Mount Holyoke College
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
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.