Manhattanville IRB: Faculty & Staff Exemption Request

INSTITUTIONAL REVIEW BOARD

FACULTY & STAFF EXEMPTION REQUEST FORM

Use this form if:

-You wish to engage in research or instructional activity that involves human subjects.

-The research is to be carried out (even in part) by Manhattanville employees, on the Manhattanville campus, or using Manhattanville resources (such as the computer network and website). If the main investigator is a student carrying out a project as part of his/her coursework, please use the Student Exemption Form instead of this one.

-The proposed activity is exempt from the College policy requiring IRB review for most types of human subject research. The checklist on the following page will allow you to determine if this is the case. If your research does not fall into one of the exempt categories, then you must submit a full proposal to the IRB using a separate form (downloadable from the IRB website at

-The proposed activity does not fall under an automatically exempt category (see the Guidelines for Community Members on the IRB website).

If all of the above are true, Manhattanville College policy requires you to confirm that your proposed research or activity is exempt from more extensive review by the Manhattanville IRB. You may do so using this form. After completing the checklist, you will be asked to describe your proposed research or activity and explain why you believe it to be exempt.

You will be notified by the IRB when your exemption has been granted. If the IRB finds that an exemption is not warranted, you will be asked to submit a full proposal for review.

This is a fillable form. Please type directly into the shaded boxes, which will resize automatically to fit your response. You can use the tab key to move directly from one box to the next. Use the “Save As” menu option to save the completed form under a new document name.

Save your document using the file name that includes your last name.

CHECKLIST. Federal regulations on human subject research (Title 45 of the Code of Federal Regulations, Part 46) exempt a few types of research from IRB oversight, and Manhattanville policy is based on these regulations. If the proposed activity involves multiple experiments involving human subjects, all experiments must fall into the exempt categories for the research to be exempt from IRB review.

Activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from further IRB review and oversight:

Category 1: Educational Research
For exemption under category 1, check both boxes:
(1a) The research described in this exemption request will be conducted in an established or commonly accepted educational setting
(1b) The research involves normal educational practices, such as studies of effectiveness of instructional strategies, techniques, curricula, or classroom management methods.
Category 2: Surveys/Interviews/Observation and Anonymous Data
For exemption under category 2, check one or more of boxes (2a) through (2d), and then all three boxes (2-i) through (2-iii).
This research is based on the use of …
(2a) educational tests.
(2b) survey procedures.
(2c) interview procedures
(2d) observation of public behavior
(2-i) Information will be recorded so that it will not be possible* at any later time to associate the human subjects with the responses. *-Do not check this box if there is a possibility that interviewers or observers may remember and be able to identify specific responders. Also do not check this box if secured lists will be kept matching names to record codes; although such lists are commonly used in research approved by the IRB, they allow the possibility of association of human subjects with their responses.
(2-ii) Any disclosure of subjects’ responses would not damage the subjects’ reputation, employability, enrollment status, or financial standing, or place the subjects at risk of criminal or civil liability.
(2-iii) This research poses minimal risk to any participants. Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (from 45 CFR 46.1).
Category 3: Existing Data
For exemption under category 3, please check one of the following boxes:
(3a) The research involves study of existing data or materials that are publicly available.
(3b) The research involves study of existing data or materials that are currently recorded or indexed so that there is no possibility of identifying the human subjects who originally provided the data or materials.

Complete federal regulations may be found at The regulations also allow exemptions for some types of studies of public office holders (or seekers), some types of public policy studies approved by federal department or agency heads, and some food tasting studies. If your study is exempt under one of these other categories, please check here () and quote the appropriate passage from federal regulations in your explanation on the next page.

Principal Investigator (PI) or Proposer: Department:

Telephone: E-mail address:

Date of Request Proposer is: Faculty Staff Student Other

(Note: If requester is a student, the Student Exemption Form must be used.)

Project Title, if applicable:

Briefly describe the research project or activity, including the research question:

What methodology will be used? Give examples of the experimental procedures, survey questions or interview questions participants will encounter.

Who are your expected participants and what is your recruiting method?

What, if any, are possible risks to human participants in your research?

Explain here why you believe this research is exempt from IRB review.

My description above accurately describes the human subject portion of the proposed research. Any proposed changes in research activity that go beyond the brief description and/or change the answers to the questions above may affect exemption status, and so if such changes are needed I will submit another exemption form or a proposal form to the IRB. I will immediately report any unanticipated problems involving risks to human subjects or others to the IRB.
Signed: Date:

Proposer

rev. Jan. 2012p. 1 of 3