1. Submitting IRB Applications (or “Do I have to do an IRB?”) Linda A. Detman, Ph.D. Research Associate Lawton & Rhea Chiles Center for Healthy Mothers and Babies Florida Perinatal Quality Collaborative 1

2. Have you completed training in the protection of human subjects? 2

3. Have you completed training on HIPAA? Health Insurance Portability and Accountability Act of 1996 Access training module at https://learn.health.usf.eduhttps://learn.health.usf.edu 3

4. Have you ever submitted an IRB application? 4

5. Agenda Overview of research and when you need IRB review Types of IRB reviews Tips for submitting your IRB application Resources Questions 5

6. What is Research? Per Federal regulations research is defined as the systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge 6

7. What is Systematic Investigation? An activity that involves a: Prospective research plan which incorporates Data collection and Data analysis to answer a research question 7

8. What is Generalizable Knowledge? Definition for IRB purposes: Contributing to generalizable knowledge means: – (1) conclusions are drawn from particular instances, and – (2) the information from the investigation is to be disseminated. To be considered research, the generalizable knowledge must be drawn from the results of a systematic investigation of human subjects. 8

9. What is a Human Subject? Per Federal regulations (45CFR46.102(f)), a human subject is defined as: – A living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information 9

10. So when do I need to submit an IRB? You are conducting research (systematic investigation to develop or contribute to generalizable knowledge), and You are interacting with human subjects to collect data or obtain identifiable private information about living individuals 10

11. Types of IRB Reviews Exempt – Does not mean no IRB review required Expedited – Does not mean fast Full Board – Reviewed by fully convened Board 11

12. Exempt Studies Must be minimal to virtually no risk Cannot involve pregnant women, human fetuses, or prisoners – Anonymous surveys – Existing data (documents, records, pathological or diagnostic specimens) recorded in de-identified fashion – Research comparing standard practice methods in an educational setting (commonly used in elementary, secondary, or post-secondary schools) 12

13. Expedited Studies Must be minimal risk—no greater risk than what is experienced in everyday life Surveys with identifiable information Analysis of data collected (or to be collected) for non- research purposes Research involving noninvasive clinical procedures Video or audio recordings Focus groups 13

14. Full Board Studies Greater than minimal risk; involves sensitive information or is invasive Pharmaceutical and medical treatment studies Studies involving prisoners or data on prisoners or other vulnerable populations (children, pregnant women) Information that could place participants at risk of civil or criminal liability or cause harms (stigma, ostracism, excommunication, etc.) 14

15. Not Human Subject Research Research using data or specimens from decedents De-identified secondary data analysis Non-private information such as available or disclosed in a public forum or that is directory information 15

16. Questions or Comments? 16

17. IRB Application Tips Write your protocol first – Everything in it can be cut and pasted into your application – No such thing as TMI Provide consistent information in all submitted documents Upload documents in the proper places 17

18. Informed Consent Use the USF informed consent templates Consider waiver of documentation of informed consent Provide adequate description of how you will carry out informed consent process 18

19. Final Tips If you are collaborating with external agencies or organization: – Draft a letter of support for them – Additional approvals may be necessary (e.g., public school systems, DOH, other universities) All study data must be retained for 5 years Last item in eIRB application: Describe your plan for ensuring the integrity of the data you collect, including how often you plan to monitor the data 19

20. The eIRB System Smart form system—as you answer questions, the forms will customize to assure only applicable questions appear Answering all questions ensures a smoother review-- questions marked * are required Click ‘continue’ to move through the application Remember to formally submit to the IRB by clicking ‘Submit Study’ under ‘My Activities’ on the left side of the system workspace 20

21. Principal Investigator Ultimately shoulders the responsibility for the conduct of the study, including the actions or inactions of the study team, support staff, etc. Is responsible for conducting research in the same ethical manner and with the same respect for the privacy and confidentiality of research subjects, no matter what type of IRB review 21

22. Remember… The review of your IRB application requires careful collaboration with multiple parties— build in time when planning your study Not all studies are approved on first submission—allow at least 30-45 days to ensure adequate time for review 22

23. Training is Available! USF Student Researcher Workshop – Tuesday, September 1, 6:30 – 9 p.m. eIRB System Training – Friday, October 9, 9 – 10 a.m. – Email TRAIN@usf.edu to sign-up (include course name in email)TRAIN@usf.edu 23

24. Resources Division of Research Integrity and Compliance http://www.research.usf.edu/dric/ -- click on ARC Portal http://www.research.usf.edu/dric/ Applications for Research Compliance (ARC) system – Tip sheets – Informed consent templates – Guidelines and procedure manual – Training videos – Sandbox 24

25. Questions? Linda A. Detman LRC 116 ldetman@health.usf.edu 813-974-5865 25