Institutional Review Board (IRB)
for Human Subject Research
Committee Members, 2014-2015
- George Schreer (Chair)
- Jessyca Arthur-Cameselle
- Vance Austin
- Mary Jo Caruso
- Micheline Malow
- Beth Williford
- Kenny Kwong (Touro College)
- Gail Simmons (Provost)
Welcome to the home page of the Manhattanville IRB. This page describes the IRB's purpose, function, and procedures. For detailed guidelines and rules for investigators on campus, to download forms, for a schedule of deadlines, or for external resources, see the links on the left. To contact the IRB, send email to email@example.com.
What is the IRB?
Scientific research on humans has produced profound social benefits, but also poses ethical questions. Accordingly, federal law requires that research activity involving human subjects be regulated by a review board, whose purpose is to ensure that the subjects are treated humanely, respectfully, and fairly. Nearly all universities, colleges, hospitals, and other research locations have such review boards for human subject research.
Manhattanville's Institutional Review Board (IRB) exists to oversee all campus human-subject research and study on behalf of the College. Its charge is to protect both faculty and students from unethical conduct or exploitation, to give guidance and support to researchers, and to ensure that individuals are treated with respect and dignity. The IRB reviews proposed research protocols and has the authority to approve, require modifications in, or disapprove the research activity.
Manhattanville's IRB is registered with the Office for Human Research Protections of the U.S. Department of Health and Human Services. Manhattanville has obtained a Federalwide Assurance (FWA) enabling investigators on campus to apply for research funding from federal agencies.
Who is subject to IRB oversight?
Any Manhattanville faculty member, staff member, or student who intends to carry out any study of other human beings is potentially subject to oversight by the IRB, as is any outside researcher collecting data on campus. Federal law, in Title 45 of the Code of Federal Regulations, Part 46 (45CFR46), specifies that any investigator who intends to initiate research involving human subjects needs to submit a research proposal for IRB review and approval before beginning the project. Human subjects are defined in 45CFR46 as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." In the regulations, research is defined as "systematic efforts to develop or contribute new knowledge to a field." Manhattanville IRB policy is intended to be faithful to the spirit as well as the letter of 45CFR46 and takes account of the various ways in which research or similar activities are carried out on our campus. The goal of the approval process is to ensure that research is carried out responsibly without creating an excessive administrative burden on any investigator.
At Manhattanville, the IRB regulates data collection during both research and teaching. Data collected could include biomedical measures, survey responses, interviews, direct observation, or any other form of systematic information gathering, and could be done as a faculty or student research project, for course or program credit, or as a classroom exercise. For detailed information on how the IRB reviews different types of activity, see our Guidelines for Investigators webpage. (Note: College officers or employees may, in the course of their jobs, survey community members for internal institutional purposes, such as strategic planning or resource allocation. This type of information gathering is not research or teaching, and is not overseen by the IRB.)
How does the process work?
The process depends on the type of activity being proposed. Research activities typically require a complete protocol to be submitted for review, but some research (especially educational research) is exempt from detailed oversight; those cases may require a shorter Request for Exemption to be submitted, or require no submission at all. Some instructional activities, in which students gather data as part of their coursework, are likewise exempt. See the Guidelines for Investigators page for details.
Forms to request review or exemption of proposed research or study can be downloaded from the IRB Forms for Download page. Forms are in Word format and can be filled out electronically. Follow the detailed instructions on the form, save a copy under a new name, and submit the filled form by email to firstname.lastname@example.org.
Many exemptions, some renewals, and most student projects may undergo expedited review, which does not require a formal meeting and is conducted on a rolling basis, with no fixed deadlines. However, full research proposals must be reviewed by the entire IRB. For further details on which projects may be expedited, see the Guidelines for Investigators page. The IRB has a monthly schedule of meetings at which full proposals can be reviewed; a proposal must have been received two weeks prior to a meeting for it to be considered at that meeting. A current schedule of deadlines can be found on the Schedule of IRB Meetings page.
Ethics Training for Human Subject Research
Any investigator, whether student or professional, who is engaged in research on human subjects must, according to 45CFR46, undergo regular training in research ethics. The term "investigator" includes all participants on a research team, including student assistants and professors teaching courses that require students to conduct research projects. Manhattanville subscribes to an online training course provided by the Collaborative Institutional Training Initiative (CITI) program and requires all investigators to complete ethics training via this course. The course is available at www.citiprogram.org and will automatically include various learning modules corresponding to the type of research and the individual's role in it. For more details, please visit the Ethics Training page.