University of the Virgin Islands Research Involving Human Subjects Protocol Application INSTITUTIONAL REVIEW BOARD FACE PAGE P.I. Name: Grant Award #: Protocol Title: Department: Phone #: Email: (If applicable) SECTION ONE: Expedited vs. Full Review Does your research involve any of the following: Does your research involve any of the following: (Check all items that apply.) YES NO Prisoners YES NO The use of deception (the research subjects are misled as to the nature of the research or their involvement in it. YES NO Gathering data that can be linked to (is identifiable with) specific research subjects. YES NO Audio or video taping of research subjects. YES NO Recruitment of HIV positive individuals. YES NO Interactions with research subjects under the age of 18 outside the normal educational setting OR beyond the observation of public behaviors. YES NO *The administration of non-standard, low-risk educational tests or survey measurements to individuals under the age of 18. (See NOTE below). YES NO The gathering of data relating to criminal behavior, drug use, sexual habits or attitudes, or any other behaviors or attitudes that, if tied to an individual research subject, could cause harm to the subject or their reputation. (Check all items that apply.) YES NO The collection or study of existing data, documents, records, or pathological or diagnostic specimens? YES NO The study, evaluation, or examination of existing public benefit or public service programs? YES NO Research conducted in established or commonly accepted educational settings involving standard educational practices such as research on the effectiveness of regular or special education instructional strategies, or a comparison among instructional techniques, curricula, or classroom management methods? YES NO *The use of standard, established, low risk educational tests, surveys, or interview procedures. (See NOTE below). YES NO Observed public behavior that does not involve your direct interaction with individuals under the age of 18 beyond the administration of surveys, tests, or interview procedures? If you answered “yes” to any of the above, your application will receive full IRB Review. If you checked “yes” to one or more of the questions above, your application may receive expedited review. *NOTE: If the test, survey, or interview procedure is developed as part of the research, or if the research is intended to validate the measure, the test, survey, or interview procedure is not considered “established” or “standard”. If the survey or interview questions relate to criminal behavior, drug use, sexual habits or attitudes, or any other behaviors or attitudes that, if tied to an individual research subject, could cause harm to the subject or their reputation, or if the questions asked may cause distress to the research subject, they are not considered “low risk.” SECTION TWO: Protocol Information TYPE OF APPLICATION Initial Annual Renewal Revision NOTE: It is your responsibility to notify the IRB of any proposed changes to an existing protocol. Any change to an existing protocol must be approved by the IRB prior to its implementation. Annual review of existing protocols is required. Complete documentation must be provided at the time of annual continuing review, protocol revision, or study termination. For Official Use Only Protocol #: Initial Protocol #: Exemption #: (If Application is a renewal or revision) (If approved by IRB Chair below.) Type of Review Recommended to IRB Chair Full IRB Review Expedited Review to determine Exemption Utilizing expedited review procedures, I have reviewed the Human Subjects Protocol Application attached to this face page and all appended documentation and have determined that this research protocol is exempt from full IRB Review. Signature:__________________________________________ Dr. Suzy Harney, IRB Chair Office of Sponsored Programs #2 John Brewer’s Bay, St Thomas, VI OO802 Tel: (340) 693-1176