University of North Florida

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1 Last edited by: Kayla Champaigne Last edited on: December 5, 2012 University of North Florida Institutional Review Board IRB Protocol Please note, this is a sample of the North Florida - IRB Protocol output. It is not a form that can be downloaded, completed and uploaded in IRBNet like Attachment A. It is a smart form that can only be completed in IRBNet. Please refer to item #2 of the Common IRBNet Functions document and other IRB guidance documents for directions on how to access and complete this document in IRBNet. Not HS Research Required Start Date [ ] Example IRBNet Project The document called "Attachment A; Study Details" must be completed and included in all IRB submissions. Additionally, incomplete submissions will be returned un-reviewed. I. Principal Investigator Name: Kayla Champaigne K.Champaigne@unf.edu Phone: (904) Address: 3/2511 Department: Other - ORSP Project Type: UNF Faculty Research UNF Master's Thesis UNF Staff Research Other Graduate Student Research UNF Dissertation Not Affiliated with UNF II. Faculty Advisor Name: Department: III. UNF Sponsor Name: Department: IV. Additional Personnel Name Role Designation Dawn O'Connor Co-PI UNF Staff All PIs, Co-PIs, data collectors, and personnel who interact or intervene with participants, or who have access to identifiable information, must be CITI certified in the protection of human subjects. V. Funding Information Type Source Status Internal City of Jacksonville Applied For Generated on IRBNet

2 Funding Title: VI. Project Information What do you plan to do with the study results? We anticipate presenting the findings at a conference or publishing it in a journal. Results will be generalized. Human Subjects Research Determination: Systematic investigation? Yes No Designed to develop/contribute to generalizable knowledge? Yes No Obtaining information about living individuals? Yes No Intervention/interaction with individuals? Yes No Individually identifiable information? Yes No Private information? Yes No Does this study appear to be research with human subjects? Yes No Risk to subjects if information is disclosed? Yes No [criminal/civil liability, damaging to a subject's financial standing, employability, or reputation] Collecting (directly or indirectly) identifiable information? Yes No Research involves deception? Yes No Vulnerable Populations: None of these populations will be specifically targeted. Prisoners Decisionally-Impaired Individuals HIV+ Individuals Economically/Educationally Disadvantaged Individuals Non-English Speaking Individuals Pregnant Women, Human Fetuses, Neonates Children Required start date? Yes No Target Date: Start Date Justification: Study Objective: Generated on IRBNet

3 We hope to compare IRB experiences between PIs at different institutions. Satisfaction, regulatory compliance, and timelines will be compared. VII. Collaborative Institutions In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human participants. Institution Name: IRB determination letter? Florida State College of Jacksonville (FSCJ) Attached Yes Will be forwarded No (no IRB at institution) Nature of Collaboration: Letter of support attached? A parallel study will take place at FSCJ and data from both institutions will be compared. VIII.Controlled Facilities If recruitment and/or study procedures will take place in a controlled facility (e.g., school, hospital, nursing home) you must provide written documentation from an authorized individual that the facility has given permission for the activity to take place there. Facility Name: Letter of support attached? Yes No Facility Description: IX. Informed Consent Describe where and how participants will be identified and recruited: Institutional research and assessment will UNF faculty and staff members on our behalf. A similar mechanism will be in place for recruitment at FSCJ. A copy of the recruitment is attached (see Attachment B). A link to the online survey will be included in the . By clicking on the link, potential participants will be taken to the informed consent document. After participants click continue on the informed consent document, they will directed to the anonymous Qualtrics survey. How will informed consent be obtained? Generated on IRBNet

4 Signed informed consent document Oral informed consent [waiver of signed informed consent requested] Electronic informed consent [waiver of signed informed consent requested] No informed consent [waiver of informed consent requested] Request for Waiver of Signed Informed Consent: The only record linking the subjects and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. The research does not qualify for a waiver of signed informed consent under one of the above conditions therefore signed informed consent will be obtained from all participants. Request for Waiver of Informed Consent: Consent Process: Informed consent will be obtained electronically. We requested a waiver of signed informed consent because signatures would be the only record identifying participants. By clicking on the link in the recruitment , potential participants will automatically be taken to the page with the informed consent document which is the first page of the online survey. Participants will be informed that by clicking continue they are granting permission to the researchers to use their data for research purposes. The informed consent will contain printing instructions so that individuals can print out the informed consent for their records. By clicking continue, participants will access the anonymous survey. X. Child Participants What is the mechanism for parent/guardian permission (when applicable)? Signed parent/guardian permission document Oral parent/guardian permission [waiver of signed parent/guardian permission requested] No parent/guardian permission [waiver of parent/guardian permission requested] What is the mechanism for informed assent (when applicable)? Signed informed assent document (generally used if minors are 7 years old or older) Oral informed assent [waiver of signed informed assent requested] Electronic informed assent [waiver of signed informed assent requested] No informed assent [waiver of informed assent requested] Generated on IRBNet

5 Describe the process for obtaining parent/guardian permission and child assent. If requesting a waiver, include a brief justification. XI. Participants with Diminished Capacity to Consent Are you likely to include those with diminished capacity to consent (e.g., limited decision-making capacity, language barriers, hearing difficulty)? Yes No If yes: Describe how the capacity to consent will be assessed: If a participant is incapable of providing consent, you will need to obtain consent from the participant's legal guardian. Outline any procedures you will include that may increase a participant's capacity to consent. If no: Provide a brief justification for excluding individuals with limited decision-making capacity: The targeted population (UNF faculty and staff) are highly functioning individuals who are capable of understanding and giving informed consent. By nature of the population, no efforts will be made to exclude individuals from participating. If a potential participant can read the informed consent document and agrees to participate, he or she will be admitted into this study as a participant. XII. Principal Investigator Certification Please confirm each item by checking the box next to each item: I have read and understand the U.S. Department of Health and Human Services Code of Federal Regulations 45 CFR 46, and I will abide by them. I agree to obtain approval from the IRB prior to engaging in any research activities related to human subjects. I agree to obtain approval from the IRB prior to implementing any changes in my project protocol, procedures, or related documents. I agree to keep signed consent forms, if required, from each subject for a minimum of 3 years past the completion of my project. For expedited and full board projects, I agree to submit a status report at 12-month or shorter time intervals, as indicated on my approval letter, attesting to the current status of my project. I agree to report any and all adverse events and unanticipated problems relating to my study to the IRB as soon as possible, but not more than 3 business days from the occurrence. I confirm that the submission package for this project is all inclusive and includes all procedures and relevant documents related to this study, and that no additional procedures or documents will be used in regard to this study without prior IRB approval. I attest that if this is an exempt study any additional personnel who interact or intervene with participants, or who have access to identifiable information will be CITI certified in the protection of human subjects Generated on IRBNet

6 INSTRUCTIONS TO RESEARCHERS Thank you for completing the IRB protocol application for your project. At a minimum, UNF's IRB requires that the Principal Investigator (PI) sign each package before it is submitted. If the PI is a student, it will be necessary for the faculty advisor to sign the package. If the PI is different than the faculty advisor on a student project, both the PI and the faculty advisor must sign the package. By signing this package in IRBNet, you attest that you have read and understand the preceding guidelines, and agree to adhere to them for the duration of the project. Please complete Attachment A from the Forms and Templates library and attach to the package before submitting this package. Depending on your project, additional supplementary documents might also need to be submitted for your submission package to be complete. If you have any questions or concerns about this application or any other IRB issue, please feel free to IRB@unf.edu Generated on IRBNet