Review Type Overview of
Non-Human Subject Research, Exempt Research, Non Engaged in Human Subject Research and Expedited Research
For Researchers
Criteria apply if research is conducted, supported or otherwise subject to regulation by any federal department or agency OR FWA states institution will follow regulations regardless of funding.
Non-Human Subject
Research
Exempt
45 CFR46.102
21CFR50
45 CFR 46.101
21CFR56.104 (a-d)
 NOT considered Human
Subject Research under
DHHS regs or a Clinical
Investigation via FDA
regs
 Determination of Human
Subject Research Form is
optional
 IRB Submission Required
 Considered Human Subject
Research
Non Engaged in Human Subjects Research
OHRP Guidance on Engagement of Institutions in HSR
This is a DHHS guidance.
Does NOT apply for FDA regulated research.
 IRB Submission Required
 Considered Human Subject Research
 Apply only if protocol involves humans subjects and does not meet
exempt criteria
 Need outside IRB approval under which data/ specimens were
collected if data/ specimens come from outside UVa.
 If FDA regulated research, and samples/data come from outside of
UVa, the UVa researchers must be included as personnel on IRB
protocol at outside institution- need an IRB Reliance Agreement.
Expedited
45 CFR 46.110 and 21 CFR 56.110.
 IRB Submission Required
 Considered Human Subject Research
 Apply only if protocol does not meet exempt or not
engaged criteria

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Non-Human Subject Research
Criteria
Project does not meet both definitions below:
(1) Research means a systematic investigation, including development, testing,
and evaluation, designed to develop or contribute to generalizable knowledge.
Activities which meet this definition constitute research for the purposes of
this policy, whether or not they are supported under a program which is
considered research for other purposes.
Exempt
Criteria
Must meet one of the
Exempt Criteria below:
Additional exempt criteria exist for nonbiomedical research
(1) Research involving the collection of existing
data, documents, records, pathological specimens,
or diagnostic specimens
(2) 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.
Existing data means all the data, documents,
records or specimens are in existence prior to
IRB-HSR review; therefore cannot be obtained
prospectively (future)
OR
(2) These sources (data, specimens, records etc..)
are publicly available OR the information is
recorded by the investigator without identifiers
directly or indirectly linking back to the subject
Criteria met from OHRP Guidance on Research Involving Coded Private
Information or Biological Specimens
Criteria
#1 and #2 must BOTH apply:
(1) The private information or specimens were NOT collected specifically for the
currently proposed research project through an interaction or intervention with
living individuals AND
(2) The investigator(s) cannot readily ascertain the identity of the individual(s) to
whom the coded private information or specimens pertain. ( see LINKS below)
Links
If a link to individually identifying information is kept one of the following must
apply
 The consultants or collaborators and the holder of the key enter into an agreement
prohibiting the release of the key to the consultants or collaborators under any circumstance.
 The releasing institution has IRB-approved written policies and operating procedures
applicable to the research project that prohibit the release of the key to the consultants or
collaborators under any circumstance; or
 There are other legal requirements prohibiting the release of the key to the consultants or
collaborators
Both # 1 and 2 must be met in order for the
project to be exempt.
(3) Research involving the use of educational
tests, survey, interview or observation of public
behavior.
If doing research involving the use of educational
tests, survey, interview or observation of public
behavior, identifiers can be recorded, however, if
subjects can be identified directly or through
links/codes AND any disclosure of the subject’s
responses would place the subject at risk of
criminal or civil liability or be damaging to the
subject’s financial standing, employability or
reputation, the study would NOT qualify for
exempt approval
Non Engaged in Human Subjects Research
Criteria
#1 and #2 must BOTH apply:
(1) Process includes a non-engaged
scenario AND does not include an
engaged scenario
( see application form)
(2) If scenario # 7 is chosen- the
investigator(s) cannot readily ascertain
the identity of the individual(s) to
whom the coded private information
or specimens pertain. ( see LINKS
below)
Links
If a link to individually identifying
information is kept one of the
following must apply
 The key must be destroyed before
the research begins or
 Signed agreement is required
between the person releasing the
data and the investigator receiving it
stating the code will never be
released or
 Confirmation from another IRB for a
repository or data center states that
the release of the code is strictly
prohibited
Expedited
Criteria
#1 and #2 must BOTH apply:
(1) No more than minimal risk to human
subjects, and
(2) Involve only procedures listed in one or
more of the following categories:
1. Clinical studies of drugs and medical devices only
when condition (a) or (b) is met. (a)Research on drugs
for IRB-HSR an IND application is not required.
(Note: Research on marketed drugs that significantly
increases the risks or decreases the acceptability of the
risks associated with the use of the product is not
eligible for expedited review.) (b)Research on medical
devices for IRB-HSR (i) an IDE is not required; or (ii)
the medical device is cleared/approved for marketing
and the medical device is being used in accordance
with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel
stick, ear stick, or venipuncture as follows:
2(a) from healthy, non-pregnant adults who
weigh at least 110 pounds; amounts drawn may
not exceed 550 ml in an 8 week period and
collection may not occur more frequently than 2
times per week; or \
2(b) from other adults and children, the amount
drawn may not exceed the lesser of 50 ml or 3 ml
per kg in an 8 week period and collection may
not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for
research purposes by noninvasive means. Examples:
hair and nail clippings in a non-disfiguring manner;
4. Collection of data through noninvasive procedures
(not involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures
involving x-rays or microwaves. Examples: MRI;
ECHO, Doppler blood flow,; moderate exercise,
muscular strength testing,
5. Research involving materials (data, documents,
records, or specimens) that have been collected, or will
be collected solely for non-research purposes (such as
medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or
image recordings made for research purposes.
7. Research on individual or group characteristics or
behavior
Note:
If done under an FDA application must have an IRB AA in place confirming
outside IRB approval of the original collection of the specimens/ data
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Non-Human Subject Research
Exempt
Non Engaged in Human Subjects Research
Expedited
Examples include:
 Research with data/ specimens from cadavers
 Case Reviews ( up to 3)
 Cell lines
 Specimens purchased from commercial supplier.
 No intervention/interaction and #1 and #2 both must
apply
Examples include:
 Questionnaires or surveys that do collect
information in a way that the subject can be
identified.
 Research being conducted in educational
settings involving normal curriculum,
 Research on archival data
 Research involving an investigational test
article under Emergency Use
 Chart review of data from medical records of
year 2004-2007 and data will be recorded in
a way that the subject cannot be identified
Examples include:
 Researcher working on the same research study with a
colleague from another institution. All subjects are
enrolled and seen at outside institution. Our researcher
is sent coded samples for analysis. Analysis results
returned to primary institution. Our researcher will
never be given the identity of the subjects.
Examples include:
 Prospective chart review and recording
identifiers
 Blood draw (meets additional criteria
required by expedited category) from
peripheral needle stick
 ECGs
 use of otherwise discarded tissue obtained
for clinical purposes during a clinical
procedure (no extra tissue, fluid etc. taken
for the research)
 use of banked specimens for minimal risk
research (e.g. no testing of polymorphisms)
 database is being developed that contains
data gathered from existing sources such as
the medical record and data has identifiers
(1) Material/data was collected for purposes OTHER
than this research project (e.g., normal discarded tissue)
or for unrelated research project with no extra material
collected for this project
(2) Material/data is given to the investigator WITHOUT
A CODE and NO CODE is kept by the receiver or
sender.
NOTE: Must also review HIPAA
regulations: need DUA if LDS or Waiver of
HIPAA Authorization if collecting
identifiable information. If sharing
identifiable data outside of UVa must do
tracking. –
Protocol may be approved under exempt
review if data/ specimens are not considered
Identifiable per HIPAA regulations. May
also be approved under exempt review if
data/ specimens meet the criteria of a
Limited Data Set.
 No intervention/ interaction by researcher
#1 and #2 both must apply
(1)
Material/data was collected FOR purposes
of the research project in question and NOT
collected for purposes other than this research
project.
(2)
Material/data is given to the investigator
WITH A CODE; however, the investigator
receiving the data/material will NEVER have
access to the key to the code OR the key cannot
be derived from or related to information about
the subject-if there is a key.
 Our institution performing commercial services for the
researchers
 Our institution providing clinical trial related medical
services as dictated by the protocol that are part of
routine clinical care.
 Informing patients about other clinical trials, providing
consent form but NOT obtaining consent.
 More scenarios found in OHRP guidance.
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Not allowed:
 Any examples found in all subsequent columns.
Not allowed:
 Collecting identifiable info from two
different sources (medical record, pharmacy
log) since this would require HIPAA identifiers
to link info from both sources.
 Surveys or interview collecting information
that may be of risk to a subject and are
collected in a manner that a subject may be
identified.
 Observation of minors
 Deception
Not allowed:
 Data/ specimens were collected for other non- related
research
 Data/ specimens will be given to the researcher along
with the key to the code
 The researcher is working on both studies: the
protocol collecting the data/ specimens and the new
study
Not allowed:
 small amount of additional fluid, tissue is
being collected for research purposes and
the collection method itself presents greater
than minimal risk (collection of additional
CSF, biopsy tissue etc)
 randomization to one of several approved
drugs/devices
 throat swab unless full board determines the
study is minimal risk (board may determine
throat swab is minimal risk if swab obtained
by a licensed health care professional)
 oral glucose tolerance test
 induced sputum,
 skin biopsy
 imaging studies ( except MRI without
contrast)
 collection of identifiable sensitive
information without a certificate of
confidentiality
 anything is being introduced into an orifice
solely for research, Examples: pap smears,
ear probes that are inserted further into the
ear than the entrance of the auditory canal;
rectal swabs, anything being placed into the
nose farther than a finger could go
 blood samples for research are being
collected from a central or arterial line or an
existing peripheral line ( unless Full Board
determines study is minimal risk)
 additional CSF is being collected from an
existing shunt or externalized CSF drain.
 assessments, surveys or questionnaires of a
sensitive nature where HIPAA identifiers
will be retained
 databases that contain sensitive information
that is identifiable and NO Certificate of
Confidentiality will be sought
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