APPLICATION REQUESTING EXEMPT REVIEW OF A RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS

Research studies involving children or vulnerable individuals must be submitted for full review.

All applicants must submit the following items:

This application
Consent form(s) if applicable
CITI Human Subjects Training Certificate

If applicable, these items must also be submitted with the application for it to be considered complete:

Advisor (found here) and Co-Pi form (found here)
An additional Consent form for participants being photographed or recorded via digital media
Copies of all survey instruments, interview questions, recruitment letters, emails, advertisement
Site permission (if applicant is conducting research anywhere other than Kean University)

Complete answers to all questions must be provided and all necessary documentation submitted.
Incomplete applications will be returned without review.

General Information

Applicant Name

Department

Home Address

Phone

Research Project Title

Anticipated Start Date

Anticipated End Date

If project was initially denied and this is a resubmission, provide date of denial letter below

Date of Denial Letter

Co-PIs must complete the Co-PI section. Students applying for IRB review must complete the student section.
NOTE: Student applications and Adjunct faculty applications that are not signed by the Faculty Advisor will not be reviewed.

Guidelines for Exempt Review. There are eight specific categories of exemption. In order to receive an
exempt review from the IRB you must fit into one of these categories. Common examples of exempt level
research at Kean University are anonymous surveys; surveys or interviews of adults about non-sensitive
topics; educational tests; or observation of public behavior. No research involving children or
individuals from vulnerable populations is eligible for exempt status.

IRB Exempt Categories

Research exempt from IRB review MUST only involve one or more of the following research categories.
Research that contains elements of exempt and non-exempt activities is NOT eligible for IRB exemption

XM1

Research conducted in established or commonly accepted educational settings
involving normal educational practices that is not likely to have adverse impacts on students
learning, required educational content, or involving assessment of educators who provide
instruction , such as: (i) Research on regular instructional strategies or (ii) Research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom management methods.
Examples of research NOT EXEMPT via this criteria

Research that involves evaluation of a radically new instructional strategy or use of random assignment of subjects to different instructional methodologies is not exempt because the methods employed deviate from normal educational practices.
Educational research that involves deception or withholding of information from subjects
Exemptions are not granted for research on physical education that involves exercise if the activity is altered in a significant way for the purposes of the research.
Research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.

XM2

Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior. In order
for research to be considered exempt under this category one of the three following criteria must be met:

Information obtained is not identifiable, directly or through identifiers linked to the subjects
Any disclosure of the human subjects' responses outside the research would not reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial
standing, employability, or reputation or
Information obtained can be identifiable but the IRB has done a limited IRB review in keeping
with 46.111(a)(7), which relates to there being adequate provisions for protecting privacy and
maintaining confidentiality

Examples of research NOT EXEMPT through this criteria

Surveys or questionnaires that ask invasive questions of a sensitive or private nature that might be deemed to
cause the subject some discomfort or distress. This includes but is not limited to questions or inquiries about
sexual preferences, sexual behaviors, substance use or abuse, or illegal conduct.
Research where subjects can be identified as participating in the study. This can be, but is not limited to
collecting personal info such as name, SS#, or student ID number.

**Important: Research on sensitive or personal topics which may cause stress to participants are not
exempt from review.

XM3

Research involving benign behavioral interventions in conjunction with the collection
of information from an adult subject through verbal or written responses (including data entry) or
audiovisual recording if the subject prospectively agrees to the intervention and information
collection and at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the
human subjects cannot readily be ascertained, directly or through identifiers linked to the
subjects
Any disclosure of the human subjects' responses outside the research would not reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial
standing, employability, educational advancement, or reputation; or
The information obtained is recorded by the investigator in such a manner that the identity of the
human subjects can readily be ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a limited IRB review to make the determination required by §_.111(a)(7).

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not
physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no
reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met,
examples of such benign behavioral interventions would include having the subjects play an online game, having
them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of
received cash between themselves and someone else.
The methods of data collection allowed under exemption category #3 are limited to verbal or written responses from
subjects (e.g., surveys or interviews, test responses, or data entry), observation, and audiovisual recording. Data
cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g., Fitbit),
eye trackers, and blood draws.
**Important: Deception is allowed if certain criteria are met. This exemption is only for benign behavioral
research with adults and is not applicable to children

XM4

Secondary Research for which consent is not required. Secondary research of
identifiable private information or identifiable bio specimens, if at least one of the following
criteria is met:

The identifiable private information or identifiable bio specimens are publicly available;
Information, which may include information about bio specimens, is recorded by the investigator
in such a manner that the identity of the human subjects cannot readily be ascertained directly or
through identifiers linked to the subjects, the investigator does not contact the subjects, and the
investigator will not re-identify subjects;
The research involves only information collection and analysis involving the investigator's
use of identifiable health information when that use is regulated under 45 CFR parts 160 and
164
The research is conducted by, or on behalf of, a Federal department or agency using
government-generated or government-collected information obtained for non-research activities,
if the research generates identifiable private information that is or will be maintained on
information technology that is subject to and in compliance with section 208(b) of the E-
Government Act of 2002, 44 U.S.C. 3501 note

XM5

Research and demonstration projects that are conducted or supported by a Federal
department or agency, or otherwise subject to the approval of department or agency heads (or the
approval of the heads of bureaus or other subordinate agencies that have been delegated
authority to conduct the research and demonstration projects), and that are designed to study,
evaluate, improve, or otherwise examine public benefit or service programs, including procedures
for obtaining benefits or services under those programs, possible changes in or alternatives to
those programs or procedures, or possible changes in methods or levels of payment for benefits
or services under those programs.

Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects

XM6

Research involving taste and food quality evaluation and consumer acceptance
studies. This IRB exemption category applies to Federal research only.

If wholesome foods without additives are consumed OR if a food is consumed that contains food ingredients, agricultural chemicals, and/or environmental contaminants at or below the level and for a use found to be safe by the Food and Drug Administration, or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture

Examples of research NOT EXEMPT through this criteria

Studies that involve consumption of alcohol, vitamins, or supplements such as protein power,
creatine, and glucosamine chondroitin sulfate should not qualify for exempt status.

XM7

Storage or maintenance for secondary research for which broad consent is required:
Storage or maintenance of identifiable private information or identifiable biospecimens for
potential secondary research use if an IRB conducts a limited IRB review and makes the
determinations required by §46.111(a)(8).

XM8

Secondary research for which broad consent is required: Research involving the use of
identifiable private information or identifiable biospecimens for secondary research use, if the
following criteria are met:

Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
Documentation of informed consent or waiver of documentation of consent was obtained in accordance with
§46.117;
An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the
determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Number of Adult (18 or older) Subjects/Participants

Number of Minor (under 18) Subjects/Participants

Research site(s): Indicate where project will take place

Time commitment for each subject/participant

Project Attributes

Check all that apply:

Use of recruitment materials (flyers, emails, letters, advertisements)

In-person surveys

Phone surveys

Mail surveys

Email surveys

Online surveys

In-person interviews

Phone interviews

Skype (or similar) interviews

Observation

Focus groups

Administration of tests, inventories, self-reports, measuring instruments, etc.

Photography, Audio or Video recording (separate Informed Consent form is needed for the participant to indicate consent for digital recording)

Use of existing/secondary data

Other attributes (please explain)

Co-PI

Complete this section if applicable

If there are multiple CO-PI, then enter the information in the same order.

Co-PI Name(s)

Co-PI Position(s)

Co-PI Department(s)

Co-PI Home Address(es)

Co-PI Email(s)

Co-PI Phone(s)

Student Applicants

Complete this section if applicable

Check this box if this research/student project is required to fulfill requirements of a course

If so, enter the course information below:

Course Title

Course ID

Will this research/student project be published or presented?

Yes

Unsure

Faculty Advisor Name

Faculty Advisor Department

Faculty Advisor Email

Faculty Advisor's Office Phone

PROTOCOL DESCRIPTION

(Note: incomplete responses will be returned without review)

1. Briefly describe your proposed research project, and describe your research goals/objectives.

2. Explain how you will recruit subjects into the research (including when and where recruitment will be conducted and methods of recruitment (e.g. flyers, email, social media, face-to-face).

3. Briefly describe the nature of the involvement of the human subjects (observation of postsecondary student behavior in the classroom, personal interviews, mailed questionnaire, survey, chart review, etc.).

4. Describe the setting (e.g., a classroom) and the location (e.g., name of school) where the research will be conducted. (NOTE: If research is to be conducted at another institution or facility (e.g. a school, community center, place of business, etc.) a signed copy of the permission letter from that institution authorizing the researcher to collect data on its grounds must be attached).

5. Explain how records will be kept; who will have access to the data and how it will be stored

6. Explain how the data or records will be deleted or destroyed

7. Explain why you think this protocol should be considered exempt. Address all known or potential risks to subjects/participants.

Attachment

Please upload a single PDF File

* Combine all the documents into a single PDF file in this specific order:

Advisor Signature Page (if needed). Click Here to download.
Extra Co-PIs Signature Page (if needed) Click Here to download.
Protocol Description Answers
CITI Training Certificates
Consent and Debrief Forms (Assent and video/audio included)
Site Permission
Copies of all measures, survey instruments, interview questions, recruitment letters or emails, advertisements
Permission to use measures created by a different researcher.
All other documents.

PDF File

Upload File

The undersigned accept(s) responsibility for the study, including adherence to DHHS regulations, New
Jersey law, and Kean University policies relative to the protection of the rights and welfare of
subjects/participants in this study. In the case of student applications, the Faculty Advisor and the student
share responsibility for adherence.

By signing this form, I certify that I am familiar with Kean University policies and federal and state
regulations regarding the protection of human subjects in research. I will not begin this study until I
receive a written notice of approval, without provisions, from the IRB. I will conduct this study following the
approved protocol. I will report any adverse events or emergent problems to the IRB; will obtain IRB
approval before implementing any modifications of protocol; and, will request continuing review and
approval for any activities beyond the study end date.

Applicant Signature

Date

Direct questions about the IRB application and review process and schedule to irb@kean.edu or visit the
IRB website at https://www.kean.edu/offices/research-and-sponsored-programs/irb-research-
compliance

Thanks for submitting!

Office of Research and Sponsored Programs