Checklist for Human Subject Protocols

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Texas A&M University
Application for the Exempt Use of Human Subjects in Research
*****TO APPLY FOR EXEMPT USE ONLY!*****
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 Training (Collaborative IRB
Training Initiative) as found at: http://researchcompliance.tamu.edu/irb/trainreq/trainreq
3. Attach Documents to Application
Training Documentation: CITI Completion Reports for PI and Co-I only
Conflict of Interest Statements for PI and Co-I as found at: http://researchcompliance.tamu.edu/irb/
Recruitment Materials as applicable: Flyers, Letters, Phone Scripts or Email
Grant/Contract Application as applicable
Any other documents referenced in this application as applicable
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: Centeq Building, 1500 Research Parkway, Suite B 150
Off Campus: IRB, 1500 Research Parkway, Suite B 150, 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: Michelle Chang
Faculty
Staff
Graduate Student
Undergraduate Student
Department: Computer Science College: Engineering Mail Stop: NA
Phone: 813-957-5761 Email: triniaggie@gmail.com Fax:
Is this study part of a Thesis or Dissertation? Yes
No
If Yes, do you have committee approval? Yes
No
Co-Investigator Name:
Faculty
Staff
Graduate Student
Undergraduate Student
Department:
College:
Mail Stop:
Phone:
Email:
Fax:
Graduate Committee Chair/Faculty Advisor Name (if student): Dr. Andruid Kerne
Department: Computer Science College: Engineering Mail Stop: 3112
Phone:
Email: andruid@cs.tamu.edu Fax: 979-847-8578
Project Title: Fleeting Social Ties
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
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Purpose of Study
1. Purpose of study: Please provide a BRIEF statement, in lay terminology, outlining the purpose of this study.
(Why you are doing this research project and what you propose to learn.) Fleeting Social Ties application
addresses the need for real time location-based services for gaining a local’s perspective about a
particular city. Tourist guides are often clichéd and do not address the genuine business traveler’s or
vacationer’s desire to experience local and authentic culture as individuals native to that location. This
application seeks to bridge this gap by creating social fleeting ties with locals in a particular city to create
a genuine communication experience. The purpose of this study is to determine whether the real time
interactions afforded by this interface actually provide useful insights for the business traveler or
vacationer. In addition, the interface will be evaluated for its ability to bring the “local” perspective to a
foreign city.
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: Business travelers and vacationers who
need quick highlights from the "locals" when they visit a foreign area. They may be interested in the best
restaurants around town, must-see places, the best hotel, the best area to stay in but from a local's
perspective. They may want to use Wondir, Flickr, Jaiku, Yahoo Answers, Wiki Ref Desk or Twitter to find
out this info from others in that area.
Subject Recruitment
Approximate number of participants: 10 to 50
Ages of participants: Approximately 10-50 participants will be selected. These participants are members of
the Tampa Bay community. Participants will be at least 18 years of age. Gender or other demographics
are not expected to have any effect on the outcome of these results.
Gender of subjects: Male
Female
What are the selection criteria for participation? Selected participants should have basic computer experience,
including how to use a keyboard, a mouse, right-click on menus, the Windows operating system, and basic
abilities on navigating in a Web browser. They will be recruited through face-to-face contact and could include
general computer users in the community as well as other students. All subjects should either be vacationers or
business travelers.
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
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): Participants will be recruited from the Tampa Bay community.
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Recruitment Method:
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) Participants at my local clubhouse where social events are
held frequently or in my neighborhood.
Other (describe)
How will initial contact be made with potential participants? (be specific) Participants will be selected based on
the following criteria: they are vacationers or they are business travelers who possess computer literacy
skills.
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:
Procedures
What will the participants be asked to do? (be specific) The participant will be asked to select a foreign
destination of choice – a location that has never been visited before by the participant. This task is
designed to give the user a qualitative experience interacting with a foreign city. The participant explores
the city using the two interfaces below to perform the task:
1.
Web browser for the participant to find any information about that foreign city e.g. by using
search engines such as Google, Yahoo, etc.
2.
Fleeting Social Ties application where the participant can browse using a 3D map interface and
select a foreign location on the map.
Approximately 10 to 50 participants will perform both steps 1 and 2 above. The order of the tasks will be
counterbalanced. This sequencing reduces the bias of ordering effects with the introduction of the new
interface. Participants will be given a brief overview of how each interface works to acquaint users with
the respective tools and the specific task will be administered. During the task, participants will engage in
a think-aloud protocol. The investigator will take notes during the task to have a permanent record of the
scope of the city that the participant explored. After the task is completed, a post-task interview will be
issued to find out specific details about the experience:
1.
Which interface did you like better?
2.
What did you like about it?
3.
What additional information was provided in your chosen interface that was not provided in the
other interface?
4.
What do you like/dislike about the information displayed in your chosen interface?
5.
What additional data would you have liked to see that’s missing?
6.
Is the value of the data worth turning on your GPS device? Why or why not?
Describe location where research activities will take place: (e.g. building name/physical address) The task will
be completed in the Country Walk Community Clubhouse, Meadowpointe Boulevard, Tampa FL.
Describe setting where research will take place: (i.e. classroom, office, park, personal computer, etc.) The study
will take place on a personal computer in a community clubhouse building. Location will not have any
effect on the outcome of their results, nor are there any negative effects with respect to the use of either
tool. The interface tools are accessible from any browser regardless of location.
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) 3 minutes for tutorial, 20 minutes for above tasks, 7 minutes for post-evaluation
interview. Total is 30 minutes.
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During data collection, describe what steps will be taken to ensure participant privacy: Anonymity will be
ensured by not attaching any names or contact information to the responses that are generated by the
participants. Participants will be assigned a random identification number (ID) only to distinguish their
responses from other participants' responses. This ID is in no way associated with their name or their
social security number or any other ID numbers.
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.
What specific steps will be followed to ensure confidentiality or anonymity of participants’ responses? (i.e. replies
coded, records securely stored) Participants' interaction with the interface will be assigned a random
identification number (ID) only to distinguish their responses from another participant’s responses. This
ID is in no way associated with the participant's name, social security number, driver's license number or
student ID. The records of this study will be kept private. No identifiers linking participants to the study
will be included in any sort of report that might be published.
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:
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:
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 information sheet? Yes
No
Will recordings be retained? Yes
No
If Yes, how long will records be retained before they are destroyed/erased?
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:
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
Has an application been reviewed by the AWAP? Yes
No
AUP Number:
Approval Date:
No
Does this study involve the use of infectious biohazards or recombinant DNA?
If Yes, complete the following:
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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:
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Signature Assurance
I understand Texas A&M University’s policy concerning research involving human
subjects and I certify that:
HSPP Office Use Only
Please initial:
_____ 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 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:
I understand Texas A&M University’s policy concerning research involving human subjects and I certify that:
Please initial:
_____ 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 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:
*If there is more than one Co-Investigator, make additional copies of Signature Assurance page as needed.
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.
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