University of Wisconsin – Stout
Protocol for Protection of Human Subjects in Research
Institutional Review Board (IRB) Application Form
Directions:
§ This form must be approved prior to any student, faculty, or staff conducting research. Data collection/analysis may not begin until there has been IRB determination of this project.
§ Handwritten forms will not be accepted. For your benefit, save your completed form in case it needs to be revised and resubmitted. (Please use the latest version of Microsoft Word to avoid compatibility issues. This form may not work on Mac computers)
§ This is a professional document; please check spelling, grammar, and punctuation.
§ Fill in the form and verify that you have included all necessary documents (consult the Checklist of Submission Documents on the final page of the form).
§ Submit the complete IRB Application Form, with required signatures and required materials, to . Electronic signatures are acceptable. Please copy all investigators and/or advisors on this email.
§ Alternatively, submit paper original documents, with required signatures and required materials attached, to the Research Services Office, 152 Vocational Rehabilitation Building.
§ Projects that are not completed within one year of the IRB approval date must be submitted again. Annual review and approval by the IRB is required. Projects that are determined to be exempt from IRB review hold exempt status for a period of 5 years, unless there are significant changes to the project.
NOTE: If your project does not involve human subject research (e.g. literature reviews) you are not required to submit an IRB application. Researchers may request that the IRB conduct the review to verify that no human subjects are involved.
THESIS REQUIREMENTS: Researchers who are preparing theses or similar projects may need to request review of projects that do not involve human subjects. If you would like confirmation and documentation from the IRB staff that your proposed activities do not involve human subjects research, please continue with this form.
The IRB examines the information provided in the application documents to determine whether exemption or 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 details. It is in the investigator’s interest to provide thorough information. Delays are most likely to occur if the investigator does not provide the information needed for the IRB to conduct its review. It may take up to ten (10) business days or more to review an application.
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University of Wisconsin – Stout
Protocol for Protection of Human Subjects in Research
Institutional Review Board (IRB) Application Form
Part 1: Cover Sheet
Project Title: Click here to enter text.
Investigator(s): (Use additional pages if necessary)
Name: Click here to enter text. ID: Click here to enter text. E-mail address: Click here to enter text.
Daytime Phone: Click here to enter text. Dept. /Program: Click here to enter text.
☐Undergraduate ☐Graduate Student ☐Faculty/Instructional Staff ☐Admin Staff ☐Other please list
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature:
Name: Click here to enter text. ID: Click here to enter text. E-mail address: Click here to enter text.
Daytime Phone: Click here to enter text. Dept. /Program: Click here to enter text.
☐Undergraduate ☐Graduate Student ☐Faculty/Instructional Staff ☐Admin Staff ☐Other please list
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature:
Name: Click here to enter text. ID: Click here to enter text. E-mail address: Click here to enter text.
Daytime Phone: Click here to enter text. Dept. /Program: Click here to enter text.
☐Undergraduate ☐Graduate Student ☐Faculty/Instructional Staff ☐Admin Staff ☐Other please list
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature:
Name: Click here to enter text. ID: Click here to enter text. E-mail address: Click here to enter text.
Daytime Phone: Click here to enter text. Dept. /Program: Click here to enter text.
☐Undergraduate ☐Graduate Student ☐Faculty/Instructional Staff ☐Admin Staff ☐Other please list
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature:
Name: Click here to enter text. ID: Click here to enter text. E-mail address: Click here to enter text.
Daytime Phone: Click here to enter text. Dept. /Program: Click here to enter text.
☐Undergraduate ☐Graduate Student ☐Faculty/Instructional Staff ☐Admin Staff ☐Other please list
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature:
By signing this form, each Investigator certifies that:
a) You have read and understand UW-Stout policies regarding the protection of human subjects in research;
b) You have not begun recruitment or testing of research participants and will not do so until formal notification of IRB determination of the proposed project has been received;
c) You will seek approval from the IRB prior to implementation of any changes in procedures or the consent process/forms for this project; and
d) You will immediately inform the IRB of any adverse events or other negative consequences incurred by participants in this research.
Required for students:
Research Advisor:
Name: Click here to enter text. Daytime Phone: Click here to enter text. Department/Program: Click here to enter text.
Have you completed UW-Stout’s Human Subjects Training? ☐ Yes ☐ No
Signature: Date of Approval: ______
By signing this form, the Research Advisor designated above certifies that:
a) You have provided appropriate training in the ethics of human research to the student signing above;
b) You have reviewed this protocol and take responsibility for the research design, and for the student investigator’s compliance with the requirements of the UW-Stout IRB; and
c) You will provide adequate supervision of the above student in the conduct of this research
Part 2: Project Description
2.1 Is this research?
Yes / Noa. Is this project being conducted solely to fulfill course requirements with no intention to share the results beyond the classroom in which it is assigned?
/ ☐ / ☐
b. Is this project a quality assurance activity or program improvement activity with no intention to share the results beyond the University community?
/ ☐ / ☐
c. Is this project a thesis or other research study for degree completion?
/ ☐ / ☐
d. Is this project a pilot study, or would you like to use this study to launch future investigations in which you would re-use the data?
/ ☐ / ☐
e. Would you like to consider using this study for publication or dissemination at a later date, including at research presentations on-or off-campus? / ☐ / ☐
If you answered “yes” to “a” OR “b” and:
· “No” to “c, “d,” AND “e,” then you are not conducting research under the federal definition. You may stop here and you do not need to complete the remainder of this form. Submit only this portion of the form to and you will receive a notification that your project is not defined as research under the federal definition.
· “Yes” to “c, “d,” OR “e,” then you are conducting a type of research. Please continue with this form.
2.2 Are Human Subjects involved? Does your research involve human subjects or official records about human subjects as defined above? ☐ Yes ☐ No
If you answered “no” to question 2.2,
complete the remainder of section 2 and submit the form.
2.3 What is the purpose of the research? (Approximately 250-500 words; descriptions are to be written in future tense.) What question(s) do you hope to answer? Summarize the proposed research/activity stating the objectives, significance, and detailed methodology. Briefly describe your data collection method (for example: observations, survey, experimental design, psychological tests, interviews, etc.) Copies of all data collection instruments must be attached to this application. Use lay language.
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2.4 When is the data collection for the research intended to begin and end? Click here to enter a date.
Please note that research cannot begin until this project has been approved by the IRB.
2.5 Sponsor (Funding agency, if applicable Click here to enter text. )
Is this project being supported by federal funding? ☐ Yes ☐ No
Is data sharing required? ☐ Yes ☐ No
Is this project being supported by the UW-Stout Research Grant funding? ☐ Yes ☐ No
2.6 Exemption
To qualify for an exemption your research must fall under one of the following six categories. If you have questions, more information about the exemption categories can be found at the Office of Human Research Protection website: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101
The following categories of research are exempt from this policy:
(1) Research conducted in an established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional
strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2/3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available OR if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The IRB will determine qualification for exemption based on information detailed in the remainder of this form.
Part 3: Participants
3.1 Special Populations
Special precautions must be included in your research procedures if any special populations or research areas are included.
Are any of the subjects:
Yes / No(a) minors under 18 years of age (consent require from parent and subject)? / ☐ / ☐
(b) legally incompetent? / ☐ / ☐
(c) prisoners? / ☐ / ☐
(d) pregnant women, if affected by the research? / ☐ / ☐
(e) institutionalized? / ☐ / ☐
(f) mentally incapacitated? / ☐ / ☐
Does the research deal with questions concerning:
Yes / No(a) sexual behaviors? / ☐ / ☐
(b) drug use? / ☐ / ☐
(c) illegal conduct? / ☐ / ☐
(d) use of alcohol? / ☐ / ☐
3.2 Participant Pool Expected number of participants or sample size: Click here to enter text.
3.3 Describe your intended participant pool in terms of:
a. Gender, race or ethnic group, age range, etc.:
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b. Affiliation of participants (e.g., institutions, hospitals, general public, students, etc.):
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c. Participants’ general state of mental health:
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d. Participants’ general state of physical health:
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3.4 Explain why you have chosen this particular group for study. If participants belong to one of the protected classes above, this justification is especially important. If participants are affiliated with a particular institution, please explain.
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3.5 Exclusions. If certain populations will be excluded from this study, please describe and justify the criteria for exclusion. Describe the method you will use to identify and exclude the individuals from the study. For example, if you are excluding pregnant women from a nutritional study due to health concerns for the fetus, describe that here.
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3.6 Participant Recruiting
a. Will participants be recruited? If not, please explain (recruitment may not be involved in some types of classroom research): ☐ Yes ☐ No
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b. Describe the method for recruiting participants. If recruitment will involve advertising, posters or scripts please provide copies):
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3.7 What is your relationship to the participants? (e.g., are you their classroom instructor, a nurse in a clinic whose participants are seeking medical care, etc.? If your only relationship is a researcher or student researcher, then there is likely no relationship).
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Part 4: Detailed Procedures
4.1 Procedures: Describe how participants will be involved in detail. 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? How long will it take?
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4.2 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 and what type of oversight, training, and instructions will they have in order to conduct this procedure.
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4.3 Will the participants experience any discomfort? If yes, please explain. ☐ Yes ☐ No
Discomfort may include physical or emotional discomfort.
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4.4 Will deception, false or misleading information be used in your procedures? ☐ Yes ☐ No
Will you withhold information such that the ability of the subject to understand the true nature of the study would be affected? Please explain why deception is necessary for this study and describe how you will debrief participants, and procedures you will follow if a participant decides to withdraw his/her consent.