Texas A&M University
Application for the Use of Human Subjects in Research
Instructions
1. Complete Form
Form must be typed, single-sided and free of typographical/grammatical errors.
HSPP Office Use Only
2. Complete Training
PI, Co-I and anyone interacting with potential participants must complete CITI (Collaborative Institutional
Training Initiative). Refresher training must be completed every two years. More details can be found at:
http://researchcompliance.tamu.edu/irb/trainreq/trainreq.
3. Attach Documents to Application
Current Training Documentation: for PI and Co-I only
Conflict of Interest Statement for PI and Co-I
Recruitment Materials as applicable: Flyers, Letters, Phone Scripts or Email
Consent Documentation as applicable: Consent Protocol, Consent Form or Waiver of Consent
Grant/Contract Application as applicable
Any other documents referenced in this application as applicable (debriefing form, payment schedule, etc.)
4. Submit Application
Review of application will not begin until all required documentation is received. Submit this application with
original signatures and any additional documentation to:
On Campus: HSPP/IRB, MS 1186
In Person: General Services Complex, 750 Agronomy Rd, Suite 3501
Off Campus: IRB, 750 Agronomy Rd, Suite 3501, College Station, Texas 77843
If you have any questions or need assistance completing this application, please call
(979)458-4067 or email irb@tamu.edu
Information
Principal Investigator Name: Patrick Webster
Faculty
Staff
Graduate Student
Undergraduate Student
Department: CSCE College: Engineering Mail Stop:
Phone:
Email:
Fax:
Is this study part of a Thesis or Dissertation? Yes
No
If Yes, do you have committee approval? Yes
No
Co-Investigator Name: Miguel Borromeo
Faculty
Staff
Graduate Student
Department: CSCE College: Engineering
Phone:
Email:
Fax:
Undergraduate Student
Mail Stop:
Graduate Committee Chair/Faculty Advisor Name (if student):
Department:
College:
Mail Stop:
Phone:
Email:
Fax:
Project Title: Physically Based Information Semantics Simulation - User Study
New submission
Re-submission
(If protocol was disapproved)
Funding Status: Funded
Not Funded
Pending
(Please attach a copy of Grant/Contract Proposal)
Funding Agency:
Funding Amount:
Funding Administrator: HSC
RF
TAES
TEES
TAMU
TTI
Standard Application
Version: 03/04/09
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Purpose of Study
Purpose of study: Provide a BRIEF statement, in lay terminology, outlining the purpose of this study. (Why you
are doing this research project and what do you propose to learn.) Test an interface and interaction design
on potential users of the final software product in order to identify problems with understandability and
usability.
Risks and Benefits
Describe any potential risks or discomforts to the participant: (Do not say “none.” If no foreseeable risks are
associated with research, state: Minimal risk) Minimal risk
Describe any potential benefits to the research participant or society: Educational: users of the final software
product will learn, through interaction, about the data sources used.
Subject Recruitment
Approximate number of participants: 5
Ages of participants: 18-50
Gender of subjects: Male
Female
What are the selection criteria for participation? Colloquial familiarity with the data source and basic
computer use.
Do the criteria for selection exclude individuals based on gender, culture, language, economics or ethnicity?
Yes
No
If Yes, please justify exclusion:
Source of participants:
Psychology Subject Pool
Marketing Subject Pool
Motor Subject Pool
Other Subject Pool (provide explanation)
Other TAMU Students (provide explanation)
Community (provide explanation)
Treatment Centers (provide explanation)
Schools (provide explanation)
Other (provide explanation)
Explanation (if applicable): Convenience sampling: our audience consists of general computer users,
and so a sampling taken from the student population of the university is satisfactory.
Vulnerable Populations:
Not Applicable
Children
Pregnant Women/Fetuses/Neonates
Prisoners
Adults who lack ability to consent
Other (provide description)
If vulnerable populations will be used, describe additional safeguards to protect their rights and welfare.
Recruitment Method:
Standard Application
Version: 03/04/09
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Telephone solicitation (attach script)
Newspaper advertising (attach ad copy)
Posted notices (attach copy)
Letter (attach copy)
Email (attach copy)
Direct person-to-person contact (describe) We will be contacting potential subjects on an individual
basis and determining if they would be willing to participate in the study.
Other (describe)
How will initial contact be made with potential participants? (be specific) Personal contact with classmates,
roommates and other existing contacts.
Other than an Investigator, do you have any other relationship with participants? (i.e. doctor-patient, teacherstudent, counselor-student, etc.) Yes
No
If Yes, explain the relationship and describe how you will avoid any type of coercion. We are making use of
existing, informal, personal contacts. These contacts do not provide leverage to elicit
participation/cooperation, and will not be effected by the study itself.
Consent
LOCATION
Describe location where consent process will take place: (i.e. building name/physical address) Texas A&M
University, Richardson Building, Interface Ecology Lab and adjacent offices/lecture halls
Describe setting where consent process will take place: (i.e. classroom, office, park, personal computer, etc.)
Indoor, academic setting, familiar to all participants.
PERSONNEL
Name individuals or group of individuals who will be speaking directly to potential participants during the consent
process: Miguel Borromeo, Nathan Clark, Luke Hersman, Justin Kern, Chris Starnes, Patrick Webster
What project specific training/experience has this person/group received? IRB Certification
Have the PI, Co-I and any persons interacting with potential participants completed CITI Training? Yes
No
PROCEDURES
Who will be providing consent/assent/permission? (i.e. participant/participant’s legal guardian/parent) Participant
When will consent initially be sought in relation to beginning participation? (i.e. same day, 1 hour prior, 1 week
prior, etc.) Same day, immediately prior
What is the waiting period between providing the participant information and obtaining consent or permission?
(i.e. none, 1 hour, 1 day, etc.) None
What steps will be taken to minimize the possibility of coercion or undue influence? No attempt will be made to
convince potential users to participate should they not indicate a desire to do so upon initial contact.
Attach Consent Protocol. Guide available at http://researchcompliance.tamu.edu/irb/
TOOLS
Please check all that apply and attach to application:
Consent Protocol
Cover Letter
Consent Form
Telephone Script
Parent Permission Form
Information Sheet
Assent Form
Location where consent forms will be filed: Interface Ecology Lab
Note: Consent forms must be kept on file for 3 years after completion of the study.
Standard Application
Version: 03/04/09
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WAIVER
Request for waiver of consent: Yes
No
Request for waiver of signed consent: Yes
If Yes, attach Justification for Waiver Request
No
If Yes, attach Justification for Waiver Request
Compensation/Course Credit
Will monetary compensation be given to the participant? Yes
No
If Yes, attach detailed description of payment including amount and schedule of payments to participant.
Will course credit be given to the participant as compensation? Yes
No
If Yes, provide details and alternate assignment to obtain equal credit.
Subject Matter
Check the appropriate box concerning the subject matter of the research:
No Sensitive Matters
Abortion
AIDS/HIV
Alcohol
Body composition
Criminal activity
Psychological Inventory
Other (specify):
Sexual Activity
Suicide
Learning Disability
Drugs
Depression
Deception or Coercion
Will deception or coercion be used? Yes
No
If Yes, describe deception and attach debriefing form.
Procedures
What will participants be asked to do? (be specific) Participants will be asked to take part in a simulated
usage of our software produt. They will be moving plastic game pieces around a game board, simulating
a computer interface with hand motions and pointing.
Describe location where research activities will take place: (i.e. building name/physical address) Texas A&M
University, Richardson Building, Interface Ecology Lab and adjacent offices/classrooms
Describe setting where research will take place (i.e. classroom, office, park, personal computer, etc.) Academic
setting: classrooms, lecture halls
How long will the participants be engaged in the research? (length of time, i.e. 15 min, 45 minutes on day 1, 60
minutes on day 2) Between 10 minutes and 1 hour
During data collection, describe what steps will be taken to ensure participant privacy: Video recording is
voluntary; all other notetaking will be anonymous.
Is this research anonymous or confidential? (cannot be both)
Anonymous: The identity of the participant cannot readily be determined by the investigator AND the
identity of the participant is not connected to information gathered.
Confidential: Research participants can be identified; however information gathered will be protected.
Neither: Research participants can be identified and information gathered may be connected to participant.
Standard Application
Version: 03/04/09
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What specific steps will be followed to ensure confidentiality or anonymity of participants’ responses? (i.e. replies
coded, records securely stored) No identifiers linking you to this study will be included in any sort of report
that might be published. Research records will be stored securely and only involved researchers wil
have access to the records.
Research type: Qualitative
Quantitative
Both
Will existing data or documents be used? (i.e. public records, survey instruments, evaluation tools, etc.)
Yes
No
If Yes, describe what data or documents will be used and how they will be obtained: Public text posted on
the web service Twitter.com will be used in the study.
Will existing specimens be used? (i.e. blood, tissue, etc.) Yes
No
If Yes, describe what specimens will be used and how they will be obtained:
Does the study involve the use of human fluid tissue and/or blood? Yes
Will any invasive or sensitive procedures be done? Yes
If Yes:
Blood Samples
Urine Samples
Physical Measurements (electrodes, etc.)
Stress Exercise
Review of Medical/Psychological Records
rDNA
Other (specify):
No
No
Will recordings be made? Yes
No
If Yes:
Video Taping
Audio Taping
Is recording mandatory
or voluntary ?
Is the use of recordings detailed in the consent process? Yes
No
Will recordings be retained? Yes
No
If Yes, how long will records be retained before they are destroyed/erased?
semester
Duration of the
Other Compliance Issues
Does this study involve the use of animals?
Yes
No
If Yes, complete the following:
Has an application been submitted for review by the AWAP? Yes
No
Has an application been reviewed and approved by the AWAP? Yes
No
AUP Number:
Approval Date:
Does this study involve the use of infectious biohazards or recombinant DNA?
Yes
If Yes, complete the following:
Has a registration form been submitted for review by the IBC? Yes
No
Is an approved registration currently on file with the IBC? Yes
No
Registration Number:
Approval Date:
No
Standard Application
Version: 03/04/09
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Standard Application
Version: 03/04/09
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Signature Assurance
I understand Texas A&M University’s policy concerning research involving human subjects
and by initialing below, I certify:
_____ I have read The Belmont Report “Ethical Principles and Guidelines for the Protection of
Human Subjects of Research” and subscribe to the principles it contains.
HSPP Office Use Only
_____ I am aware of Section 600: Investigator Responsibilities of the HSPP’s Standard Operating Procedures and will
abide by these procedures. These SOP can be found at: here.
_____ I accept responsibility for the scientific and ethical conduct of this research study.
_____ I will obtain prior approval from the Institutional Review Board (IRB) before amending or altering the research
protocol or implementing changes in the approved information sheet.
_____ I will immediately report to the IRB any serious adverse events and/or unanticipated effects on subjects which
may occur as a result of this study.
_____ I will complete a Final Review Form upon completion of this study.
Principal Investigator Signature: _____________________________________ Date:
Typed Name: Patrick Webster
I understand Texas A&M University’s policy concerning research involving human subjects and by initialing below, I
certify:
_____ I have read The Belmont Report “Ethical Principles and Guidelines for the Protection of Human Subjects of
Research” and subscribe to the principles it contains.
_____ I am aware of Section 600: Investigator Responsibilities of the HSPP’s Standard Operating Procedures and will
abide by these procedures.
_____ I accept responsibility for the scientific and ethical conduct of this research study.
_____ I will obtain prior approval from the Institutional Review Board (IRB) before amending or altering the research
protocol or implementing changes in the approved information sheet.
_____ I will immediately report to the IRB any serious adverse events and/or unanticipated effects on subjects which
may occur as a result of this study.
_____ I will complete a Final Review Form upon completion of this study.
Co-Investigator Signature: ___________________________________________ Date:
Typed Name: Miguel Borromeos
I certify that I have read and agree with this proposal, that the Principal Investigator has received adequate training to
perform this research, and will receive adequate supervision while performing this research.
Faculty/Research Advisor’s Signature: __________________________________ Date:
Typed Name:
Undergraduate and graduate students must have faculty/research advisor’s signature in addition to the signature of the department
head.
This is to certify that I have reviewed this research protocol and agree that the research activity is within the mission of
the Department and appropriate for the responsibilities and assigned duties of the principal investigator.
Department Head Signature: ________________________________________ Date:
Typed Name:
All investigators must have the signature from the department head for completion of the signature assurance. If the principal
investigator is also the Department Head, the College Dean or equivalent must sign.
Standard Application
Version: 03/04/09
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