Fillable Application for Exempt Status for Human Subjects Research (University of Hawaii at Hilo)

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Application for Exempt Status for Human Subjects Research (University of Hawaii at Hilo)

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Exempt Application Revised 5/2/2010 Page 1 of 5
Application for Exempt Status for Human Subjects Research
University of Hawaii Committee on Human Studies (CHS)
1960 East-West Road, Biomedical Building B-104, Honolulu, HI 96822, (808) 956-5007, uhirb@hawaii.edu
Aloha! Most research involving human subjects at the University of Hawaii must be approved by the UH
Committee on Human Studies (CHS). Some research may be exempt from certain Federal requirements.
Please read and follow all instructions carefully when filling out this application. For more information, please go
to the CHS website at www.hawaii.edu/irb
or contact CHS with any questions. Underlined words are defined in
the Glossary on page 5.
I. Is Your Project “Research”?
To determine if your project qualifies as research, please answer the question below.
If you answer “Yes” to the following question, your project meets the federal definition of research.
Please answer Section II to determine of your project is human subjects research. If you answer “No”,
your project does not meet the federal definition of research. No CHS application is required.
1. Is your project a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge
? (Underlined words are
defined in the Glossary on page 5.)
Yes
No
II. Is Your Project “Human Subjects” Research?
To determine if your project qualifies as human subjects research, please answer the questions below.
If you answer “Yes” to either of the following 2 questions, your project does not require CHS review
and approval and you do not need to complete or submit this application.
1. Does your project involve only the analysis of publicly available data? Examples include census
data, large public survey datasets with no individual identifiers, and public information available
on the internet.
Yes
No
2. Is this a UH class project (whether individual or group) from which the data will only be submitted
to your instructor for a class grade and will not be published, presented at an academic
conference, given to an agency as a formal report, and will not be used in future research or to
qualify for a graduate degree (e.g. Master’s or Doctoral dissertation)?
Yes
No
If your answer to the following questions is “Yes” for both 1 and 2, or both 1 and 3, please complete
Section III of this form. If you answer “No” for 1, 2, and 3 below, your project does not require CHS
review and approval and you do not need to complete or submit this application.
1. Does your research involve obtaining information about living individuals? Yes
No
2. Will the information be obtained through intervention or interaction with these individuals? Yes
No
3. Will your research involve access to private information from which individuals can be identified
directly or indirectly through a link or code? This includes access to existing data that identifies
individuals but these individuals will not be contacted in your research project.
Yes
No
III. Categories of Exemption
Complete all the categories 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 CHS Application
available on the CHS website at www.hawaii.edu/irb under
“Forms”.
Research on Educational Practices (Federal Category 1)
N/A
Your research will take place in an established or commonly accepted educational setting, involving
normal educational practices
.
Yes
If Yes, complete Section IV and Section V of this application.
✔
✔
✔
✔
✔
✔
✔
Exempt Application Revised 5/2/2010 Page 2 of 5
Research Involving Surveys or Interviews (Federal Category 2)
N/A
1. Your research will involve the use of educational tests, surveys or interviews for participants
ages 18 and older. (educational tests may include cognitive, diagnostic, aptitude, and
achievement tests)
Yes
2. Your survey/interview research will involve only adult participants (18 and older) who would not
be considered part of a vulnerable
population. (for definitions, see glossary on page 5)
Yes
3. 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 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).
Yes
If you answered “Yes” to 1, 2 and 3, complete Section IV and Section V of this application.
Research Involving Public Observation (Federal Category 2)
N/A
Your research will involve observation of human subjects in a public setting where there is no
expectation of privacy.
Yes
If Yes, complete Section IV of this application.
Research Involving Public Officials (Federal Category 3)
N/A
Your research will involve surveying or interviewing elected or appointed public officials (or
candidates for public office).
Yes
If Yes, complete Section IV and Section V of this application.
Research Involving the Use of Existing Data (Federal Category 4)
N/A
1. Your research will involve the study of existing data, documents, records, pathological
specimens, or diagnostic specimens.
Yes
2. You will record the information in such a manner that participants cannot be identified either
directly or through identifiers linked to the participants, or the sources of these data are publicly
available.
Yes
If you answered Yes to 1 and 2, complete Section IV of this application.
Research Involving Public Benefit or Service Program Evaluation (Federal Category 5)
N/A
Your research will evaluate, study or otherwise examine a public benefit or service program at the
request of a department or agency head. (CHS permission is required to perform research under this
category.)
Yes
If Yes, complete Section IV and Section V of this application.
Research Involving Taste and Food Quality (Federal Category 6)
N/A
Your research will involve an evaluation of taste and food quality, or a consumer acceptance
assessment.
Yes
If Yes, Complete Section IV and Section V of this application.
IV. Description of Project
Please attach 1 – 2 typed pages answering questions 1 – 6. (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 practice,” 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, and how you have access to the data.
✔
✔
✔
✔
✔
✔
✔
✔
Exempt Application Revised 4/30/2010 Page 3 of 5
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 audio or videotape the participants, please see
Section V. If videotaping, please explain how you plan to use and store the videotape(s). In
most cases, if your project involves videotaping, it will not qualify as exempt.
6. Describe your participant population (e.g., age, as special needs, etc…). How will you identify,
contact and recruit participants? How many participants do you intend to involve in your
research? How will you explain your research to participants?
V. Attachments
1. Please provide a consent form
to be given to research participants. Examples can be found on the CHS
website under “Forms”.
a. If audio or video recordings will be a part of the research records, there must be a clear
description in the consent form of: 1) how the recordings will be used including any uses beyond
this research project, 2) how the recordings will be stored, 3) and what will be done with the
recordings when the project is complete. A separate consent form, or yes/no checkbox on the
main consent form must be provided so that participants can agree or refuse to be recorded.
b. As applicable, include language in the consent form that describes how the data or 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 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 understandable to them.
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 space for a
signature and date.
3. Attach a copy of all survey instruments and interview guides. If you are using recruitment flyers, or
advertisements, please provide copies of these as well. If draft instruments are submitted, final drafts
must be submitted for final CHS approval before use.
Approval of this Exempt Application is valid for the entire life of the research project and does not need to be
renewed annually. However, any changes in the procedures or instruments must be prospectively approved by
CHS, a process which can occur via email for Exempt projects. Once the study is complete, please notify CHS.
If you have questions, or you are unsure whether your research project is Exempt, please call the CHS
Office at (808) 956-5007, or send an inquiry by email to uhirb@hawaii.edu
.
VI. How to Submit Your Application:
Please provide CHS with this application (typed and signed on page 4), a description of the project, and all
relevant documents listed in Section V. (Email is preferred for exempt applications. However, paper is accepted)
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.
Mail or Deliver: Send/provide 2 copies of all materials (collated) with original signatures to UH Committee
on Human Studies, 1960 East-West Road, Biomedical Building B-104, Honolulu, HI 96822.
Fax to: (808) 956-8683, applications must be signed and dated.
CHS # ______________
Exempt Application Revised 5/2/2010 Page 4 of 5
Please type the information below. Thank you.
Researcher
name:
Researcher
email:
Researcher phone:
Department: Campus:
Status: Faculty Student
Masters Ph.D. Other:
If student, name of faculty advisor:
Advisor email: Advisor phone:
Title of Research Project:
Signatures
I certify that the Information in this application is accurate and complete.
Researcher: Date:
I have reviewed and approved this application:
Advisor:
Date
:
(for student research)
This box for CHS Use Only: CHS#
Exempt Request: Approved Approved with Stipulations Not Approved Exempt Category _______
Reviewer comments / recommendations:
Approved by: ______________________________________ Date: ______________________
John Coney
jconey@hawaii.edu
808-933-3907
UH Manoa
✔
✔
Staff, UH-Hilo Marine Option Program
Eddie Gose
gose@hawaii.edu
956-9765
TeachingMarine Species Identification using web based learning modules
Exempt Application Revised 5/2/2010 Page 5 of 5
VII. Glossary
Assent A child’s affirmative agreement to participate in research. Mere failure to object should not, absent
affirmative agreement, be construed as assent.
CHS Application (these forms are found on the CHS website under “Forms at www.hawaii.edu/irb)
• Application for Exempt Status for Human Subjects Research Use this application to determine if
and to apply for CHS approval as an exempt study.
• Application for New Approval of a Study Involving Human Subjects Use this application for
research that is not exempt.
Consent Form A document which explains a research study (including a description of any procedures, the
potential benefits and risks of participation, etc.) to potential research participants. Most consent forms
require a signature and date of the participant. By signing the consent form, a participant asserts his or her
voluntary agreement to participate in a study. Examples of consent forms are available on the CHS website
at www.hawaii.edu/irb.
Educational Practices Includes teaching, curriculum development and other activities consistent with the
process of formal education.
Educational Setting A school, classroom, and other locations where formal education is typically
conducted.
Exempt Research Under federal regulations, specific categories of research can be designated as exempt
from certain regulatory requirements as well as initial and continuing review by the IRB committee. Research
at UH must be approved as exempt by the UH Committee on Human Studies (CHS).
Existing Data Data that has been previously compiled for research or non-research purposes, such as
school records or census information. Existing data may include data sets, interview notes or audio or video
tapes.
Generalizable Knowledge When study results are intended to answer a research question, to draw
conclusions about a specific premise (or hypothesis), or to apply study results beyond the specific focus of
the research (the research data or study participants), they are considered to be generalizable. Study results
that will be published (in a scholarly journal, book, or on-line), placed in a library (such as a masters or
doctoral dissertation), or presented at an academic meeting are considered to be generalizable.
Human Subject A human subject is a living individual about whom a researcher, whether professional or
student, obtains data through intervention or interaction, or obtains identifiable private information about
them.
Informed Consent The process by which a person voluntarily agrees to participate in research based on
adequate knowledge and understanding of the research project.
Identifiable Data Data that can be used to identify individual research participants. Identifiers include but are
not limited to names, addresses, phone numbers, social security numbers, geocodes, and images (but not
voices). Identifiers may also include codes that can be used to link an individual’s identity with information
about them.
Private Information Information that an individual would reasonably expect to not be shared without the
individual’s permission. Private information may also refer to observed behavior about a person in a setting
in which the person would not expect to be observed for research purposes without permission.
Public Benefit or Service Program A government agency or program established to provide services to
eligible members of the public (e.g. WIC, Veterans Affairs, etc.) Research must be supervised by the agency
in charge of the public benefit or service program. Please contact the CHS office if you believe your project
may qualify under this category.
Vulnerable populations Children, prisoners, pregnant women, physically or mentally disabled persons, or
economically or educationally disadvantaged persons.
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