Submit Initial Research Proposal Application

Please do not complete this form until you are ready to complete the form in its entirety. It may be helpful to complete your answers in a separate document and then paste them into the form when you are ready to submit.

IMPORTANT: READ BEFORE COMPLETING APPLICATION*
Before completing the application make sure that your proposal project meets the federal definition of Human Subjects Research. See the FAQ in the website for more information. If you do not think that it meets the federal guidelines of human subjects research, you can contact the IRB with a summary and explanation and request a letter from the IRB stating that the project is NOT considered Human Subjects Research for your records. See the FAQ on the website. Contact the IRB if you have any questions. A confirmation of your submission will be sent to the email address you provide. Please check your spam folder if you do not receive it. UPDATE MARCH 16, 2020: PLEASE READ THE INFORMATION IN THE "ABOUT" SECTION REGARDING HOW COVID-19 IMPACTS WLU HUMAN SUBJECTS RESEARCH
- Yes I have read the above statement
Name of Principle Investigator (P.I)*
The PI is the primary individual responsible for the project (aka the researcher) and is the main WLU IRB contact regarding the submitted proposal.
First Last
Email*
Date of Submission
MM slash DD slash YYYY
Researcher Information
Type of Research (P.I.) Check all that apply
- Select All
- WLU Faculty
- WLU Undergraduate student (required to include faculty sponsor information)
- WLU graduate student (required to include faculty sponsor information)
- Other WLU (please describe below)
- Non-WLU (please describe below)
Faculty Research Sponsor
If you are a WLU student researcher, list the name, email and program/department of your WLU faculty research sponsor. This could be the instructor of the course &/or your academic advisor, or another faculty member. By including their information below, you attest that your faculty research sponsor has reviewed your submission materials BEFORE you submit them to the IRB.
Faculty Research Sponsor, Number
Enter the number of faculty research sponsors you will have here.
Please enter a number from 0 to 5.
Faculty Research Sponsor 1 - Contact Information
Faculty Research Sponsor 1, Name
First Last
Faculty Research Sponsor 1, Email
Faculty Research Sponsor 2 - Contact Information
Faculty Research Sponsor 2, Name
First Last
Faculty Research Sponsor 2, Email
Faculty Research Sponsor 3 - Contact Information
Faculty Research Sponsor 3, Name
First Last
Faculty Research Sponsor 3, Email
Faculty Research Sponsor 4 - Contact Information
Faculty Research Sponsor 4, Name
First Last
Faculty Research Sponsor 4, Email
Faculty Research Sponsor 5 - Contact Information
Faculty Research Sponsor 5, Name
First Last
Faculty Research Sponsor 5, Email
Other WLU or Non-WLU Affiliation
If NOT a WLU student or faculty member, explain WLU affiliation, or why submitting to WLU IRB as a non WLU researcher.
Co-Investigators / Co-Primary Investigators*
List any co-investigators / co-P.I.'s. Include email and researcher type (i.e. student, faculty). This should include anyone who will be directly working with participants or their data. {Consider discussing possible authorship & author order before submitting the application}
Number of Co-Investigators / Co-Primary Investigators
Please enter a number from 0 to 15.
Co-Investigator / Co-Primary Investigator 1 - Contact Information
Co-Investigator / Co-Primary Investigator 1 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 1 - Email
Co-Investigator / Co-Primary Investigator 2 - Contact Information
Co-Investigator / Co-Primary Investigator 2 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 2 - Email
Co-Investigator / Co-Primary Investigator 3 - Contact Information
Co-Investigator / Co-Primary Investigator 3 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 3 - Email
Co-Investigator / Co-Primary Investigator 4 - Contact Information
Co-Investigator / Co-Primary Investigator 4 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 4 - Email
Co-Investigator / Co-Primary Investigator 5 - Contact Information
Co-Investigator / Co-Primary Investigator 5 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 5 - Email
Co-Investigator / Co-Primary Investigator 6 - Contact Information
Co-Investigator / Co-Primary Investigator 6 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 6 - Email
Co-Investigator / Co-Primary Investigator 7 - Contact Information
Co-Investigator / Co-Primary Investigator 7 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 7 - Email
Co-Investigator / Co-Primary Investigator 8 - Contact Information
Co-Investigator / Co-Primary Investigator 8 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 8 - Email
Co-Investigator / Co-Primary Investigator 9 - Contact Information
Co-Investigator / Co-Primary Investigator 9 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 9 - Email
Co-Investigator / Co-Primary Investigator 10 - Contact Information
Co-Investigator / Co-Primary Investigator 10 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 10 - Email
Co-Investigator / Co-Primary Investigator 11 - Contact Information
Co-Investigator / Co-Primary Investigator 11 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 11 - Email
Co-Investigator / Co-Primary Investigator 12 - Contact Information
Co-Investigator / Co-Primary Investigator 12 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 12 - Email
Co-Investigator / Co-Primary Investigator 13 - Contact Information
Co-Investigator / Co-Primary Investigator 13 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 13 - Email
Co-Investigator / Co-Primary Investigator 14 - Contact Information
Co-Investigator / Co-Primary Investigator 14 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 14 - Email
Co-Investigator / Co-Primary Investigator 15 - Contact Information
Co-Investigator / Co-Primary Investigator 15 - Name
First Last Researcher Type
Co-Investigator / Co-Primary Investigator 15 - Email
Required Research Ethics and Compliance Training
All WLU affiliated researchers (including faculty research sponsors) conducting human research are required to complete CITI training as part of the IRB application. See WLU IRB website for additional information about training requirements. Most human subject research at WLU requires the "Social and Behavioral Research" CITI course completion, completed within the last three years. Contact the WLU IRB for details regarding other training (i.e. Biomedical research), or questions regarding certifications.
Upload the relevant CITI completion certificates (PDF form) for ALL investigators.
This should be the certificate (the one that looks like a diploma) NOT the completion report (the one that has the information about the quiz scores).
Drop files here or
Accepted file types: pdf, Max. file size: 250 MB, Max. files: 5.
Purpose of Project: HUMAN SUBJECTS RESEARCH
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subjects means a living individual about whom an investigator conducting research obtains information. Class research projects may, or may not, meet the requirements of being labeled as "human subject research". If there is the INTENT or possibility that a project will lead to a publication or presentation outside the scope of the course (i.e. conference presentation, pilot study, paper submission), then it is classified as research. Note that IRB approval for projects is NOT given retrospectively. See WLU IRB website for more information regarding what does and does not constitute human research, or contact the IRB if you have any questions.
Title of Project*
Type of Project*
Check all that apply. Class research projects may, or may not, meet the requirements of being labeled as "human subject research". Talk to your research sponsor/professor before submitting this form. If there is the INTENT or possibility that a project will lead to a publication or presentation outside the scope of the course (i.e. conference presentation, pilot study, paper submission), then it is classified as research. Note that IRB approval for projects is NOT given retrospectively.
- Graduate level thesis or capstone project
- Undergraduate capstone project with the intent to disseminate or use information beyond the context of the classroom (i.e. poster presentation at a conference)
- Honors project with the intent to disseminate or use information beyond the context of the course (i.e. honors research symposium)
- Undergraduate or Graduate class project with the intent to disseminate or use information beyond the context of the classroom (i.e. poster presentation at a conference)
- Undergraduate or Graduate independent study project with the intent to disseminate or use information beyond the context of the independent study
- Faculty research project associated with a specific course(s)
- Faculty research project NOT associated with a specific course
What funding is associated with the project? If other, be specific.*
- No funding
- WLU grant funding
- Federal funding
- Other
If funded, describe the nature of the funds (i.e. WLU Faculty research grant, NFS, NIMH).
Risk level to human subjects*
Minimal risk is: “The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
- Minimal risk to human subjects
- More than minimal risk to human subjects
- Unsure of risk to human subjects
Type of review requested*
(See WLU IRB website & CITI training for information on the different types of reviews). Note: WLU IRB may determine that the proposal requires a different type of review selected below based on information provided.
- Exempt
- Expedited
- Full review
- Unsure
Explanation of Type of Review Selection*
Briefly explain your type of review selection from above (why do you think the proposal qualifies for that type of review). See website for description of different categories. (i.e. explain which exempt category, or how falls under minimal risk for expedited?)
Project Description
Details about the proposal project. Keep in mind the IRB does not review the quality of the proposal - the IRB is concerned with the safety and well being of the human subjects. The IRB may request clarification or additional information after reviewing the submission. Please respond promptly to any emails from the IRB in order to complete the review process as quickly as possible.
Length of project.*
Include start and end dates. Some projects may require continuing review. Can be based on semesters (i.e. Fall 2018, or Fall 2018 - Spring 2019).
List the main research questions &/or hypothesis.*
Describe the type of study design (i.e. qualitative, quantitative, action research, case study, survey, observational). Include and describe the main variables of interest (i.e. predictor variables, outcome variables, dependent measures) .
Provide a brief overview of the project.*
Describe the objectives, methods, and procedures.The emphasis should be on the human participant involvement. What will the participants be asked to do and how will you interact with them? Discussion of the theoretical or statistical aspects of the project should be avoided. Keep in mind that the people reading the proposal may not be familiar with terminology and typical practices/procedures within your field of study. (How to think about this question: If you had 1 minute to explain your project to a 10 year old child, what would you tell them?)
If applicable, describe how this projects relates to previous submissions (i.e. uses same or similar procedure &/or materials as a previous approved study).
Does the project include any of the following?*
This questions is used to assist in the determination of the type of review needed. Projects can still be approved with any of these. Transparency and clarity for the potential participants is what is needed, and if not then an explanation and justification should be provided in the next question.
- Deception (purposefully lying or misleading participants regarding the true nature of the research)
- Topics of a sensitive nature (i.e. sexual preferences or history, drug use, racial issues, medical history,
- Manipulation of the persons attitudes, perceptions, or self-esteem
- Contrived (made up) social situations
- Psychotheraputic procedures or other psychological influences (i.e. meditation, mindfullness, CBT)
- Non-invasive health measurements (i.e. blood pressure, temperature)
- Biomedical samples (i.e. blood, urine)
- Other
- None of the above
Unless N/A, explain any checked boxes from above. Why is it being used? How is potential harm to participants minimized?
Participant Information
Details about the intended participants.
Describe the intended research population/characteristics.*
(i.e. adult college students, 4th graders, adults with dementia, women soccer players). Additional information may be required for protected populations.
Anticipated number of participants.*
Give a justification of your intended sample size. Include any a priori power analysis (if applicable).
Describe how and where potential participants will be recruited.*
(i.e. via email, flyers) and how they will be selected. Include any information given to people who are not selected or not eligible for participation. If you are recruiting your own students (i.e. faculty or education students), give a justification of why you are using your own students (opposed to a different group) and how any possible coercion will be mitigated.
Upload any recruitment materials.
(i.e. email template, flyer, newspaper ad).
Drop files here or
Accepted file types: jpg, pdf, png, doc, Max. file size: 250 MB.
Describe the requirements to participate.*
Include anything that would specifically exclude a person from participating. (For example a study that uses color identification would need to exclude people who are color blind. Or, if a survey was written in English only and for adults, those would be requirements to participate)
If participants are to be drawn from an institution or organization that has the responsibility for the participants (e.g. high school, hospital, social service agency, prison,etc.), then documentation of permission from that institution/organization must be provided. Upload relevant documents here.(See WLU website for examples, i.e. K-12 school research).
It is up to the P.I. to determine the required permissions from outside organizations regarding conducting their research.
Drop files here or
Accepted file types: jpg, pdf, png, Max. file size: 250 MB.
Informed Consent
Make sure to clearly state and include ** ALL ** of the required informed consent document (ICD) components. *** Lack of information or clarity in the ICD is the most common reason IRB proposal decisions are delayed. See the WLU IRB website for details and example consent forms.
Procedure for obtaining consent*
- Electronically (i.e. before the administration of an online survey)
- A printed copy that is signed by the participant (or legal guardian if applicable).
- Orally, no written signature. Explanation of why no signed informed consent is required on the next question.
- Other
Other
Description of Other for Obtaining Consent
Explanation of why no informed consent is required.
(if applicable). See WLU IRB website for examples of when written consent can be waived.
Informed Consent Document components*
Typically, the informed consent document (written or given orally) should contain the following components. Check all that apply to your proposal. The WLU IRB can waive or alter the informed consent under certain conditions (see WLU IRB website)
- A statement that they study involves research
- An explanation of the purpose(s) of the research
- The expected duration of the subject's participation
- A description of the procedures to be followed
- Identification of any procedures that are experimental
- A description of reasonably foreseeable risks or discomforts to the subject
- A description of any benefits or incentives (ie. money or extra credit)
- A disclosure of appropriate alternative procedures or course of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- (If applicable, typically on survey research) A statement that responses are confidential and no names (or other identifying information) will be used in the study
- For research involving more than minimal risk, an explanation as to whether any counseling or medical treatments are available and, if so, where further information may be obtained
- Information about whom to contact for answers to questions about the research, research subjects' rights, and whom to contact in the event of research-related injury or harm to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitles, and the subject may discontinut participation at any time without penalty or loss of benefits
- Written in plain language at a level appropriate to the subject population (generally at an 8th grade reading level)
Upload the Informed Consent Document (include an Assent document if applicable).*
It is suggested to use the WLU provided template - complete/fill in and delete information as needed. Any electronic consent must include the same components/information as a traditional paper consent form. If consent will be given orally or other attached document with explanation. Assent forms are typically used for minor aged participants (written or orally at a developmentally appropriate level).
Drop files here or
Accepted file types: jpg, pdf, png, doc, Max. file size: 250 MB.
Study Materials
Details about the study materials that the participants will be interacting with. Include references to study materials if applicable.
Briefly list and describe study materials (questionnaires, surveys, testing instruments, or interview protocols).*
Include how they will be administered to participants (orally, self completed online, self-completed in person). If not applicable, write n/a.
Upload any documents related to study materials (i.e. survey questions, testing instrument information)
Drop files here or
Accepted file types: jpg, pdf, png, xls, xlsx, doc, Max. file size: 250 MB.
Data Collection, Storage, Retention and Destruction
Details about data collection, data storage, and data destruction. For the IRB, the emphasis is on protecting the confidentiality of the human subjects and adhering to federal guidelines. Data information presented here is for IRB purposes only; it is up to the P.I. to follow any grant or program specific requirements that are above and beyond the information presented here. Check with your program / dept to see if they have a data retention protocol.
Describe how the data will be collected (i.e. in person, email, website, phone, medical charts, archives, or combination). If applicable, how will subject confidentiality be maintained?*
Where will the data be stored both during the study and after the study completion? If applicable, how will subject confidentiality be maintained?*
How long will the data be stored?*
Federal regulations require a minimum of three years AFTER completion of the study. This is for expedited and full review. Additional standards from your discipline, funding source, or other regulations (i.e. HIPAA) may be applicable.
What will happen to data after end of storage?*
Additional Information
Is there anything else not included in previous questions that you want the WLU IRB to know about this project?
Do you have any questions or comments for the WLU IRB? This could be related to your project or the submission process / form.
Thank You for Your Responses.
The WLU IRB will contact you for additional information if necessary regarding the project.See WLU IRB website for information on submission timeline.
Phone
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Submit Initial Research Proposal Application

Faculty Research Sponsor 1 - Contact Information

Faculty Research Sponsor 2 - Contact Information

Faculty Research Sponsor 3 - Contact Information

Faculty Research Sponsor 4 - Contact Information

Faculty Research Sponsor 5 - Contact Information

Co-Investigator / Co-Primary Investigator 1 - Contact Information

Co-Investigator / Co-Primary Investigator 2 - Contact Information

Co-Investigator / Co-Primary Investigator 3 - Contact Information

Co-Investigator / Co-Primary Investigator 4 - Contact Information

Co-Investigator / Co-Primary Investigator 5 - Contact Information

Co-Investigator / Co-Primary Investigator 6 - Contact Information

Co-Investigator / Co-Primary Investigator 7 - Contact Information

Co-Investigator / Co-Primary Investigator 8 - Contact Information

Co-Investigator / Co-Primary Investigator 9 - Contact Information

Co-Investigator / Co-Primary Investigator 10 - Contact Information

Co-Investigator / Co-Primary Investigator 11 - Contact Information

Co-Investigator / Co-Primary Investigator 12 - Contact Information

Co-Investigator / Co-Primary Investigator 13 - Contact Information

Co-Investigator / Co-Primary Investigator 14 - Contact Information

Co-Investigator / Co-Primary Investigator 15 - Contact Information

Required Research Ethics and Compliance Training

Purpose of Project: HUMAN SUBJECTS RESEARCH

Project Description

Participant Information

Informed Consent

Study Materials

Data Collection, Storage, Retention and Destruction

Additional Information

Thank You for Your Responses.

WLU IRB

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