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IRB Form #1. The Office of Research Compliance. Undergraduate 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. - PowerPoint PPT Presentation

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  • IRB Form #1The Office of Research Compliance

  • Undergraduate 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. 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 (or upon IRB approval). 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- DevelopmentalClick here for some more examples of research designs

  • 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. Interview if it is oral or written, you must state which one. You need to also attach an interview script and / or the interview as the subjects will see it if it is written.

  • 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 the approval process.

  • Section C: Summary of the Research Protocol Question 14b: If you are using pre-existing materials and it is unidentified then you can skip Sections D through G. If you will be in contact with and / or know who your subject population will be then you cannot skip any sections. Skipping this section is only for medical chart reviews when the subjects are completely unknown; biological specimens that are unidentifiable; publicly available datasets, etc. Basically, if you dont know who your subjects areyou wont be able to complete Sections D-G.

  • Section D: Study PopulationCheck all subjects involved in your research. Please note that if you choose to use non-English speaking people, you will have to supply the consent forms, all surveys, tests, etc. basically everything the subject will see in the primary language(s) of all subjects included in the research.

  • Section D: Study PopulationQuestion 16 total number of subjects : If you do not know exactly, then put an estimate. As long as you do not exceed the number that you have approved, then you do not need to do

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