West Virginia University
Office of Research Integrity & Compliance
Human Research Protections Program
Human Subjects Research
 Any Human Subjects Research conducted by or
under the auspices of any WVU faculty, student or
staff must be reviewed by the WVU IRB.
 These human subject research projects must be
submitted to the IRB office for review.
IRB Review
 Flexibility is a primary characteristic of WVU IRBs.
 Minimal risk studies will receive a thorough but
quick review.
 More than minimal risk research will receive full
board review at a convened meeting.
Is Your Study Research?
 There are Federal guidelines that define research and
“human participant research”
 Some studies that are sent to Office of Research
Compliance are clearly not research. If this is the case,
they do not require IRB or ORIC input.
Not Human Subject Research
 There are three questions at the beginning of the
protocol approval application. One of the three must
be answered “no” in order for the study to be classified
as Not Human Subject Research (NHSR). These are:
 Does the protocol meet the federal definition of
"Research"?
 Does the research involve living person(s)?
 Are you collecting information from individual person(s)
as part of this research?
Not Human Subject Research
 First, does the protocol meet the federal definition of
“Research”
 “a systematic investigation designed to develop or
contribute to generalizeable knowledge”
 http://oric.research.wvu.edu/r/download/104456
Not Human Subject Research
 Most case reports and most oral histories are not
generalizable and, therefore, not human subject
research.
 Many classroom projects, if not intended to be
published, are also not human subject research.
 Many quality improvement projects are not human
subject research.
 Many program evaluation projects are not human
subject research.
The Three Levels of Review
 Exempt
 Expedited
 Full Board
Authority of IRB
 Requirement of review
 Approve, disapprove or modify
 Conduct continuing review
 At any time and in person if desired
 Must be done at least once per year
 Observe/verify changes
 Suspend or terminate approval
Exempt Research
 Assume three questions have been answered “yes”
 The Office of Research Integrity and Compliance
reviews exempt research
What is Exempt Research?
 Some human subject research is exempt from the
necessity for IRB review by 21 CFR §56.104 and 45
CFR §46.101(b)(2).
 If it is judged to qualify as exempt, research must still
be reviewed and must be conducted in accordance
with WVU policies, the Federalwide Assurance, federal
guidelines and the ethical principles stated in the
Belmont Report.
 Exempt research is not classified.
Exempt Categories
 There are 6 distinct categories for exemptions.
 There are some that we don’t receive.
 Additional information on categories discussed here,
can be obtained at the WVU Research Compliance
website (Document 210r) or the appropriate Federal
Regulations.
Exempt – Category 1
 Research conducted in established or commonly
accepted educational settings involving normal
educational practices.
 It would include research on educational strategies,
comparison among instructional techniques, or
classroom management methods.
Exempt – Category 2
 Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of
public behavior, if human subjects cannot be identified
directly or through identifiers
Exempt – Category 2
 When survey procedures involve sensitive questions, there
should be provisions to make sure that the procedure
provides anonymity. If anonymity is promised, there must
be a clear explanation of how this will be accomplished.
 Also, must provide information on where to go for
counseling (i.e., Carruth Center or other)
Exempt – Category 3
 The participants are elected or appointed public
officials, or candidates for public office.
 Research involves the use of educational tests,
interview or survey procedures, or observation of
public behavior (same as category 2).
Exempt – Category 4
 The research involves the collection of existing data,
documents, records, pathological specimens, or diagnostic
specimens.
 The reviewed materials must currently exist and may
not be collected after the protocol is approved.
 The data to be collected and recorded must be
described. A complete list of variables to be collected,
must be submitted.
Exempt – Category 4
 The information to be collected or studied:
 Must be publicly available or,
 Information is recorded by the investigator in such a
manner that participants cannot be identified either
directly or through identifiers linked to them.
Exempt – Category 5
 The project is a research or demonstration project or
 The project is conducted by or subject to the approval
of a particular Federal Department or Agency head.
 Consist of study, evaluation, or examination a public
benefit program
Exempt – Category 6
 The research involves taste and food quality
evaluations and consumer acceptance studies.
Additional Requirements for
Exemption
 There must be no more than minimal risk; this needs
to be adequately explained.
 If investigator interacts or intervenes, it cannot be
exempt.
Cover Letter
 A cover letter is used in conjunction with a survey or
questionnaire to explain the study. The first item must
be a statement, “This is research”
 State that the IRB approval is on file
 Must be on department letterhead
 If the study could possibly include students, the letter
must state that prospective participants must be 18 or
older to participate
Cover Letter
 A statement that explains the reason for the research
(dissertation project, course requirement, etc)
 A statement explaining what the study is designed to
show.
 A statement that subjects’ response will be kept
anonymous or confidential and explain how this is to
be accomplished.
Cover Letter
 If audio taping, inform subject and explain storage and
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
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disposal of tape.
A statement that not all questions need answered.
A statement that class standing, job, grades, etc. will not be
affected if subjects does not participate.
A statement that participation is voluntary.
If sensitive questions are asked, provide counseling
information.
HIPAA Waiver
 Use or disclosure of PHI must involve no more than
minimal risk to privacy.
 Must be a plan to protect the identifiers from improper
use
 Must have a plan to destroy identifiers at earliest
opportunity.
 Must be written assurances that PHI will not be reused
or disclosed, except as required by law.
 Must be statement explaining why research could not
practicably be conducted without waiver and why it
could not practicably be conducted without access to the
PHI.
Exempt Research and Children
 Children can be subjects of exempt research unless the
research involves the use of survey procedures or
interview procedures.
 Observation of public behavior involving children can
be exempt if the investigator(s) does not participate in
the activities being observed.
Summary for Exemptions
 A study cannot be exempt if:
 There is intervention with subjects
 The research is subject to FDA regulations
Expedited
 Research that fits these categories must be reviewed
by the IRB.
Expedited
 Requires one or more experienced IRB reviewers, but
does not require a convened IRB.
 There must be no more than minimal risk to subjects.
 The identification of participants will not place them at
risk of criminal or civil liability or be otherwise
damaging
Expedited
 The research must fit into one of several specific
categories.
Expedited – Category 1
 Research on medical devices in which an IDE is not
required or if the device is approved for marketing and
it is used in accordance with its labeling.
Expedited – Category 2
 Collection of blood samples by finger stick, heel stick,
ear stick, or venipuncture from healthy non-pregnant
adult where
 Participants weigh more than 110 lbs and
 Amounts drawn will not exceed 550 ml in 8 wk period
and
 No more frequently than 2/week.
Expedited – Category 3
 Prospective collection of biological specimens for
research purposes by noninvasive means.
Expedited – Category 4
 Collection of data through noninvasive procedures
routinely employed in clinical practice where:
 No general anesthesia or sedation
 Do not involve x-rays or microwaves
 If medical devices are employed, they are approved for
marketing.
Expedited – Category 5
 Research involving materials (data, documents,
records, or specimens that have been collected; OR
 Research involving materials that will be selected
solely for non-research purposes (medical treatment
or diagnosis).
Expedited – Category 6
 Collection of data from voice, video, digital, or image
recordings made for research purposes.
Expedited – Category 7
 Research on individual or group characteristics or
behavior (including research on perception, cognition,
motivation, identify, language, cultural beliefs, social
behavior, etc.)
Full Board
 If your protocol does not fit into any of the previously
mentioned categories, it will go full board
 Full board means that the review process will take
more time
 There are currently two boards that each meet once
per month: the Blue Board and the Gold Board
Flow through System after
Submission
 Routed to IRB Administrator for training check
 If training check is OK, then it is assigned to an ORIC
HRPP staff person for review
 If all points are addressed appropriately, the ORIC
HRPP staff person does one of the following:
 Exemptions are approved or disapproved
 Expedited protocols are sent to one or more board
members for further review
 Full board protocols are assigned to an agenda for
review by the full board quorum
Additional Points
 The procedures must be adequately described.
 The selection of participants must be equitable, and
this must be explained.
Additional Points
 If medical records are accessed, the nature of the data
to be recorded must be explained in detail.
 If identifiable PHI is to be collected from medical
records, a HIPAA waiver of authorization is required.
 The need for HIPAA waiver must be justified and
explained.
Additional Points
 The research does not involve prisoners as participants
 There are copies of all advertisements, surveys, scripts,
cover letters, and letter of permission.
 If incentives are provided (extra credit, coupons,
vouchers), they must be justified and explained.
Privacy
 Privacy refers to persons and to their interest in
controlling access of others to themselves.
 Confidentiality refers to data.
Coercion and Undue Influence
 Care must be taken to ensure that there is no coercion
or undue influence placed on potential subjects. For
example, if faculty member wants to use his/her own
students as subjects, it must be made clear that there
are no penalties for not participating. Same for
employer/employees, coach/players, etc.
General Summary
 Try to fit a research project into an exempt or
expedited category if it can be done without
compromising the study.
 It will save time and effort.