Research Project Number:
POINT LOMA NAZARENE UNIVERSITY
Institutional Review Board (IRB)
Full Review
PROPOSAL COVER SHEET
To be completed for all research, defined in 45 CFR 46.102, involving human participants, defined
in 45 CFR 46.102, and conducted at Point Loma Nazarene University, by or under the direction of any employee,
agent or student of this institution, including research conducted at or in cooperation with another entity. Click
Regulations at http://www.hhs.gov/ohrp.
1. Title of Research:
2a. Principal Investigator (PI):
(If student, please circle one: Undergraduate, Masters) If
not affiliated with PLNU, please explain.
2b. Additional Investigators:
2c. Faculty Advisor (if applicable):
2d. Course Number and Title (if applicable):
2e. PLNU Sponsor (if PI is not PLNU employee or agent):
3. Review Category
Exempt (Complete Section A) by category
Expedited (Complete Section B) by category
Full (Complete Section C)
4. Anticipated Date on which Data Collection will begin:
5. If this is a funded project, please name funding source(s).
(See 46.101 on above website.)
(See 46.110 on above website.)
6. If this proposed research has been, or will be reviewed by an Institutional Review Board (IRB)
elsewhere please name the IRB(s). If applicable, attach a copy of each IRB’s recommendations and dated
approval.
You must submit this form, all supporting documents and a description of the proposed research
(see below) in pdf format. Prior to submission, all proposals require that you read the Guidelines
to Professors and require signatures below as necessary.
Researcher (signature), Department
Date
Researcher (printed)
Phone or email
Faculty Advisor or PLNU Sponsor
(except if P.I. is current PLNU faculty)
Phone or email
Proposals that are incomplete or lacking signatures will be returned.
Section C: Full Review
1.
Please address the following items in the space below. Add additional space if necessary.
Please pay particular attention to potential risks to participants and what will be done to
minimize those risks.
a. Briefly describe the study, giving its justification and rationale.
b. Who are the participants? How will you recruit them? How many will be used?
Specifically, note whether participants belong to a protected group as defined in 45
CFR 46.111(b) and see Subparts B and C there for further details.
Click Regulations at http://www.hhs.gov/ohrp.
c. What steps will you take to assure the participation is voluntary?
d. What will the participants do? How will you interact with the participants (e.g.,
describe any bodily invasive procedures)?
e. Describe all the equipment you will use or with which the participant will interact.
f.
Will questionnaires or other materials be used? Please attach copies of questionnaires
or other materials that will be used (such as interview questions or topics, experimental
stimuli or other instruments).
g. Note the estimated time duration of participant participation.
h. Will the participants incur any expenses? If so, please explain.
i.
Name the facilities other than PLNU where research will be conducted and provide
copies of any letters of permission or support that you have obtained. If you have not
obtained any letters, please explain.
j.
List the foreseeable risk(s) to participants, describe how you will minimize each risk,
and why each risk is justifiable in light of benefits (either directly to the participant or
indirectly to generalizable knowledge) to be gained by the research.
k. Document how informed consent will be gained. Include the exact words and method
of delivery that will, prior to their agreement to participate, inform participants of the
nature of the study and of the extent of their involvement. Attach a copy of the consent
form(s). This form will be examined closely.
l.
How will debriefing be handled? Please attach the written debriefing statement you will
give to each participant.
m. Are copyrighted tests, scales, or inventories are to be used? If s0, please attach a copy of
the approval letter.
2. Save the entire document as a pdf and email an electronic copy of the proposal to
IRB@pointloma.edu.
3. Once a description of your proposed research has been approved and filed with the IRB, your
project will be approved for one year. After one year, you must submit a SummaryContinuation Form to the IRB.
Point Loma Nazarene University
IRB Submission Preparation Checklist
Use this guide to help you make sure you have all necessary documents for
submission. Missing or incomplete documentation delays the review and approval
process!
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Signed Proposal Cover Sheet
 If student- initiated research: needs to be signed by both the student
(who is the PI) and the faculty advisor.
 If proposal is from a faculty member – only PI signature required.
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Completed Research Proposal (either Exempt, Expedited or Full Review)
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Participant Consent Form
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Measurement tools, instruments, data collection forms (if applicable)
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Documentation of permission to use instrument (if applicable)
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Permission/letter of approval to conduct research (only if research performed
off-site from PLNU)
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Clear debriefing statement