CHS # _____________
APP 01 – Application for Exempt Status for Human Subjects Research
Please type the information below. Mahalo!
* Please note - If the Researcher / Principal Investigator (P.I.) is a student, per UH policy, the Faculty Advisor serves as the primary
P.I., and the student serves as the co - P.I.
Researcher (P.I.) / student co - P.I. name:
Email address:
Phone number:
Campus:
Department:
Status:
Faculty
Staff
Student (If the Researcher/ Principal Investigator is a student, per UH
policy, the Faculty Advisor serves as the P.I., and the student serves as the co-P.I.)
For degree:
Masters
Ph.D.
Other:
Student’s Faculty Advisor /
Primary - P.I. Name:
Advisor email
address:
Title of Research Project:
_____________________________________________________________________
Advisor phone
number:
Signatures
I certify that the Information in this application is accurate and complete.
Researcher (P.I.) /
Student co - P.I.:
Date:
I have reviewed and approved this application:
[Advisor: Please review your student’s application for the following required documents. Thank you. ]
‘Description of Project’ (Section II) questions answered
Survey / interview questions
Informed consent(s)/ assent(s) form
Online Training Requirement Certificates
Recruitment flyer(s) / script (if applicable)
Advisor:
Date:
(for student research only)
This box is for Human Studies Program Use Only:
Exempt Request:
Approved
Not Approved
Training:
P.I.
Advisor (if applicable)
Reviewer comments / recommendations:
Exempt Category ________________
Is this study involving?
DOH
DOE
Approved by: ______________________________________________________________________ Date: ______________________
APP-01 Application for Exempt Status, v. 04-08-15
University of Hawai'i Human Studies Program
(808) 956-5007, uhirb@hawaii.edu
Page 1
Application for Exempt Status for Human Subjects Research
Aloha! Research involving living human beings at the University of Hawaii must be approved prior to being
conducted. Please read and follow all instructions carefully when filling out this application.
For more information, please go to the Human Studies Program website at:
https://manoa.hawaii.edu/researchcompliance/human-studies
or contact our office with any questions. Underlined words are defined in the Glossary on the HSP website.
To help you determine whether or not your project meets the definition of “research” or “human subjects
research,” and therefore warrants a need to complete an application see Worksheet 301 – ‘Is my project
“human subjects research”?’ BEFORE completing this application.
Graduate students planning to file a Form II with the Office of Graduate Education but whose projects are
“Not Human Subjects Research” are required to complete an exempt application. The Human Studies
Program will review the application to verify that the project is "Not Human Subjects Research" and will
provide necessary documentation of this verification.
I. Categories of Exemption
Complete all the categories below that apply to your research. If a category does not apply to your study,
check “Not Applicable” (N/A). If your research does not meet the requirements for any of the six categories
below, please complete and submit the standard Non-Exempt, Biomedical or Social & Behavioral Research Initial Review application form available on the Human Studies Program website at
https://manoa.hawaii.edu/researchcompliance/submit-new-protocol.
Research on Educational Practices (Federal Category 1)
Your research will take place in an established or commonly accepted educational setting,
involving normal educational curriculum (appearing as normal classroom activities).
N/A
Yes
If Yes, complete Section II and Section III of this application.
Research Involving Surveys or Interviews (Federal Category 2)
N/A
1. Your research will involve the use of
a. educational tests, (educational tests may include cognitive, diagnostic, aptitude, and
Yes
achievement tests) or
b. surveys or interviews for participants ages 18 and older
2. The research data that you collect (including field notes) will be recorded in such a manner
that if participants can be identified, they would not be at risk of damage to their
Yes
reputation, financial standing, employability, or criminal and civil liability or this data will
be recorded anonymously (so that participants cannot be identified, either directly or
through identifiers linked to them).
If you answered “Yes” to both 1 and 2, complete Section II and Section III of this application. If your
survey or interview research does not meet these two criteria, it may not qualify for exempt status. You
should instead complete the non-exempt application form.
Research Involving Public Observation (Federal Category 2)
a. Your research will involve observation of adult human subjects in a public setting
where there is no expectation of privacy, or
b. observation of public behavior of participants younger than 18 when investigators in
your research will not participate in the activities being observed.
If Yes, complete Section IV of this application.
APP-01 Application for Exempt Status, v. 04-08-15
N/A
Yes
University of Hawai'i Human Studies Program
(808) 956-5007, uhirb@hawaii.edu
Page 2
Research Involving Public Officials (Federal Category 3)
Your research, not exempt under Category 2, will involve educational tests, survey, interview,
or observation of public behavior if
1. The subjects are elected or appointed public officials (or candidates for public office)
If Yes, complete Section II and Section III of this application.
N/A
Yes
Research Involving the Use of Existing Data (Federal Category 4)
N/A
1. Your research will involve the study of existing data (collected in the past), documents,
Yes
records, pathological specimens, or diagnostic specimens.
2. You will record the information in such a manner that participants cannot be identified
Yes
either directly or through identifiers linked to the participants, or the sources of these data
are publicly available.
If you answered Yes to 1 and 2, complete Section II of this application. If your research does not meet
both of these criteria, it does not qualify for exempt category 4, existing data, and you should instead
complete the non-exempt application form.
Research Involving Public Benefit or Service Program Evaluation (Federal Category 5)
Your research will evaluate, study or otherwise examine a public benefit or service program
conducted by or subject to approval of a federal department or agency. (IRB approval is
required to perform research under this category.)
If Yes, complete Section II and Section III of this application.
N/A
Research Involving Taste and Food Quality (Federal Category 6)
Your research will involve an evaluation of taste and food quality, or a consumer acceptance
assessment.
If Yes, Complete Section II and Section III of this application.
N/A
Yes
Yes
II. Description of Project
Please attach 1-2 typed pages answering questions 1 through 7. Provide your answers as separate
responses to each question. If the question does not apply to your project, respond with a “N/A.”
(Do not attach a master’s proposal or contract/grant.)
1.
Briefly describe the purpose and objectives of your research in non-technical language.
2.
Briefly describe your research design and methods.
3.
For research being conducted as “educational curriculum,” describe how the activity being studied is
part of “normal” educational practice.
4.
If you are using existing data, describe the source(s), the extent to which individuals are identified,
the time frame of when the data was collected, and how you have access to the data.
5.
If your research will be observational, describe how the observations will be recorded (e.g., audio,
video, field notes). If you are planning to audiotape the participants, please see Section III-1b of this
form for instructions.
a. If your project involves videotaping in a setting that would not be considered public, please
fill out an application for non-exempt review.
Application for Exempt Status, v. 04-08-15
University of Hawai'i Human Studies Program
(808) 956-5007, uhirb@hawaii.edu
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6.
Describe your participant population (e.g., age, as special needs, etc…). How will you identify, contact
and recruit participants? Approximately how many participants do you intend to involve in your
research? How will you explain your research to participants?
7.
If you are requesting a waiver of consent, or a waiver of documentation of consent (signature,) please
provide your justification.
III. Attachments
1. Please provide a consent form to be given to research participants. Examples using preferred
language and formatting can be found on the Human Studies Program website under “Templates.”
Students should include their faculty advisor's name and contact information, their own contact
information (no personal phone numbers please,) and the Human Studies Program contact
information on the consent form.
a. If audio recordings will be a part of the research record, there must be a clear description in
the consent form of:
i. how the recordings will be stored,
ii. how the recordings will be used including any uses beyond this research project,
iii. and what will be done with the recordings when the project is complete.
b. A separate consent form or yes/no “initial one” boxes on the main consent form above the
signature line must be provided so that participants can agree or refuse to be audio recorded.
c. If applicable, include language in the consent form that describes how the data or audio
recordings are likely to be used for future research purposes.
2. For research involving minors (ages 17 and younger), you must provide the following:
a. A parent/guardian consent form requesting permission for their child to participate in
research that includes space for a signature and date.
b. A way of obtaining assent or refusal to participate from the child(ren) that is easy for them to
understand. If the participants are 5 to 11 years old, please provide an oral assent script with an
explanation of how you will explain the project to them and obtain their assent or refusal to
participate. If the participants are 12 to 17 years old, please provide a written assent form that
includes a space for a signature and date.
3. Attach a copy of all survey instruments and interview guides. If draft instruments are submitted,
final drafts must be submitted as a modification for final Human Studies Program approval before
use.
4. Recruitment materials need to be submitted. Recruitment is how you first reach out to potential
participants to let them know about your study and invite them to consider participating. This may
be done verbally (requiring a written script to be submitted) or in writing (requiring the email, letter,
and/or flyer to be submitted). Recruitment of participants occurs before the consent process, which
occurs before the planned research interaction (e.g., interview or survey); the consent form is not
considered a recruitment document. Examples and Guidelines are found on the Human Studies
Program website for what types of information you should consider including in any recruitment
materials.
5. Translation of Written Documents - If your participants do not read English and/or the research
will be conducted in their native language, written documents to be shared with them (e.g., consent
form, survey) must be translated into their native language. Verbal recruitment scripts and verbally
asked interview questions do not need to be translated - only written documents that will be shared
with potential research participants. These translated documents must be submitted to the IRB
Application for Exempt Status, v. 04-08-15
University of Hawai'i Human Studies Program
(808) 956-5007, uhirb@hawaii.edu
Page 4
before approval will be given to use such documents and the research can begin. If all other aspects
of your application are satisfactory, then approval for the study may be given, but translated
documents cannot be used until they are submitted to the Human Studies Program office as a
modification and approval is given for the modification(s).
6. Attach a copy of your CITI training completion report. See the Human Studies Program website
under “Learning Commons - HSP” for instructions on how to complete the training. Your application
will not be reviewed until training requirements have been met.
Approval of this Exempt Application is valid for the entire life of the research project. No annual renewal
is required. However, any changes in the procedures or instruments must be prospectively approved by
the Human Studies Program, a process which can occur via email to uhirb@hawaii.edu for Exempt
projects. Once the study is complete, please notify the Human Studies Program also by email to
uhirb@hawaii.edu.
If you have questions, or are unsure about whether or not your research project qualifies as Exempt,
please call the Human Studies Program office at (808) 956-5007, or send an inquiry via email to
uhirb@hawaii.edu.
IV. How to Submit Your Application:
Please email your application to the Human Studies Program including pages 1 - 5, typed and signed on page
1, a description of the project - Section II, and all relevant documents listed in Section III.

Email to: uhirb@hawaii.edu. Subject line: “Exempt Application.” A signed application is required. To
convert your signed application to an e-file, please scan.
Thank you!
Application for Exempt Status, v. 04-08-15
University of Hawai'i Human Studies Program
(808) 956-5007, uhirb@hawaii.edu
Page 5