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    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 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 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.

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

    In a letter to the National Institute of Allergy and Infectious Diseases (NIAID), IDSA shared its concerns about the regulatory burdens that clinical researchers face in the U.S.  IDSA suggests that a centralized Institutional Review Board (IRB) for multicenter infectious disease studies overseen by NIAID would reduce redundancies in research oversight.


    IDSA Comments on List of Research Categories Qualifying for Expedited IRB (PDF)

    IDSA applauded the efforts of the Office for Human Research Protections to clarify the criteria for expedited institutional review board 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.

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