Instructions for Submitting your

CE/Thesis/Dissertation Proposal

All student CE/thesis/dissertation proposals must be submittedto the UTSPH Office of Research (RAS W-210)for review and approvalby the Associate Dean for Research. Details on the proposal process can be found in the CE/Thesis/Dissertation Guides.

Your project mightalso require review by the UTHealth Committee for Protection of Human Subjects (IRB)and/orother institutional review committeessuch as the UTHealthInstitutional Biosafety Committee. For help determining which institutional reviews are necessary for your project, please refer to the Research Compliance Guide.

Proposal Submission and Approvaldeadlines must be met for the semester in which you intend to graduate. The submission and approval deadlines applyonly to proposals that are submitted during the same semester as the final CE/thesis/dissertation. Deadlines can be found here and on the Planning to Graduate page.

After your CE/Thesis/Dissertation committee members have approved your proposal and signed theproposal cover sheet and other required forms, you may submit the proposal to the UTSPH Office of Researchvia hard copy,and (if applicable) toUTHealth CPHS via online application in iRIS. Proposals may be submitted to both offices concurrently. Doctoral Students must complete their oral defense of proposal BEFORE submitting the proposal to the Office of Research. Doctoral dissertation proposal defense forms are available at:

Submission instructions follow:

Submit your proposal to the UTSPH Office of Research:

1)ALL STUDENTS:Submit aprinted copy of your proposalalong with the following completed, printed, and signed forms to Rebecca Novak in the Office of Research (see below for our mailing address and specific instructions for Regional campus, out-of-town, and Houston campus students):

____Student Proposal Cover Sheet

____ Authorship, Publication Plan & Data Ownership

____Student Research Approvals Document

____CITI training certificate

2)If you will borrow/analyzeexisting data for your study, please also includethe following documents:

____Data Handling Procedures

____Letter of Permission from owner of data (for data that are not publicly available)

____Copy ofIRB approval letter(s)(if applicable),which may include:

a)Copy of parentstudy’s IRB approval letter;

b)Copy of letter from CPHS showing the student has been added to a UTHSC Faculty member’s study;and/or

c)CPHS approval/Exemption letter in the student’sown name

3)ALL STUDENTS: Attach the signed formsand required documentation to the front of your proposal:

____Your proposal

  • Houston students: submit your proposal and signed forms to Rebecca Novak, Office of Research,RAS W-210, or to Rebecca Novak’smailbox, located inRAS E-217 (Student Affairs Office).
  • Regional campus students: submit a printed copy of your proposal and signed forms to your Regional campus Student Affairs staff person, who will overnightthe hard copy to Rebecca Novak in the Office of Research.
  • Out of town students: please mail a printed copy of your proposal and signed forms to Rebecca Novak in the Office of Research (address below). Alternately, your documents may be submitted by a committee member in Houston or a Regional campus (see instructions above). However, it is the student’s responsibility to coordinate the submission of his/her proposal to the Office of Research.
  • Students with committee members located at a different campus: Students may obtain scanned or faxed signatures from committee members who are located at a different campus or who are otherwise unavailable (e.g. traveling) to provide an original signature. However, paper copies of these documents (e.g. not PDFs) must be submitted to the Office of Research. In addition, all proposals require a cover page with the student’s original signature.

Mailing address:

UTHealthSchool of Public Health/Office of Research

1200 Pressler Street

RAS W-210

Houston, TX 77030

ATTN: Rebecca Novak

4)ALL STUDENTS: In addition to your printed proposal and forms, please email an electronic copyof just your proposal (without forms) to:

Questions regarding procedures or forms should be addressed to Rebecca Novak at (713) 500-9055 or

2015-2016

If applicable, submit your proposal to CPHS (UTHealth IRB) in iRIS:

Projects requiring IRB approval from the UTHealth Committee for Protection of Human Subjects (CPHS) are submitted in the iRIS online system. See the Research Compliance Guide to determine if your proposal requires submission in iRIS, or contact CPHS at (713) 500-7943, or Rebecca Novak in the SPH Office of Research at (713)

  1. Log in to iRIS with your UT username and ID.
  2. Click on “Add a New Study.” If you cannot see “Add a New Study,” you might need to click on the “Compatibility view” button on your browser (located to the right of the URL).
  3. When completing your application:

a)Add an SPH “Department” to question #2 (typically, this should be your Department or campus)

b)List your name as PI/student

c)List one SPH committee member as“Faculty Advisor” (only list them here, not as “Co-Investigator”)

d)Add Rebecca Novak as an additional “Study Contact” (this action will forward a copy ofyour IRB approval letter to the Office of Research)

e)“Department” signature person in iRISis NOT required for CE/Thesis/Dissertation proposals. If your application is for anindependent research study (i.e., not for a CE/Thesis/Dissertation), then you should add a Department Chair for signature.

  1. After the application questions have been answered, you must attach your proposal and other items to the iRIS submission packet (most of them under “Study Documents”). Your iRIS submission should include the following attachments:
    ____Student Proposal Cover Sheet (Cover sheet must be signed by committee members)
    ____ CITI training certificate
    ____ Authorship, Publication Plan & Data Ownership
    ____ Data Handling Procedures
    ____Your proposal (referred to as “protocol” in iRIS)
    ____Letter of Permission from owner of data (if applicable)

____Copy of outside IRB approval letter (if applicable)

____ Your CV or resume

____Survey instruments (if you are doing Primary data collection);Letters of Information/Consent Forms (for Primary data collection. Make sure to attach in the “Informed Consent” section of the submission); Letters of Support; Recruitment materials (if applicable);Grantapplication (if applicable).

  1. When completed, “Send” the submission through iRIS, making sure to apply your electronic signature (username and password),and Route the submission to your Faculty Advisor for his/her signature.

For technical assistance, call the iRIS Helpline at 713-500-7960. You may also contact Rebecca Novak at 713-500-9055for additional assistance with the iRIS application or attachments.

  • Allow approximately 3 weeks for Exempt or Expedited review; allow approximately 4 weeks or more for Subcommittee/full review.
  • You MUST be able to access your UT email account to receive notifications and approval through iRIS. For assistance contact the UTHSC Helpdesk at 713-500-4848.
  • Stipulations must be addressed to the CPHS within the iRIS system.
  • After the IRB approves your study, you will receive an approval letterfrom the SPH Associate Dean for Research, provided your proposal has been submitted to the Office of Research, and approved by the ADR(see above).
  • Changes to your study must be submitted to CPHS via a Change Request/Amendment form in iRIS, and a copy of the changes as well as the letter of approval of changes must be forwarded to the Office of Research for our files.
  • Expedited review and Subcommittee review studies are required to submit a Continuing Review form annually in iRIS.
  • At the completion of your study, you must close the study by submitting a “Study Closure Report” in iRIS.

ADR approval letters will be sent via email attachment to the student, your SPH committee members, the Office of Student Affairs, and the Regional Campus support person (if applicable).

Questions regarding submission procedures or forms should be addressed to Rebecca Novak at (713) 500-9055 or

CITI training course

ALL STUDENTSundertaking a CE/thesis/dissertation must complete the CITI training course. Access the CITI training course at:

  1. Click on “Register” under “Create an Account.”
  2. Select “University of Texas Health Science Center at Houston” as your institution.
  3. “Employee ID number” is not necessary (where asked for this number, please use any number).
  4. Complete ONE of thebasic courses in Protection of Human Subjects: Choose either Group 1: Biomedical Researcher and Key Personnel, orGroup 2: Social and Behavioral Researchers and Key Personnel course.
  5. When you have completed the training, print your certificate of completion.
  6. Certificates are valid for three years, and may be accessed at any time by logging back in to CITI.

UTSPH CE/Thesis/Dissertation Proposal Cover Sheet

STUDENT NAME / LAST: / FIRST:
STUDENT PROPOSAL TITLE
UT EMAIL ADDRESS / Student.Name@uth.tmc.edu
PHONE NUMBER
(Area Code & Number) / Day: ( )
Evening: ( )
COMMITTEE NAMES / Academic Advisor/Chair:
CE/Thesis/Dissertation Supervisor:
Additional Committee Member(s):
DEGREE PROGRAM (circle) / MPH / MS / DrPH / PhD
STUDENT DEPARTMENT (circle) / Biostat / Epi / Env Science / HPBS / MPCH / General
CAMPUS (circle) / Austin / Brownsville / Dallas / El Paso / Houston / San Antonio
FUNDING for Your Project? (circle) / YES NO
If YES, indicate Amount and Source(s):
(Doctoral Students ONLY)
Proposal Defense passed? / YES N/A (circle)
If YES, date Proposal Defense was passed: ______/ ______/ ______
If N/A, date Qualifying Exam was passed: ______/ ______/ ______

SIGNATURES (Student and all Committee Members must sign. Please add signature lines as needed.)

Student / Date

By signing below, you indicate that you have reviewed and approved this research project for scientific merit:

Academic Advisor/Chair / Date / CE/Thesis/Dissertation Supervisor / Date
Committee Member / Date / Committee Member / Date
Committee Member / Date

Office Use Only

Submitted ______
Associate Dean for Research / Date / Complete ______
IRB Approval ______

UTSPH STUDENT PROPOSAL

Research Approvals Document

Does your project involve human subjects or data derived from humans?(circle one)

YES(includes Exempt research & publicly available data) NO(not human subjects research)

More information about what constitutes human subjects research is available within the UTSPH Research Compliance Guide at: and the CPHS web at:
If YES, please complete the following section:

UTHSC CPHS approval/exemption for my project will be, or has been, obtained through (choose one):

Student application to CPHS in iRIS (with student’s name as PI):

PI (student):______

HSC #:HSC-____-____-______(leave blank if no number yet)

Project title: ______

iRIS submission date:_____/_____/______

Approval/Exemption date*:_____/_____/______(leave blank if not yet approved)

Student is on, or will be added to, a UTHSC Faculty member’s CPHS-approved protocol:

PI (faculty):______

HSC#:HSC-____-____-______

Project title:______

Amendment submission date: _____/_____/______

Approval date*:_____/_____/______(leave blank if not yet approved)

*A copy of the appropriate CPHS Approval/Exempt letter must be provided to the Research Office. Only after CPHS approval is obtained will the Associate Dean for Research approve the project.

If NO, please complete the following section:

My research involves only:

_____ Published literature/Systematic review of the literature

_____ Simulated data

_____ Other(please describe): ______

*Please describe your data source below. Attach supporting documentation as needed (for example: a copy of email correspondence from CPHS, etc.):

______

______

Does your project involve animals or animal-derived materials?(circle one)

YES NO

If YES, please complete the following section:

AWC approval for this project will be/has been obtained through:

Submission of this project to AWC:

Project Title:______

AWC #:AWC-____-____ - ______

Principal Investigator:______

Submission Date:_____/_____/______

Approval/Exempt Date*:_____/_____/______

Amendment of an existing AWC protocol:

Project Title:______

AWC#:AWC-____-____-______

Principal Investigator:______

Amendment Submission Date:_____/_____/______

Amendment Approval Date*:_____/_____/______

* A copy of the appropriate AWC approval/exemption letter must be provided to the Research Office.

Only after institutional approval is obtained will the Associate Dean for Research approve the project.

Signatures

By signing below, you acknowledge that you have discussed the pertinent information above regarding student research approvals.

Student DateCE, Thesis, or Dissertation Supervisor Date

Academic Advisor/ChairDate

Authorship, Publication Plan and Data Ownership

Please discuss each item with your committee and summarize your responses on this form.

  1. Who is the owner of the data that will be used for the CE/thesis/dissertation?
  1. Do you plan to publish the results of your CE/thesis/dissertation? Yes / No (circle)

If yes, please describe the publication plan:

  1. If co-authorship is appropriate, how will the order of authors be determined? (Pay special attention to first and senior author positions, and the norms for the journal(s) to which you intend to submit your papers.)
  1. What is the expected timeframe for the publication of results?
  1. If the student or faculty member chooses not to publish, or cannot publish the results within above timeframe, what alternative plans have been made for publication?

We, the undersigned, have discussed all points above, and understand all summaries made on this document. This information is to be used as a planning tool only, and is not intended as a binding agreement. Subsequent changes to this understanding will be discussed as needed.

Student DateCE, Thesis, or Dissertation Supervisor Date

Academic AdvisorDateData Owner (If applicable)Date

**The student and Academic Advisor should each keep a copy of this document**

Data Handling Procedures

Use of Existing Data or Samples

  1. Name the source of data for your project(e.g., what is the title/name of the parent study, name of database(s), or type of data to be used? If more than one, please list all):
  1. How will you access the data? List the name of data owner(s), PI, or organization(s) providing data to the student, or list the URL(s) where data will be accessed(If more than one, please list all):
  1. Please show the beginning and end dates for the data set(s) that you will use(If more than one data set, please list all):

____/____/____ - ____/____/_____

  1. Were data/samples originally collected under the oversight of an Institutional Review Board (IRB)?
  2. YES
  3. NO
  4. Will personal identifiers1 or protected health information (PHI)2be provided to the student?
  5. YES
  6. NO
  7. If you answered YES to # 5: Which personal identifiers or PHI will be used or transcribed for your CE/thesis/dissertation project? CPHS prefers that you avoid using identifiers, but if you feel you must use identifiers, please provide an explanation:
  1. Explain how you will maintain security of the data/samples to be used for the student CE/thesis/dissertation:

I have discussed all points listed above with my CE/thesis/dissertation Chair, and I understand the points summarized on this document.

Student Date

1For more information about personal identifiers:

2For more information about PHI:

Letter of Permission for Use of Data or Samples

INSTRUCTIONS: THIS DOCUMENT IS TO BE USED AS EXAMPLE ONLY. PLEASE EDIT THE EXAMPLE BELOW, OR CREATE A NEW DOCUMENT. PLEASE REMOVE ALL TEXT IN THIS SECTION FROM YOUR DOCUMENT BEFORE PRINTING/SIGNATURE.

When is a letter of permission required? A letter of permission is typically required to use data/samples owned by another individual.

Who writes the letter? Letters of permission are typically written and signed by the individual who owns the data or who otherwise has the authority to share the data. LETTERS SHOULD BE PRINTED ON OWNER’S LETTERHEAD STATIONARY.

What information should the letter include? The content of a typical letter is summarized below. However, not all information is required for all projects, and some projects may require additional information. If you have questions about the content of this letter, please contact Rebecca Novak at or Dr. Laura Mitchell at

MEMORANDUM

DATE:Today’s Date

TO:Anne Dougherty, MD

Chair, UT Committee for the Protection of Human Subjects

FROM:Data owner’s name, title, and contact information

SIGNATURE:

RE:Permission for Use of Data/Samples

The data owner should:

  • indicate that s/he gives the student permission to analyze the data (or samples) collected during the project, “original project name,” expressly for the CE/thesis/dissertation project (select the appropriate project type) titled, “student’s project name.”
  • explain whether there are identifying variables in the parent data set, and if so, whether or not the student will be given access to identifiers.
  • indicate whether data were collected with the approval of an Institutional Review Board (IRB). For data collected within UTHSC, list the original study’s CPHS approval number (HSC-SPH-__-____). For data collected outside of UTHSC, provide a copy of the study’s IRB approval letter.
  • indicate whether the student is part of (or will be added to) an active UT-CPHS protocol, and if so, provide appropriate documentation (e.g. a copy of the CPHS letter approving the personnel changes). For more information about adding a student to a UT CPHS protocol, please see the Research Compliance Guide at:

2015-2016