Instructions for Submitting your CE/Thesis/Dissertation Proposal

Transcription

1 Instructions for Submitting your CE/Thesis/Dissertation Proposal All student CE, Thesis, and Dissertation proposals must be submitted to the UTSPH Office of Academic Affairs and Student Service for review and approval by the Senior Administrative Coordinator. Your project may also require IRB review by the UT Committee for Protection of Human Subjects (CPHS) and/ or other UTHealth institutional review committees, such as the Institutional Biosafety Committee (IBC). For help determining which institutional reviews are necessary for your project, please refer to the Research Compliance Guide. Proposal Submission deadlines must be met the semester before you intend to graduate. Deadlines can be found here and on the Planning to Graduate page. After your CE/Thesis/Dissertation committee members have approved your written proposal, and signed the student proposal cover sheet and other required forms, you may submit your proposal to the Office of Academic Affairs and Student Services via electronically and to CPHS (if applicable) via the online application system, iris (see below). Proposals may be submitted to both offices concurrently. More information on the proposal process can be found in the CE/Thesis/Dissertation Guides. Note: Doctoral Students must complete the oral defense of the proposal BEFORE submitting their written proposal for approval. The Doctoral Dissertation Proposal Defense Form IV is available at: Submit your proposal to the Office of Academic Affairs and Student Services via electronically (both electronic and handwritten signatures are accepted): 1) ALL STUDENTS: Send an electronic copy of your proposal along with the following completed and signed proposal forms to (both electronic and handwritten signatures are accepted) Student Proposal Cover Sheet Authorship, Publication Plan & Data Ownership Institutional Approvals Document CITI training certificate Data Handling Procedures (for use of existing data) * Please indicate Not Applicable (N/A) on this form if you will not be using existing data

2 2) Include the below items in your proposal submission if they are applicable to you: Letter of Permission from owner of data/samples (if data are not publicly available) * Example and instructions can be found here: Copy of IRB or other institutional review letter(s) (if applicable), which may include: a) Copy of parent study s IRB approval letter; b) Copy of letter from UT CPHS showing the student has been added to a UTHealth Faculty member s study; and/or c) UT CPHS Approval/Exemption letter in the student s own name 3) ALL STUDENTS: Attach the signed forms and required documentation to the front of your proposal and submit electronically to SPHStudentResearch@uth.tmc.edu (both electronic and handwritten signatures are accepted) Your proposal Questions regarding procedures or forms should be addressed to Terri DeHoyos at Terri.M.DeHoyos@uth.tmc.edu or and Brooke Burns at Brooke.Burns@uth.tmc.edu or

3 If applicable, submit your proposal to UT CPHS (IRB) in iris: Projects requiring IRB approval from the UT 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) , Terri DeHoyos at or , and Brooke Burns at or 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 Terri DeHoyos and Brooke Burns as an additional Study Contact (this action will forward a copy of your IRB approval letter to the Office of Academic Affairs & Student Services e) Department signature person in iris is NOT required for CE/Thesis/Dissertation proposals. If your application is for an independent research study (i.e., not for a CE/Thesis/Dissertation), then you should add a Department Chair for signature. 4. 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); Grant application (if applicable). 5. 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 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 account to receive notifications and approval through iris. For assistance contact the UTHSC Helpdesk at

4 Stipulations must be addressed to the CPHS within the iris system. After the IRB approves your study, you will receive an approval letter from the SPH Assistant Dean for Academic Affairs and Student Services, provided your proposal has also been submitted to the Office of Academic Affairs and Student Services and approved by the Assistant Dean (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. SPH approval letters will be sent via attachment to the student, your SPH committee members, the Office of Academic Affairs and Student Services, and the Regional Campus support person (if applicable). Questions regarding submission procedures or forms should be addressed to CITI training course ALL STUDENTS undertaking a CE/thesis/dissertation must complete the CITI training course. Access the CITI training course at: 1. Under Create an Account, click on Register. 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 the basic courses in Protection of Human Subjects: Choose either Group 1: Biomedical Researcher and Key Personnel, or Group 2: Social and Behavioral Researchers and Key Personnel, Basic course. 5. When you have completed the training, you may print or save your certificate of completion. Certificates may be accessed at any time by logging back in to CITI. 6. Students who have already completed CITI training through another institution can log in to CITI and then add another affiliation with University of Texas Health Science Center at Houston. The CITI program will display which modules have already been completed, and which additional CITI modules may be needed for the UT training certificate. 7. Certificates are valid for three years, and can be renewed by taking a Refresher course through CITI.

5 UTSPH CE/Thesis/Dissertation Proposal Cover Sheet STUDENT NAME LAST: FIRST: STUDENT PROPOSAL TITLE UT ADDRESS PHONE NUMBER Day: ( ) (Area Code & Number) Evening: ( ) COMMITTEE NAMES Academic Advisor/Chair: CE/Thesis/Dissertation Supervisor: Additional Committee Member(s): DEGREE PROGRAM MPH MS DrPH PhD STUDENT DEPARTMENT Biostat Epi Env HPBS MPCH General Science CAMPUS Austin Brownsville Dallas El Paso Houston San Antonio FUNDING for Your Project? YES NO If YES, indicate Amount and Source(s): (Doctoral Students ONLY) YES N/A Proposal Defense passed? If YES, date Proposal Defense was passed: / / If N/A, date Qualifying Exam was passed: / / SIGNATURES (Student and all Committee Members must sign. External Reviewers should not sign this document) Student (Sign) Date By signing below, you indicate that you have reviewed and approved this research project for scientific merit: Academic Advisor/Chair (Print) Date Academic Advisor/Chair (Sign) Date CE/Thesis/Dissertation Supervisor (Print) Date CE/Thesis/Dissertation Supervisor (Sign) Date

6 Office Use Only Administrative Review Completed Submitted Senior Administrative Coordinator Date Complete IRB Approval

7 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? 2. Do you plan to publish the results of your CE/thesis/dissertation? Yes / No If yes, please describe the publication plan: 3. 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.) 4. What is the expected timeframe for the publication of results? 5. 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 (sign) Date CE/Thesis/Dissertation Supervisor (sign) Date Academic Advisor (sign) Date Data Owner (If applicable) (sign) Date **The student and Academic Advisor should each keep a copy of this document**

8 UTSPH STUDENT PROPOSAL Institutional Approvals Document Does your project involve human subjects or data derived from humans? YES (includes Exempt research & publicly available data) research) NO (not human subjects More information about what constitutes human subjects research is available within the UTSPH Research Compliance Guide and the CPHS web at: If YES, please complete the following section: UT CPHS approval/exemption for my project will be, or has been, obtained through (choose one): Student application to UT CPHS in iris: PI (student): HSC #: HSC- - - (leave blank if not yet received) Project title: iris submission date: / / Approval/Exemption date*: / / (leave blank if not yet approved) Student is on, or will be added to, UTHealth 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/exemption letter must be provided to the Office of Academic Affairs and Student Services. Only after institutional approval is obtained will the Assistant Dean 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 correspondence from CPHS, etc.):

9 Does your project involve animals, animal-derived materials, or hazardous materials? (circle one) YES NO If YES, please complete the following section: AWC, IBC and/or other institutional safety approval(s) for this project will be/has been obtained through: Submission of this project to AWC, IBC, etc.: Project Title: UT Study # (AWC, IBC, etc.) AWC- - Principal Investigator: Submission Date: / / Approval/Exempt Date * : / / Amendment of an existing AWC, IBC, etc. protocol: Project Title: UT Study # (AWC, IBC, etc.): AWC- - Principal Investigator: Amendment Submission Date: / / Amendment Approval Date * : / / * A copy of the appropriate AWC approval/exemption letter must be provided to the Office of Student Services. Only after institutional approval is obtained will the Assistant Dean approve the project. Signatures By signing below, you acknowledge that you have discussed the pertinent information above regarding student research approvals. Student (sign) Date CE/Thesis/Dissertation Supervisor (sign) Date Academic Advisor/Chair (sign) Date

10 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): 2. 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): 3. 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): / / - / / 4. Were data/samples originally collected under the oversight of an Institutional Review Board (IRB)? a. YES b. NO 5. Will personal identifiers 1 or protected health information (PHI) 2 be provided to the student? a. YES b. NO 6. 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: 7. 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 (sign) Date 1 For more information about personal identifiers: 2 For more information about PHI: