When must I submit a Request for Approval
of Human Participants Research Application Form to St. John’s
University’s Institutional Review Board (IRB)?
The principal function of the IRB is to protect individuals who
volunteer to participate as human participants in research. The
federal regulations (i.e. Title 45 CFR Part 46) define research as:
“ a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to
generalizable knowledge” (§46.102, D). Thus, any project that
involves human participants, is carried out at St. John’s
University, and meets the above definition is considered research.
The regulations define human participants as “a living individual
about whom an investigator (whether professional or student)
conducting research obtains (1) data through intervention or
interaction with the individual, or (2) identifiable private
information” (§46.102, F). There are, however, recurring questions
about what exactly constitutes reviewable research or
research-related activities.
Student Projects
Over the years, questions have arisen as to whether certain
student’s projects constitute research. For example, in a number of
courses (e.g., research methodology) students might be required to
carry out “research” projects in which anonymous data from surveys,
interviews, or laboratory tasks are collected from class peers or
from students outside of class or outside of the University.
Because the main purpose of such typically minimal risk projects is
to teach students about the process of research and because by
their nature they do not lead to generalizable knowledge (that is,
they will not be disseminated in a public forum or published), they
are NOT considered research and, therefore do not have to undergo
IRB review.
On the other hand, in more advanced courses (e.g., Independent
Study) student projects are sometimes carried out with the
potential intention to present or publish the results of the
project. In those cases, IRB review is necessary. Likewise, all
master’s thesis and doctoral dissertation research projects that
involve human participants must undergo IRB review, since they are
research by definition and are considered publications when they
are filed with ProQuest (formerly UMI). All such projects must be
approved by the IRB before data collection begins. Data that
are collected from any type of project prior to or without IRB
review, even if such data are preliminary in nature, such as from a
pilot study, may not be used later for dissemination (e.g.,
publication, conference presentation, thesis).
It is also possible that certain student projects that do not
constitute research place their participants at some level of risk.
For example, a seemingly innocuous survey or interview could
conceivably cause a subject considerable amount of stress or
embarrassment. Perhaps a student researcher is interested in
surveying students for other not uncommon behaviors, such as,
under-age drinking or speeding. However, these behaviors are
illegal and any breach in confidentiality of such data could
conceivably place the subject at some risk, and even neophyte
researchers incur some responsibilities when in possession of such
knowledge of their peers’ behavior. Such projects can be
problematic and therefore the IRB should be consulted before any
data are collected. Faculty members are strongly urged to exercise
care and judgment in designing such classroom exercises, to
incorporate informed consent training into their curricula and to
refer individual student projects for IRB review as necessary.
Incomplete or Inadequate
Applications
On occasion an IRB application must be returned to the individual
because it is either incomplete or so poorly prepared that it
cannot be properly evaluated. Therefore, we strongly recommend that
faculty carefully review IRB applications (their own as well as
those from their students) for accuracy and completeness before
submitting them. In addition, everyone should keep in mind that
such applications must go through various stages or review and
approval (e.g., Department chair, Dean) before they reach the IRB.
Thus it pays to carefully plan the research project and craft the
application.
Please note: the IRB has begun returning unreviewed protocols
which fail to answer the questions posed and refer to an attached
methodology section or statement from a thesis or dissertation
proposal. The questions must be answered within the protocol
form itself. The only attachments required are copies of
survey instruments, consent forms, letters of institutional
permission (when necessary), correspondence with any other IRB, and
the signed pledge of compliance.
Contact Information
Institutional Review Board
Dr. Jay Zimmerman
Chair
Marie Nitopi, Ed.D.
IRB Coordinator
(718) 990-1440
nitopim@stjohns.edu
Newman Hall, Room 106
Modeled after CUNY’s policy for student research with human
participants.