1. Adam Mills Human Subjects Office September 18, 2015 IRB Basics

2. What is an IRB? Institutional Review Board (responsible to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated) IU has 7 IRBs between Indianapolis and Bloomington to review all student, faculty, staff research 2

3. WHY ARE THERE REGULATIONS?

4. ExamplesTuskegee Stanford Prison Sponsor Public Health Service (1932-1972) US Office Naval Research (1946-1948) Purpose Document disease progression, justify future treatment options Conflicts Between Guards and Prisoners Subject Population Black malesMale Students InterventionsMedical examsPrison Simulation BenefitsFree meals, burial insuranceNo Direct Benefit Unethical Conduct Lack of informed consent, failure to treat, deception Physical and Mental Harm

5. HISTORY OF RESEARCH ETHICS National Research Act (1974) o Created due to publicity from the Tuskegee Syphilis Study o Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Drafted the Belmont Report 5

6. HISTORY OF RESEARCH ETHICS, con’t Belmont Report (1979) o A statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects o 3 basic ethic principles: Respect for persons Beneficence Justice 6

7. HISTORY, con’t o Respect for Persons Individuals should be treated as autonomous (independent) agents Persons with diminished autonomy are entitled to protection o Beneficence Human subjects should not be harmed Research should maximize possible benefits and minimize possible harms o Justice The benefits and risks of research must be distributed fairly 7

8. Role of HSO and IRB Provides administrative support to IRBs and guidance to investigators Human Subjects Office Makes final determination IRB

9. IRB Review Process cont’d Team 3 Sara Brand, Associate Dir.slbenken@indiana.edu812-856-3753 Senta Baker, Associateskbaker@iu.edu812-855-0945 Adam Mills, Associatemillsa@iu.edu812-856-4687 Casey Mumaw, Consultantkmumaw@iu.edu812-855-1741 Screening and Review

10. 9 RESEARCH: Systematic investigation to develop or contribute to generalizable knowledge HUMAN SUBJECT: Research about a living individual either through intervention/ interaction or identifiable private information IRB Review Questions to ask: –Is it research? –Does it involve human subjects? Scope of the Regulations

11. 11 Levels of IRB Review 1.Exempt review (minimal risk, 6 categories*) 2.Expedited review (minimal risk, 7 categories) 3.Full Board review (Greater that minimal risk) Minimal Risk: the risks of harm anticipated in the proposed research are not greater considering the probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests

12. Examples Exempt o Common Educational Practices o Educational Tests, Survey Procedures, Interview Procedures, Public Observations o Pre-Existing (identifiable) Data Expedited o Surveys, interviews o Prospective collection of data (Non-Research) o Research on individual or group characteristics, Language, Communication o Research employing oral history, focus groups, or program evaluation Full o Experimental drug or device studies o Most invasive procedures o Surveys/interviews that include sensitive questions or questions that are likely to be stressful to the subject, or that involve illegal behavior o Many types of research involving children, pregnant women and fetuses, cognitively impaired, and prisoners

13. Flex Exempt Categories Flex Category 6 (Traditional Expedited 6) Flex Category 7 (Tradtional Expedited 7) What qualifies? o Non-Federal Funding o Non FDA Regualted o Non VA Regulated o Children 14+ o No Other Vulnerable Populations

14. Pre-Submission Requirements: IU Policy Complete the required IU Conflict of Interest Disclosure form (COI)* Complete the required Collaborative Institutional Training Initiative human subject test (CITI) Eligible Principal Investigator (PI) 14

15. CITI Test Required human subject test for investigators who are interacting with subjects are receiving identifiable data. There are two educational tracks: Biomedical or Social and Behavioral. You would choose the Social Behavioral Researcher Stage 1 Missing CITI will hold processing Log In: http://researchcompliance.iu.edu/eo/eo_citi.html 15

16. CITI cont. A passing score of 80% is required Sign onto the site with your IU email address Make sure that you affiliate yourself with IUB Tutorial and the test will immediately follow Modules will be about Regulations, Informed Consent, Privacy and Confidentiality 16

17. ONLINE COI FORM The University requires annual disclosures of "significant financial interests" by all faculty/ staff members and any other key personnel involved in the design, conduct or reporting of research or sponsored program activities. This is a brief online form that is required every year. Log in page: http://researchcompliance.iu.edu/coi/coi_disc losure.html http://researchcompliance.iu.edu/coi/coi_disc losure.html 17

18. Eligible PI Students are not eligible to serve as Principal Investigator Faculty Members/ Advisors List of eligible PI’s: http://researchcompliance.iu.edu/hso/hs_in v_req.html 18

19. Exempt Submission Materials Study information sheet (If Applicable) Include all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable 19

20. Expedited Submission Informed Consent Template Include all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable 20

21. Kuali Coeus (KC-IRB) Online submission database KC-IRB can be accessed through onestart o Soon to be one.iu.edu Required for all submission types 21

22. Q & A