Fillable Irb Proposal Submission Form (Southern Utah University)

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Irb Proposal Submission Form (Southern Utah University)

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IRB PROPOSAL FORM FOR USE
OF HUMAN SUBJECTS IN
RESEARCH
SOUTHERN UTAH UNIVERSITY
IRB PROPOSAL FORM FOR USE OF HUMAN SUBJECTS IN RESEARCH
Information entered into this form may be lost if this file is not first
downloaded (i.e., saved to a local device) and then opened with Adobe
Reader or Adobe Acrobat prior to the entry of any information.
1. Title of Research Proposal:
2. Principal Investigator (PI): Title of PI (e.g. Faculty Staff, Student):
College, Organization, or Office Department:
Address: Phone Number or Extension:
E-mail: Fax
3. Is the PI is a Student? If YES Complete this Section.
YES NO
Faculty Supervisor T
itle of Faculty Supervisor:
Faculty Supervisor's College, Organization, or Office
Faculty Supervisor's Address: Faculty Supervisor's Phone (xxx.xxx.xxxx):
Faculty Supervisor's Department:
Faculty Supervisor's E-mail:
4. Other Investigators: (may be named individually or collectively if a whole class is involved)
5. IRB Training Certificates
The principal investigator and supervisor, if applicable, has submitted an NIH Ethics in
Research Training Completion Certificate to The SUU IRB or SUU’s SPARC Office. Please
note: It is the PI’s responsibility to make certain that all individuals involved with the project
receive appropriate and adequate training in the protection of human research participants. If
the PI is a student, this responsibility rests with the supervisor:
YES
NO
Will be Attached to Signed Paper Copy
6. Start Date of Proposed Research
End Date of Proposed Research
(Please note that IRB approval may only be granted for one year at a time.)
7. The Proposed Research is for ( Check All that Apply)
Faculty Research Student Research Project
Class Project SUU Administration
SUUSA Grant Proposal
Other
Specific Course for Class Project (If Applicable)
8. Intended Dissemination of Results
Off Campus Presentation and/or Publication
Class Presentation
SUU Campus Community
Other
9. Describe Your Research Question(s) And Justify Why This Research Needs To Be
Conducted.
10. Describe How Research Subjects Will Be Recruited And Any Proposed Compensation Or
Incentives There Are To Participate.
Which Method(s) Of Recruitment Will Be Used:
Flyer Newspaper Ad Online Recruitment
Class Presentation
Other
Paste Here Or Attach A Script, Flyer, Or Recruitment Text To The Printed Copy Of This
Document.
11. Describe All Materials And/Or Apparatuses To Which The Participants Will Be Exposed.
Include A Copy Of The Materials Here Or As An Attachment To The Printed Document.
12. Describe The Research Methodology In Common, Non-technical Language. Describe Your
Research Design. The SUU IRB Needs To Know Exact Procedures And Exactly What Will Be
Done With Your Research Participants. If Any Form Of Deception Is Used, It Must Be Described
And Justified.
RISK/BENEFITS & PARTICIPANT INFORMATION
ASSESSMENT OF RISK AND VULNERABLE POPULATION STATUS
Part A: Assessment of Vulnerability
13. Indicate which of the following describes the research participants (the individuals from or
about whom you will be obtaining information).
Active Independent Adults (Non-SUU) SUU Faculty, Staff or Students
Estimated Number of Participants
Inclusion of Potentially Vulnerable Participants (Check all that apply):
Pregnant Women or Fetuses
Cognitively Challenged Individuals
Physically Challenged Individuals
Individuals 65 Years of Age or Older
Hospital Patients
Individuals with Learning Disabilities
Prisoners
Children (Minors, Less than 18 Yeas of Age)
Economically Disadvantaged Individuals
Faculty's Own Students
Others Who Might Be Subject to Risk
Estimated Number of Potentially Vulnerable Participants. List Category and Estimated Number
Part B: Privacy & Confidentiality
Will the Data Collected Be Anonymous: No Names or Other Identifiers (e.g. SSN’s, Student
ID’s) Will be Attached to Any of the Data OR Will the Data Be Confidential: Names or Other
identifiers (e.g. SSN’s, Student ID’s) will be Associated with At Least Some of the Data
Collected?
Anonymous Confidential
If You Selected Confidential. Please Answer Each of the Following Three Questions. Your
Answers Should be Complete and as Concise as Possible.
I. Who specifically will have access to the confidential data?
II. What steps will be taken to ensure that the data remains confidential?
III. For all confidential data (visual, auditory, or printed), when and how will this data be
destroyed or de-identified?
Will Participation in this Research Be Anonymous: participants’ identity will not be
known, directly or indirectly, to the researchers OR Confidential: At least some of the
participants’ identity will be known?
Anonymous Confidential
If You Selected Confidential. Please Answer Each of the Following Two Questions.
Your
Answers Should be Complete and as Concise as Possible.
I. Who specifically will have access to the participants’ identity?
II.
What steps will be taken to ensure that participation in the study remains
confidential?
Part C: Risks & Benefits
T
otal Time Commitment
Requested from Participants
If Total Time Commitment Varies According to Each Type
of Participant, Please Describe Below.
Indicate Which Of The Following Types Of Information Will Be Solicited From or About The
Participants.
Physical health disorders, past or present
Mental health disorders, past or present
Sexual attitudes or behaviors
Alcohol or tobacco use
Illegal activities
Feelings/thoughts/attitudes about colleagues or co-workers
Feelings/thoughts/attitudes about employers
Feelings/thoughts/attitudes about significant others
Financial status or activity
Behaviors considered undesirable in the present local culture
Any other information which might reasonably cause embarrassment and/or other
emotional distress to participants
Any other information which most people generally keep private and/or confidential
If any of the above information is solicited, then this is an indication that a risk (physical,
psychological, social, economical, or legal) could present itself. To minimize these risks,
participants must be informed of the nature of the risks and how they will be minimized.
Describe how risk will be explained to participants and minimized.
Will Participants be Subjected to the Following Procedures? Check All that Apply
Blood sampling
Other invasive biomedical procedures
Moderate or strenuous exercise
Procedures which could cause physical pain/discomfort
Procedures which could cause psychological pain/discomfort
Procedures designed to increase stress levels
Consumption of food or beverage other than water
Administration of a non-food related drug or chemical
Physical therapy
Psychological intervention/treatment
X-ray or similar imaging techniques
Use of radiation or lasers
Use of potentially hazardous materials
Exposure to stimuli of a mature nature (language, violence, nudity, sexual content)
Any other procedure capable of causing harm. Please describe:
If You Indicated A Procedure Above, This Indicates That A Risk (Physical, Psychological, Social,
Economical, or Legal) Could Present Itself. For Each Procedure Indicated Above:
A. Explain the procedure, relevant apparatus and/or stimuli involved;
B. Explain the nature of the risk, its consequences, and how it will be minimized;
C. Explain what will be done in the event the risk does become a reality.
Please Describe all Probable Benefits to Participants, Others, and the Discipline/Organization
Affected by this Research
14. Indicate All Locations of Data Collection
On Campus
Off Campus
Online (Internet, Web-Based)
Off Campus Locations (If Applicable)
Private residence
Commercial establishment (e.g., restaurant, store, gym clubs)
State or federal office (e.g., Dept. of transport, Workforce services)
Other university/college campus
School (public or private)
National or state parks
Other. Please Describe
NOTE: Except for participants tested/interviewed on campus, in their private residence, or via the
internet, it is likely that on site testing/interviewing will require permission from the site manager/
director. A copy of the request must be attached. Documented approval from the site manager/
director MUST be obtained prior to initiating on site research activities. Failure to obtain such
documentation will void any IRB approval for the research project and could result in disciplinary
action.
15. An Informed Consent Statement/Document:
will not be presented verbally or in writing
will only be read to all participants
will only be read by all participants
will be presented to be read and signed by all participants
If the proposed research involves more than minimal risk and/or tests one or more vulnerable
populations, the SUU INFORMED CONSENT TEMPLATE should be used to construct the
informed consent document. In almost all of these cases, this document will need to be signed by
the participant and/or his/her legal guardian, and the primary investigator.
Explain why Informed Consent Will not be Sought (If Applicable)
Include the Script to be Read to Participants (If Applicable) in the Section Below. If the Script
Cannot be Included on this Form, then Attach it with the Submitted Application.
Include the Informed Consent Document (If Applicable) in the Section Below. If the
Informed Consent Document cannot be included on this Form, then Attach it with the
Submitted Application.
Be Sure All Required, and Applicable Elements are Included in Your Informed Consent
Document:
Your name and position at SUU
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
If a survey or interview is involved, include the following statement: You may skip
any question you do not wish to answer.
If surveying/interviewing participants, a description of the type/nature of the questions
Include the statement: Participation is voluntary. You may discontinue the study at any
time for any reason without penalty. You may ask questions at any time (via e-mail if
internet-based).
A description of any reasonable, foreseeable risks or discomforts to the participant
A description of any benefits to the participant which may reasonably be expected from
the research
A statement explaining whether participation and the data collected is anonymous or
confidential
Who to contact for information or concerns regarding the study (both PI and SUU IRB
contact information should be provided)
A statement whether or not compensation will be awarded and the details thereof
The following statement: The Instititutional Review Board (IRB) of Southern Utah
University has reviewed this study for the protection of the rights of human subjects in
research studies, in accordance with federal and state regulations.
Is this Research being Funded (or Intended to be Funded) by a Grant?
NO
YES (Please Describe)
I approve this protocol for submission to the SUU IRB:
Principal Investigator's Signature (Typed Signature is Acceptable)
Date
Faculty Supervisor's Signature (If Applicable; Typed Signature is Acceptable) Date
The PI or Faculty Supervisor (if PI is a student) will be informed in writing of the IRB’s decision. The
proposed research may not be initiated prior to receipt of IRB approval.
Should you wish to modify this proposal prior to its approval, please contact the SUU IRB
Chairperson immediately with intended modifications, and submit the revised proposal as soon as
possible.
Modifications to an approved IRB proposal MUST be requested by completing the Proposed
Changes to a Previously Approved Protocol Form. No changes may be initiated until such approval
is granted, unless they are to eliminate or reduce immediate harm to participants.
Everyone named (individually or collectively) in this proposal is required to be familiar and comply
with SUU policy 6.20.
Please submit this proposal via email to irb@suu.edu along with all applicable
attachments and supplemental materials.
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Completed 23 July 2020

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