IRB USE ONLY________________
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Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Request for EXEMPTION from IRB Review
Please email this completed form to the IRB Administrator Mary.Eckart@va.gov If you have any
questions please call (216) 791-3800 ext. 4658.
EXEMPT research includes research activities in which the only involvement of human subjects is
in one or more of the categories listed in Section 3 (38 CFR 16.101(b).) The exempt status must be
determined by the Institutional Review Board (IRB) Chairperson.
Section 1 – General Information
1. Date:
2. Title of Project:
3. Principal Investigator (name& degree):
E-mail:
Pager Number/Cell Phone Number:
Signature (electronic is fine):
Date:
Section 2 – Summary
4. Please provide a brief summary of the proposed project.
Include how data will be accessed and if identifiable private information will be used.
Submit a HIPAA Waiver Request when accessing or collecting identifiers.
5. Is there a list of identifiers, existing and/or shared with investigator, regardless of whether
or not the list was pre-existing and generated for non-research purposes?
*YES

NO
If YES this activity does not qualify for an exemption under Category 4 as Record
Control Schedule 10-1 indicates that all research records are to be retained
indefinitely.
Section 3 – EXEMPTION Categories
Please check all applicable categories below:
LSCDVAMC
March 2014
Exemption Request
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LSCDVAMC
Exemption Request
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April 2014
1.
2.
3.
4.
Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods. The research is not
FDA regulated and does not involve prisoners as participants.
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless: (i) Information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; and (ii) 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. If the research involves children as participants, the
procedures are limited to educational tests and observation of public behavior where the
investigators do not participate in the activities being observed. The research is not FDA
regulated and does not involve prisoners as participants.
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: (i) the human subjects are elected or appointed
public officials or candidates for public office; or (ii) federal statute(s) require(s) without
exception that the confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter. Attach to this application a copy of any
questionnaire or survey to be used. The research is not FDA regulated and does not involve
prisoners as participants.
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. (Specimens must be
preexisting.) The research is not FDA regulated and does not involve prisoners as
participants.
*** If there is a list of identifiers this activity does not qualify for an exemption
under Category 4 as Record Control Schedule 10-1 indicates that all research
records are to be retained indefinitely.
Please submit full study documents to R&D Committee Coordinator
LSCDVAMC
April 2014
5.
Exemption Request
Page 3 of 5
Research and demonstration projects which are conducted by or subject to the approval of
federal Department or Agency heads, and which are designed to study, evaluate, or
otherwise examine: Public benefit or service programs; Procedures for obtaining benefits or
services under those programs; Possible changes in or alternatives to those programs or
procedures; or Possible changes in methods or levels of payment for benefits or services
under those programs. Such projects must be conducted pursuant to specific federal
statutory authority, there must be no statutory requirements for IRB review, the research
must not involve significant physical invasions or intrusions upon the privacy of subjects,
and the exemption must be invoked only with authorization or concurrence by the funding
agency.
NOTE: 1) This determination must be made by the Under Secretary for Health on behalf of the
Secretary of Veterans Affairs, after consultation with the Office of Research and
Development, the Office of Research Oversight, the Office of General Counsel,
and other experts, as appropriate. The research is not FDA regulated and does not
involve prisoners as participants.
6
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient at
or below the level and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food Safety and Inspection Service
of the U.S. Department of Agriculture. The research does not involve prisoners as participants.
IRB USE ONLY
Evaluation of Exemption
DETERMINATION
"Research means a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]
Common Rule Definition of Human Subject
Human subject means a living individual about whom an investigator conducting research
obtains (1) Data through intervention or interaction with the individual, or
(2) Identifiable private information
• An intervention includes both physical procedures by which data are gathered (for
example, venipuncture) and manipulations of the subject or the subject’s environment
that are performed for research purposes
• Interaction includes communication or interpersonal contact between investigator and
subject
• Private information includes information about:
Behavior in which an individual can reasonably expect that no observation or recording is
taking place, and
Information provided for specific purposes which the individual can reasonably expect will
not be made public (e.g., medical record)
• Private information must be individually identifiable to constitute research involving
human subjects (identity of the subject is or may readily be ascertained by the
investigator or associated with the information) 38 CFR 16.102(f)
Research may be exempt from review when the only involvement of human subjects in the
research falls into one of the following categories:
Mark all applicable categories:
Category 1: Research conducted in established or commonly accepted educational
LSCDVAMC
April 2014
Exemption Request
Page 4 of 5
settings, involving normal educational practices, such as (i) research on regular and
special education instructional strategies, or (ii) research on the effectiveness of or the
comparison among instructional techniques, curricula, or classroom management
methods. The research is not FDA regulated and does not involve prisoners as
participants.
Category 2: Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation of public
behavior, unless: (i) Information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked to the subjects; and (ii)
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. Attach questionnaire(s) and/or surveys.
If the research involves children as participants, the procedures are limited to educational
tests and observation of public behavior where the investigators do not participate in the
activities being observed. The research is not FDA regulated and does not involve
prisoners as participants.
Category 3: 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: (i) the human subjects are
elected or appointed public officials or candidates for public office; or (ii) federal
statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter.
Attach to this application a copy of any questionnaire or survey to be used. The research
is not FDA regulated and does not involve prisoners as participants.
Category 4: 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. (Specimens must
be preexisting.) The research is not FDA regulated and does not involve prisoners as
participants.
***** If there is a list of identifiers this activity does not qualify for an exemption under
Category 4 as Record Control Schedule 10-1 indicates that all research records are to be
retained indefinitely.
Category 5: Research and demonstration projects which are conducted by or subject to
the approval of department or agency heads, and which are designed to study, evaluate,
or otherwise examine: (i) public benefit or service programs; (ii) procedures for
obtaining benefits or services under those programs;(iii) possible changes in or
alternatives to those programs or procedures; or (iv) possible changes in methods or
levels of payment for benefits or services under those programs. The protocol will be
conducted pursuant to specific federal statutory authority; has no statutory requirement
for IRB review; does not involve significant physical invasions or intrusions upon the
privacy interests of the participant; has authorization or concurrent by the funding agency
and does not involve prisoners as participants.
Category 6: Taste and food quality evaluation and consumer acceptance studies, (i) if
LSCDVAMC
Exemption Request
Page 5 of 5
April 2014
wholesome foods without additives are consumed or (ii) if a food is consumed that
contains a food ingredient at or below the level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration or approved by the Environmental Protection
Agency or the Food Safety and Inspection Service of the U.S. Department of
Agriculture. The research does not involve prisoners as participants.
The research meets the following ethical standards for exempt research:
Research holds out no more than minimal risk
Yes
No
Selection of subjects is equitable
Yes
No
HIPAA Waiver submitted
Yes
No
Consent Form/Script suggested*
*Yes
No
*The consent process will disclose :
 That the activities involve research
 The procedures to be performed
 That participation is voluntary
 Name and contact information for the investigator
Exempt
Not Exempt. Submit full study documents to R&D Committee Coordinator
HIPAA Waiver Request approved
Not human subject research
As a reviewer if you have a financial interest; or if you have any conflict of interest with this
research please return this to the IRB office.
Signature of IRB Chairperson or Designee
Date
NOTE: All research must be reviewed and approved by the Research & Development
Committee, prior to initiating any study activities. Contact R&D Committee Coordinator
at x4657.
ISO/PO will determine that Confidentiality and Privacy provisions are adequate
during the Research & Development Committee review and approval process.
You must notify the IRB office if your research changes after approval because the exemption may no longer
apply. Please refer to the LSCDVAMC Human Research Protection Program Standard Operating Procedures for
additional information and examples of what qualifies as exempt research. (See also VHA Handbook 1200.05; 38
CFR 16.101(b); 45 CFR 46.101(b))