Exempt Review Form

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Marquette University, Exempt Review Form
October 15, 2013
Human Research
Protocol #:
ORSP #:
For Office Use Only
Institutional Review Board
Exempt Review Form
It is strongly recommended that you review the MU Determination of IRB Submission form to determine
if IRB review is needed for your project and/or the IRB Flowsheet to determine the appropriate exempt
category or categories that apply to your project prior to completing this form.
Instructions:
1. Enter PI/Project Information
2. Complete this form including the Certification section on the last page
3. Submit this form with any supporting documents
PI/Project Information
Principal Investigator:
Department:
Phone:
Marquette E-mail:
@marquette.edu
FOR STUDENTS – Name of Faculty Supervisor:
Project Title:
Date Submitted: Click here to enter a date.
PI Status:
Undergraduate
Graduate
Faculty/Administrator
Other (specify):
Project Type:
Research Proposal
Thesis/Dissertation
Professional Project (i.e. Professional Studies, DNP, etc.)
Class Project (list Dept. & Course #):
Other (specify):
Submission Instructions: Email this completed form and any supporting documents including information
sheets, surveys, interview questions, etc. as attachments to [email protected] with the following subject line:
New Exempt Study Submission for [first and last name of PI]
 In the body of e-mail, include the title of the study and an itemized list of attachments.
 The email address of the sender must be the Principal Investigator’s Marquette email.
 If the PI is a student, the faculty advisor must send or be cc’d on the email.
Once submitted, the ORC will e-mail back a response of receipt. If you do not receive an e-mail
confirmation of submission within 3-5 days, please contact the ORC by phone (414) 288-7570 or email
([email protected]) to verify receipt.
th
Marquette University Office of Research Compliance, 560 N. 16 Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
Screening Questions
1.
2.
3.
4.
Does your project involve prisoners as subjects?
Do FDA regulations apply to your study (is it an FDA regulated device or drug study)?
Does the study involve deception of research subjects (regarding the study purpose, etc.)?
Does the project involve more than minimal risk to participants (risk is greater than subjects would
experience in everyday life)?
5. Does the project involve minors (age 17 or under)? If yes, research activities are only exempt if
they qualify under Category 1: Normal Educational practices, or if the research only involves
observation of public behavior and the researchers do not participate in the activities being
observed.
If yes to any of these questions, your protocol may not qualify for exempt status – please consult the
ORC for more information.
Exemption Category Selection
The IRB and/or ORC are ultimately responsible for determining if research qualifies for exemption.
Researchers are asked to make an initial determination of the appropriate exemption category or
categories. The MU ORC/IRB Flowsheet is available to assist with the determination.
Please select the category or categories that apply to this research project from the list below:
CATEGORY #1
☐
CATEGORY #2
☐
CATEGORY #3
☐
CATEGORY #4
☐
Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as:
a. research on regular and special education instructional strategies
b. research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior, unless:
a. information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; AND
b. any disclosure of the human subjects' responses outside the research could reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects'
financial standing, employability, or reputation
NOTE: This exemption does not apply to research in which the subjects are minors, except for
research involving observation of public behavior if the investigator does not participate in the
activities being observed.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation of public behavior that is not exempt
under Category 2, if:
a. the human subjects are elected or appointed public officials or candidates for public office,
OR
b. federal statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter
Research, involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the information is
recorded by the investigator in such a manner that subjects cannot be identified directly or through
identifiers linked to the subjects.
If you believe your project qualifies for Exemption under Category 5 or 6 please contact the ORC.
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
Project Description
In the space allowed, please provide a brief description of the research project including the purpose
of the study and research goals. Please do not cut and paste from grant applications,
thesis/dissertation proposals, or other documents. The description should be written in lay language
that can be understood by someone from any discipline.
1. Planned duration of study: (Project may not start prior to exempt determination)
From* (anticipated start date): Click here to enter a date.
*Be sure to allow enough time for exempt determination
To: Click here to enter a date.
2. Indicate which of the following specially protected or potentially vulnerable groups will be
specifically targeted in this study as research subjects or sources of data/specimens. (Check all that
apply):
Pregnant Women/Fetuses
Children (minors under 18)
Physically Disabled
3
Prisoners
Institutional Residents
Cognitively Impaired
Marquette College Students
Terminally Ill
Subordinates of the researcher
1, 2
or Alumni
(i.e. patient, student, employee)
Marquette Employees2
Any other population that, due to some characteristic, condition, or status, is likely to have either
diminished capacity or diminished sense of voluntariness
None of These
1
Your project may be subject to FERPA regulation and/or HRP Policy 98.102 Participation of Students and Employees in
Research
2
Your project may be subject to HRP Policy 98.102 Participation of Students and Employees in Research
3
Prisoner research does not qualify for exempt status.
3. Describe the subject selection/recruitment process including subject inclusion/exclusion criteria
(age range, etc.), and approximately how many subjects will be recruited.
OR
For data or specimen research, describe the data and/or specimens in detail, including where the
materials will be obtained, whether or not data sources are publicly available, and whether data or
specimens have all been collected prior to submission of this form.
4. Data collection methods: (Check all that apply and provide copies of all tools)
Paper Survey
Online/Email Survey
Instruction/Curriculum
Testing/Evaluation
Chart/Record Review
Other (please describe):
Observation
Intervention
Focus Groups
Archival Data
Interview
Video Recording
Audio Recording
Specimen Analysis
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
5. Describe the study procedures.
 If researchers will interact with participants, describe each data collection activity, who
from the research team will be facilitating the activity, where the activity will take place1,
the approximate time for completion, and the number of sessions/frequency of sessions.
 If the study involves subject data or specimens, please describe how data or specimens will
be used for this study. For specimens, describe storage procedures and how disposal will
occur.
1
If the research will be conducted in a school or institution other than Marquette University, provide a letter of support
(template available) or IRB approval/exemption letter. The IRB/ORC reserves the right to require the letter of
permission prior to making an exemption determination but may grant exceptions.
6. Will research subjects be compensated or rewarded?
Yes*
No
If Yes, describe the amount of compensation, how and when it will be disbursed, and in what form:
Describe how compensation will be handled if a subject withdraws from the study:
* If subjects are recruited from MU classes, indicate whether students are receiving course credit (regular or extra
credit) and, if so, what alternatives are offered to those students who do not wish to participate in the research.
7. Describe the consent process that will be used; if consent will not be sought please provide
justification:
8. Will researchers collect or have access to any information that if disclosed outside of the research
study could reasonably place subjects at risk of criminal or civil liability, be damaging to their
financial standing, employability, insurability, reputation or be stigmatizing?
Yes
No
9. Describe any potential risks to participants and how risk will be minimized:
10. How will individual research subjects be differentiated in the research data (by name, code,
number, random number, etc.)?
11. At any time during your project will research personnel have access to participant names or other
identifiers (email address, phone number, medical chart, class list, etc.)? This includes access to
identifiers for recruitment, scheduling, obtaining records, etc.
Yes
No
If yes, describe how materials containing identifying information will be kept secure:
12. Will any participant names or other identifiers (Social Security numbers, addresses, telephone
number, medical/dental record number, audio/video recording, etc.) be recorded/used as part of the
research data (includes coded data if investigators have access to the code)?
Yes
No
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
If yes, explain why use of identifiable data is necessary and if applicable describe what measures
will be taken to protect against disclosure (coding system, secure storage of video recordings,
deletion of audio recordings after transcription, destruction of identifiers after analysis, etc.):
If a coding system will be used, will you retain a link between study code numbers and direct
identifiers after the data collection is complete?
No
Yes
If yes, explain why this is necessary and for how long you will keep the link.
13. Data will be stored by the following means:
Hard Copy:
Electronic Storage:
Locked filing cabinet
Computer File (desktop computer)
Locked office
Computer File (laptop computer)
Locked desk
Portable media device (flash drive, portable hard drive, etc.)
Other (please describe):
Electronic recording device (audio or video)
Electronic Security:
Password protected computer
Password protected computer file
Identified electronic data will be encrypted
Audio/Video files password protected
Audio/Video recording device kept in secured area
Portable media device/laptop kept in a secured area
Other (please describe):
14. Is deception or incomplete disclosure used in this study? If you cannot adequately state the true
purpose of the study to the subject through the consent process, deception/incomplete disclosure is
involved.
Yes
No
If yes, describe the following:
What information will be withheld from the subject?
Why is deception or incomplete disclosure necessary?
Describe how and when subjects will be debriefed and attach a copy of your debriefing sheet, if
applicable:
15. Are there any pre-existing relationships that may influence a research subject’s decision to
participate in the project? (for example, a student being recruited by a teacher who controls his or
her grade, or a health provider recruiting his or her patient)?
Yes
No
If Yes, explain what steps researchers will take during the recruitment process to minimize
potential undue pressure, influence, or coercion, or the potential appearance of undue pressure,
influence, or coercion:
16. Will you or any member of your research team obtain, access, or use a subject’s protected health
information (PHI) by any method, and for any purpose including “pre-screening”?
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
Methods may include but are not limited to: directly looking at a health record (electronic or
paper), using an electronic charting system to screen for research subjects, examining clinic
records, appointment books, etc. Examples of where PHI may be located include: medical records,
dental records, clinical lab tests, pharmacy records, medical billing records, clinical databases, etc.
Yes
No
If yes, consult the ORC website regarding any necessary HIPAA documentation. If PHI will be
obtained from a non-Marquette entity, consult that institution’s HIPAA policies.
17. Grant or Contract Funded (external only):
Yes
Funding is Pending
No
Sponsor/Source of funding:
Is this project funded by any Health & Human Services or other federal agency?
Yes
Funding is Pending
Intend to apply in the future
NO INTENT to apply for future federal funding
Is this projected funded by CTSI?
Yes
Funding is Pending
No
Have you registered your project with the Office of Research and Sponsored Programs (ORSP)?
Yes
No
If Yes, Please list your Marquette ORSP Reference #:
(numbers are formatted by year and a three digit number YY-XXX, ex. 12-301)
18. Does the investigator or key personnel have a potential financial conflict of interest in this study
that should be disclosed?
Yes
No If Yes, Please explain:
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Marquette University, Exempt Review Form
October 15, 2013
Research Personnel
Provide the names, titles and affiliations of all investigators (include yourself, co-PIs, other investigators, and
students). For student PI’s please also list your faculty supervisor(s) as research personnel.
4.
Before completing the chart below, verify that any personnel meet the OHRP definition of investigator:
OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research
studies. Such involvement includes:
 obtaining information about living individuals by intervening or interacting with them for research purposes;
 obtaining identifiable private information about living individuals for research purposes;
 obtaining the voluntary informed consent of individuals to be subjects in research;
 studying, interpreting, or analyzing identifiable private information or data for research purposes.
5.
Verify that investigators to be listed have completed NIH Protecting Human Research Participants training.* To see if
a certificate is on file with the ORC access the IRB Training Lookup page on SharePoint. This form cannot be
processed until certificates are on file for all MU investigators.
*Marquette also accepts CITI and equivalent human subjects training. For investigators involved with the protocol who
are not affiliated with Marquette, the Marquette IRB requires that the PI ensure a proper level of training.
6.
If training is not already on file, follow the instructions for formatting certificates. New certificates may be attached
with this form, or sent separately to [email protected]
Name
Institution
Marquette
University
Status
Project Role
(Faculty, Grad.,
Undergrad., etc.)
(Co-PI, Key or
Non-Key
Personnel,
Consultant, etc.)
Contact e-mail
PI
For additional personnel please complete the Research Personnel Addendum.
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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Tutorial
(Attached
or On File
w/ MU
ORC)
Marquette University, Exempt Review Form
October 15, 2013
PI Certification and if applicable Faculty Supervisor Certification are REQUIRED prior to review
PI Certification
By entering my name below and submitting this document, I certify the following:
 I accept primary responsibility for the ethical conduct of this project and for safeguarding the rights
and welfare of all involved human participants and/or their information.
 The information in this submission accurately reflects the proposed research.
 I will communicate any changes to this protocol by emailing [email protected] for verification
that the project remains exempt before proceeding with the change.
 I will submit a Final Report, Study Complete or Study Closed Form when this project is complete.
 I accept responsibility for assuring adherence to applicable Federal and State research regulations
and Marquette University policies applicable to this project.
 I understand that this project cannot begin until I receive documentation of a determination
of exempt status.
Principal Investigator
Date
Faculty Supervisor Certification (FOR STUDENT PI’S ONLY)
FOR STUDENTS, a Marquette faculty supervisor must review this completed form and enter his/her
name and date of review below prior to submission. The advisor must also be copied on the email when
this document is submitted.
Faculty Supervisor: As faculty supervisor for the student investigator named above, I certify the
following:
 I have reviewed the research plan and this document and I have approved the scientific and ethical
aspects of the project.
 I will supervise the above listed student and ensure compliance with applicable Federal and State
research regulations and Marquette University policies applicable to this project.
 I acknowledge that I am ultimately responsible for the conduct of this research project, including
ensuring that all study procedures are followed as written, and that a Final Report, Study Complete
or Study Closed Form is completed in a timely fashion after study completion.
 I understand that this project cannot begin until documentation of a determination of exempt
status has been received.
Faculty Supervisor
Date this form was reviewed
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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