Institutional Review Board

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 University. 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 participants 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 (in-person and on-line), 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 Section 5: Guidelines for Investigators below. (Note: University 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 Section 5: Guidelines for Investigators below for details.

Forms to request review or exemption of proposed research or study can be downloaded from Section 3: IRB Forms below. 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 irb@mville.edu.

Most exemptions and renewals 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 Section 5: Guidelines for Investigators below. The IRB has a monthly schedule of meetings at which full proposals can be reviewed; a proposal should be received two weeks prior to a meeting for it to be considered at that meeting. A current schedule of deadlines can be found in Section 5: Schedule of IRB Meetings below. 

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 Section 2: Ethics Training below.

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All investigators involved with a project (including student research assistants and professors that are mentoring student research) must complete a course in ethics for human-subject research before proposals can be approved.

On completion of ethics training, investigators receive a certification that is 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. 

To access the online training, visit www.citiprogram.org, create an account, and choose Manhattanville University as your affiliation. When you click on "Add a course", you will be asked to select your curriculum.

Scroll down to the Human Subjects Research area and choose one of the 6 learner groups, depending on your subject area and status:

Social/Behavioral Research (for investigators in the social and behavioral sciences)- required for all non-exempt projects. All course instructors or mentors of any non-exempt project (i.e. any project not deemed "minimal risk")  should take this course. 

Biomedical Research (for investigators in the biological or biomedical sciences)

Students conducting no more than minimal risk research (for all student research assistants as long as the research is classified as minimal risk*)

Education students engaged in fieldwork (for fieldwork or graduate projects)

Instructors (for course instructors where ALL projects in the course are deemed minimal risk" research.)

IRB Members (for members of the IRB only).

Note: Research assistants must complete the Social Behavioral Research course if the research is not minimal risk.

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Instructions
The forms are provided in Word format and are designed to be filled out electronically.  Fill in the forms by clicking on and typing into any grey box, which will expand to fit your answer. You can also use the TAB key to move from one box to another. Save your completed forms using a new file name that includes your last name, attach any necessary appendices, and submit via email to irb@mville.edu.

To all submitters: Depending on your status (faculty/staff or student) and type of project (research or exempt), please follow the instructions below. Also, please use the following Informed Consent template.

Request for Review of Research, Faculty and Staff
Use these forms for any non-exempt research activity. The forms can be used for a new proposal, for amendment to an approved proposal, or for yearly renewal, and can be used by faculty, staff, or students doing independent research (including non-exempt doctoral dissertation research), or off-campus researchers. Manhattanville students carrying out projects for coursework should use the Student Research Form or Exemption Form, below.

You must submit both the Request for Review of Research form and the Informed Consent Form Checklist with your submission to irb@mville.edu. The General IRB Submission Checklist is provided below for your reference, but is not required for submission.  

For doctoral students, the forms must be approved and submitted to irb@mville.edu by a faculty member who is supervising the research. This faculty member should be listed as a co-principle investigator on the proposal. 

• Download the required Request for Review of Research form.
• Download the required  Informed Consent Checklist form. 
• Download the General IRB Submission Checklist (not required)

Request for Exemption, Faculty and Staff
Use this form for faculty and staff investigators to request an exemption from review, if you believe it is warranted. A detailed checklist on the form will help to determine whether the activity is likely to be exempt, though only the IRB can certify it as such.

• Download the required IRB Faculty and Staff Exemption Request Form.

Student Exemption Form
This form is used by student investigators who are carrying out an exempt research project as part of a university course, for exempt doctoral dissertations, or for exempt master's research projects.  (A detailed checklist on the form will help to determine whether the activity is likely to be exempt; if not, you will need to use the Student Research Form, below.) The form must be approved and submitted by a faculty mentor or instructor to irb@mville.edu

• Download the required IRB Student Exemption Form.

Student Research Form
These forms are used by student investigators who are carrying out a project as part of a university course, and the research includes activities that are not expected to be exempt. For doctoral students working on a dissertation research project, use the Faculty Staff Research Form above.  (For guidance on whether an activity is exempt, see the detailed checklist on the Student Exemption Form, above, or the Guidelines for Investigators.)  

You must submit both the Student Research Form and the Informed Consent Form Checklist with your submission.  The General IRB Submission Checklist is provided below for your reference, but is not required for submission. The forms must be approved and submitted by a faculty mentor or instructor to irb@mville.edu.

• Download the required IRB Student Research form.
• Download the required Informed Consent Checklist form. 
• Download the General IRB Submission Checklist (not required).

 

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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. View and download the guidelines in Word format.

I. Definitions

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:

1. 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 University IRB will not approve projects using passive consent.

2. 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).
3. 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 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 university 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:

1. 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.
2. 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.
3. 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 Section 2: Ethics Training above.

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 in Section 3: IRB Forms for Download above. 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 irb@mville.edu. 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 IRB meetings and deadlines in the section below.  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.

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Student Research at Manhattanville 
This handout describes and gives examples of student research projects, and how they are reviewed by the IRB.  The examples are especially applicable to School of Education graduate students.

US Department of Health and Human Services 
Main website of the Office for Human Research Protections

45 CFR 46 
The full text of the federal Policy for Protection of Human Research Subjects, otherwise known as the Common Rule.

The APA Ethics Code 
The American Psychological Association's Statement of Ethical Principles and Code of Conduct; applicable to social and behavioral research.

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Full Review
For a research proposal to be considered for full IRB review, it must be received 2 weeks prior to the next IRB meeting (see deadlines below). Once a proposal has been reviewed, the principal investigator (PI) will be notified of the outcome within 4 days. A proposal may be approved, approved subject to requested modification, or denied. If modification is requested, the principal investigator will be asked to resubmit the proposal showing the changes; however, the modified proposal can normally be reviewed using an expedited process.

Expedited Review
Most renewals and minor amendments to approved research, as well as requested modifications for initial approval, can be reviewed without a formal meeting, using an expedited process. Student projects for course credit can generally be expedited as well.  In that case, no deadline applies; the principal investigator will normally be notified of the outcome within 1-2 weeks of receipt. The IRB Chair determines whether expedited review of a proposal is possible, using guidance from 45CFR46.

24/25 IRB Meeting Dates	Submission Deadline
August 21, 2024	August 7, 2024
September 9, 2024	August 26, 2024
October 7, 2024	September 23, 2024
November 4, 2024	October 21, 2024
December 2, 2024	November 18, 2024
February 3, 2025	January 21, 2025
March 3, 2025	February 17, 2025
April 7, 2025	March 24, 2025
May 5, 2025	April 21, 2025
June 9, 2025	May 19, 2025

 

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