WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Request for Review of Human Subjects Research
Western Carolina University
Please complete and send this form and any attachments electronically to: irb@wcu.edu
INSTRUCTIONS: Prior to submitting your application to the IRB, please make sure all personnel listed on the
protocol have completed human subjects training. Your application will not be reviewed until training completion
has been verified.
WCU’s human subjects training can be accessed at www.citiprogram.org. Please note: The required
course for WCU's IRB training is the Social/Behavioral Research or the Biomedical Research Course. The
Responsible Conduct of Research (RCR) will not meet the requirement.
Detailed instructions for registering, affiliating with WCU, and selecting the correct course can be found
on the IRB website.
Please contact the IRB at irb@wcu.edu if you have any issues editing this form.
IRB Application Checklist – please initial each item below.
PRELIMINARY STEPS
Completion of Mandatory CITI Online Human Subjects Training by all members of the investigative team.
THE PROTOCOL
Check to ensure your application is complete and all questions have been answered and filled out
appropriately.
All protocols must have a Principal Investigator (PI), who is ultimately responsible for the project. A PI must
be a member of the faculty or staff member of WCU (students cannot be listed as the PI for any study). The PI
must also be listed on the consent form for the study. All members of the investigative team must review and sign
the application before submitting to the IRB.
RECRUITMENT
If applicable, include a copy of your recruitment material (e.g. flyers, posters, emails).
DATA INSTRUMENTS
If applicable, have you attached to your application all data instruments and other materials to be
distributed to participants (e.g. surveys, questionnaires, interview questions).
INFORMED CONSENT/INFORMED ASSENT
If applicable, have you attached to your application the appropriate consent and assent form, letter, or script
containing all elements of informed consent/informed assent.
AGREEMENTS FROM OUTSIDE INSTITUTIONS
If applicable, have you obtained permission from outside institutions or agencies that either serve as a
source of subjects, a source of records and information, or on whose facilities your project will be conducted.
***NOTE: If your study will include tribal members from the Eastern Band of the Cherokee Indians (EBCI) or will
occur on Cherokee lands (e.g. the Qualla Boundary or Snowbird community), approval may also be required by
the EBCI Cultural IRB and/or Health & Medical IRB). For more information, please contact the WCU IRB Office at
irb@wcu.edu or by calling 828.227.7212.
Western Carolina University
IRB Request for Review Form
May 2015
1
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Request for Review of Human Subjects Research
Western Carolina University
Please complete and send the form and any attachments electronically to: irb@wcu.edu
I.
Research Personnel (PI must be member of faculty or staff)
Name*
Department
Investigator Status:
(PI, co-PI, Other
investigator, Other
personnel)
WCU Status:**
(Faculty, Staff,
Undergraduate,
Graduate Student,
Unaffiliated)
Preferred Phone
Number (optional)
*If you have more investigators than the form will allow, please complete the Additional Investigator Form.
**An Unaffiliated Investigator Form is required for all non-WCU personnel that do not have an institutional IRB.
The Principal Investigator (PI) is responsible for maintaining data records. Data should be stored for a
minimum of three years after a study has been closed and be available for inspection by the IRB or
state/federal investigators.
II. Project Summary
1. Project Title:
2. Funding Source, if applicable:
3. Project Description: provide a concise (3-5 sentences) summary of the purpose and rationale of
the activity. (Members of the IRB may not be familiar with your field’s methods and literature.
Explain your project in an accessible language for non-experts. You may include citations you
may believe relevant in an additional sheet):
4. Intended use(s) of data collected: check all that apply
Thesis or Dissertation
Grant Proposal
Other Research
Publication
Classroom Project
Off-Campus Presentation
III. Investigator Signatures
“I/We assure the IRB that the following statements are true: All information provided in this form is
correct. I have evaluated this protocol and have the resources necessary to protect participants, such as
appropriately trained staff, and necessary facilities. I will not begin my research until I have received
written notification of final IRB approval. Any research conducted prior to IRB approval is considered
noncompliance, and no guarantee of legal protection shall be afforded to the investigator(s) for research
Western Carolina University
IRB Request for Review Form
May 2015
2
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
conducted prior to the approval date. I will obtain written approval from the IRB for any modifications
including changes in procedures, investigators/research staff, questionnaires, etc. I will promptly report
any unanticipated problems that may occur in the course of this study. I will report any significant
findings which may affect the risks and benefits to participation. I will comply with all IRB requests to
report on the status of my study. I will maintain records of this research according to Federal, State, and
Institutional standards. If any of the above conditions are not met, I understand that the approval of this
research may be suspended or terminated, and/or all federally funded research at WCU could be
suspended by the Office of Human Research Protections (OHRP)”
Investigator name and email address together constitute an electronic signature to this application.
Note: all personnel must sign and date the application prior to submission.
Name
IV.
Email Address
Date
Conflict of Interest
1. Are there any known or potential conflicts of interests related to this research?
Conflict of interest relates to situations in which financial or other personal considerations may
compromise or involve the potential/have the appearance for compromising an investigator’s objectivity
in meeting University responsibilities including research activities. (see University Policy 54)
No
Yes. If yes, describe and explain how participants will be protected from the
influence of competing interests.
V.
Participant Population and Recruitment
1. Enrollment Information
a. Expected number of participants:
b. Does the study include any of the following populations, either as the target population
or incidentally? If the following populations will be excluded from your study, please
select “Not applicable.”
Vulnerable Populations:
Minors
Prisoners
Pregnant Women
Target
Incidental
Not applicable
Western Carolina University
IRB Request for Review Form
May 2015
3
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Special Populations:
Non-English speaking
Decisionally or Mentally Impaired
WCU Students / Employees
Native Americans
c. What are the inclusion criteria for the study? (What characteristics of the study
population make them eligible to participate?):
d. What are the exclusion criteria for participation in the study? (What characteristics
would make someone ineligible to participate? (e.g. age or physical restrictions; “not
meeting inclusion criteria” is not sufficient):
e. Explain special procedures for handling vulnerable populations (enter N/A if your study
involves no vulnerable or special populations):
2. Give a brief description or outline of your recruitment and inducement procedures as they
relate to human subjects.
a. Explain details of the recruitment process. (How will you find participants?)
b. Does this research study include any compensation, monetary inducements, or
reimbursement for participation?
No
Yes. If Yes, please explain:
Please include a copy of your recruitment material (e.g., flyers, e-mails) with your protocol.
VI.
Informed Consent/Assent
“Consent” is obtained from adult individuals participating in a study.
“Assent” is given by minors agreeing to participate in the study. Additionally, parents must give “consent”
allowing their children to participate in research.
1. Explain how informed consent and assent (if applicable) will be obtained. Include information
about: the setting, whether participants will have an opportunity to ask questions, and the roles
of any non-research personnel involved.
Please include a copy of your informed consent/informed assent materials with your protocol.
Standard templates for informed consent and informed assent are available on the IRB website.
2. Are you requesting a modification to the required elements for informed consent for
participants, or legally authorized representatives?
(See http://www.hhs.gov/ohrp/policy/consentckls.html)
No
Western Carolina University
IRB Request for Review Form
May 2015
4
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Yes. If yes, include your request here:
3. Will participants or their legally authorized representative sign the consent / assent form?
No
Yes
VII. Study Procedures
Note: The study start date MUST be “date of IRB approval” or a date in the future, or the
application will be returned for editing.
1. Projected recruitment, data collection, and data analysis dates:
From: date of IRB approval
To:
2. List and describe the types of data that will be collected (you may provide links to information
that may be reviewed electronically):
Please include a copy of all data collection instruments which does not have an electronic reference
3. Describe the activities in which participants will engage, including length of participation, nature
of intervention (if applicable), and frequency of data collection:
VIII.
Risk and Benefits Section
1. The risks to participants must be reasonable in relation to the anticipated benefits, if any, to the
participants and the importance of the knowledge that may be reasonably expected to result.
Select all applicable:
Participants of the study may directly benefit (describe): (note that compensation for
participation is not considered to be a benefit):
Society may benefit from the study (describe):
2. Give a full description of potential risks to study participants.
Minimal Risk:
a)
Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests. [45 CFR 46.102]
b)
Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the
daily lives, or in the routine medical, dental, or psychological examination of healthy persons [45 CFR 46.303] (This
definition only applies to research involving prisoners.)
Western Carolina University
IRB Request for Review Form
May 2015
5
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
a. Select the appropriate level of risk for each category below.
*Options are: no foreseeable risk, no more than minimal risk, or more than minimal risk
Legal
Psychological
Social
Economic
Physical
b. If you answered anything other than “no foreseeable risks,” explain the nature of the
risk, its likelihood of occurring, and its potential impact on participants:
c. Explain what steps have been taken to minimize these risks:
d. What provisions have been made to insure that appropriate facilities and professional
attention necessary for the health and safety of the subjects are available and will be
utilized?
IX. Confidentiality, Anonymity and Safeguards
1. Confidentiality and Anonymity
a. Will the data from your study be (check one)
Anonymous (Not even the researcher can match the data to the participant.)
Confidential (The researcher can match the data to the participant but participant
identity is not disclosed.)
Neither (The researcher can match the data to the participant and participant
identity will be disclosed.)
b. If the data will be confidential, explain the steps you will take to maintain
confidentiality:
c. Do the data to be collected relate to illegal activities?
No
Yes. If yes, explain:
d. Is deception involved?
No
Yes. If yes, explain:
2. Safeguards
a. How will data be monitored to ensure the safety of subjects (e.g., if during a trial it is
found that an intervention has increased risk/benefit not in the consent, how will you
ensure that this is monitored and conveyed to the IRB and participants)?
Western Carolina University
IRB Request for Review Form
May 2015
6
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
b. Describe what will be done with the data and resulting analysis:
(Note: data should be stored by the PI for a minimum of three years after a study has been
closed such that they are accessible for inspection by the IRB, federal, and state agencies.
c. Describe measures you are taking to safeguard study data:
Data is not linked to identifying information
Maintain consent forms in a separate location from data. List location:
Using subject codes on all data collected and maintaining the key linking subject
codes with identifiable information in a separate location from data. List location:
Locking cabinets/doors. List locations:
Data kept in area with limited public access. List locations:
Password protected computers. List locations:
Encryption
iPads, tablets, digital storage devices and removable media will be kept in a secure
location. List locations:
Other, describe:
d. Data Sharing. What type of data will be shared? (Note, sharing includes releasing,
transmitting, and providing access outside of the research team). Check all that apply:
Data collected anonymously
De-identified or de-linked data
Identifiable data; Indicate which secure methods of transmission will be used:
Secured website, or FTP client; Provide name of website:
Encrypted email
US Postal Service or other traceable courier
Fax in a secured area
Shared drive with password protection
Personal delivery by member of research team
Private telephone conversation
Other, please describe:
FOR RESEARCH INVOLVING Qualtrics SURVEYS, the PI must initial this statement:
I understand
that approval of the use of WCU’s online survey software (Qualtrics) is limited to the survey(s)
specifically described in this IRB proposal. Any further use of Qualtrics for research purposes will require
me to submit and receive approval for an amendment to this proposal or a new IRB proposal before I
can proceed. Use of Qualtrics is governed by WCU Policies on Conducting Surveys (#51) and Ethics in
Research (#56), and to IRB policies. My initials indicate adherence to these policies.
Please send this application form with any accompanying attachments to irb@wcu.edu
Western Carolina University
IRB Request for Review Form
May 2015
7