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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 

     

     

    8/1/2009

    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 in the journal Clinical Infectious Diseases outlining our concerns regarding excessive regulatory oversight and the 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.

    12/2/2011

    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 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.
    7/19/2011

    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.
    9/10/2009

    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 differences between FDA’s and the Office of Human Research Protection's (OHRP) guidance on adverse event reporting and urged FDA to align its guidance with OHRP.

 

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