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Institutional Review Board Procedures and Implications

Institutional Review Board Procedures and Implications.

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Institutional Review Board Procedures and Implications

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  1. Institutional Review Board Procedures and Implications • After the applied dissertation committee has approved the proposal and the IRB package, the student should forward a copy of the approved proposal together with the completed IRB submission package to the ARC for review. (See the ARC Web page, Navigating the IRB Process). • NO RESEARCH STUDY ACTIVITY SHOULD TAKE PLACE BEYOND THE PROPOSAL STAGE UNTIL OFFICIAL NOTIFICATION HAS BEEN RECEIVED FROM THE ARC, INDICATING THAT THE PROPOSED RESEARCH STUDY MEETS THE UNIVERSITY’S IRB REQUIREMENTS.

  2. Responsibilities of the IRB The purpose of the IRB is to guarantee that • the welfare and rights of human subjects are adequately protected and informed consent given, if necessary. • human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research. • the researchers are qualified to conduct research involving human subjects. • subjects are fully aware of the study’s parameters and what role they (and/or their data) play.

  3. Additional Responsibilities of the IRB • To ensure that ethical and safe research is conducted at Nova Southeastern University • To protect NSU students and faculty • To fulfill NSU requirements according to Federal-wide Assurances that guarantee the oversight and enforcement of federal regulations that protect human subjects involved in research

  4. Types of IRB Reviews • Exempt or Center Level • Expedited • Full All studies, regardless of the nature of the review, must be reviewed by IRB representatives prior to the beginning of research-related activities (e.g., asking friends and colleagues to participate constitutes a research activity).

  5. Consequences of Not Obtaining IRB Approval • Implementing your study again—starting over! • Inability to use collected data • Loss of funding • Dismissal from FSEHS and NSU • If in doubt, please contact the ARC IRB representatives to get the information before you begin research activities

  6. How to Retrieve the Navigating the IRB Process Manual • Visit the Applied Research Center Web site: http://www.schoolofed.nova.edu/arc/ • Click “Academic Resources” • Click “Online Guides” • Review “Institutional Review Board” section

  7. Required IRB Documents NSU IRB New Submission Form (requires student and committee chair signatures) Research Protocol (in detail) Administration Letter (from site where study will take place) Informed Consent/Assent forms (number of required consent forms may vary with each study) Informed Consent Form Checklist (one per consent form) Recruitment materials (e.g., flyers, brochures)

  8. Required IRB Documents (Cont.) • One copy of the approved proposal • Data collection instruments • Proof of Collaborative IRB Training Initiative (CITI) completion

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