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Regulatory Burdens in Research

July 2, 2009

The Infectious Diseases Society of America recently released a policy statement on the effects of the increasing regulatory burdens on research and quality improvement efforts.

I couldn’t agree more with their evaluation of the impact of HIPAA and other regulatory procedures on patient privacy and safety in medical research.  As clearly outlined in their statement, researchers want to take any and all necessary steps to insure patient privacy and safety when participating in research.  However, regulations passed in recent years have done nothing to further this goal and only serve as a substantial roadblock to furthering our understanding of diseases and their cures through medical research.

This paper deserves to be read in its entirety, but I want to highlight one paragraph in particular:

We are particularly concerned about HIPAA’s effects on medical record reviews, because such studies are often the initial exposure of trainees to research. Medical record review introduces patient‐oriented research, and its retrospective nature often allows completion of a project in the limited time available during training. In the post‐HIPAA era, nearly all record reviews are judged to require IRB approval, and an increasing percentage are sent for full‐committee review [20]. Even expedited review often requires 1–3 months [37]—a delay that may preclude completion of a project.

I have had the privilege of working with medical students and residents on such research projects.  Fortunately, I was in a position to deal with the regulatory burdens on behalf of these students and residents, freeing them to focus on their research.  However, for many students working on projects in their spare time, this is a hurdle they can’t overcome and may very well leave them with a bad taste in their mouth in terms of research.  At a time when we need more and more graduating medical students to go into research, we can’t have their first experiences in the field be so negative or cumbersome.

I applaud the IDSA for writing and presenting such a paper.  I think it is a critical area of scrutiny, especially in the current health care policy climate where there is an increasing focus on quality improvement and comparative effectiveness research.

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One Comment leave one →
  1. August 14, 2010 9:43 am

    excellent writing .

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