IRB Form #1

1. IRB Form #1 The Office of Research Compliance

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

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

13. 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.

14. 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”.

15. 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.

16. 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-Experimental • Descriptive - Developmental • Click here for some more examples of research designs

17. 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!

18. 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.

19. 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.

20. 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.

21. 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. • 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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 don’t know who your subjects are…you won’t be able to complete Sections D-G.

27. 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.

28. 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.

29. 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.)

30. 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.

31. 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. • Click here for the Belmont Report

32. 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 compensation for time, however.

33. 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.

34. 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.

35. 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.)

36. 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.

37. 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.

38. 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.

39. 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.

40. Section F: Risks • Psychological Risks: Questions (25- 27) – complete if there are any possible psychological risks that could be associated with this protocol.

41. Section F: Risks • Physical Risks: Questions ( 28-30) – complete if there are 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.

42. 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.

43. Section H: Cost of Research • Question 32: If the subject will be charged to participate in your research protocol – check yes and explain why.

44. 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.

45. 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 Karshena Valsin / kvalsin@uta.edu . • Requests for training must come from your faculty sponsor, (an individual student cannot put in a training request), and must include your name (as you are listed at the registrar’s office).

46. 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 formsmust 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!

47. 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.

48. Section I: Informed Consent • Question 33a: 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.

49. Section I: Informed Consent • Question 33a: (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.

50. Section I: Informed Consent • Question 33b: 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!