IRB Application for Full or Expedited Review

YOU MUST RECEIVE APPROVAL FROM THE IRB PRIOR TO BEGINNING YOUR RESEARCH

Date Date / MM / DD YYYY
1. Title of Study
2. List Principal investigator (P.I.) and all sub-investigators. If you have additional investigators, use the Upload button to submit a document that details additional investigators. Protection of Human Research Subjects or CITI training must be completed by all investigators, sub-investigators, and other key personnel before submission of application.
Principal Investigator Principal Investigator First Last
Dept./University
Address Address
Street Address Address Line 2 City State / Province / Region Postal / Zip Code Country
Email
Phone Phone - ### - ### ####
I certify that I have completed PHRP or CITI training. Your Certificate of Completion must be submitted to be eligible for IRB review.
Name Name First Last
Dept./University
Address Address
Street Address Address Line 2 City State / Province / Region Postal / Zip Code Country
Email
Phone Phone - ### - ### ####
Name Name First Last
Dept./University
Address Address
Street Address Address Line 2 City State / Province / Region Postal / Zip Code Country
Email
Phone Phone - ### - ### ####
3. Research Period
NO research activity may be conducted until formal IRB approval. This includes advertising, subject recruitment, data collection, etc.
Project Start Date Project Start Date / MM / DD YYYY
Project End Date Project End Date / MM / DD YYYY
4. Reason for conducting research

4. Reason for conducting research Professional Dissertation Thesis Class assignment Capstone Project Other (specify below)
5. Investigators at institutions other than Waynesburg University

5. Investigators at institutions other than Waynesburg University None
Institutional Affiliation
Investigator's Name Investigator's Name First Last
Investigator's Title
Role in Study
Institutional Affiliation
Investigator's Name Investigator's Name First Last
Investigator's Title
Role in Study
6. List any additional key personnel other than the investigators who will have contact with the subject:

6. List any additional key personnel other than the investigators who will have contact with the subject: None
Name Name First Last
Title
Degree(s)
Name Name First Last
Title
Degree(s)
Name Name First Last
Title
Degree(s)
Name Name First Last
Title
Degree(s)
7. Key personnel other than the investigators who will obtain informed consent:

7. Key personnel other than the investigators who will obtain informed consent: None
Name Name First Last
Title
Degree(s)
Name Name First Last
Title
Degree(s)
Name Name First Last
Title
Degree(s)
8. Key personnel other than the investigators who will have contact with data
None
Name Name First Last
Degree
Title
Name Name First Last
Degree
Title
9. Location for interaction with subjects (provide name of institution, address, and brief description).
10. Indicate which of the following populations will be included in the research.

10. Indicate which of the following populations will be included in the research. Patients Children (under 18) Intellectually or emotionally impaired subjects Elderly subjects (over 65) Pregnant subjects Employees of institutions associated with study Prisoners, parolees, incarcerated subjects Illiterate subjects Students whose primary language is not English Students or trainees Identifiable student or trainees whose professors are names on this protocol Identifiable students or trainees who are academic advisees or mentors of someone named on this protocol None of the above
11. Indicate which, if any, of the following items are involved

11. Indicate which, if any, of the following items are involved Data collected from data banks, archives, medical records Data to be stored in data banks, archives, medical records Filming, videotaping, or voice-recording of subjects Questionnaires Pathological or diagnostic tissue or fluids Deception of subjects None
12. Source of Funding

12. Source of Funding None Yes, as described below:
13. Will there be any financial remuneration, rewards, reimbursement of expenses, or other inducements to participate?

13. Will there be any financial remuneration, rewards, reimbursement of expenses, or other inducements to participate? Yes (explain below) No
14. Will there be any potential added cost to subjects?

14. Will there be any potential added cost to subjects? Yes (explain below) no
15. Do you have any supervisory or evaluation responsibilities over any of your subjects?

15. Do you have any supervisory or evaluation responsibilities over any of your subjects? No Yes (explain below)
16. Are you seeking expedited review?

16. Are you seeking expedited review? Yes (explain why you think this project qualifies for expedited review). No
17. Please provide an abstract (a brief summary of the purpose and procedures), written in language that can be understood by the non-specialist.
18. Please provide information for each of the following items.

a. Purpose and procedures: State the research methodology, design, and objectives or specific aims of the project. Provide a complete but concise description of the procedures, including the nature and location of the contact of the participants.
b. Research questions: State the research questions you intend to answer with this project.
c. Participants: State the proposed number of participants. Describe and explain the criteria and methods of recruiting, selecting, including, and excluding participants. Also include the smallest number of subjects from which you plan to collect data at one time.
d. Assent and Consent: Indicate method of obtaining informed consent or assent from children (under age 18) or incompetent subjects.

d. Assent and Consent: Indicate method of obtaining informed consent or assent from children (under age 18) or incompetent subjects. Written consent form (include a copy) Written assent form (include a copy) No assent, under age 7 or severely impaired (discuss below)
Requesting waiver or alteration of assent process (discuss below)
e. Attachments: Provide a copy of each survey tool, questionnaire, or other test instrument. Attach "permission to use" communication, if proprietary. Provide any other attachments as well.
f. Risks, discomforts, and benefits: Describe and explain any risks, discomforts, and benefits to the subjects, the scientific community, and/or the local community. If no known risks, state same.
g. Intervention: Do you have an intervention?

g. Intervention: Do you have an intervention? No Yes (Describe and explain the intervention below).
h. Confidentiality:

h. Confidentiality: Anonymous Confidential
Explain how and to what extent confidentiality will be maintained for records that identify participants. Please describe how paper, electronic, and/or media files will be stored and secured during the study and how they will be disposed at the end of the study).
i. Advertisements: Using the Upload Button, attach ALL printed and electronic ads or media used to recruit/communicate with study participants.
Signatures

The IRB will not review the protocol without these signatures. By signing, department chairs acknowledge approval of this study on the basis of scientific merit and compliance with applicable professional standards; deans and other administrators signify their approval of the use of resources and faculty and student effort on the study. Multi-unit protocols require the signatures of each chair and dean).

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.
I certify that all sub-investigators have completed Protecting Human Research Participants or CITI training. Please provide a copy of certificate of completion for each.
Principal Investigator's name Principal Investigator's name First Last
Date Date / MM / DD YYYY
Principal Investigator's signatgure
Draw your signature into the box below.

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.
We have reviewed the above information and recommend this study for consideration.
Faculty Advisor Faculty Advisor First Last
Date Date / MM / DD YYYY
Dept. Chair/Program Director Dept. Chair/Program Director First Last
Date Date / MM / DD YYYY
Email
Phone Phone - ### - ### ####
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IRB Application for Full or Expedited Review

IRB Application for Full or Expedited Review

Signatures