|IRB Guidelines for Investigators|
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:
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:
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:
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:
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:
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 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
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.