Unified IRB Application & Study Lifecycle Form

Approval from the IRB is required before your study may begin.

Section 1: Responsible Persons, Primary Contact, and Affiliations

This section identifies who the IRB should contact and who is responsible for the study.
Primary Contact Person Primary Contact Person First Last
This is the individual the IRB will contact regarding questions, determinations, and approval notifications.
For student‑led research, this is typically the student coordinating the project.
Primary Contact Person's Email
Role of Primary Contact
Is this a student‑led research project?

Is this a student‑led research project? YES NO
Principal Investigator (PI) Principal Investigator (PI) First Last
The Principal Investigator (PI) is the individual with overall responsibility for the design, conduct, and compliance of the research study.
For undergraduate student research, the faculty advisor must be listed as the Principal Investigator.
Principle Investigators Email
Student Level
Does this project involve more than one student investigator?

Does this project involve more than one student investigator? YES NO
Student Investigator Student Investigator First Last
Student Investigators (Group)

List the names of all student researchers involved in this study.
Faculty Advisor/Supervisor (Required for Undergraduate Research) Faculty Advisor/Supervisor (Required for Undergraduate Research) First Last
Undergraduate student research requires a faculty advisor who provides oversight and serves as the Principal Investigator.
Section 2: External Investigators
Does this study involve investigators from another institution or organization?

Does this study involve investigators from another institution or organization? YES NO
External Investigator(s) and Institutional/Organizational Affiliation(s)
Section 3: Additional Study Personnel (Key Personnel)
Are there any additional individuals (e.g., research assistants, staff, or volunteers) who will interact with participants or have access to identifiable data for this study?

Are there any additional individuals (e.g., research assistants, staff, or volunteers) who will interact with participants or have access to identifiable data for this study? YES NO
Additional Study Personnel and Role Descriptions
Section 4: Training Confirmation
Human Subjects Research Training

Human Subjects Research Training I confirm that all investigators and student investigators listed above have completed required human subjects research training (e.g., CITI).
Section 5: Study Overview/Abstract
Project Classification

Project Classification Human Subject Research Quality Improvement (QI) Program Evaluation Educational Assessment Other (Please describe)

Select the category that best describes the primary intent of this project. This selection will guide IRB review requirements.
Project Title
Purpose/Abstract:

Provide a brief abstract describing the study. This should include the problem under investigation, relevant background or context (not a full literature review), and the overall purpose of the research. This section should provide context for the study and should not simply restate the research question.
Research Question(s) or Project Aim/Objectives
Is this project part of a thesis, dissertation, honors project, or course requirement?

Is this project part of a thesis, dissertation, honors project, or course requirement? YES NO
If yes, specify the program, course, or academic requirement
Primary Project Type
Is the intent of this project to contribute to generalizable knowledge (e.g., publication or presentation)?

Is the intent of this project to contribute to generalizable knowledge (e.g., publication or presentation)? YES NO
Justification for Quality Improvement / Non‑Research Determination *

Explain why this project is considered Quality Improvement, Program Evaluation, or another non‑research activity rather than human subjects research. Include how existing knowledge is being applied, the local scope of the project, and why the activity is not intended to contribute to generalizable knowledge.
Section 6: Departmental Approval
Does this project require Department Chair approval?

Does this project require Department Chair approval? YES NO
Department Chair Name Department Chair Name First Last
Department Chair Email
Department Chair Approval Attestation

Department Chair Approval Attestation I confirm that the Department Chair is aware of this project and has approved it to proceed to IRB review.
Facility / Administrative Approval Attestation

Facility / Administrative Approval Attestation I attest that I have obtained all required facility‑level and/or administrative approvals (e.g., Department Chair, site administrator, CNO, or other appropriate authority) to conduct this Quality Improvement project and that documentation of such approval is available upon request.

The IRB does not collect or verify external facility approvals for Quality Improvement projects. By selecting this box, the investigator assumes responsibility for compliance with all applicable institutional and site requirements.
Approving Facility or Administrative Authority

List the department, facility, or administrative role that granted approval (e.g., Nursing Administration, Department Chair, Clinical Site).
Section 7: Study Procedures & Participants
Describe the research procedures in detail

Describe exactly what participants will be asked to do, in what order, and how data will be collected.
Where will interaction with participants take place?

Include the name of the institution or site and a brief description of the setting. Physical address is not required.
What populations will be included in the research?

What populations will be included in the research? Children(under 18) College Students Cognitively Impaired Elderly(over 65) Pregnant Individuals Employees Prisoners, parolees, incarcerated subjects Economically/Educationally Disadvantaged General Adult Population OTHER
If OTHER, decribe the population
HIPAA / Protected Health Information
Will this project involve access to identifiable Protected Health Information (PHI) as defined under HIPAA?

HIPAA / Protected Health Information Will this project involve access to identifiable Protected Health Information (PHI) as defined under HIPAA? YES NO UNSURE
HIPAA Notice + Acknowledgment

HIPAA Notice + Acknowledgment I acknowledge that Waynesburg University does not authorize access to Protected Health Information (PHI). If this project involves access to identifiable PHI, I understand that authorization must be obtained directly from the covered entity (e.g., hospital, clinic, or healthcare system) and that the University’s HIPAA/PHI Access Form—which identifies authorized study personnel and the specific PHI elements to be accessed—must be completed prior to accessing PHI, even if the project is determined to be Quality Improvement, program evaluation, or not human subjects research.
Estimated total number of participants
Inclusion criteria

Describe who can participate in the study.
Please list the characteristics participants must have to be eligible. Criteria should be directly related to the purpose of the study, not convenience.
Exclusion criteria:
If there are no specific exclusion criteria, you may state:“None.”

Exclusion criteria describe who cannot participate in the study, even if they meet the inclusion criteria.
List any characteristics or conditions that would make participation inappropriate, unsafe, or methodologically problematic.
What is the maximum number of participants present at one time?

This question asks for the largest number of participants who will be involved in the research at the same time during any study activity.
This is not the total number of participants enrolled in the study over time.
Please consider:

Whether participants are involved individually or in groups
The largest session, class, focus group, or observation period

If participation occurs one‑on‑one or individually (e.g., interviews or online surveys), enter 1.
Recruitment methods

Describe how participants will be identified and recruited (e.g., email, flyer, classroom announcement, referral).
Does any investigator or study personnel have supervisory, evaluative, or authority responsibilities over potential participants?

Does any investigator or study personnel have supervisory, evaluative, or authority responsibilities over potential participants? YES NO
If yes, describe how coercion or undue influence will be minimized
Section 8: Consent and Assent
How will informed consent be obtained?

How will informed consent be obtained? Written consent Verbal consent Online/electronic consent Requesting waiver or alteration of consent Not applicable — this project consists of quality improvement or program evaluation activities using existing data or operational feedback only
Explanation for No Consent or Consent Waiver

For Quality Improvement or Program Evaluation projects, explain why informed consent is not required (e.g., use of de‑identified data, standard operational processes, anonymous staff feedback).
Who will obtain informed consent?
(List roles or titles. Do not list names unless necessary.)
Will assent be obtained from participants unable to consent for themselves?

Will assent be obtained from participants unable to consent for themselves? Yes No Not Applicable

Participants who may require assent include:
- Children and minors (under age 18)
- Individuals with cognitive impairments
- Individuals with developmental disabilities
- Individuals with conditions that limit decision making capacity
If requesting a waiver or alteration of consent or assent, provide justification
Section 9: Risks, Benefits, and Confidentiality
Potential risks or discomforts
Risk minimization strategies
Potential benefits
Confidentiality protections
Section 10: Study Materials
Will advertisements, surveys, questionnaires, or instruments be used?

Will advertisements, surveys, questionnaires, or instruments be used? Yes No
Upload all applicable materials
Section 11: Funding and Compensation
Does this study have any source of funding?

Does this study have any source of funding? Yes No

Many student and faculty studies are unfunded. Select “No” if this study has no financial support.
Source of Funding
Will participants receive compensation or incentives?

Will participants receive compensation or incentives? Yes No
Describe compensation or incentives
Are there costs to participate?

Are there costs to participate? Yes No
Describe participant costs
Section 12: Review, Timeline & Certification
Does the investigator believe this study qualifies for expedited review?

Does the investigator believe this study qualifies for expedited review? Yes No
Projected study start date Projected study start date / MM / DD YYYY
Projected study end date Projected study end date / MM / DD YYYY
Principal Investigator's Signature
My signature below indicates: 1) that I am submitting this protocol as the principal investigator and 2) that I have read the Waynesburg University IRB policy and have had the opportunity to have any questions answered.

Draw or Type

I understand this is a legal representation of my signature. Clear

Full Name

I understand this is a legal representation of my signature.
Study Update

Use this section when your approved study is complete, expired, or requires an update.

Adverse Event Reporting: If an adverse event or unanticipated problem occurs during an approved study, investigators must promptly complete the Adverse Event Report Form. Do not wait until an amendment, extension, or study closure is submitted.
Current Study Status

Current Study Status Study is complete — request closure Study has expired or will expire — request extension Study will end early — request early termination Study requires amendment/modification Not applicable — this is a new study submission

Select the option that best describes the current status of the previously approved IRB study.
Date of final participant interaction Date of final participant interaction / MM / DD YYYY

Enter the date the last participant completed all study‑related activities.
Are all data collection activities complete?

Are all data collection activities complete? Yes No
Are there any outstanding adverse events or unanticipated problems related to this study?

Are there any outstanding adverse events or unanticipated problems related to this study? Yes No
If yes, describe the adverse events or unanticipated problems
Will identifiable data be retained after study closure?

Will identifiable data be retained after study closure? Yes No

Identifiable data includes names, ID numbers, recordings, or information that could reasonably identify participants
If yes, describe how identifiable data will be stored or destroyed
Study closure requirements acknowledgment

Study closure requirements acknowledgment All participant interactions are complete No additional data will be collected after closure All adverse events and amendments have been reported to the IRB Data will be stored or destroyed in accordance with the approved protocol This study will not resume without prior IRB approval

All statements below must be affirmed to request IRB closure.
Principal Investigator confirmation of study closure

Principal Investigator confirmation of study closure I confirm that this study has concluded and that all IRB requirements related to study closure have been met.
Briefly describe why the study needs an extension
New anticipated study end date New anticipated study end date / MM / DD YYYY
Have there been any changes to procedures, risk level, or subject population?

Have there been any changes to procedures, risk level, or subject population? Yes No
If Yes, describe all changes
Principal Investigator confirmation of extension request

Principal Investigator confirmation of extension request I confirm that this extension request is accurate and that the study will continue in compliance with IRB requirements.
Reason for early termination
Were any participants enrolled prior to early termination?

Were any participants enrolled prior to early termination? Yes No
Describe the disposition of any collected data
Principal Investigator confirmation of early termination

Principal Investigator confirmation of early termination I confirm that this study will be terminated early and that all IRB requirements will be followed.
Describe the requested amendment

Provide a detailed description of all proposed changes
Reason for amendment

Why are these changes being requested?
Which of the following are being changed? (check all that apply)

Which of the following are being changed? (check all that apply) Principal Investigator Co-Investigators / Study Personnel Recruitment Methods Recruitment Materials Consent Form Assent Form Study Procedures Study Location Participant Population Sample Size Data Collection Methods Timeline Other
Will this amendment increase risk to participants?

Will this amendment increase risk to participants? YES NO
If the amendment will increase the risk to participants, explain:
Amendments

Upload all revised documents
Revised consent forms
Recruitment materials
Surveys
Study instruments
Other supporting documents
Principal Investigator Amendment Certification

I certify that no proposed changes will be implemented until IRB approval has been received.

Principal Investigator Amendment Certification I certify that no proposed changes will be implemented until IRB approval has been received. Acknowledged
FOR OFFICE USE ONLY

Unified IRB Application & Study Lifecycle Form

Unified IRB Application & Study Lifecycle Form

Section 1: Responsible Persons, Primary Contact, and Affiliations

Section 2: External Investigators

Section 3: Additional Study Personnel (Key Personnel)

Section 4: Training Confirmation

Section 5: Study Overview/Abstract

Section 6: Departmental Approval

Section 7: Study Procedures & Participants

Section 8: Consent and Assent

Section 9: Risks, Benefits, and Confidentiality

Section 10: Study Materials

Section 11: Funding and Compensation

Section 12: Review, Timeline & Certification

Study Update

FOR OFFICE USE ONLY