Transcript Exempt Research - West Virginia University

Not research, Exempt research,
and Expedited research
First, is what you are doing
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 ORC input.

Questions
First, does the protocol meet the federal
definition of “Research”
 The federal definition is provided in the
“help” icon and is
 “a systematic investigation designed to
develop or contribute to generalizeable
knowledge”
 Additional information in “help” icon.

Is it research?
Most case reports and most oral
histories are not generalizable and,
therefore, not research.
 Many classroom projects, if not intended
to be published, are also not research.

Is it research?
Many quality improvement projects are
not research.
 Many program evaluation projects are
not research.

Not research in BRAAN II
Question in BRAAN II (Second required
category), Human Subject Research
 There are three questions. All three
must be answered “yes” in order for the
study to be classified as Human Subject
Research.
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Exempt research

Assume three questions have been
answered “yes”
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.

Who evaluates exempt research?

The Research Compliance Office (Barb
White) since the advent of BRAAN II.
Categories
There are 6 distinct categories for
exemptions.
 There are some that we don’t receive.
 Information on these, seldom used,
categories and additional information on
ones discussed here, can be obtained at
the WVU Research Compliance website
(Document 210r) or the appropriate
Federal Regulations.

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.

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
Category 2, cont’d

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)
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).

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.
Category 4 (part II)
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.

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

Category 6

The research involves taste and food
quality evaluations and consumer
acceptance studies.
Reviewers action
1. Determine that the project is human
subject research.
 2. If it is, determine that it fits a particular
category for exempt acknowledgment.
 3. Check additional 12 points on
checklist (Document 210r)
 4. Notify investigator that research
qualifies as exempt and under which
category.

Additional requirements for
exemption
The procedures must be adequately
described.
 There must be no more than minimal
risk; this needs to be adequately
explained.
 The selection of participants must be
equitable, and this must be explained.
 If investigator interacts or intervenes, it
cannot be exempt.

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.

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.
Cover letter

If 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”
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
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If audio taping, inform subject and explain
storage and 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.

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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.

Still more and summary

A study cannot be exempt if:
A consent form is used
 There is intervention with subjects
 The research is subject to FDA regulations.
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Research reviewed under expedited
procedures

Research that fits these categories must
be reviewed by the IRB.
Expedited Research
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.
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.
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.
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Category 3
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Prospective collection of biological
specimens for research purposes by
noninvasive means.
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.

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).

Category 6

Collection of data from voice, video,
digital, or image recordings made for
research purposes.
Category 7

Research on individual or group
characteristics or behavior (including
research on perception, cognition,
motivation, identify, language, cultural
beliefs, social behavior, etc.)
Category 8a
The research is permanently closed to
enrollment of new participants and
 All participants have completed all
research-related interventions and
 The research remains active only for
long-term follow-up of participants.

Category 8b
The research is permanently closed to
enrollment of new participants and
 No participants have been enrolled and
no additional risks have been identified.

Category 8c
The research is permanently closed to
enrollment of new participants and
 The remaining research activities are
limited to data analysis.

Category 9
Medical Device research.
 The research is not conducted under an
IDE and the IRB has determined that
 The research involves no greater than
minimal risk.

If your protocol does not fit in any of
above?

It will go “full board”. This will ordinarily
take more time.
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.

Thou shalt not start until
You have completed CITI training
 You have a Master ID
 You have some knowledge of BRAAN II

Thou shalt not
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Begin your research until you have an
approval from the Office of Research
Compliance (via BRAAN II).
Thou shalt not

Have any correspondence with
respondents (including advertisements)
without IRB approval.
Thou shalt not

Forget to submit all requests for changes
(reports of deviations, amendments, any
matters of non-compliance, or
unexpected problems) on BRAAN II.
Thou shalt not

Forget to file a continuing application via
BRAAN II.
Finis