A Guide to Navigating the IRB

1. A Guide to Navigating the IRB

2. Objectives • Provide practical and technical assistance for navigating the IRB process. • Provide an explanation as to the regulatory requirements necessary for IRB approval.

3. Human Participant Research • Governed by ethical principles of the: • Belmont Report • Requirements of the Department of Health and Human Services (DHHS) • Food and Drug Administration (FDA) regulations

4. Definition of Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizableknowledge. 45 CFR 46.202

5. Definition Human Participant A living individual about whom an investigator conducting research obtains: • data through intervention or interaction with the individual, -or- • identifiable private information. 45 CFR 46.202

6. IRB Purpose The IRB is an administrative body established to protect the rights and welfare of human research participants recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. (IRB Guidebook – OHRP – Department of Health & Human Services)

7. Getting Started • Complete required research http://phrp.nihtraining.com/users/login.php • Carefully review the IRB Application • Consult with your College IRB representative • Determine whether other IRB’s in addition to USF’s need to review and approve your study

8. Getting Started • Determine whether other committee approvals are required for study approval, e.g., from an outside agency, a funding source, etc. • Contact the USF IRB for guidance, if needed • Allow yourself enough time to complete the required paperwork, obtain the necessary signatures, and obtain the required committee approvals

9. IRB Review Process Types Of Human Participant Research • Exempt Research • Expedited Review • Full Board Review

10. Exempt Research Research that is “exempt”: • Research in established or commonly accepted educational settings, involving normal educational practices • Educational tests, surveys, interviews, or observation of public behavior unless identified and sensitive • Research using existing data, documents, records, pathological specimens, or diagnostic specimens, if publicly available or unidentifiable 45 CFR 46.110(b)

11. Exempt Research • Exemptions must be verified by a trained and qualified IRB or institutional official(s) • Exemptions may not be determined by the investigator

12. Expedited Review Eligible research includes minimal risk and: • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes • Collection of data from voice, video, digital, or image recordings made for research purposes • Research on individual or group characteristics or behavior or research employing survey, interview, oral history, etc. methodologies 63 FR 60364 - 60367

13. Expedited Review An Expedited Review: • Is not a quick review • Requires the same review as that that performed by the convened Board • Requires only two committee members to review • Can be referred to the full review if the two reviewers determine a need for further input

14. Full Board Review • Requires full committee to meet in person and review the study • Quorum must be present • Non-Scientist must be present

15. IRB Review Criteria Risks to participants are minimized and reasonable in relation to anticipated benefits. Types of risks to which research participants may be exposed include but are not limited to: • Physical harm • Psychological harm • Spiritual harm • Invasion of privacy • Breach of confidentiality • Social and economic harm • Financial costs • Harm to family and friends

16. IRB Review Criteria Risks to participants are minimized and reasonable in relation to anticipated benefits: • Risks to participants are clearly and accurately identified and considered • Risks to others (relatives, friends, etc.) are accurately identified and considered • Risks are minimized through sound research design • Research personnel are qualified • Anticipated benefits to participants and importance of knowledge to be gained clearly and clearly accurately identified

17. IRB Review Criteria Risks to participants are minimized and reasonable in relation to anticipated benefits: • Research personnel are qualified • Anticipated benefits to participant and importance of knowledge to be gained are clearly and accurately identified

18. IRB Review Criteria Selection of participants is equitable -Justification for exclusion of any group from the study is provided. • Minority/ethnic representation is appropriate • Gender representation is appropriate • Recruitment methods and advertising materials are non-coercive and appropriate • Additional protections for children, pregnant women, fetuses, neonates, and prisoners and others who may be vulnerable

19. IRB Review Criteria Informed consent will be obtained from each prospective participant or their legally authorized representative (See discussion of exceptions in manual)

20. IRB Review Criteria Adequate provisions for monitoring the data collected to ensure study participant’s safety • Minimal risk • Greater than minimal risk studies • Internal and/or external data safety monitoring • Data Safety Monitoring Board or Data Monitoring Committee

21. IRB Review Criteria Adequate provisions to protect the privacy of participants and to maintain the confidentiality of data • Methods for obtaining, recording, and coding of data and/or samples are adequately described and provide a satisfactory plan • Plan for storage of data and/or samples is described and is satisfactory

22. IRB Review Criteria Adequate provisions to protect the privacy of participants and to maintain their confidentiality are in place. • Specific procedures for sharing of data and/or samples are described and it is a satisfactory plan for maintaining confidentiality

23. IRB Review Criteria Additional safeguards included to protect the rights and welfare of vulnerable participants: • Children • Adults with impaired capacity for decision-making • Pregnant women and fetuses • Neonates • Prisoners • Other (for example someone who cannot read or write)

24. IRB Review Decisions • Approved • Modifications Required • Tabled/Deferred (Full Review Only) • Disapproved (Full Review Only)

25. In summary, IRBs review… • Study Design • Recruitment Process • Participant Population • Informed consent document and process • Risk/Benefit Ratio • Privacy & Confidentiality • Data Storage/Protection • Protections for Vulnerable participants

26. Helpful Hints • Put yourself in the research participant’s shoes – what information would you want to know in order to agree to participate in the study? • Provide information on the current research and justification for your study, e.g., explain why the study is worth doing • Know potential ethical issues associated with your research – review guidelines/other studies • Be clear about your methodology and the procedures your will use in your study

27. Helpful Hints • Plan ahead • Contact the IRB if you have any questions • Use the correct and current version of the IRB forms • Answer all questions in the application fully, completely and consistently. • Know the committee deadlines • Proof read all documents before submission • Be prepared to answer questions and/or receive feedback from the IRB if they have concerns.

28. AFTER RECEIVING IRB APPROVAL • Monitor study to assure protocol compliance • Request IRB approval for any changes in protocol • Report any protocol violations or adverse events occurring during the study • Submit application for IRB renewal at least one month prior to the expiration date of your approval letter • Submit study closure report

29. Contact Information University Of St. Francis Institutional Review Board 500 Wilcox Street Joliet IL 60436 IRB@stfrancis.edu

30. Questions?