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 statement if
applicable

Outlines for interviews

Survey instruments or any other data collection
systems/forms/questionnaires

Letter(s) of administrative approval/permission from an authorizing
official for any off-campus site(s) where data collection will occur

A minimum 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 Completion
Report 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):
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E-mail:
Field Study/Thesis/Dissertation
Class Project:
Other (please specify):
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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)
Please see the “IRB Review: Quick Guide” for guidance on determining whether IRB review is mandated for your
research
Signature:
Date:
CITI Certificate Reference #:
By signing this form, the Faculty Supervisor designated above certifies that:
a) s/he has thoroughly reviewed the application, has provided guidance to the student in research design, and is
providing signatory testimony that the application exhibits clarity and completeness;
b) 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;
c) s/he understands that the active protocol becomes the responsibility of the Faculty Supervisor if the student/PI
graduates, leaves campus or otherwise abdicates the role of study PI. The Faculty Supervisor, in these cases,
would be responsible for submitting continuing reviews, renewals, modifications, and study closures as requested
by the IRB
d) s/he has provided appropriate training in the ethics of human research to the student signing above;
e) 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
f) s/he will provide adequate supervision of the above student in the conduct of this research
Please see the “IRB Review: Quick Guide” for guidance on determining whether IRB review is mandated for your
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, observation chart,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. If a waiver is requested please provide an Information Sheet. See
IRB website for example documents.
Debriefing statement (required if deception is used)
Letters of administrative 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 Dempsey 214 on:
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Instructions for Collaborative Institutional Training Initiative (CITI) Training Course:
1. Prior to receiving IRB Approval, Principal Investigators and Faculty Supervisors must complete a web-based training
course sponsored by CITI (Collaborative Institutional Training Initiative. The training is valid for three (3) years. A
refresher training course will be required once the original training 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 must complete the Integrity Assurance and then you may
enter the training course. There will be short quizzes at the end of the modules that you will need to take to earn
credit for the course. The training consists of various modules and may take 2-4 hours to complete, so please
plan accordingly
3. At the completion of the training, a CITI Completion Report is issued verifying the curriculum completed. A hard copy
of the Training Completion Report must be attached to this IRB Application Form. Please direct training questions to
irb@uwosh.edu or contact Kelly Schill, the IRB Administrator, at (920) 424-3375.
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Part I: 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, HIPAA training must also be completed
and documented. Please indicate each person’s role in the project (for example: research design, recruitment, informed
consent, data collection, data analysis- include who will have 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?
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. 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?)
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b. If data collection will occur off campus, please attach a letter of administrative approval/permission
from an authorizing individual at the off-site location as an appendix.
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 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.
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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?
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
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.
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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?
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
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Consent must be obtained in a setting that minimizes the possibility of real or perceived coercion or undue influence.
a. In what setting?
b. Who will be present?
c. What information will be provided and by whom?
d. Will there be an opportunity for questions to be asked and answered?
2. Describe the precautions you have taken to ensure that consent is freely and voluntarily obtained.
3. Do you wish to request a:
waiver of documentation of informed consent
waiver or alteration of informed consent process
If Yes to waiver or alteration of informed consent process, provide justification as to how the research meets the
appropriate regulatory categories 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.
d. When appropriate, the subjects will be provided with additional pertinent information after participation.
If Yes to waiver of documentation of informed consent, provide justification as to how the research meets the
appropriate regulatory categories below:
a. The only record linking the participant and the research would be the consent document, and the
principal risk would be potential harm resulting from a breach of confidentiality;
b. The research presents no more than minimal risk to the participant and involves no procedures for which
written consent is normally required outside of the research context
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.
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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.
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, explain who will have access to the data and whether that access will be with or
without identifying information.
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
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]
*Please attach all appendices and submit as one single document to irb@uwosh.edu. Please submit (1) hard copy with
signature(s) to Grants and Faculty Development Office, Dempsey 214, Attn: IRB.
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