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IRB Basics

IRB Basics. Adam Mills Human Subjects Office September 18, 2015. What is an IRB?.

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IRB Basics

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

  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

  3. WHY ARE THERE REGULATIONS?

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

  5. HISTORY OF RESEARCH ETHICS, con’t • Belmont Report (1979) • 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 • 3 basic ethic principles: • Respect for persons • Beneficence • Justice

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

  7. Role of HSO and IRB

  8. IRB Review Process cont’d Screening and Review

  9. Scope of the Regulations • Questions to ask: • Is it research? • Does it involve human subjects?

  10. Levels of IRB Review • Exempt review (minimal risk, 6 categories*) • Expedited review (minimal risk, 7 categories) • 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

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

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

  13. 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. 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. 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. 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_disclosure.html

  17. 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_inv_req.html

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

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

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

  21. Q & A

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