is imperative that federal and local governments support science-based information and programs to assist persons of all ages in protecting themselves from the acquisition of STIs, including HIV/AIDS.

    IDSA Outlines ID Policy Issues for Trump Transition Team (PDF)

    IDSA outlines important ID policy issues for Vice President-elect Mike Pence, head of the Trump Transition Team.

    Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts

    Burman et al., Clinical Infectious Diseases vol. 49 no. 3 August 1 2009 328-335.

    IDSA published a statement outlining its concerns regarding excessive regulatory oversight and its impact on translational research and quality improvement projects. The statement provides recommendations to federal agencies and the research community on how to alleviate regulatory burdens thereby improving clinical research overall.


    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 Voices Concern on House-Proposed National Institutes of Health (NIH) Policies (PDF)

    IDSA joined other medical societies, research institutions and patient groups to express concern over proposed policies, including lowering the salary cap for NIH grantees.

    IDSA Urges Congress to Establish New National Center for Advancing Translational Sciences (NCATS) in NIH (PDF)

    IDSA and others sent letters to congressional appropriations committee leaders urging them to establish NCATS in the FY 2012 appropriations bill to move high-need medical cures through the development pipeline faster.

    IDSA Supports Continued Investment in Comparative Effectiveness Research (PDF)

    A coalition of medical societies sent a letter to U.S. Senators supporting its investment in Comparative Effectiveness Research (CER). The coalition urges the Senate to maintain its investment in CER so that physicians can continue to rely on evidence-based medicine to provide quality care to its patients.

    IDSA Endorses Legislation to Strengthen Public Health Surveillance Infrastructure (PDF)

    IDSA joined other organizations in support of new legislation to support public health capacity to identify and monitor the occurrence of infectious diseases and other conditions of public health importance, including laboratory capacity to detect antimicrobial resistant infections; and to improve electronic disease surveillance and reporting.


    Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)

    Table displaying the annual support level for various research, condition, and disease categories based on grants, contracts, and other funding mechanisms used across the NIH.  Table shows historical data for FY 2008 through FY 2011 and FY 2012-2013 estimates are based on RCDC actual data.

    Antibiotic Resistance: Implications for Global Health and Novel Intervention Strategies-Workshop Summary

    Workshop Summary, Institute of Medicine Forum on Microbial Threats September 7 2010.

    Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 (2006)

    Hahm et al. The National Academies Press, Washington DC 2006.

    Based on a 2003 workshop, this study describes current public and private programs and recommends ways to recruit and retain more women and underrepresented minorities into clinical research, especially physician-scientists and nurses.

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