Youngstown State University
Institutional Review Board
Office of Grants & Sponsored Programs
Coffelt Hall
Phone: 330-941-2377
INSTRUCTIONS FOR CLAIM OF EXEMPTION OF RESEARCH APPLICATION
Request for designation as Exempt for a research project involving no risk to human subjects
All research projects conducted under the auspices of Youngstown State University that
involve the use of living human subjects, samples or data obtained from them, directly or
indirectly, with or without their consent, must receive approval from the Institutional Review
Board before the project can begin. The preliminary determination that a research project
meets the criteria for an exempt determination is made by the Principal Investigator after a
careful evaluation of his/her project and review of the Screening Questions. It is the
responsibility of the Investigator to provide adequate documentation for the IRB to certify the
request.
If your research project appears to qualify for exemption:
1. The Principal Investigator should complete the Exempt Screening Questions. If the
answer to all of the Questions is “no”, then the Investigator can complete the Claim of
Exemption application. If any of the answers is “yes”, the Investigator should complete
the Expedited/Full Review Form for Expedited or Full Board Review, as appropriate.
2. The Principal Investigator should submit two copies of the completed Claim of
Exemption Form and all applicable attachments to the IRB Coordinator in the Office of
Grants and Sponsored Programs.
3. Applications will be screened, logged, and forwarded for review to the IRB Chair, or the
Chair’s designee when appropriate, to determine if they do in fact qualify for
exemption.
4. Applications will be reviewed as they are submitted and turn-around time will be 5-10
days for feedback from the IRB, depending upon caseload and completeness of the
application.
5. The IRB reviewer will notify the Principal Investigator the determination of the review
via email, to be followed by a formal letter signed by the Authorized Institutional
Official.
NOTE: A determination of Exempt status carries with it the expectation that the Principal
Investigator will ensure that the welfare of the subjects participating in the research is fully
protected and that the research is conducted in a manner consistent with the University’s
Ethical standards as set forth in the IRB Policies Manual.
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Please Remember:
You may not begin your research project until you receive a written communication from the
YSU IRB confirming that the research project meets exemption criteria.
EXEMPT SCREENING QUESTIONS
Please complete the following sections. If you answer YES to any of the questions A through C below,
then STOP and complete the Expedited/Full Review Application Form.
If you answer NO to all questions A through C below, continue to complete this Claim of Exemption
packet.
A. For research involving special populations, interventions or manipulations
Yes
No Does your research involve pregnant women, fetuses, prisoners, or the mentally ill or
incapacitated?
Yes
No Does your research involve using survey or interview procedures with children,
minors less than 18 years old?
Yes
No Does your research involve the observation of children in settings where the
investigator(s) will participate in the activities being observed?
Yes
No Does your research involve deception?
Yes
No Does this research involve more than minimal risk to the human subject?
B.
For research using survey procedures, interview procedures, observational procedures and
questionnaires (Note: Exemption is not allowed in surveys or interviews with children.)
Yes
No
Yes
No
Yes
No
If data are to be recorded by audiotape or videotape is there potential harm1 to
subjects if the information is revealed or disclosed?
If the subjects are to be identifiable either by name or through demographic data, is
there potential harm to participants if the information is revealed?
Will collection include sensitive date (e.g. illegal activities, or sensitive themes such
as sexual orientation, sexual behavior, undesirable work behavior, or other data that
may be painful or very embarrassing to reveal, such as death of a family member,
memories of physical abuse)?
C. For research using existing or archive data2, documents, records, or specimens only
Yes
No Will any data, documents, records or specimens be collected from subjects after the
submission of this application?
Yes
No If the data, documents, records, or specimens are originally labeled in such a manner
that subjects can be identified, directly or indirectly through identifying links, is the
investigator recording the data in such a manner that subjects can be identified,
directly or indirectly through identifying links (i.e., demographic information that
might reasonably lead to the identification of subjects—name, phone number, or an
code number that can be used to link the investigator’s data to the source record—
medical record number or hospital admission number)?
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Harm to subjects means that any disclosure of the human subject’s responses outside the research
could reasonably place the subjects at risk of criminal or civil liability or can be damaging to subjects’
financial standing, employability, or reputation.
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Existing data means the items existed before the research was proposed or was collected prior to the
research for a purpose other than the proposed research. (For purposes of a grant, this refers to data
collected prior to the time the research was proposed.
EXEMPT CATEGORY CLAIMED
Identify all that apply to your research (check applicable boxes)
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Research conducted in established or commonly accepted educational settings, involving
normal education practices. This category may include children
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement
for which subjects cannot be identified, OR release of information would not be harmful1 to
the subject. This category may include children.
Research involving the use of survey procedures or interview procedures or observation of
public behavior for which subjects cannot be identified, OR release of the information would
not be harmful to the subject. This category may not include children. If subjects are 18 years
of age or younger parental consent is required. Research may be reviewed by expedited
procedures—do not use this form!
Survey or interview of public or elected officials. Testing of public officials.
Research involving the collection or study of existing 2, 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.
Research and demonstration projects that are conducted by or subject to the approval of
Federal Department or Agency heads, and which are designed to study or evaluate public
benefits or services (e.g. evaluation of public benefits programs: Medicare, Public Assistance)
This category may include children.
Taste and food quality evaluation and consumer acceptance studies. This category may
include children.
Unidentifiable human body parts, sections or samples obtained from a morgue.
If your research involves only those procedures listed in one or more of the categories above, it may be
exempt. Please complete the Claim of Exemption Form.
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