Author: Jon Merz
Date: 01-15-08 16:38
Source: OHRP
URL: http://list.nih.gov/cgi-bin/wa?LIST=OHRP-L
Date published: January 15th 2008
Following the publication of an op-ed entitled "A Lifesaving Checklist" in
the December 30, 2007, edition of The New York Times, some readers have
contacted the Office for Human Research Protections (OHRP) concerning
OHRP's activities referenced in the op-ed. While some expressed concern
that OHRP has prohibited hospitals in Michigan and elsewhere from
implementing a program intervention consisting of a checklist and other
measures to prevent certain hospital-acquired infections, OHRP has taken
no such action. On the contrary, if any hospital or intensive care unit
decides to implement the use of checklists or other measures only for the
reason that they believe those measures will improve the quality of care
provided, they may do so without consideration of the requirements of the
Department of Health and Human Services (HHS) regulations for the
protection of human research subjects (45 CFR part 46).
We note that the op-ed also inaccurately characterized certain facts of
the case involving the Michigan hospitals and how the regulations apply.
In the case the op-ed refers to, the HHS regulations for the protection of
human research subjects applied in an earlier time period when the use of
a checklist was originally implemented as part of a multi-component
program intervention being evaluated in a research study funded by HHS.
The purpose of the study was to find out whether that intervention
decreased the rate of certain infections, which had not previously been
proven. In research studies where the regulations apply, an institutional
review board (IRB) must review the study before it begins to ensure that
the appropriate protections for the prospective subjects are in place.
For example, the IRB looks to see whether the risks to the subjects
participating in the research study have been minimized, and whether the
informed consent of the subjects must be obtained before participation or
whether the proposed research satisfies the regulatory criteria for waiver
of informed consent (see 45 CFR 46.116(d)). OHRP received a complaint
about the research study and determined that no such IRB review had taken
place before the research study began. The institutions were notified, and
a corrective action plan was developed and is being implemented. OHRP is
working with the institutions involved to resolve this situation and to
take action to avoid having this problem happen again.
As stated above, the regulations do not apply when institutions are only
implementing practices to improve the quality of care. At the same time,
if institutions are planning research activities examining the
effectiveness of interventions to improve the quality of care, then the
regulatory protections are important to protect the rights and welfare of
human research subjects. OHRP continues to work to develop guidance to
assist institutions in determining when the regulatory protections are
required and appropriate and when they are not. OHRP will not stand in
the way of practitioners who are only carrying out the important task of
providing the highest quality of care.
To better inform interested individuals about the human subjects research
referenced in the December 30 New York Times op-ed and OHRP's compliance
oversight evaluation of that research, OHRP notes the following:
(1) The research was described in an article published in the December
28, 2006 edition of the New England Journal of Medicine (Pronovost P,
Needham D, Berenholtz S, et al. An intervention to decrease catheter-
related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-
32). (http://content.nejm.org/cgi/content/full/355/26/2725 )
(2) The research was supported by a grant from the Agency for
Healthcare Research and Quality, Department of Health and Human Services
(HHS).
(3) In response to a written complaint about this research, OHRP
opened a compliance oversight evaluation with the Johns Hopkins University
and the Michigan Health & Hospital Association, regarding allegations of
non-compliance with HHS regulations for the protection of human subjects
(45 CFR part 46, see
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The
complainant alleged that the research was conducted without prior review
and approval by an institutional review board and without the informed
consent of the human subjects who participated.
(4) The determination letters issued by OHRP so far during its
compliance oversight evaluation of the research in this case can be found
at:
http://www.hhs.gov/ohrp/detrm_letrs/YR07/jul07d.pdf
http://www.hhs.gov/ohrp/detrm_letrs/YR07/nov07c.pdf
http://www.hhs.gov/ohrp/detrm_letrs/YR07/nov07b.pdf
(5) OHRP is working closely with Johns Hopkins University and the
Michigan Health & Hospital Association to resolve the outstanding issues
expeditiously, as it does in all compliance oversight investigations.
Information about how OHRP conducts compliance oversight investigations
can be found at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf.
Please feel free to contact Dr. Michael Carome, Associate Director for Regulatory Affairs, OHRP, by telephone (240-453-8237) or e-mail (Michael.Carome@hhs.gov) if you have further questions regarding this matter.
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