ࡱ> a 5JbjbjZZ E0i0i'B ""8:! -*,,,,,,;r,555,4A# # # 5R*# 5*# # *)wI&}RW0x}cFcc55# 55555,,:5555555c555555555"Y {: Institutional Review Board Application for Human Participants Research Part 1: Researcher Information and Funding Source A. Title of Study: B. Principal Investigator: Department: Campus Address/Office # or Mailing Address: Phone #: Email Address: Check one: ___ Faculty ___ Staff ___ Graduate Student ___ Undergraduate Student C. List all other researchers involved in the research study. For the purposes of the 鶹P IRB, a researcher is defined as a faculty member advising a student and/or an individual who played a significant role in the experimental design, data collection, and/or data analysis. Please note that research assistants and statisticians who do not have access to identifiable data should not be included here. Include the researchers name, campus address, email address, and whether they are a faculty advisor, following the template below. You may copy the template below as many times as needed. Researcher: Department: Campus Address/Office # or Mailing Address: Phone #: Email Address: Check one: ___ Faculty ___ Staff ___ Graduate Student ___ Undergraduate Student D. Funding Source or Sponsor __ Federal __ State __ 鶹P __ Other (specify): __ None Name of Funding Source: Please include any additional, or relevant, information. Part 2: Conflict of Interest Questions The following questions apply to all researchers, as outlined in Part 1, study staff engaged in all aspects of the study (i.e., design, conduct, analysis, and reporting), and/or their immediate family members. For these purposes, family includes the individuals spouse, domestic partner, and dependent children. Spouse and/or domestic partner includes a person with whom one shares a residence, responsibility for each others welfare and financial obligations. For each item, please check YES or NO. If you answered YES to Questions #1A-1E, please explain. 1. Currently, or during the term of this research study, does any member of the research team and/or their family members have or expect to have: A. A personal financial interest in or personal financial relationship (including gifts of cash or in-kind) with the sponsor of this study? YES NO B. A personal financial interest in or personal financial relationship (including gifts of cash or in-kin) with an entity that owns or has the right to commercialize a product, process, or technology studied in this project? YES NO C. A board membership of any kind or an executive position (paid or unpaid) with the sponsor of this study or with an entity that owns or has the right to commercialize a product, process, or technology studied in this project? YES NO D. Given the University or a University-related foundation cash or in-kind gift from the sponsor of this study for the use or benefit of any member of the research team? YES NO E. Given the University or a University-related foundation a cash or in-kind gift for the use or benefit of any member of the research team from an entity that owns or has the right to commercialize a product, process, or technology studied in this project? YES NO Part 3: List of IRB Application Materials Below is a list of items to include in your protocol application. 1. This completed Application for Human Participants Research form 2. Informed Consent Form(s) for participants who are 18 years old or older and parents or guardians for individuals under 18 years old 3. All recruitment materials including, but not limited to flyers, letters, announcements, or emails 4. All instructions given to participants during the research project 5. All CITI certificates for all researchers (see Part 4) 6. If applicable, assent form(s) for participants who are 17 years old or younger 7. If applicable, debriefing form(s) 8. If applicable, questionnaires, surveys, focus group and/or interview scripts used during the research project 9. If applicable, the grant application and/or proposal supporting this submission 10. If applicable, data use agreements 11. If applicable, the Application for a Title IX/Clery Reporting Exception for Research form if you are researching individuals who have experienced sexual and/or physical violence Please note that the IRB only has templates for informed consent forms*. Researchers can modify the informed consent form to create an assent form. */academics/research/institutional-review-board/forms-and-guidelines Part 4: CITI Courses 1. When you register for the CITI program, CITI will ask you a series of questions regarding your role as a researcher and the scope and/or nature of your research. You are required to answer these questions and, subsequently, CITI will populate a series of courses for you to take. The PI will need to upload all certificates to IRBNet along with their other application materials. 2. Researchers who have direct contact with participants (i.e., data collection), are in direct contact with identifiable data, and faculty sponsors are required to complete all CITI courses outlined in the first paragraph. Researchers involved with only statistical analyses with de-identified data will need to complete a COI course. Researchers involved only in manuscript preparation are not required to complete the CITI courses. 3. All researchers, as outlined above, will need to take a Conflict of Interest (COI) course. If the COI course does not populate for you, then you will need to add it. To do this, you should go to the Add a Course link at the bottom of the CITI page and select 1 and 2 in the curriculum. At this point, the COI course should be available to you. There is a PowerPoint slide on the IRB website* to help researchers with this process. *HYPERLINK "/academics/research/institutional-review-board/forms-and-guidelines"/academics/research/institutional-review-board/forms-and-guidelines 4. Are researchers working with Native American populations and specifically referencing the tribe in their work? If so, then researchers will need to complete the corresponding Native American CITI course. For example, if researchers are working with Lumbee individuals and reference the Lumbee Tribe in their work, then they will need to complete this course. However, if researchers are working with Native American populations and do not specifically reference the tribe in their work, then they will not need to complete these courses. For example, if researchers are working with Lumbee individuals and do not reference the Lumbee Tribe specifically in their work (i.e., researchers mention Native Americans instead) then they do not need to complete this course. 5. Are researchers performing biomedical research? If so, then they will need to complete the Biomedical Research CITI program and the Biomedical Responsible Conduct of Research CITI course. 6. The PI is required to sign the attestation below. As the Principal Investigator (PI), I attest that all researchers, as outlined in Part 4 of this protocol, have completed the required CITI courses. _________________________________________ ______________________ (Signature or typed name) (Date) Part 5: Summary Checklist Are the following involved? If yes, enter Y. If no, enter N. 1. Existing data, research and/or patient records, or human biological specimens? ______ 2. Surveys, questionnaires, interviews, or focus groups? ______ 3. Video/audiotaping of participants or analysis of existing video/audio tapes? ______ 4. Do you plan to specifically enroll participants from these vulnerable or select populations? 鶹P students and/or employees ______ B. Individuals who do not speak English ______ C. Individuals with mental impairments ______ D. Medical patients ______ E. Prisoners (i.e., incarcerated or parolees) ______ F. Pregnant women ______ G. Minors (i.e., 17 years old or younger) ______ H. Individuals who have experienced sexual and/or physical violence? ______ 5. Are sites outside of 鶹P engaged in this research? ______ If yes, list all locations below. Has this project been reviewed by any other IRBs? ______ Is there an approval letter and/or reliance agreement with these other IRBs? ______ If you answered YES to C, indicate below which IRB issued the letter and/or agreement. Other IRB: 6. Are you collecting sensitive information* from participants? ______ * Sexual behavior, medical information, recreational drug use, illegal behaviors, child abuse, immigration status, etc. 7. If you answered YES to #6, do you plan to obtain a federal Certificate of Confidentiality for this study? ______ 8. Are you planning any genetic studies on participants biological specimens? ______ 9. Are you planning on storing any participants biological specimens for future research? ______ Part 6: Research Study Information Questions 1. Provide a brief non-technical description of the study. The summary should not be longer than 100 words. 2. Provide a summary of the relevant background literature. Any citations will require a corresponding reference. Do not include references for citations not discussed. Discuss why the study is needed. The summary, excluding references, should not be longer than 200 words. 3. Fully describe the participant population. Approximately, how many participants will be in the study? How will participants be recruited? 4. Describe required characteristics of potential participants. What are the inclusion criteria? What are the exclusion criteria? 5. Describe the studys design. Provide a sequential description of what happens during the study. 6. Describe how the data will be collected. Who will collect the data? Where will the data be collected? What is the duration of the study? 7. Describe any benefit to participants beyond monetary inducements or course credit. Describe any benefits to society. 8. Are there any monetary inducements? For monetary compensation in foreign currency, provide an American dollar amount. If a participant is paid more than $200.00 a year, researchers are required to report the compensation to the IRS. If there is a monetary inducement, describe how a participant will get paid if they drop out of the study? For example, does the participant need to complete the entire study to receive the monetary inducement? 9. Describe any additional inducements, such as course credit. If there is course credit, describe the alternative scholastic assignment that participants can complete if they choose not to participate in the study. The alternative assignment needs to have an equivalent amount of course credit as the research study and require the same amount of effort. 10. Describe any costs (e.g., childcare, travel, parking fees, clinic fees, and diagnostic fees) to participants. Is the only cost to participants their time? 11. Describe any potential. psychosocial harm to participants. If there is no potential harm, please state None. 12. Describe any economic harm to participants. If there is no harm, please state None. 13. Describe any legal jeopardy to participants. If there is none, please state None. 14. Describe any physical harm to participants. If there is no harm, please state None. 15. Are you collecting data on sexual violence/abuse or physical violence/abuse? If yes, please describe and complete the Title IX form on the HYPERLINK "/academics/research/institutional-review-board/forms-and-guidelines"IRB website.. 16. Will you be collecting any of the following identifiers? If yes, enter Y. If no, enter N. A. Names _____ B. Telephone / fax numbers _____ C. Any elements of dates, other than year, directly related to participants _____ D. Mailing addresses _____ Email addresses _____ Social Security numbers _____ Medical record / health plan numbers _____ Bank account / credit card numbers _____ Drivers license numbers _____ License plate numbers / VINs (Vehicle Identification Numbers) _____ Internet addresses / social media handles _____ IP (Internet Protocol) addresses _____ Voice recordings _____ Photographic / video images _____ Fingerprints _____ Student account / Banner ID numbers _____ Any other uniquely identifying information* _____ *If yes to Q, specify below. 17. If you answered YES to any of the questions in #16, justify why you need to collect this identifying information. 18. If you answered YES to any of the questions in #16, describe who will have access to this identifying information. 19. In some instances, other individuals may be able to identify a participant given their identifying information. Describe how you will protect the participants identity. 20. Are you assigning pseudonyms to participants? If so, describe how you will assign pseudonyms to participants. Remember that no identifying information (i.e., anything listed in #16) should be included in the pseudonym. 21. Describe how the data will be remain confidential. 22. Describe how the data will be securely stored, transmitted, and disseminated. 23. Describe the informed consent process. Do you plan to use a signed consent form? If not, please justify why you are not using a signed consent form. 24. Describe attempts to limit coercion of participants. 25. If minors are included in the study, describe both the assent process for the minors and the consent process for their parents or legal guardians. 26. Describe your plans for reporting an unexpected adverse effect. Given the unexpected adverse effect, the protocol may need to be revised and resubmitted to the IRB. The IRB chair can assist in making this determination. How will the unexpected adverse effect be identified? How often will you monitor for unexpected adverse effects? 27. Describe the process for withdrawal from the study. Clarify it participants will be able to withdraw their data from the study if they themselves withdraw from the study. 28. If you need to access Protected Health Information (PHI) to identify potential participants who will then be contacted, you will need a limited waiver of HIPAA authorization. If this applies to your study, describe what information you are planning to collect for recruitment purposes. How will confidentiality or privacy be protected during this process? Describe how you will destroy the PHI after contact with the participants. Part 7: Tips for a Better Survey and Informed Consent Forms 1. If you are asking participants about their gender on a survey, include non-binary, trans, gender not listed above, and prefer not to answer as options. 2. If you are asking about ethnicity and/or race, Hispanic should not be included in the race question. There should be a separate Yes/No question (i.e., Do you identify as Hispanic?) 3. If you are asking about race, ethnicity, social economic status (SES), education level, or income, include a prefer not to answer as an option. 4. If you are asking questions about gender, race, ethnicity, and/or sexual orientation, do not include other as an option. 5. If you are asking about sexual orientation, include straight, gay, queer, bisexual, pansexual, sexual orientation not listed above, and prefer not to answer as options. 6. On the informed consent, if you are obtaining consent from a participant 18 years old or older, be sure to include a line indicating that the participant is, at least, 18 years old. 7. On the informed consent, include a line indicating how the individual obtaining consent is trained in human subjects research. Do not say that the individual is CITI trained. 8. 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