1. Institutional Review Board (IRB) Research Methods Professional Development Institute December 3, 2015

2. About Our Speaker Katherine (Kathi) J. Conger, Professor of Human Development and Family Studies, Department of Human Ecology, University of California, Davis Member of Social-Behavioral Committee C for past 5 years

3. IRB Process Why do we have an IRB? How do we know if we need to submit our research proposal to the IRB? What happens once we hit “submit”? Where does it go, what is the review process?

4. Objectives for Today’s Talk  Explain the history of Institutional Review Boards (IRBs)  Describe the IRB review categories and regulatory criteria for approval  Discuss the IRB application process  Discuss tips for success 4

5. An earlier time…..

6. Edward Jenner - Founder of Immunology - Known for contribution to Small Pox eradication Hand of Mary Nelms, Milkmaid “On May 14, 1796, using matter from Nelms' lesions, he inoculated an 8-year-old boy, James Phipps. Subsequently, the boy developed mild fever and discomfort in the axillae. Nine days after the procedure he felt cold and had lost his appetite, but on the next day he was much better. In July 1796, Jenner inoculated the boy again, this time with matter from a fresh smallpox lesion. No disease developed, and Jenner concluded that protection was complete.”

7. NAZI Experiments

8. Tuskegee Syphilis Study

10. Funded by Public Health Service Objective was to study the lifespan of syphilis. Enrolled African American sharecroppers who were infected with syphilis. The men were never treated and were told they had “bad- blood.” Information about the study became public in 1972. Congress reaction by requiring DHHS to develop regulations. Congress formed the National Commission for the Study of Ethical Problems in Research. In 1997 President Clinton apologized to the participants

11. US History of Human Research Protections Resulted from the Nuremberg Trials Created the first principles of: Informed Consent Proper formulated scientific experimentation Beneficence towards participants Adopted into the Declaration of Helsinki No legal precedent Nuremberg Code (1947) 11

12. US History of Human Research Protection (cont.) Prompted by the Tuskegee Syphilis Study Established three fundamental ethical principles:  Respect for Persons  Beneficence  Justice Expanded and revised regulations that protect human research subjects in the United States Led to the establishment of the Office for Human Research Protections (OHRP) Led to the creation of Institutional Review Boards (IRBs) Belmont Report (1978) 12

13. Institutional Review Board (IRB) UC Davis IRB Administration Federalwide Assurance #00004557 Approve/modify/disapprove research protocols involving human subjects Protect rights and welfare of human subjects Four Committees: Biomedical, Social/Behavioral, and Fast Track Full committees and expedited/exempt reviewers Multi-campus collaborative review and agreements Education and training Administration and record-keeping 13

14. The Common Rule Basic Policy for Protection of Human Research Subjects Extra Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Extra Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Extra Protections for Children Involved as Research Subjects 45 CFR 46 (Public Welfare) 14

15. Research as defined by Department of Health and Human Services: What is Research? “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” 45 CFR 46.102(d) 15

16. What is a Human Subject? A living individual about whom an investigator (professional or student) conducting research obtains:  data through intervention or interaction with the individual, or  identifiable private information. 45 CFR 46.102(f) 16

17. My protocol is ready, what do I do now? 17

18. Submit the Protocol Through IRBNet  Complete the Smart Form  Administrative Approvals (HRP-226)  Protocol  Consent Document  Subject facing documents The following forms, if applicable:  Sponsor Fee Form  Qualifying Clinical Trials Form  Others? (HINT: Secondary Reviews) IRB Submission Forms 18

19. 19

20. IRB Determinations and Definitions Full Committee Review Expedited Exempt Determined as Not Human Research

21. Full Committee Review  Most rigorous level of review  Any study which does not meet the Exemption or Expedited Criteria  A full quorum is assembled  Members receive all study documents  All members participate in the discussion and vote  Decision is rendered by a majority of the assembled quorum.  No member with a conflict of interest can participate and vote in the decision.  Decision is rendered by a majority of the assembled quorum  No member with a conflict of interest can participate in the decision 21

22. Expedited Review  Must be minimal risk  Fits one or more of nine specific categories  Approval requirements are the same as full committee review, but only one IRB member reviews the project  Expedited reviewer may not disapprove research 22

23. Exempt Review  Must be minimal risk research  Fits within one of six categories  Determination is not an IRB approval – instead the determination is that the research is exempt from IRB oversight.  Review is typically conducted by a designated IRB member 23

24. How does the IRB figure this all out? Answer: Worksheets  HRP-310 Human Research Determination  HRP-311 Engagement Determination  HRP-312 Exemption Determination  HRP-313 Eligibility for Review Using the Expedited Procedure 24

25. Criteria for Approval of Research [45 CFR Part 46.111] 1. Risks to subjects are minimized by using procedures, which are consistent with sound research design and which do not unnecessarily expose subjects to risk. 2. Risks to subjects are minimized by using procedures already being performed on the subjects for other purposes. 3. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 4. Selection of subjects is equitable. 5. The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. 25

26. Criteria for Approval of Research (cont.) 6. There are adequate provisions to protect the privacy of subjects. 7. There are adequate provisions to maintain the confidentiality of data. 8. Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence. (“N/A” if no vulnerable subjects) 9. The informed consent process is adequate. 10. The documentation of informed consent is adequate. 26

27. How Do Researchers Meet These Regulations? 27

28. 28 IRB Documents (Available on the IRB Website)  Human Research Protection Program Plan (HRP-101)  Investigator Manual (HRP-103)  Submission Information  Initial Review Application Smart Form  Continuing Review Progress Report (HRP-212)  Modification (HRP-213)  Reportable New Information Form (HRP-214)  Template Protocol (HRP-503)  Template Consent Document (HRP-502)  SOPs on consent process and documentation (HRP-90, HRP-91)

29. 29 Template Protocol (HRP-503)  Guide to writing a protocol  If something is not applicable, say so, skip, or delete  Content is important, not format.  Template is a guide that, if followed, reduces the likelihood of not submitting the right information.  There are versions of the HRP 503 for research involving review of data and specimens and for research involving surveys.

30. 30 Template Consent (HRP-502)  Guide to writing a consent  If something is not applicable, delete  Content is important, not format.  This is a guide that, if followed, reduces the likelihood of not submitting the right information.

31. Basic Elements of Informed Consent (45 CFR 46.116(a)) 1.Research Description 2.Risks 3.Benefits 4.Alternatives 5.Confidentiality (Include FDA) 6.Compensation 7.Contacts 8.Voluntary participation and withdrawal The 8 Necessities 31 Note: If research is exempt consent must contain only the following: 1.The project is research; 2.A description of the procedures; 3.Participation is voluntary 4.Investigators name and UC Davis contact information

32. When Do I Need an IRB? As a general rule of thumb, evaluation done for program improvement does not require IRB approval - - - Information collected for research does. Given that we work mainly with youth, it’s better to be safe than sorry – Always go back to definition of human research

33. Program Improvement Example You deliver a nutrition education program to youth at an afterschool program. You deliver pre-program and post-program surveys to youth. You notice that youth show increases in the knowledge about healthy choices, but not in their behavior. You share a summary these results with your staff and volunteers involved in the program so that you can alter the program to help increase healthy behavior change.

34. Research Example You and colleagues administer a survey to gain youth and adult attitudes and perspectives on a program. You are interested in their satisfaction with the program so that you can make improvements, if needed. The results are much more interesting than you anticipated and you decide to share the results at a conference like the American Evaluation Association.

35. Yeah, it’s approved! Anything else? 35

36. Investigator Responsibilities after Approval  Protect human subjects.  Ensure all personnel comply with protocol requirements and determinations of IRB.  Avoid undue influence in enrolling subjects.  Ensure that informed consent is adequate and understandable to subjects.  Report new information as stated within HRP-214, Reportable New Information Form.  Submit changes in research to IRB for approval prior to implementation. 36

37. 4-H STATE OFFICE RESOURCES

38. 4-H State Office IRBs Who’s covered?Delivery Mode AgesMeasuresData Collection Type 4-H Individually Enrolled Youth Club9-19 http://4h.ucanr.edu/Re sources/Evaluation/ ORB, paper and pencil 4-H Group Enrolled Youth All5-19 http://4h.ucanr.edu/Re sources/Evaluation/ Qualtrics*, paper and pencil

39. Resources Basic IRB information: http://4h.ucanr.edu/Resources/Evaluation/ Institutional_Review_Board/ http://4h.ucanr.edu/Resources/Evaluation/ Institutional_Review_Board/ Sample Assent Language:http://4h.ucanr.edu/Resources/E valuation/http://4h.ucanr.edu/Resources/E valuation/

40. Qualtrics Qualtrics is an online data collection tool like SurveyMonkey or Mturk. UCCE academics and staff can create an account for free (contact Kit Alviz- Kit.Alviz@ucop.edu)Kit.Alviz@ucop.edu If data is collected this way, and is not through a 4-H State Office IRB, all 4-H academics and staff need to include Kendra Lewis & Kit Alviz on the IRB protocol as having access to the data, but “not engaged in the research”. Please contact Kendra Lewis (kmlewis@ucanr.edu) for language necessary for Qualtrics data collection to include in your IRB.kmlewis@ucanr.edu

41. Action Steps Get CITI certified: https://www.citiprogram.org/https://www.citiprogram.org/ Also make sure everyone on your research project is certified Set up in IRBnet account: http://research.ucdavis.edu/policiescompliance/i rb-admin/irbnet/#IRBNet Registration Link your CITI certification to your IRBnet account

42. Other Resources http://research.ucdavis.edu/policiescomplian ce/irb-admin/irb-faqs-3/

43. 43 Questions? Thank you!