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). 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. 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.

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. 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. 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. 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. subjects are fully aware of the study’s parameters and what role they (and/or their data) play.

Additional Responsibilities of the IRB To ensure that ethical and safe research is conducted at Nova Southeastern University To ensure that ethical and safe research is conducted at Nova Southeastern University To protect NSU students and faculty 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 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

Types of IRB Reviews Exempt or Center Level Exempt or Center Level Expedited Expedited Full 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).

Center-Level Review Research that is regarded as having no more than minimal risk to subjects and does not involve special populations (e.g., mentally retarded, prisoners, some studies with children, etc.) Research that is regarded as having no more than minimal risk to subjects and does not involve special populations (e.g., mentally retarded, prisoners, some studies with children, etc.) Review conducted by ARC/IRB representatives. Review conducted by ARC/IRB representatives.

Center-Level Review Examples of research that may be reviewed at the center-level: Examples of research that may be reviewed at the center-level: Research on the effectiveness of educational, classroom, and/or instructional strategies, provided that these strategies are familiar and nonintrusive in their implementation Research on the effectiveness of educational, classroom, and/or instructional strategies, provided that these strategies are familiar and nonintrusive in their implementation Research using educational tests if subjects' identities are thoroughly protected Research using educational tests if subjects' identities are thoroughly protected Research using survey or interview procedures where subjects' identities are thoroughly protected and their answers do not subject them to criminal and civil liability Research using survey or interview procedures where subjects' identities are thoroughly protected and their answers do not subject them to criminal and civil liability

Expedited Review Studies that do not meet the requirements for a Center-Level Review, but also do not represent more than a minimal risk to the subjects (i.e., the study may not involve more than a minimal risk but could include a protected group such as prisoners) Studies that do not meet the requirements for a Center-Level Review, but also do not represent more than a minimal risk to the subjects (i.e., the study may not involve more than a minimal risk but could include a protected group such as prisoners) Review conducted by the IRB chair or the designated representative and the IRB administrator Review conducted by the IRB chair or the designated representative and the IRB administrator

Expedited Review Examples of research that may be expedited: Examples of research that may be expedited: Studies that expose normal populations to levels of physical or emotional stress that are somewhat greater than normal life or routine procedures, but that do not represent significant risks Studies that expose normal populations to levels of physical or emotional stress that are somewhat greater than normal life or routine procedures, but that do not represent significant risks Surveys that request information that potentially exposes the informant to criminal or civil liability or that is extremely personal in nature (in which the likelihood of associating the individual with the responses is very small). Surveys that request information that potentially exposes the informant to criminal or civil liability or that is extremely personal in nature (in which the likelihood of associating the individual with the responses is very small). Studies that involve video recordings and/or audio recordings made for research purposes. Studies that involve video recordings and/or audio recordings made for research purposes.

Full Review A full review is required for studies that have potential risk to human subjects. A full review is required for studies that have potential risk to human subjects. Review is conducted by the voting members of the NSU IRB. Review is conducted by the voting members of the NSU IRB. Meetings take place monthly. Meetings take place monthly. A minimum of 11 members (one of whom must be a non-scientist) must be present. A minimum of 11 members (one of whom must be a non-scientist) must be present.

Full Review Examples of research that may require full review : Examples of research that may require full review : Research involving prisoners, pregnant women, or fetuses in utero. Research involving prisoners, pregnant women, or fetuses in utero. Research that places protected populations (such as children, mentally retarded individuals, mentally ill individuals, patients with medical disorders) at more than minimal risk. Research that places protected populations (such as children, mentally retarded individuals, mentally ill individuals, patients with medical disorders) at more than minimal risk. Research that may result in a significant level of psychological or physical stress. Research that may result in a significant level of psychological or physical stress. Research that potentially could put the subject at risk for legal or civil liability or invade a subject’s privacy in regard to sensitive aspects of his or her behavior when there is a possibility that the subject could be identified. Research that potentially could put the subject at risk for legal or civil liability or invade a subject’s privacy in regard to sensitive aspects of his or her behavior when there is a possibility that the subject could be identified.

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

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

CITI Training Required for all individuals involved in research activities with human subjects Required for all individuals involved in research activities with human subjects Consists of 19 modules that are completed online Consists of 19 modules that are completed online Students should review each module and complete a short quiz at the end of each section (quiz may be repeated as many times as necessary). Students should review each module and complete a short quiz at the end of each section (quiz may be repeated as many times as necessary). CITI TRAINING MUST BE COMPLETED BY THE STUDENT AND COMMITTEE CHAIR PRIOR TO IRB SUBMISSION. CITI TRAINING MUST BE COMPLETED BY THE STUDENT AND COMMITTEE CHAIR PRIOR TO IRB SUBMISSION. Students should visit the following Web site for information regarding registration and completion of this training: Students should visit the following Web site for information regarding registration and completion of this training:

How to Retrieve the Navigating the IRB Process Manual Visit the Applied Research Center Web site: Visit the Applied Research Center Web site: Click “Academic Resources” Click “Academic Resources” Click “Online Guides” Click “Online Guides” Review “Institutional Review Board” section Review “Institutional Review Board” section

Process of IRB approval Most students require revisions after first submission. Some students may require several rounds of revisions prior to IRB approval. Most students require revisions after first submission. Some students may require several rounds of revisions prior to IRB approval. Center Level – typically requires 2 weeks (from time of receipt) per submission. Center Level – typically requires 2 weeks (from time of receipt) per submission. Expedited – typically requires 4 weeks (from time of receipt) and an additional 4 weeks for review by the IRB chair. Expedited – typically requires 4 weeks (from time of receipt) and an additional 4 weeks for review by the IRB chair. Full – typically requires 8 weeks (from time of receipt) and an additional 8 weeks for review by the IRB committee (2-4 months total) Full – typically requires 8 weeks (from time of receipt) and an additional 8 weeks for review by the IRB committee (2-4 months total)

IRB Communications If Approved: An official memo will be sent via e- mail to the student, AD chair, and applied research program professor informing them that the study has received IRB approval and that implementation may begin. If Approved: An official memo will be sent via e- mail to the student, AD chair, and applied research program professor informing them that the study has received IRB approval and that implementation may begin. If Pending: An message will be sent to the student’s NSU account and committee chair indicating the revisions that are needed to receive approval. If Pending: An message will be sent to the student’s NSU account and committee chair indicating the revisions that are needed to receive approval.

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