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 from this link.
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 the IRB.
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 passive consent.
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 training again.
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 on the Forms page of this site: 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 for approval.
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.
III. Ethics training for human-subject research
All investigators must complete a course in ethics for human-subject research before proposals can be approved. On completion of ethics training, investigators receive certification valid for three years; re-certification every three years is required. Manhattanville subscribes to an online training program, the Collaborative Institutional Training Initiative (CITI), and as of January 2009 all new certifications must be obtained through online courses at CITI.
For further details on CITI training, see the Ethics Training page on this site.
IV. Renewal and amendment
Any approval expires in one year, and a new application must be submitted at that point if participant recruitment and data collection for the study is to continue. The same form is used, with appropriate boxes checked in Section C. If there are no changes to the approved protocol, the application has renewal (or continuing review) status and can generally be expedited (i.e. approved without a formal IRB meeting).
If the investigator wants to modify the protocol or change personnel when continuing the project, the application has amendment status; the IRB must approve the modified research protocol, although in some cases (e.g. changes of personnel only) this can be expedited. Examples of modifications include replacing a survey, adding additional measures or interview questions, replacing a student investigator, or mounting new safeguards for previously unanticipated risks. Any new investigators added to the project must provide evidence of ethics training as part of the application.
Any change in the project during the approval period is an amendment, and a new application must be filed before the proposed modifications can take effect.
V. How to apply
Forms to request review of proposed research or exemption are available for download on the IRB Forms for Download page. All forms are fill able Word documents; they are locked to disable changes to the form text. When the form has been filled out, it should be saved under a new filename and emailed, along with a separate project description if required, to firstname.lastname@example.org. Please use Word (.doc or .docx) or PDF format for all submitted files.
Full research proposals are considered by the IRB at its monthly meetings; please see the Schedule of meetings and deadlines. Most student proposals and exemptions can be reviewed using an expedited process, which does not require a full IRB meeting; in that case, deadlines do not apply.