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 • Allow 2 weeks – one week for finalization and one week for faculty review • Once the Thesis proposal is approved (by vote) then an IRB proposal can be submitted – UTA IRB meets on the 3 rd Tuesday of each month • IRB proposals must be received no later than the 2 nd Monday of each month • Plan 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? 1. Cover Letter 2. IRB Form #1 – – Needs faculty sponsor signature Needs Department Chair signature 3. Informed Consent Form(s) 4. Health Status Questionnaire – Decision-making criteria for inclusion/exclusion 5. Curriculum Vita / Resume – 6. 7. 8. 9. From you and your faculty sponsor Copy of any/all advertisement fliers Copies of any/all letters from off-campus collaborators Copy of pages 24 -27 of ACSM’s Guidelines Manual (6 th Edition) Copy of the completed Conflict of Interest Form 1. You, your collaborators, and your faculty sponsor 10. Copy of the completed Tier II compliance training certificate – You, your collaborators, and your faculty sponsor 11. Copies of any other documents referred to or used in your study.
IRB Form #1 Definition 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 20 th. If you plan to begin your research as soon as it is approved, put upon approval by the IRB. Do not put May 21 st! • Or even worse, do not put April 30 th 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 3 rd. You find at the end of January that you will need more time. Notify the IRB before February 2 nd 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 Departmental” • If 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 layman’s terms. • This means that anyone with an 8 th 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 – Descriptive -Quasi-Experimental - 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 IRB’s 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 sponsor’s qualifications.
Section C: Summary of the Research Protocol • Question 14: Check all that apply to your research! Below are some helpful hints… – Analysis 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 hints… – Questionnaire 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 hints… – Audio/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 hints… – Psychological 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…) 14 a: 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 14 b: 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 don’t know who your subjects are…you won’t be able to complete Sections D-G.
Section D: Study Population • Check 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 Population • Question 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 anything further. • If you exceed the number of subjects that you put on this question, you will need to submit IRB Form #4 to get approval to collect data from additional subjects.
Section D: Study Population • Question 16 – total number of subjects (continued…) – Be sure to estimate high enough for your protocol. – Example: You cannot estimate that you will have 20 subjects and then collect data from 250 subjects without first getting approval for those additional 230 subjects! – Example: If you estimate 100 subjects, but only end up collecting data from 25 subjects, then outline this on your annual or final report (IRB Form #7. )
Section D: Study Population • Question 17: Subject Recruitment- Check the boxes that apply with how you will recruit your subjects. – If the method that you will use to recruit subjects is not listed here, check other and you must include an explanation. – Also, please attach all recruitment flyers, advertisements, etc. – Basically anything the subjects will see or be subjected to the IRB will need a copy.
Section D: Study Population • Question 17 a and b: Inclusion and Exclusion criteria – Be very specific in this section. • You should include a reason for the criteria if it was not outlined in your research design. • Be aware that the DHHS regulations are based on the Belmont Report. • One of the principles of this report is justice (equitable distribution. ) This means that you need to justify why you are excluding a subject population from your research or justify why you only include a certain population.
Section D: Study Population • Question 18: What type of rewards, remuneration, or other incentives will be used to recruit subjects. – The incentives cannot be perceived as being coercive to the subjects for participation. They can be compensated for time, however.
Section D: Study Population • Question 18: What type of rewards, remuneration, or other incentives will be used to recruit subjects. (continued…) • Example: Offering $250. 00 to participate in your research to low income individuals would probably not be acceptable as this would be coercive. • Example: Offering the subject lunch during participation or compensation for travel to the research site, or even a $10. 00 gift certificate would most likely not be perceived as being coercive.
Section D: Study Population • Question 19: Students participating in research – outline how you will be sure that a student is not coerced into participating. • You can not make someone participate in any research protocol under any circumstances. • Human subjects are voluntary in all circumstances.
Section D: Study Population • Question 20: Alternatives to participation: If a subject refuses to participate or withdraws from your research, what alternatives will you give them and how do you guarantee that there will be NO negative consequences? – Example: If it is a student participating in the research for a course credit, if they withdraw or refuse, how can they still get the course credit? (Write a paper in place of the research participation for the same credit, etc. )
Section E: Confidentiality, Privacy and Coercion • Question 21: If data was collected for other purposes than this research, check yes. If you plan to keep the data beyond the scope of this research (data repository), then attach IRB Form #5 to the IRB Form #1. – Answer 21 a and b accordingly.
Section E: Confidentiality, Privacy and Coercion • Question 22: If any of the procedures listed in Section 14 of this form “could” result in the potential identification of child abuse, elderly abuse, communicable diseases, or criminal activities – that would not have otherwise been identified – you must check “yes”. – Make sure that your consent form discloses this to the subjects! – You must also disclose that when research reveals these issues, confidentiality will be maintained to the extent that the law allows.
Section E: Confidentiality, Privacy and Coercion • Question 23: Coercion: Outline any part of the research (other than the recruitment incentives listed on Question 18) that could be considered to be coercive to the subjects. • Include the safeguards you will have in place to protect the subjects from being coerced.
Section E: Confidentiality, Privacy and Coercion • Question 24: Confidentiality – explain where all of your signed consent forms & identifiable data (documents, audiotapes, etc. ) will be stored on campus – lock and key. You must have these behind the 3 lock system. – Building, Office, Filing Cabinet = 3 locks. – Building, Suite, Office = 3 locks.
Section F: Risks • Psychological Risks: Questions (25 - 27) – complete if there any possible psychological risks that could be associated with this protocol.
Section F: Risks • Physical Risks: Questions ( 28 -30) – complete if there any possible physical risks that could be associated with this protocol. – If you are doing only a test, survey, questionnaire, you do not need to put “paper cut” as a research related risk. – You only need to disclose any risks directly related to your research protocol.
Section H: Cost of Research • Question 31: If the subjects will be charged for any procedures that are related to your research – you need to disclose it. – Example: If you are studying their blood and they will be charged for the blood to be drawn. – Example: If you are studying their IQ test results, but they are being charged for the IQ test.
Section H: Cost of Research • Question 32: If the subject will be charged to participate in your research protocol – check yes and explain why.
Section I: Informed Consent • If you have not taken the Tier II Training module in human subjects research through the UTA compliance training program, you will have a hard time understanding this section. • It is necessary to complete the training before you attempt to complete this form if at all possible.
Section I: Informed Consent • Double check with your faculty sponsor that s/he has put in the request for you to have the training to • Requests for training must come from your faculty sponsor, (an individual student cannot put in a training request), and must include your name, student ID and department.
Section I: Informed Consent • You must attach a finalized consent form along with the IRB Form #1 in all primary languages of the subjects. • Please note that these signed consent forms must be held on UTA Campus under lock and key during the research and for a period of 3 years following the conclusion of the research!
Section I: Informed Consent • These consent forms are subject to inspection at any time by the Research Compliance Officer, the IRB, or the Department of Health and Human Service’s Office for Human Research Protections.
Section I: Informed Consent • Question 33 a: If you plan to give oral consent instead of written consent, you still have to attach a copy of what will be read to the subjects. You also have to justify why oral consent is necessary.
Section I: Informed Consent • Question 33 a: (Continued…) – Example: If you plan to study illiterate subjects who cannot read, then oral consent is acceptable. You must have a witness signature line and a Principal Investigator signature line (your signature) on the consent form. This document is what will be held as the record of consent.
Section I: Informed Consent • Question 33 b: Native language consent forms – you need to submit a finalized copy of the consent form in English as well as any primary language spoken by the any subjects in your subject population. – If some of your subjects will have the primary language of Spanish, you will be required to submit both an English consent form as well as a Spanish consent form. Both consent forms must have the exact same content!
Section I: Informed Consent • Question 33 b: (Continued…) • If you will be dealing with illiterate, Non. English speakers. – This is the same situation as with illiterate English speaking subjects. – You will outline who will give the oral consent (it must be someone who is fluent in the language spoken by the subjects. )
Section I: Informed Consent • Question 33 b: (Continued…) • If you will be dealing with illiterate, Non-English speakers. – And you will be required to submit a consent form to the IRB and collect them as you get participants. – You and a witness will be required to sign the consent form stating that the oral consent process was presented to the subjects and that you allowed the subject to ask any questions (the “consent form” that you will submit and use will be essentially the oral script of the consent that you present to the subjects. )
Section J: Cooperative Agreements with Other Institutions • If you will conduct your research at another institution (besides UTA), you will be required to submit your protocol through their IRB (other universities, hospitals, etc. ) The UTA IRB will need a copy of their IRB approval letter.
Section J: Cooperative Agreements with Other Institutions • (Continued…) • If the institution does not have an IRB (public library, animal shelter, school district, etc. ), then we will need an agreement letter from the head of the institution (CEO, VP, Principal) where you will be performing your research. • If you are researching subjects “in the field”, then this would not apply to you.
Section J: Cooperative Agreements with Other Institutions • If you will collect data and then send it to another institution, then you will need to check yes on “a” and then fill out b and c. • We will also need the agreement letter and / or IRB approval letter from the cooperating institution if you are sending your collected data to them.
Section K: Consultation and Collaboration • Question 35: Subject Recruitment and Management – – If you will need the approval of “anyone” to recruit your subjects, we will need a signed agreement or letter from the head of the institution. • Example: If you wish to obtain survey data from children of Arlington ISD, we’d need an approval letter from the Superintendent and Principal of the school (s) you will be recruiting subjects from
Section K: Consultation and Collaboration • Question 35: Subject Recruitment and Management – (continued…) – Make certain that your agreement/ approval letter states the person’s name and title. – Do not submit an agreement letter with just an illegible signature on it. This will be returned to you. The agreement letter must be on letterhead with the person’s title and contact information included.
Section K: Consultation and Collaboration • Question 36 Research Collaboration – – If you are collaborating with an individual at any other institution, they must sign your protocol on question 36. If you cannot obtain their signature, you can attach an agreement letter. – Basically, if anyone will be listed on the publication with you, they need to be listed in question 36. • The only exception would be to your faculty sponsor as s/he is already listed on the General Information Section.
Section L: Conflict of Interest Disclosure • If your project is a federally funded project and you have decision making capacity in your research – then you need to submit an annual conflict of interest disclosure to the Office of Research. • The form can be found on the web site: www. uta. edu/research - click on Research Compliance and then Conflict of Interest. Complete, have the Chair of the Dept. sign the second page and submit to PO 19145.
Section L: Conflict of Interest Disclosure • If it is not funded and / or you do not have a decision making capacity – just skip this section by putting an N/A across it. • The Office of Research will, however, check to make sure your faculty sponsor has submitted a conflict of interest disclosure for the current fiscal year. If they do not have on file, they will be required to submit one. This could cause a delay in the IRB approval.
Section M: Signatures • The IRB will not approve a protocol without having original signatures on Section M of the IRB form #1! • You as a student must sign as the Principal Investigator. • Make CERTAIN that your faculty sponsor signs the line designated “faculty sponsor” or the protocol cannot be approved. • Check with your department to see if it is a departmental policy if you need to have the Chair or the Dean sign the bottom line. This is not an IRB requirement, but a departmental requirement.
Section M: Signatures • Please pay careful attention to what you are agreeing to when you sign as Principal Investigator. • There are federal requirements governing how you maintain your research documents. • Please note that your signed consent forms must be on UTA campus during the research and for a period of 3 years following the research. These consent forms are subject to inspection by the Research Compliance Officer, the IRB and / or federal auditors.
Tier II Training in Human Subjects Research • Your IRB protocol cannot be approved unless you have taken the UTA Human Subjects Training Module. • You must make a request to your faculty sponsor. • Your faculty sponsor must send the request to Sara Perkins along with your name, department and student ID number.
Tier II Training in Human Subjects Research • The training can be accessed at: http: //compliance. uta. edu/training • Once your request has been sent by your faculty sponsor, please allow at least 24 hours for your information to be put into the system.
Where to go for help: • If your questions were not answered in this module regarding how to complete IRB Form #1, you can do the following: – www. uta. edu/research - click on Research Compliance and then Human Subjects – Contact the Office of Research at 2 -2105.
What all do you need to submit to the IRB? 1. Cover Letter 2. IRB Form #1 – – Needs faculty sponsor signature Needs Department Chair signature 3. Informed Consent Form(s) 4. Health Status Questionnaire – Decision-making criteria for inclusion/exclusion 5. Curriculum Vita / Resume – 6. 7. 8. 9. From you and your faculty sponsor Copy of any/all advertisement fliers Copies of any/all letters from off-campus collaborators Copy of pages 24 -27 of ACSM’s Guidelines Manual (6 th Edition) Copy of the completed Conflict of Interest Form 1. You, your collaborators, and your faculty sponsor 10. Copy of the completed Tier II compliance training certificate – You, your collaborators, and your faculty sponsor 11. Copies of any other documents referred to or used in your study.
Once you submit your protocol: • Your faculty sponsor must be the one to submit your protocol. The Office of Research will not accept a protocol submission directly from an undergraduate student. • Once your protocol is submitted to the IRB, you must contact your faculty sponsor, not the IRB, to find out the status. • All correspondence from the IRB will go through your faculty sponsor, so make sure that you keep in contact with them.
How long does it take? • If you are found to be exempt, this will only take 3 days at the most. Your faculty sponsor will be contacted when you are approved. – Exempt protocols are typically anonymous surveys that are of no risk to subjects. – Another common type of exempted research would be the use of non-identifiable pre-existing data.
How long does it take? • If your protocol qualifies for an expedited review, the IRB has a five working-day review period. • This entire process could take up to 2 weeks (or more) if modifications are required for approval. • Again, your faculty sponsor will be contacted for any modification request and / or when you are approved.
How long does it take? • The third type of review is the full board review. • If your protocol is found to need a full board review (more than minimal risk), it will be scheduled for the next scheduled IRB meeting. The meeting dates can be found on the web site at www. uta. edu/research • You and your faculty sponsor will be asked to attend the meeting to discuss your protocol. If you do not attend, this could cause your protocol to be tabled until the next scheduled IRB meeting. Meetings are only scheduled for once per month.
Informed Consent Forms All the Necessary Components
Two Phases • Informed Consent for the Health History – Not always necessary, but if you need detailed health history information (which is often needed), you’ll need consent from the subject to attain that information • Informed Consent for the Study Protocol – Documentation that the subject knows and understands what they will be going through
Component Parts • • • Title of Research Study Invitation to Participate Basis for Subject Selection Purpose of the Study Explanation of Procedures – Remember, 8 th grade level • • • Schedule of Assessments (if necessary) Potential Risks and Discomforts Protection Against Risks Potential Benefits to Subjects Potential Benefits to Society In Case of Emergency Contact Procedure Emergency Care Compensation in Case of Injury Assurance of Confidentiality Rights of Research Subjects Voluntary Participation and Withdrawal Statement of “signage”
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