Institutional Review Board (IRB) Application Form s1

University of Wisconsin Oshkosh

Office of Sponsored Programs and Faculty Development

Institutional Review Board (IRB) Application Form

Cover Sheet: Page 1 of 2

Title of Research Project:
Funding Source:
Is this a federally funded project? Yes* No *If yes, please list date of last FCOI Disclosure to office:
Principal Investigator Name:
Department(s): / State
E-mail: / Phone:
Principal Investigator (PI) Status: Select one of the following eligible categories below for PI status. For student projects, a faculty or staff mentor must be listed as PI. Student projects/ student name can be indicated under Project Type below. For further details, please see IRB SOP #6 for Principal Investigator Status Requirements.
Faculty or Instructional Academic Staff
Professional Academic Staff
Visiting Faculty/Scientist
Co-Principal Investigator(s) on Project? Yes No
Name(s) of Co-Principal Investigator(s):
Department(s):
E-mail: Phone:
Co-Principal Investigator Status: (check all that apply)
Faculty or Instructional Academic Staff
Professional Academic Staff
Visiting Faculty/Scientist
Post-Doctoral Student
University Staff
Other (explain):
Project Type:
Research
Student Research Project: Field Study Thesis Dissertation Honors McNair
Student Name:
Class Project*
Name of Class:
Name of Student(s): a class roster may be attached as an appendix:
Project Title:
Other** (please specify):
* Please contact the IRB if you are uncertain whether your class project requires IRB review. For further details, please see SOP #7 Student Research and Class Projects
**If your project is a collaborative effort with another institution, please contact the IRB for assistance early in the process to determine which IRB(s) will review.

Cover Sheet: Page 2 of 2

Individual Research Roles in Project:
Please include PI, Co-PI(s), and all research personnel who will work on the project. For status, please indicate if the individual is faculty, instructional or professional academic staff, undergraduate student, graduate student, doctoral student, or volunteer. Indicate each person’s role in the project using the following number *key: 1) research design, 2) recruitment, 3) informed consent, 4) data collection, 5) data analysis, 6) Other (indicate role). Please attach an appendix if additional room is needed.
Name / Institution/Affiliation / Status / Role in Project / Email
Principal Investigator Certification:
By signing this form, the Principal Investigator certifies that:
a)  the information provided in this application is correct
b)  s/he has read and understands UW Oshkosh policies regarding the protection of human participants in research;
c)  s/he has completed and submitted HIPAA training documentation if working with private health information (PHI) under a covered entity and has HIPAA authorization if applicable
d)  s/he will not begin research (including recruitment of research participants) until formal notification of IRB approval is received
e)  s/he takes responsibility for the research design, and will make best efforts to ensure all personnel engaged in the research are in compliance with the requirements of the UW Oshkosh IRB;
f)  for student projects, s/he has thoroughly reviewed the application, has provided training and guidance in research design, and is providing signatory testimony that the application exhibits clarity and completeness. Adequate supervision will be provided to students conducting research.
g)  s/he agrees to be available to answer questions from the IRB regarding the application and is willing to attend fully-convened meetings of the IRB to answer questions about the application, if requested to do so;
h)  s/he will report in writing any significant new findings which develop during the course of the study which may affect the risks and benefits to participation
i)  s/he will seek approval from the IRB in advance of implementation of any changes (Modification Request Form);
j)  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);
k)  s/he agrees to update the IRB on the status of the research at least annually for non-exempt projects as required by federal regulations (IRB Continuing Review Form)

Last updated: 03/23/2017

Page 1 of 11 Date of Last Update: 11/8/2010

University of Wisconsin Oshkosh

Office of Sponsored Programs and Faculty Development

PI Signature: / Date:
Co-PI Signature: / Date:
Student Project/ Student Signature: / Date:

Last updated: 03/23/2017

Page 1 of 11 Date of Last Update: 11/8/2010

University of Wisconsin Oshkosh

Office of Sponsored Programs and Faculty Development

Instructions for completing this application

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 . You must also submit one (1) hard copy of the entire completed IRB Application Form with signed Cover Sheet and CITI Completion Report to the Office of Sponsored Programs and Faculty Development, Dempsey Hall 214. Please note that 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. Principal Investigators and all research personnel on the protocol are required to participate in training from CITI Program on human subjects’ protections. To register and complete the training, see instructions below.

The IRB will examine 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 PI’s timely interest to provide thorough information. Delays are most likely if the PI 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.

Note: If you are working with an existing dataset that contains identifiable or private information please complete the IRB Existing Human Subjects Data Application. If you will be conducting a human subject research project for a course that will involve individual student projects, please complete the IRB Course Umbrella Protocol Application. If you will be conducting a project and would like a determination on whether IRB review and oversight will be required, please complete the IRB Determination of Human Subjects Form. Please direct questions to .

Last updated: 03/23/17

Page 3 of 11 Date of Last Update: 11/8/2010

University of Wisconsin Oshkosh

Office of Sponsored Programs and Faculty Development

Instructions for Collaborative Institutional Training Initiative (CITI) Training Course:

Principal Investigators and all research personnel must complete a web-based training course in Human Subjects Research sponsored by CITI (Collaborative Institutional Training Initiative). This training is federally mandated.The training is valid for three (3) years. A refresher training course will be required once the original certificate expires for continuing IRB projects. Enter the CITI training website

1.  Select: New Users Register Here. You will need to create your profile and affiliate with the University of Wisconsin Oshkosh. You will be prompted by questions that determine what human subjects course and modules you will be required to complete. Faculty and staff are required to complete the Social and Behavioral Science Module or Biomedical Research Module as applicable. Students are required to complete the Students Conducting Human Subjects Research Module. If you will be working with a colleague from another Institution, please contact the IRB office regarding training requirements.

2.  If you will be working with private health information under a covered entity, the CITI HIPAA course is required in addition to the human subjects training. Documentation of alternate HIPAA training completed within the last 12 months (i.e. through employer) may be substituted for the CITI course.

3.  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.

4.  The training consists of various modules and may take 2-4 hours to complete, so please plan accordingly. If you wish to break up the training into shorter sessions, you are free to exit the training at the end of any module (after taking the quiz) and your completed training will be saved.

5.  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 the IRB Application Form.

6.  For questions about the CITI Program, please contact IRB Administration at or contact the office at (920) 424-3215.

Part I: Training in Human Subjects Research

Include PI, Co-PI(s), and any research personnel. All individuals listed on protocol must complete CITI Training in Human Subjects. If the research involves collection of Private Health Information (PHI) from a HIPAA covered entity, HIPAA training must also be completed and documented. Please attach appendix if additional space is needed.

Name / Training / CITI Training Completion Date / CITI Completion Report ID

Part II: Project Description

1.  What is the purpose of the research?
a.  What question(s) do you hope to answer?
b.  How will the results of the study be disseminated?
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.
a.  How will your study contribute to the knowledge of this topic?
b. 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 only, please complete an IRB Existing Human Subjects Data Application Form.
4.  Explain why you have selected this particular data collection method.
5.  Will the research be conducted at a location/site other than UW Oshkosh? Yes No
If yes, please attach a signed letter of administrative approval/permission from an authorizing individual at the off-site location as an appendix.
6.  Describe the location in which the research will be conducted.

a.  What is your relationship to that site? (For example, is it your place of employment? A campus/ class where you are a student or instructor?)

Part III: Participants

1.  Do participants belong to a vulnerable population for which special protections may be required? Check all that apply:
No/Not Applicable
Minors
Pregnant Women
Human Fetuses/Neonates
Prisoners
Non-English Speaking (Please submit IRB Supplement Form:“Non-English Speaking Participants Form” found on IRB website as an appendix)
Other (Ex: Cognitively Impaired, Diminished Consent Capacity, Institutionalized, Economically/Educationally Disadvantaged): Explain:
Human Fetuses/Neonates
Prisoners
Other (Ex: Cognitively Impaired, Diminished Consent Capacity, Institutionalized, Non-English Speaking, Economically/Educationally Disadvantaged)
None of the Above
2.  In one to two sentences, describe your participant pool in terms of
a.  Sex, race or ethnic group, age range, etc:
b.  Affiliation of participants (e.g., institutions, hospitals, general public, etc.):
c.  Participants’ general state of health (mental):
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.
a. Where will they be?
b. Will they be alone or in a group?
c. 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?

a. How many times will the procedure be done and over what time span?

6. Will participants experience any discomfort? Yes No

If yes, please explain:

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 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