REVIEW
OF QUALITY MEASUREMENT INITIATIVES
Federal regulations require the Partners
Human Research Committee (PHRC) to review and approve
all activities that involve the systematic collection
of information about living individuals if the collection
may contribute to generalizable knowledge and if the information
is recorded in any way that allows the individuals, directly
or indirectly, to be identified*[see
below].
Accordingly,
the Partners PHRC requires submission of any quality measurement
initiative or database if the primary (or part of a dual)
intent is to conduct or support research (i.e., internal
or external analyses of identifiable clinical information
for a generalizable purpose, such as a scientific publication).
Alternatively, if the only purpose of a quality measurement
initiative or database is quality measurement (including
publication of benchmarking analyses or reports), then
no submission to the PHRC is required. Note, however,
that if at some point the purpose of such an initiative
or database changes to include research conducted by someone
at or outside a Partners institution, then the initiative/database
must be submitted for PHRC review at that time.
In
situations when PHRC submission is required, the PHRC
will review protocols on an expedited basis under agency
guidelines permitting expedited review for minimal-risk
research involving identifiable data collected solely
for nonresearch purposes. When more than one research
project is to be performed through one database, and the
projects are sufficiently similar and involve a similar
level of risk to participants, the PHRC will generally
require only one protocol to be submitted for the database.
See the Research
Data Repository submission form within Insight/eIRB for submitting databases
for review.
The
following examples help illustrate the PHRC's policy on
review of quality measurement initiatives.
Examples
of Initiatives That Need Not Be Submitted for PHRC Review:
-
Initiatives in which Partners institutions submit identifiable
(including coded) clinical data to a database maintained
by an outside entity that will aggregate the data with
information from other hospitals and report benchmarking
standards to participating institutions. If this is
the sole purpose of the database, and the database will
not be used by anyone (whether at or outside of Partners
institutions) for research projects, then the initiative/database
does not need PHRC review.
- Initiatives
(whether for benchmarking or other purposes) that use
anonymized information (i.e., there is no way
for anyone, anywhere, even someone at a Partners institution,
to link the information back to a specific individual).
-
Initiatives that are required by state or federal law,
if the identifiable data collected will be used solely
for quality measurement purposes. For example, if the
Centers for Disease Control and Prevention mandates
that hospitals report to the agency or to a database
maintained by a third party all incidences of meningococcemia
they treat, that reporting effort does not require PHRC
review if the information will be used by the hospital,
the agency, and/or any third party only for quality
assurance or improvement purposes. Similarly, if a state
agency requires hospitals to report all maternal deaths
to the agency or a third party for those limited purposes,
PHRC review is not required.
Examples
of Initiatives That Should Be Submitted for Review:
- An
initiative in which a Partners physician proposes to
collect and/or study a set of identifiable (including
coded) clinical data, analyze the data for general trends,
and publish a paper in a scientific or other professional
journal based on his or her work.
- An
initiative in which Partners institutions submit identifiable
(including coded) clinical data to a database maintained
by an outside entity that will use and/or share the
data for research purposes in addition to providing
any benchmarking analyses to participating institutions.
- An
initiative that is required by law, but in which the
hospital, the relevant state or federal agency/government
body, and/or a third party will be using or sharing
the data for research purposes in addition to quality
measurement purposes.
Tips
for Submission of Quality Measurement Protocols:
In
practice, and in light of HIPAA Privacy Rule Requirements,
the PHRC also requires review of such activities when
they involve deceased individuals or both deceased and
living individuals. |