The Manhattanville IRB has prepared these guidelines to specify what activities are
regulated by the IRB, under what conditions approval must be obtained from the IRB,
and how to apply for approval. A version in Word format can be downloaded here.
The IRB regulates all research or study of living persons that involves interaction
with, or collection of information about, identifiable individuals. These activities
fall into three categories:
- Research activities are systematic efforts to develop or contribute new knowledge to a field. These are
usually intended for publication, described in a formal protocol, and have well-defined
objectives. Faculty research and senior projects generally fall into this category. All planned research activities involving human subjects (except educational research;
see below) at Manhattanville must be submitted to the IRB for approval or exemption.Study subjects can only be recruited once approval or exemption has been granted by
Please note that the Manhattanville IRB will not approve a protocol that uses “passive consent” procedures. Instead, all proposals must describe how you will obtain “active consent” from your participants, in that the participant (or the participant’s legal guardian
if under 18 years old) must read an informed consent form and actively indicate that
they are willing to participate in the research. By contrast, “Passive consent” procedures
are those in which a consent form is distributed (typically to parents of minors)
that indicates that the child will be automatically included in the research project
unless the parent signs and returns the form indicating that they refuse to allow
their child participate. Passive consent is sometimes referred to as “opt out” consent
practice. This practice is ethically questionable given that it does not comply with
the regulatory requirement of obtaining parental permission for the research participation
of children and there is often no way to confirm that all parents received the consent
letter. As such, the Manhattanville College IRB will not approve projects using
- Educational research involves research on educational practices, techniques, and/or curriculum that is
conducted in an established educational setting: for example, research comparing teaching
methods conducted in a public school, or a study by a faculty member of educational
outcomes in her own classes. This activity is regulated differently from research
in general; some educational research may be exempt from IRB oversight, and fieldwork by education students is automatically
exempt (see below).
- Instructional activities take place when students gather data (on other students or off-campus) under the
direction of a faculty member as part of a course. The goal of these activities is
to train students in research methods, not primarily to contribute new knowledge to
a field. Examples include students in a course doing field interviews on each other,
observing human behavior in public settings, or measuring and recording biomedical
data (heart rate, skin galvanic response, etc.) in a lab course. These activities may or may not require approval or exemption by the IRB: some instructional activities are automatically
exempt (see below), but most other cases will require an exemption request.
Note: Manhattanville administrators, staff, or faculty may gather survey data from students
or employees for internal institutional use (for example, allocation of resources,
improving retention, or strategic planning). These sorts of surveys do not fall into any of the three categories above (they are neither research nor instruction)
and are not overseen or regulated by the IRB.
II. Standards for approval or exemption
A. Formal approval.
Most research projects (as defined above), and some instructional activities, will
require a formal approval from the IRB before the study may begin. To apply for approval,
a researcher must complete a form (on the website) and also submit a description of
the proposed project, following directions on the form.
This description includes:
- current knowledge about the research question, including citations;
- the rationale for the current project, and its benefits for the participants or society;
- all "scripts" for recruiting, instructing, and debriefing study subjects;
- forms for obtaining and documenting informed consent;
- specific procedures, forms, or surveys used to collect information from subjects.
In addition, all investigators (including student research assistants) on a proposed
project must submit evidence of ethics training for human subject research, typically a web-based course. (For Manhattanville's course
requirement, see below.) Training is valid for three years from the certification date; if certification has expired, investigators must complete
The IRB evaluates the proposals with the following standards in mind:
- Risks to subjects should be minimized
- Risks should be reasonable in relation to anticipated benefits
- Selection of subjects should be equitable
- No subjects may be unduly influenced or coerced to participate
- Informed consent must be sought and documented for each subject
- Privacy and confidentiality of subjects must be protected
The IRB may request changes in the study, or more information in the application,
before approval can be granted. Approval, once granted, is valid for one year from the approval date. After that time, the investigator(s) must file for renewal
if the study is to continue.
B. Request for exemption
Certain kinds of research or study posing minimal risk to subjects are exempt from
oversight and approval by the IRB. Some activities are considered automatically exempt,
and do not require anything to be filed with the IRB. These activities are listed
specifically in the next section. Any proposed activity not included in that list may be exempt if one of the following conditions applies:
- It is educational research, as defined in I.2 above
- Information collected consists entirely of surveys, educational tests, or observations,
and is entirely anonymous
- It involves study of existing data
However, only the IRB can determine if the activity is indeed exempt. If the investigator concerned believes the study
to be exempt, s/he must file a request for exemption with the IRB. There are two forms
for this purpose, available in the Forms for Download section above: one for faculty
and staff investigators, and one for students carrying out a research project as part
of their college coursework. The IRB may find the study not to be exempt, in which case the investigator will be asked to file a full application
The student form must be signed by the student's faculty instructor or mentor. By so doing, the instructor certifies that s/he has reviewed the project in detail
and approved it. When reviewing the project, the instructor/mentor is expected to
verify that appropriate ethical standards for the discipline are being followed.
C. Automatic exemption
Some instructional activities are automatically exempt and do not need to be reported to the IRB. A study is automatically
exempt only if one of the following descriptions applies; in all other cases, a request for exemption
must be filed.
The study is automatically exempt if it is one of the following:
- An instructional activity in which students collect data from other students, if the
data will not be aggregated, published, or disseminated in any way beyond the classroom
setting in which the data is obtained. The data collected cannot include sensitive
information (such as data on sexual behavior or preference, substance abuse, illicit
behavior, immigration status, income level, and the like; if any uncertainty exists,
submit an exemption request). If there is any chance that collected data may be published or presented, the instructor
must submit an exemption request.
- An instructional activity in which students observe adult behavior in a location commonly accepted to be public space, do not interact with,
approach, film or record the subjects, and cannot subsequently identify the subjects.
Safeguards must be in place to prevent the students from observing any behavior which
might reasonably be expected to be private (e.g. overhearing conversations between
individuals). If the subjects are minor children (under the age of 18), a request
for exemption is required.
- Fieldwork in educational settings carried out by students enrolled in an education
program, as part of their required coursework.