The fundamental charge
of a Human Subjects Review Committee is to look out for the interests
of volunteers in “research” studies. Research policies
distinguish between studies that are designated as “research”
and studies that are designated as “assessment." So
for human subjects review purposes, studies or evaluations that
would be only for use inside a given institution -- such as “assessment”
or “institutional research” studies -- are not normally
deemed "research."
What exactly is this
distinction between “research” and “assessment?"
For human subjects
review purposes the
distinction is not always an easy one to make. One indicator that
a project should be considered “research” is that
it is intended not just for internal assessment or quality assurance
purposes, but is intended to be a contribution to “generalizable
knowledge” and its results are intended to probably be made
public in some way. (Most Scholarship of Teaching and Learning
studies will fit this definition.)
The
Belmont Report, for example, designates as research those
studies that are intended
to develop or
contribute to generalizable knowledge (expressed, for example,
in theories, principles, and statements of relationships).
Research is usually described in a formal protocol that sets
forth an objective and a set of procedures designed to reach
that objective.
As a rule, says The
Belmont Report, “if there is any element of research
in an activity, that activity should undergo review for the protection
of human subjects.”
Federal regulations
governing human subjects research (45
CFR 46.102d) say that the term “research” “means
a systematic investigation...designed to develop or contribute
to generalizable knowledge.”
The regulations go
on to say that
Activities which
meet this definition constitute research for purposes of this
policy, whether or not they are conducted or supported under
a program which is considered research for other purposes.
For example, some demonstration and service programs may include
research activities.
The University of Washington
Human Subjects Division defines “research” using the
same terms quoted above, but adds:
if the data collected
are generalizable and are to be shared outside of the institution
through discussion, presentation, or publication, the activity
qualifies as research. Sometimes, data from a quality improvement
or quality assurance activity become of interest to the external
community after they have been analyzed. In these cases, the
research use of the data collected for another purpose must
be reviewed.
The UW Human
Subjects Manual also mentions certain kinds of studies
that would not be considered research:
Precedent and practice
have established the principle that certain kinds of activities...do
not require review for the protection of human subjects. The
following kinds of activities do not require such review:
a.
accepted and established service relationships between professionals
and clients where the activity is designed solely to meet
the needs of the client;
b. research using only historical documents...
However:
Pilot studies,
pre-tests, and other "preliminary" investigations
are considered research, and must be reviewed unless they
fall into one of the excluded categories listed above.
One thing is clear:
the body that ultimately determines whether a study should count
as “research” or as “assessment,” "institutional
research," or as some other purely internal, quality assurance
tool, is the Human Subjects Review Committee. If there is any
question as to whether a study should be considered “research”
or “assessment,” the federal Office of Human Research
Protections says that the HSRC is the body to make that determination.
The UW Human Subjects
Division has developed a simplified rubric to help determine whether
a study should be considered “research” or “assessment."
That rubric is expressed in a one-page
flowchart that can be downloaded here.
Once a project has
been deemed to be “research” the HSRC may place it
into one of three categories:
1.
The project qualifies as being “exempt” from review
(as determined by the HSRC)
2. The project qualifies for “expedited”
review by the HSRC
3. The project will receive "full review"
by the HSRC
At this point the Committee
expects that most SoTL projects will probably fall into one of
the first two categories, but we can’t be sure about that
till we start to see proposals.
