Student
Research with Human Subjects at
Faculty in a
number of different disciplines at Bryn Mawr College supervise students (both
undergraduate and graduate) in projects that involve the collection of data
from human subjects. Learning how to conduct such projects in conformity with
ethical guidelines is an important part of a student’s educational
experience. While the College encourages
student projects of this sort, it wishes at the same time to minimize risk to
participants, to protect participants’ right to informed consent, and to preserve
the confidentiality of their data.
The purpose of
this policy is to provide general guidelines to faculty advisors regarding
oversight of student projects involving human participants and to clarify when
such projects must be reviewed by the IRB for the Protection of Human Subjects
in Research.
IRB review is
governed by the applicable federal definition of research as "any
systematic investigation, including research development (pilot testing)
designed to develop or contribute to generalizable knowledge.” Research
involving human participants is that in which a researcher obtains data through
intervention or interaction with or obtains identifiable private information
from a living individual.
Generally, student
projects involving human subjects fall into one of two categories: (1)
practica, internships, or class projects that involve the collection of data
from human participants but are NOT
designed to contribute to generalizable knowledge; or (2) directed or
independent research projects that are designed to contribute to generalizable
knowledge. Projects in category one do
not require IRB review. Projects in
category two must be reviewed by the
IRB before any data collection begins.
Pratica,
internships, and class projects may be designed to provide students with an
opportunity to practice various methods such as interviews, observation/participant
observation, and survey techniques, as well as data analysis. These projects
may include, but are not limited to, those associated with research methods or
data analysis classes, as well as those taught within the Praxis Program. In
these cases, data may be gathered from human participants. However, because such projects are designed
solely to provide training to students and not designed to lead to
generalizable knowledge, they do not constitute "research" as defined
by federal guidelines and do not require IRB review.
Any inquiry
conducted by students, graduate or undergraduate, that uses human beings as
subjects and does not fall into the
category of research practicum/internship or class project as defined above, must be reviewed and approved by the IRB
before data collection begins.. These may include, but are not limited to,
independent undergraduate research projects and honors theses, masters theses
and doctoral dissertations, all of which are intended to contribute to
generalizable knowledge.
Level
of IRB Review Required
This
determination depends on the level of risk involved and whether or not research
involves categories of activity, specified in the federal regulations.
There are three
levels of review: Please consult the Office of Sponsored Research website,
Institutional Review Board link, for more detailed explanation about the
criteria for each of these levels of review and the required forms.
Research
that is exempt from expedited or full IRB review. The departmental
reviewer for each department
reviews the research, confirms that it meets
the standard for exemption from
further review, and files the paperwork
(Forms B-1 and B-2) with the Office
of Sponsored Research.
Research
requiring expedited review. One member of the IRB reviews the research.
An answer is provided by the IRB Chair to the researcher within a
two to three week time frame. Complete Forms B-1 and B-3 on the Office of
Sponsored Research website and forward them to the IRB chair.
Research
requiring full IRB board review. This research must be reviewed at one of
the standing meetings of the IRB in
October, December, February, and May.
Exact dates are provided at the beginning of
each semester. Complete forms B-1 and B-4
on the Office of Sponsored Research website and forward 10 copies
of the complete proposal to the IRB Chair.
It is the
responsibility of faculty advisors to determine whether a student project
qualifies as a practicum/internship/class project or whether it constitutes
research and must therefore be reviewed by the Bryn Mawr College IRB before
data collection may begin. Advisors who are uncertain whether IRB review is
needed are encouraged to err on the side of caution and contact the IRB chair
for advice.
When student
projects involve research as defined above, it is the further responsibility of
faculty advisors to assist students in preparing review materials for the IRB
and to ensure that the research is conducted in accordance with federal
regulations and
Regardless of
whether a student project constitutes research or qualifies as a practicum,
internship, or class project as defined above, faculty advisors have an
affirmative obligation to:
Effective,
October24, 2005