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Policy and procedures for the conduct of research involving
human subjects
Procedures: Who must apply
Any principal investigator related to Mount Holyoke College (as defined below)
who engages in scholarly research involving human subjects, either on-
or off-campus, must apply to the Board for approval of the research. Such
approval
must be obtained before undertaking the research. Individuals who meet
the definition of a “principal investigator” must apply for approval
from Mount Holyoke's Board even if their research has been approved by another
institution's or organization’s Institutional Review Board.
Under this policy, the following individuals are considered to be principal
investigators:
• Mount Holyoke College faculty and staff.
• Mount Holyoke College faculty who are on leave, and who are conducting
research involving human subjects either at Mount Holyoke College, with grant
funds administered by Mount Holyoke College, or with Mount Holyoke College
students.
• Students enrolled in Mount Holyoke College courses who conduct independent
research (see section below on Student Projects for additional clarification).
All student proposals must also be signed by a Faculty Supervisor who attests
that s/he has read and approves of the proposal.
• Researchers not affiliated with Mount Holyoke College who are conducting
primary research with human subjects on campus. These unaffiliated researchers
include visitors to the campus and off-campus scholars engaged in human subjects
research on campus. While at Mount Holyoke, these individuals may, through
the courtesy of an on-campus liaison, conduct Board-approved research on human
subjects. The liaison should provide the visitor with appropriate institutional
forms including this Policy, and assure that the forms are sent to the Board
before the research is undertaken.
Special protection for research involving children
Any research involving children or other minors (individuals under the age
of 18 years), unless the research is part of a "research practicum" experience
as defined below, must be approved by the Board. Research involving children
is subject to additional regulations designed to provide for protections for
children. See
45 CFR 46.401 to 45 CFR 46.409 for applicable federal guidelines.
Student Projects
There is often confusion as to what student projects are required to be considered
by the Institutional Review Board. Generally, student research involving human
subjects falls into one of two categories:
A) research practica, the goal of which is to provide research training; and
B) directed or independent research projects which employ systematic data
collection with the intent to contribute to generalizable knowledge.
Research practica do not require Institutional Review Board review, but research
projects do.
A “research practicum” is a course of study that involves the
supervised practical application of previously studied theories of research
method. A number of departments offer courses that require students to undertake
projects in which other people are interviewed, observed or otherwise serve
as participants. The purpose of these courses is to train students and give
them an opportunity to practice various research methods. Such projects do
not require review by the Board.
A “research project” is any student-initiated and/or student-conducted
research that does not fall under the definition of a research practicum, which
uses human subjects, and is undertaken with the intent to contribute to generalizable
knowledge. Thus it requires review and approval by the Institutional Review
Board. Thesis projects that involve the use of human subjects fall within this
category.
Advice to faculty and departments regarding student research projects
Student research practica as defined above do not require Board review, unless
the instructor chooses to invite Board review. Students engaged in the process
of learning research techniques understandably want to focus on compelling
or real-life issues. Thus, student research practica often focus on issues
that raise concerns for the well-being of the subjects and for the students
themselves. Projects that involve the collection of data about illegal activities
(such as drug use or underage drinking), those which could cause emotional
distress, and those which would place the students at risk if confidentiality
were breached need to be constructed with special care. Although research practica
are not under the purview of the Board, its members are available for consultation
with students and instructors. However, faculty members who engage in instructional
activities are expected to protect all human subject(s) in accordance with
their discipline's Codes of Conduct and Ethics (see the Principles & Ethics
section for a list of some of those disciplinary codes). It is the responsibility
of the faculty member to include research ethics and principles of responsible
research when teaching research techniques.
Departments are encouraged to develop an internal review process for research
involving human subjects undertaken by their students and faculty. Such internal
review should conform to the relevant discipline's Codes of Conduct and Ethics.
Although departmental review cannot substitute for Board review when it is
required (for “research projects” as defined above), departmental
review will facilitate Board review. Departmental review can also be used to
teach responsible conduct of research.
What is exempt from Board review
In addition to “research practica,” as defined above, the following
types of projects are exempt from Institutional Board Review: data gathered
for the purposes of fundraising; market research for the purposes of admissions
recruiting; recruiting efforts for faculty or staff; and statistical data collected
for the management of institutional affairs, including surveys of students,
prospective students, and alumnae. Please note that a project that does not
clearly fall into one of these categories should be brought to the Board for
a determination of whether it is exempt. The determination as to whether a
project is exempt from Board review cannot be made by the principal investigator(s)
themselves.
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