Institutional Review Board (IRB) Application Form Complete this form then attach copies of any of the following to your application, as appendices if applicable. Demographic forms Informed Consent document Debriefing statements Outlines for interviews Survey instruments or any other data collection systems/forms/questionnaires Letter(s) of approval/permission from an authorizing official of any offcampus site(s) where data collection will occur A one-half page abstract of the proposed project Submit one (1) IRB Application Package including this IRB Application Form, CITI Program Training Completion Report, and any applicable Appendices as a single pdf or word document electronically to irb@uwosh.edu. (Note: Students must cc: their Supervising Faculty at time of submission and all correspondence with the IRB.) You must also submit one (1) hard copy of the entire completed IRB Application Form with signed Cover Sheet and Training Certificate to the Office of Grants and Faculty Development, Dempsey 214. Your application will not be processed until we receive the signed hard copy of your application. Application deadlines for Full Board Review can be located on the Grants/IRB website. To conduct research involving human subjects, you are required to participate in training from CITI Program on human subjects’ protections in order to be in compliance with UW Oshkosh’s Federal Wide Assurance agreement. To register and complete the training, visit www.citiprogram.org. The CITI Program training certificate is valid for three (3) years. A refresher course will be required at the time of expiration for continuing projects. The IRB examines the information provided in the application documents to determine whether approval can be granted, and under what conditions. If the IRB cannot determine the status based on the information provided, the application will be returned to the investigator with a request for additional information. Hence, it is in the investigator’s timely interest to provide thorough information. Delays are most likely if the investigator does not provide the information needed for the IRB to conduct its review. It may take 2-4 weeks or more to review your application, so please plan accordingly. INCOMPLETE APPLICATIONS WILL BE RETURNED WITHOUT REVIEW. Cover Sheet Title of Research Project: Funding Source: Is this a course or class project? Yes No Is the project a Master’s Thesis or Field Study for degree completion? Yes No Principal Investigator Name: Department/Major: Mailing Address: Phone: Principal Investigator Status (check one): City State ZIP E-mail: Faculty or Instructional Staff Administrative Staff Doctoral Student* Graduate Student* Undergraduate Student* (*Students must complete the Faculty Supervisor section below and obtain your Faculty Supervisor’s Signature.) Non-UW Oshkosh (please specify): For Student Projects Only (required when the principal investigator is a student): Name of Supervising Faculty: Department: Phone: Type of Project (check all that apply): Last updated: 07/15/15 E-mail: Field Study/Thesis/Dissertation Class Project: Other (please specify): Page 1 of 7 By signing this form, the Principal Investigator certifies that: a) s/he has read and understands UW Oshkosh policies regarding the protection of human participants in research; b) s/he has not begun recruitment or testing of research participants and will not do so until formal notification of IRB approval of the proposed project has been received; c) s/he will seek approval from the IRB in advance of implementation of any changes in procedures or the consent process/forms for this project have been approved (Modification Request Form); d) s/he will immediately inform the IRB of any adverse events, unanticipated problems or other negative consequences incurred by participants in this research (Adverse Event Form or Unanticipated Problem Form); e) s/he agrees to update the IRB on the status of the research at least annually as required by federal regulations (IRB Continuing Review Form) Signature: Date: CITI Certificate Reference #: By signing this form, the Faculty Supervisor designated above certifies that: a) s/he has provided appropriate training in the ethics of human research to the student signing above; b) s/he takes responsibility for the research design, and will make best efforts to ensure the student investigator’s compliance with the requirements of the UW Oshkosh IRB; and c) s/he will provide adequate supervision of the above student in the conduct of this research. Signature: Date: CITI Certificate Reference #: Principal Investigator Checklist: 1. One (1) electronic copy of the protocol, CITI training, and all appendices as one pdf or word document submitted to irb@uwosh.edu on (date). Appendices Checklist: Check all that pertain to your project and attach as part of your application. Appendices that do not pertain to your project may be omitted when submitting your application. CITI Training Certificate (Required) Abstract of the proposed project (1/2 page Required) Demographic Forms if demographic information will be collected Survey Instruments or other data collection systems (forms, tools, questionnaires, etc) Outlines for Interviews Informed Consent Document (unless waiver is requested). Note: If participants are minors, an Assent Document is required in addition to parental consent. See IRB website for example documents. Debriefing statement (required if deception is used) Letters of approval/permission from an authorizing official is required for any off-campus site(s) where data collection will occur 2. One (1) hard copy of the complete protocol application packet to the Office of Grants and Faculty Development, Dempsey 214 on Instructions for Collaborative Institutional Training Initiative (CITI) Training Course: 1. Prior to receiving IRB Approval, Principal Investigators must complete a web-based training course sponsored by CITI (Collaborative Institutional Training Initiative). This training is federally mandated as part of our University’s compliance with our Federal Wide Assurance. The training is valid for three (3) years. A refresher training course will be required once the original certificate expires for continuing IRB projects. 2. The training is found at www.citiprogram.org a. Select: New Users Register Here. You will need to create your profile and affiliate with University of Wisconsin Oshkosh. You will be prompted by questions that determine what course and modules you will be required to complete. b. Once your Courses appear on your training page, you may enter the training. There will be short quizzes at the end of the modules that you will need to take to earn credit for the course. 3. The training consists of various modules and may take 3-6 hours to complete, so please plan accordingly. 4. At the completion of the training, a certificate is issued verifying the curriculum completed. A hard copy of the Training Certificate must be attached to this IRB Application Form. 5. For more information or questions about the CITI training requirement, please contact the IRB Coordinator, Kelly Schill at (920) 424-3375 or irb@uwosh.edu. Last updated: 07/15/15 Page 2 of 7 Part 1: Research Personnel (Include PI, Co-PI(s) or Faculty Supervisor if applicable, and any research assistants. All research personnel must complete CITI Training in Human Subjects. If the research involves Private Health Information, HIPPA training must also be completed and documented. Please indicate each person’s role in the project (for example: recruitment, consent, data collection, data analysis, access to identifiable information) on the chart below. Name Qualifications/Training Institution/Affiliation Role in Project CITI Training Completion Date CITI Completion Report ID Part II: Project Description 1. What is the purpose of the research? What question(s) do you hope to answer? Note: Projects lacking a valid research question and a method likely to produce meaningful results are not approvable. Ethical and regulatory standards do not permit investigators to expose participants to research risks when the work lacks scientific merit. 2. Briefly describe research that has already been done in this area. How will your study contribute to the knowledge of this topic? Please cite one or two scholarly references where appropriate. 3. Describe your data collection method. (For example: observations, survey, experimental manipulation, psychological test, interview, etc.) If you are using published surveys or instruments, name them. Copies of all instruments must be attached as an appendix to this application. If you are requesting to analyze existing human subjects data, please complete an IRB Existing Human Subjects Data Application Form. 4. Explain why you have selected this particular data collection method. 5. Describe the location in which the research will be conducted. What is your relationship to that site? (For example, is it your place of employment? A campus or class where you are a student or instructor?) If data collection will occur off campus, please attach a letter of approval/permission from an authorizing individual at the off site location. Part III: Participants 1. Do participants belong to a group for which special protections are required? Check all that apply: Minors Human Fetuses/Neonates Other (Ex: Mentally Disabled/Handicapped, Diminished Capacity, Institutionalized, Non-English Speaking) Pregnant Women Prisoners None of the Above 2. In one to two sentences, describe your participant pool in terms of a. Sex, race or ethic group, age range, etc: b. Affiliation of participants (e.g., institutions, hospitals, general public, etc.): c. Participants’ general state of health (mental): Last updated: 07/15/15 Page 3 of 7 d. Participants’ general state of health (physical): e. Number of participants or sample size: 3. Explain why you have chosen this particular group to study: (Justification is especially important for special protection groups) 4. What is your relationship to the participants? (e.g., are you their classroom instructor, a nurse in a clinic where participants are seeking medical care, etc.) 5. If there is an authority relationship between you and the participants, describe the measures you will take to ensure that participation is voluntary. Part IV: Participant Recruitment 1. Will participants be recruited? Yes No If not, please explain. (Recruitment may not be involved in some types of record review and/or some types of classroom research.) 2. Identify the people who will approach potential participants. If these people have a dual or authority relationship with potential participants, please describe. (e.g., caregiver, teacher, employer, service provider, etc.) 3. Describe the process that will be used to approach participants. If the approach will be verbal, provide a script; if by advertisement, letter, poster, or email please provide a copy as an appendix. 4. If you will exclude certain classes of individuals from your recruitment, describe and justify the criteria for exclusion. Describe the method you will use to identify and exclude those individuals from the study. Part V: Procedures 1. Describe the setting in which the participants’ involvement will take place. Where will they be? Will they be alone or in a group? Will there be any specific conditions such as darkness, specific background noises or music? 2. Describe the instructions that will be given to participants about the procedures. (Please reserve discussion of consent information for the section on consent below.) 3. What will they do/or what will be done to them? 4. Will you be the one administering the procedure, or will someone else do it for you? If someone else, describe how they will be involved. 5. How long will the procedure take? How many times will the procedure be done and over what time span? 6. Will participants experience any discomfort? If yes, please explain. Yes No Part VI: Deception NOTE: Deception is defined as the deliberate attempt to fabricate and/or manipulate in any way, factual and/or emotional information. The use of deception is common in studies that evaluate fundamental aspects of human behavior. Because Last updated: 07/15/15 Page 4 of 7 the use of deception in experimental procedures requires a modification of the required informed consent, the use of such procedures triggers the requirement for Full Board IRB review. Student researchers are discouraged from employing deception in their experimental procedures except with specific training in those techniques under close faculty supervision. 1. Will deception be used in your experimental procedures? Yes No If no, skip this section and proceed to Part VII. If you answered yes to this question, you must answer the following questions and attach a copy of the study Debriefing Form as an appendix. a. Explain why deception is necessary for the conduct of this study. b. Describe how you will debrief participants, and procedures you will follow if a participant decides to withdraw his/her consent. Part VII: Risk/Benefit Analysis NOTE: Research that lacks benefit is not approvable. Ethical and regulatory standards require that the benefits of research outweigh the risks, which is impossible if there are no benefits. All researchers are expected to carefully consider the benefits and risks to participants in designing their study. Participants should be asked to assume no more risk than what is absolutely necessary to accomplish the research objective. For projects in which risks exceed the regulatory definition of minimal risk, researchers are expected to take all possible measure to minimize risks and/or minimize the consequences of such risks. 1. Will the participants benefit from being a part of your study? If yes, explain. 2. What are the benefits to knowledge or to society at large that will accrue as a result of this research? 3. Are there other benefits? Describe. 4. Will you offer incentives, reimbursement of costs, or other compensation to participants? Yes No If yes, answer the following: a. What will you offer as incentive, reimbursement or compensation? b. What conditions must a participant meet to receive these benefits? c. Justify this benefit as necessary to the research, adequate to meet your research purposes, and explain why it will not contribute to perceived or actual coercion of participants. Risks most commonly encountered in research may be physical, social, psychological, legal, or risks to employment or economic well-being. All risks must be fully disclosed to participants, even if they are no greater than minimal risks. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 5. Describe all risks, perceived and actual, that participants might encounter during this study. (NOTE: a response of “not applicable” is unacceptable for this answer.) 6. Do you believe those risks to be no greater than minimal? If so, explain why you believe that to be the case? 7. If risks are greater than minimal, describe the following: a. What have you done to minimize risks to the extent possible without compromising your research objectives? Last updated: 07/15/15 Page 5 of 7 b. What protections have you put in place to minimize the consequences of risks if they should become realized? c. What procedures have you established for reporting adverse events should they occur? d. Explain why these risks are essential to the conduct of your study. Part VIII: Consent Legally effective, voluntary, and prospectively obtained informed consent is required from all research participants or their legal representative. Consent to participate in research is a process. The informed consent process involves three key feature: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. The circumstances under which consent is sought must allow the prospective participant or their representative (in the case of minors or others legally incapacitated) sufficient opportunity to consider whether or not to participate, including an opportunity to seek explanations and have questions answered. A signature on a consent form does not necessarily mean that full consent has been obtained. A signed consent form constitutes documentation of consent, not consent per se. In some circumstances, the IRB may waive or modify the requirement for documentation of informed consent. (The requirement for informed consent may be modified, but is very rarely waived.) 1. Describe how you will obtain informed consent from your participants: In what setting? Who will be present? What information will be provided? By Whom? Will there be an opportunity for questions to be asked and answered? Consent must be obtained in a setting that minimizes the possibility of real or perceived coercion or undue influence. 2. Describe the precautions you have taken to ensure that consent is freely and voluntarily obtained. 3. If you wish to request a waiver of documentation of informed consent, explain how your research plan meets each of the criteria below: a. The research involves no more than minimal risk to the subjects; b. The waiver will not adversely affect the rights and welfare of the subjects; c. The research could not practicably be carried out without the waiver. 4. Attach the consent form that you will use to document the informed consent for each of your participants as an appendix. For participants less than 18 years old, please attach parental consent form and assent form for minors. Examples can be found on the IRB website. 5. Attach a copy of the debriefing script or information that you will provide to participants for their reference as an appendix. Examples can be found on the IRB website. Informed consent must not include any exculpatory language by which the participant or their representative is made to waive, or appear to waive, any of the subject’s legal rights. Informed consent must also not release, or appear to release, the investigator, the sponsor, the institution, or its agents from liability for negligence. The IRB will review your consent scripts, documents, and procedures to ensure that this is the case. NOTE: Projects employing deception (and therefore requiring approval or a modified consent process) must address the specific requirements outlined in Part VI above. Part IX: Confidentiality/Anonymity In much social/behavioral research, the primary risk to participants is breach of confidentiality. Risks to reputation, financial well-being, or social standing can be minimized with appropriate protections for privacy and confidentiality of data. Last updated: 07/15/15 Page 6 of 7 When possible, complete anonymity (participants identity is unknown to researcher and the researcher does not have any codes to the data that could potentially re-identify participants) is the most desirable protection against such risks. Preserving anonymity may be used as a justification for requesting a waiver of documented consent for minimal risk research. When anonymity is not possible, data shall be kept confidential (researcher may know the identity of the participants OR data contains identifiable private information), and the researcher is responsible for safeguarding the identities, responses, and other private information of all research participants. For example, to protect confidentiality, codes may be assigned to participants and the researcher keeps the codes and the master list and/or signed consent forms separate from the data and results, and all results are shared in aggregate or group form. The safeguards for protection of confidentiality should be disclosed in the informed consent process, as they may impact a prospective participant’s willingness to engage in the research. 1. If the data collected in your research will be anonymous (identity of participants is unknown to researcher during all phases of the research), explain the procedures you will use to create and preserve anonymity. 2. If the data will not be anonymous, explain the procedures you will employ to protect the confidentiality of your data. a. During the data collection process, b. While results are being analyzed, c. In publication or other reporting of results, and d. In storage after research is complete and results are reported. 3. At each phase of the project listed above in question 2 (data collection, analysis of data, publication/reporting of results, and storage after research is complete), please explain who will have access to the data and will that access be with or without identifying information? 4. Where will raw data, transcripts, consent forms, and other materials that may contain identifiers be stored upon completion of the project? (Note: all materials must be retained and available for inspection by the faculty advisor [if student research], the IRB, and/or an IRB audit for a minimum of seven years following completion and closure of the research project. Note: The research project must maintain IRB approval status during data analysis if data has identifiers.) [END] Last updated: 07/15/15 Page 7 of 7