1 STETSON UNIVERSITY IRBHP PROPOSAL FORM Instructions Please scroll through the entire form prior to reading these instructions. Doing so will make the instructions clearer. The different sections of the form are in Microsoft Word tables. Thus, as you type in information don’t be surprised if the row and table expand. (So, don’t be concerned if table rows break across pages.) Please complete only those sections that are useful in presenting your proposal and supporting information. For example, if there is only one Principle Investigator you only need to enter information for that person (and, thus, leave the second section blank). In some sections you will be asked to enter information into a text field. This kind of entry looks like this: . To enter information, simply place your cursor on the box and click. The box will change color when you do so. You then may start typing. You probably will need to submit supplemental materials such as a survey or a letter of permission/cooperation. You also have to submit an Informed Consent Form. Please copy and paste any of these materials into this file, if possible. IRBHP Proposal Form (Rev. 2/17/14) 2 STETSON UNIVERSITY IRBHP PROPOSAL FORM Project Title: Date (mm/dd/yy) Research is to begin: Date (mm/dd/yy) Research is to conclude (anticipated): Principal Investigator(s) Name (1): Dept.: Ext: Email: Name (2): Dept.: Ext: Email: Faculty Adviser (required for all student research) Advisor Name: Dept.: Ext: Email: Acknowledgement of Responsibilities As the typed signature below testifies, the principal investigator pledges to conform to the following: As one engaged in investigation utilizing human subjects, I acknowledge the rights and welfare of the participants involved. I acknowledge my responsibility to secure the informed consent of the participants by explaining the procedures and by describing the risks as weighed against the potential benefits of the investigation. I assure the IRBHP that all procedures performed under the project will be conducted in accordance with those Federal regulations and College policies that govern research involving human subjects. Any deviation from the project (e.g., change in principal investigator, research methodology, etc.) will be submitted to the IRBHP via email for its approval prior to implementation. I agree to report all adverse events IMMEDIATELY to the IRBHP. PRINCIPLE INVESTIGATOR: DATE: The Faculty Adviser's typed signature on the Research Proposal confirms that he or she supervised the composition of the proposal and approves of the research proposal as submitted. FACULTY ADVISOR: IRBHP Proposal Form (Rev. 2/17/14) DATE: 3 SUMMARY: Briefly summarize in one paragraph the purpose of the research and planned use of human participants in terms understandable to a layperson. IRBHP Proposal Form (Rev. 2/17/14) 4 LITERATURE REVIEW: Provide a brief 1-2 page review of the most current research that covers the background and rationale for your research. This review should convey the importance of the topic, summarize the current state of the literature, and indicate what topics warrant further study. Provide in-text citations (and full citations in the references section provided later in this form). Single space within paragraphs and double space between paragraphs. IRBHP Proposal Form (Rev. 2/17/14) 5 PURPOSE AND HYPOTHESES: State in one sentence the purpose of your research. State any hypothesis you will be testing in the null form. IRBHP Proposal Form (Rev. 2/17/14) 6 METHODOLOGY Participants: If you are only observing public behavior, skip to question d in this section. a) How many participants will be involved in the research? (Enter text here): b) List specific eligibility requirements for participants (or describe screening procedures), including those criteria that would exclude otherwise acceptable participants. For example, if your study uses only male or female participants, explain why. If using data from a secondary de-identified source only, skip to question e in this section. (Enter text here): c) How will participants be recruited? (In your Appendices, attach any flyers, letters, announcements, etc. that will be used to recruit participants.) Also, describe your sampling method (convenience, simple random, stratified random, etc.) (Enter text here): d) Is there any formal relationship between researcher and participant (e.g. teacher/student, principal/teacher, employer/employee, etc.) that might lead to the perception of coercion? If so, identify options to participation. (Enter text here): IRBHP Proposal Form (Rev. 2/17/14) 7 e) Does your study focus specifically on any of the following vulnerable participant populations? (If so, please type an “x” in the appropriate box(es)): minors (under age 18 – specify age range) prisoners pregnant women & fetuses persons with physical disabilities persons with mental disabilities economically or educationally disadvantaged other, please specify: If any of the above are to be participants in this research project, state the necessity for doing so. Please indicate the approximate age range of the minors to be involved. (Participants under age 18 require the participant’s assent and written consent from a parent or legal guardian.) (Enter text here): IRBHP Proposal Form (Rev. 2/17/14) 8 Research Methods Please indicate your research methods (please place an “x” in all that apply): Interview, Focus Group or Non-Anonymous Questionnaire Anonymous Questionnaire Observation of public behavior Experimental design (if stating causal hypotheses): (If you are using an experimental design, please describe the design you will be using. Consult the discussion here to help you appropriately describe your design.) Analysis of de-identified data collected elsewhere: Where did this data come from originally? Did this original research get IRB approval? Other (specify): Please describe the procedure to be followed in your research (e.g. what participants will do). Describe step-by-step the nature of the interaction between the researcher and the participants. Include, if appropriate, a description of the ways in which different subjects or groups of participants will receive different treatment. (Enter text here): IRBHP Proposal Form (Rev. 2/17/14) 9 How many times will you meet/interact with the participants? If you are only observing public behavior, skip to question d in this section. (Enter text here): a) How much total time will be required of each participant? (Enter text here): b) Where are the performance sites for this research (i.e., where it will it take place)? (Enter text here): c) If you are using surveys, attach a copy of the survey instrument to this proposal. If you are conducting individual interviews or focus groups, including ethnographies and oral histories, attach, or list here, a list of interview questions. If the interview format is not yet specified or you are conducting unstructured interviews, please attach, or list here, a list of specific topics to be discussed. (Enter text here): IRBHP Proposal Form (Rev. 2/17/14) 10 d) If you are using a copyrighted questionnaire, psychological test, or scale, please indicate how you obtained permission and attach in the appendices a copy of the permission. (Enter text here): IRBHP Proposal Form (Rev. 2/17/14) 11 Analysis a) Statistical Analysis: If you are using a form of parametric or nonparametric statistical analysis, please identify the name of the technique(s) (e.g., t-test, correlation, etc.) and the steps you will follow to conduct the analysis. Please indicate the technique and steps for each hypothesis you plan to test. (Enter text here): b) Qualitative Analysis: If you are using a form of qualitative analysis please indicate the type of analysis (e.g., grounded theory, ethnographic, etc.), your approach, and any coding procedures you plan to use. (Enter text here): REFERENCES Please include references cited in your review of the literature and any citations in your discussions. (Start references here) APPENDIX Please include in your appendix any of the following items (in the order listed here) that are part of your research: IRBHP Proposal Form (Rev. 2/17/14) 12 Copyrighted surveys, psychological tests, and scales. Written permission to use the copyrighted materials. Surveys, psychological tests and scales that are not copyrighted or that you have designed yourself. Any qualitative data collection instruments (e.g., structured interview questions). Letters of cooperation for any organizations (except Stetson) you are working with to collect your data (e.g., a school, a company, etc.). Letters should be signed by a person with authority to approve you data collection at the site and who will serve as a contact person. Any other documents that will help the Stetson University IRBHP determine the value of your research. Your INFORMED CONSENT FORM! Please remember to copy these materials within this document, if possible. IRBHP Proposal Form (Rev. 2/17/14)