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IRB Proposals. Documents Necessary to Receive IRB Approval for your Thesis. Timing. When should you seek IRB approval? Select a faculty mentor Determine a Thesis project Write the Thesis proposal (first 3 chapters) Usually allow 6 12 weeks for completion Orally propose the Thesis - PowerPoint PPT Presentation

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  • IRB ProposalsDocuments Necessary to Receive IRB Approval for your Thesis

  • TimingWhen should you seek IRB approval?Select a faculty mentorDetermine a Thesis projectWrite the Thesis proposal (first 3 chapters)Usually allow 6 12 weeks for completionOrally propose the ThesisAllow 2 weeks one week for finalization and one week for faculty reviewOnce the Thesis proposal is approved (by vote) then an IRB proposal can be submittedUTA IRB meets on the 3rd Tuesday of each monthIRB proposals must be received no later than the 2nd Monday of each monthPlan on IRB approval taking 6 full weeks.Once IRB has approved, then data collection can start

  • What all do you need to submit to the IRB? Cover LetterIRB Form #1Needs faculty sponsor signatureNeeds Department Chair signatureInformed Consent Form(s)Health Status QuestionnaireDecision-making criteria for inclusion/exclusionCurriculum Vita / ResumeFrom you and your faculty sponsorCopy of any/all advertisement fliersCopies of any/all letters from off-campus collaboratorsCopy of pages 24-27 of ACSMs Guidelines Manual (6th Edition)Copy of the completed Conflict of Interest FormYou, your collaborators, and your faculty sponsorCopy of the completed Tier II compliance training certificateYou, your collaborators, and your faculty sponsorCopies of any other documents referred to or used in your study.

  • IRB Form #1Definition of Terms and Sections to Complete

  • Undergrad/Grad Students: Please work with your faculty sponsor in the development of your protocol. Your faculty sponsor should be the one to submit your protocol to the IRB. All IRB forms must be typed and free from typographical errors.

  • Section A: General Information Project title: Put the current title of your research in Question 1. If you change or add a title in the future, be sure to submit IRB Form #4 to the IRB.

  • Section A: General Information Principal Investigator: As a student, you are the principal investigator (Question 2.) You must have a faculty sponsor (Question 4.) This faculty sponsor will be the one ultimately responsible for your compliance with all regulations involving research. You and your faculty sponsor must have completed the Tier II Training in Human Subjects Research for the current fiscal year to be your sponsor.

  • Section A: General Information Co-Investigator (question 3): If you have anyone at UTA collaborating with you on the research protocol, they should be listed in Question 3. If you have additional Co-Investigators, you can continue listing them on Question 36.

  • Section A: General Information Question 5: Expected Start Date You cannot commence your research until you have the official approval from the IRB. Please put a reasonable time period for the IRB to approve your research. If you do not plan to start for a few months, then put an estimated date.

  • Section A: General Information Question 5: Expected Start Date (Continued)Example: The protocol is submitted to the IRB on May 20th. If you plan to begin your research as soon as it is approved, put upon approval by the IRB. Do not put May 21st! Or even worse, do not put April 30th of the same year (it appears as you have already started your research!) This will cause a delay in the approval process.

  • Section A: General Information Question 5: Expected Completion Date (Continued) As a student, this will be how long your approval is granted by the IRB. Please allow yourself enough time to complete your research. If you find that you do not have enough time to complete your research, you must notify the IRB before the expiration date if you plan to continue. You have not completed your research until all data analysis is complete.

  • Section A: General Information Question 5: Expected Completion Date (Continued)Example: You state that you will complete the research by February 3rd. You find at the end of January that you will need more time. Notify the IRB before February 2nd that you will need to extend the approval period. Please note that the IRB can only approve a protocol for a maximum of 3 years pending annual reports are received by the anniversary date of the approval.

  • Section B: Funding If this research is funded by a grant or contract, you will need to check the box that applies (federal, state, industry.)If your department is funding the project check Local DepartmentalIf it is being funded by something other than federal, state, industry, etc. - then check other and explain what the funding source is.

  • Section B: Funding (Continued)Make sure to include your grant or contract number. This can be given to you by Grant and Contract Services at extension 2105.Please note: If you are seeking funding, the IRB will need a copy of the research proposal.

  • Section C: Summary of the Research Protocol This section must be written in laymans terms. This means that anyone with an 8th grade education should be able to comprehend what is taking place with human subjects.

  • Section C: Summary of the Research Protocol If you must use a technical term to describe your research, please define it within this section. The IRB is made up of members across different disciplines, a community member and a non-scientist. Every IRB member must be able to understand every procedure of your protocol.

  • Section C: Summary of the Research Protocol Question 9: List primary research questions. This is the section to state your hypothesis & outline your purpose in doing the research your primary research questions.

  • Section C: Summary of the Research Protocol Question 9:(Continued)Example: Do not list the actual interview questions that you will be asking the subjects (in the case of an interview based research protocol.) You are required to submit an interview script that you will attach to the IRB Form #1.

  • Section C: Summary of the Research Protocol Question 10: Describe the research design- You need to outline which type of research design that you are using in this research protocol and an explanation of why you feel that your research fits this type of design. Some examples of types of research design are as follows: Experimental-Quasi-ExperimentalDescriptive- Developmental

  • Section C: Summary of the Research Protocol Question 10: Describe the research design- Please keep in mind that bad science does not benefit anyone! Your research design will be reviewed by the IRB, so please make sure that you have your faculty sponsor review your Form#1 before you submit it to the IRB!

  • Section C: Summary of the Research Protocol Questions 11-12: You must list any and all benefits to the subject (Question 11) and to society (Question 12). One of the IRBs purposes in the review is to determine that benefits outweigh the risks. If the subjects will not benefit, then none is your answer. If society will not benefit, then none will be your answer.

  • Section C: Summary of the Research Protocol Question 13: Regarding the qualifications relevant to the research you have to be qualified through experience and / or education to perform different types of research. Example: Some types of procedures may require you to be certified or licensed. Outline who will be responsible for any of these types of procedures requiring certifications or licenses.

  • Section C: Summary of the Research Protocol Question 13: If you do not have procedures that require certification or licenses, then list your qualifications as being an undergraduate / graduate student and the courses or specialized training that you have had to prepare you to do the type of research that is listed. You can list the UTA Tier II Training in Human subjects compliance training in this section as well. Also be sure to list your faculty sponsors qualifications.

  • Section C: Summary of the Research Protocol Question 14: Check all that apply to your research! Below are some helpful hintsAnalysis of existing data: Be certain that this data was collected for other purposes and not for this research protocol.

  • Section C: Summary of the Research Protocol Question 14: Check all that apply to your research! Below are some helpful hintsQuestionnaire or Survey: You must attach a finalized copy of these documents along with your application. Use of Private Health Information: PHI (Private Health Information) is anything that would be collected by a doctor during a medical visit (vital signs, diseases, blood test results, x-rays, etc.) or anything not collected during a medical visit that describes a subjects health status.

  • Section C: Summary of the Research Protocol Question 14: Check all that apply to your research! Below are some helpful hintsAudio/Video recording of subjects these are at a minimum an expedited review. Make sure that you put a separate line on your consent form for the signature of consent for audio or video taping of the subject. Deception if deception is used in the research, you must attach a debriefing procedure/ script along with the IRB Form #1.

  • Section C: Summary of the Research Protocol Question 14: Check all that apply to your research! Below are some helpful hintsPsychological tests even if these tests are standardized, the IRB will need to have a copy of them for the review.

  • Section C: Summary of the Research Protocol Question 14: (Continued)14a: You must describe any items that are checked and you can attach a separate sheet of paper if needed. Please do not skip this question! If you skip this question and do not attach the supplemental materials for the items that you checked in question 14, this will cause a delay in t

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