1. IRB and the Proposal Process http://www.brockport.edu/irb/IRB Julie Wilkens, IRB coordinator jwilkens@brockport.edujwilkens@brockport.edu or 395-2779

2. Presentation Overview What is the IRB? Why is the IRB process in place? What is the path to IRB approval? Proposal Guided Tour – CITI – Proposal Categories – Project Description – Consent & Assent forms

3. What is the IRB? The Institutional Review Board is a committee that follows federally mandated guidelines designed to protect human participants from harm

4. Why is the IRB important? IRB exists to protect human subjects from harm. Tuskegee (1932-1972) Milgram (1961) – Watch a short clip here: https://www.youtube.com/watch?v=yr5cjyokVUs https://www.youtube.com/watch?v=yr5cjyokVUs Henrietta Lacks (1951-present)

5. The Path to Approval CITI training Work with advisor to complete proposal Hand in draft to IRB office – IRB coordinator sends it out to 2 or more reviewers Receive feedback via IRB coordinator Revise and resubmit until approved

6. Focus: CITI Training (2+ hours) https://www.citiprogram.org/ Username Password Forgot Username or Password? Log in through my institution Log in via SSO Create an account Register Register Access requires registration as an affiliate of a subscribing CITI institution or as an unaffiliated learner.

7. Main MenuMain Menu My Profiles My CEUs My Reports Support AdminMy ProfilesMy CEUsMy ReportsSupportAdmin Main MenuMain Menu › Add Course/Update Learner Groups Select Curriculum - SUNY - College at Brockport * indicates a required field. View instructions page * Question 1 Human Subjects Research If you have not previously completed Human Subjects Research training: Select the group appropriate to your research activities. You will be enrolled in the Basic Course for that group. Choose one answer Group 1: Undergraduate students working on a class project. Group 2: Faculty, staff, graduate students and undergraduate students working on a thesis or independent study project. In addition to the required modules, complete any of the following modules applicable to your research: Research with prisoners Research with children Research in public and elementary schools International research Internet research Questions? E-mail the Brockport IRB coordinator at jwilkens@brockport.edu. jwilkens@brockport.edu Which group are you in?

8. Focus: Proposal Categories Three categories which indicate increased amounts of risk to participant(s): – Cat 1 = no possible risk; over 18 only – Cat 2 = minimal risk, including interviews and non- anonymous surveys; can involve regular in-school procedures for minors – Cat 3= potential for harm; can involve minors in non-school setting or at-risk populations

9. Which category is this? 1.An anonymous online survey about preferred junk food 2.A paper survey given to suspected shoplifters at a police station 3.An anonymous survey about whether college students prefer team-based essays v. individual essays 4.How sports affect the achievement of high school students 5.A study of inmate stress and anxiety at a state prison 6.A paper survey asking freshman about their knowledge of drug use on campus 7.Face-to-face interviews with three teachers in an urban school district 8.A survey for both parents and children asking about literacy activities in the home 9.Interviews with grandparents and grandchildren about how they play together

10. Focus: Your Proposal Narrative What is the IRB’s main concern? In order for the IRB to do its job, the proposal narrative must: – Be clearly written – Have a specific, achievable focus – Include a summary of research in the field – Include a list of research references

11. Problematic Project Description (excerpt) 1. Brief project description The purpose of this study is to have a better understanding of what beliefs inner city school teachers have about their work. Opinions vary on what type of school is better, which ones rank at the bottom, and the schools that are average. What goes on behind school doors and why do so many people believe one type of school is better than another? Don’t all teachers teach and students learn? From my experience of working at an inner city school district, urban teachers are stereotypes as having a difficult job on a day-to-day basis due to the students they work with. “Stereotypes are generalized judgments about an individual based on his/her membership in a particular social group,” Kurtz-Costes, Rowley, Woods, 2004). Are all stereotypes about inner city schools make believe or do teachers and students have struggles/obstacles to overcome everyday while attending certain schools? This study is important because it will provide documentation of beliefs particular inner city school teachers have about their work. What kinds of beliefs? Be specific. Unclear & general language. Who are “so many people”? Instead of asking questions, make statements. Explain how this relates to your research Are you only looking to document beliefs, or are you doing something further? Original was missing research design, summary of research in the field, research references, and a clear purpose

12. Not perfect, but improved… 1. Brief project description The purpose of my research is to examine the factors that influence the perceptions and pedagogy of teachers within the inner city school setting. Surveys, interviews, and observations will be used to gain a clearer understanding of how teachers working in an inner city school express their attitudes and beliefs about their work. There are many factors that influence the perceptions, pedagogical beliefs and practices of teachers within urban schools which may have a negative impact. As Clauhs, Hawkins, Martignetti, Niknafs and Talbot point out, “Urban schools and the students and teachers within, are often characterized by a meta-narrative of deficit and crisis” (2014, p. 1). The negative impact can include frustration, fear, low expectations of students, poor teacher-student relationships and teacher burnout. On the other hand, there are aspects of teaching in an urban district can positively impact the teaching/learning experience resulting in high expectations of students, strong teacher-student relationships and effective classroom instruction. These factors include classroom interactions between the teacher and students during facilitation of instruction, home-school connections, and facilitating learning of the curriculum. Connects quotation to study. Clearer focus. More specific

13. Focus: Informed Consent STATEMENT OF INFORMED CONSENT (EXAMPLE FOR PARTICIPANTS OVER 18) This is an example; the language should be modified for your proposal as necessary. Note that it contains the required elements of informed consent. I am a faculty member [staff or student] at The College at Brockport, SUNY, and I am conducting a research study to examine some of the ways adults, 65 and older, take care of their health. Four areas will be studied including exercise, diet, taking medications, and seeking medical care. [This research project is also being conducted in order as part of my Master’s thesis for the Department of ___________ at the College at Brockport, SUNY.] [You will be paid X dollars for the two hours of your time.] The study will take place in Cooper Hall during the fall semester. In order to participate in this study, your informed consent is required. You are being asked to make a decision whether or not to participate in the project. Your participation in this study is completely voluntary. [If needed: Being in it, or refusing to be in it, will not affect the services or benefits that you are entitled to through your school, agency, etc.] You are free to change your mind or withdraw from the study at any time. If you wish to participate in the project and agree with the statements below, please sign your name in the space provided at the end [required for all Category 3 proposals]. Again, you may change your mind at any time and leave the study without penalty, even after the study has begun. Brockport affiliation Study purposeStates that study is degree requirement Study location and time Indicates that participation is voluntary.

14. I understand that: 1.My participation is voluntary, and I have the right to refuse to answer any questions. 2.My confidentiality will be protected. My name will not be written on the survey. There will be no way to connect me to my written survey. If any publication results from this research, I will not be identified by name. 3.There will be no anticipated personal risks or benefits because of my participation in this project. [Note that time to complete the study is a minor risk and should be noted here.] 4.My participation involves reading a written survey of X# of questions and answering those questions in writing. It is estimated that it will take X# of minutes to complete the survey. 5.A maximum of X# people will take part in this study. The results will be used for the completion of a Master’s thesis by the primary researcher. 6.Data will be kept in a locked filing cabinet in the investigator’s office. Data and consent forms will be destroyed by shredding within 2 years of collection. ConfidentialityRisks & Benefits Participant involvement, including estimated time Maximum number of participants Data protection

15. I am 18 years of age or older. I have read and understand the above statements. All my questions about my participation in this study have been answered to my satisfaction. I agree to participate in the study realizing I may withdraw without penalty at any time during the survey process. Returning the survey/Signing this form/Completing the interview/etc. indicates my consent to participate. Participant signature_____________________ Date______________ 18 or over Not all studies need a signature Primary researcherFaculty Advisor Name Phone Number Email Department and phone number Email If you have any questions you may contact:

16. Focus: Minor Assent Age appropriate Can be read aloud Less formal than consent form

17. STATEMENT OF MINOR ASSENT (EXCERPT) This is an example; the language should be modified for your proposal as necessary. My name is ______________. I am your teacher, but I am also a student at The College at Brockport. I am doing a study to learn about the stresses or problems that families face. I want to learn more about how young people can get along better in school or with their parents. If you agree to participate in this study, you will be asked questions about your feelings and behavior, your family and friends, and school. You will also fill out a questionnaire [or complete an interview]. Your parents will work with a staff member from the study as well. This study will take about two hours. [Insert if appropriate: You will be receive X for the two hours of your time.] One risk of taking part in this study is that some questions I ask may be upsetting, but you do not have to answer any question you do not want to answer. You will have a chance to discuss any questions you have about the study with the interviewer/ researcher after you complete the interview/questionnaire. Any information that you give in this study will remain private. [Sometimes needed with minors when interviewing about high risk behaviors: The only exception to this would be if in talking to you, project staff find that there is something happening in your life that is an immediate and serious danger to your health or physical safety. In that case, your parents or another professional might have to be contacted. We would always talk to you about this first.] Your name will not be on the survey/questionnaire. Even if I publish this study, you will not be identified. What age group is this for?

18. STATEMENT OF ASSENT (EXCERPT) My name is ______________. I am your teacher, but I am also a student at The College at Brockport. I want to see what happens when you choose to read on your own, not because you are told to by a teacher or adult. You may see me writing in my notebook and recording what you say, and I may do an activity with you related to reading. If you decide to let me talk about reading with you, I won’t write your name down or let anyone else know who you are. When I write about my study, I will only say what you did during the lessons. Your participation in this study is completely your choice. You can change your mind at any time. If you would like to be part of this study, please sign in the space provided. You can choose not to participate even though your parent/guardian gave permission for you to participate. If you have any questions while I am working with you, you may ask me at any time and I will answer them for you. What age group is this for?

19. Review What is the IRB? Why is the IRB process in place? What is the path to IRB approval? Proposal Guided Tour – CITI – Proposal Categories – Proposal Narrative – Consent & Assent forms

20. Will my proposal get approval? Yes. We will work with you until your proposal is clear, includes all necessary parts, and meets federal guidelines for protections of human subjects. You can contact Julie Wilkens at any time with questions or concerns even before you turn in your proposal at jwilkens@brockport.edu or 395-2779.jwilkens@brockport.edu