Perfect Protocols

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Perfect Protocols
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P2 The Sequel
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Perfect Protocols
Linda Kephart Fallon
Coordinator, Research Programs and Services
Senior Editor / HIPAA Coordinator
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Perfect Protocols
When should the Protocol be prepared?
It depends upon the funding source.
Federal grant sources no longer require IRB
approval prior to the submission of the grant.
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Perfect Protocols
Three types of submissions
Exempt Submissions
Expedited Submissions
Full Board Submissions
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Perfect Protocols
UF FWA Part 2, III, D
The IRBs are responsible for reviewing the
preliminary determinations of exemption by
investigators and supervisors and for making the
final determination based on Section 101 of the
regulations. Notice of concurrence for all exempt
research will be promptly conveyed in writing to
the investigator. All nonexempt research will be
reviewed in accordance with 45 CFR 46.
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Exempt Protocols
When is a study considered Exempt?

• Virtually no risk to humans

• No Informed Consent Form

• Reviewed by a member of the Executive Committee

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Exempt Protocols
1. Research conducted in established or commonly
accepted educational settings involving normal
educational practices such as research on
regular and special education instructional
strategies, or research on the effectiveness of
or the comparison among instructional techniques,
curricula, or classroom management methods.
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Exempt Protocols
2. Research involving the use of educational
tests (cognitive, diagnostic, aptitude,
achievement), survey or interview procedures, or
the observation of public behavior, so long as
confidentiality is maintained. Exempt status
cannot be granted if (a) information is recorded
in such a manner that the subject can be
identified, directly or through identifiers
linked to the subject, and (b) the subjects
responses, if known outside the research, could
reasonably place the subject at risk of criminal
or civil liability or be damaging to the
subjects financial standing, employability, or
reputation.
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Exempt Protocols
3. Research involving the use of educational
tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview
procedures, or the observation of public behavior
that is not exempt under 2 if The human
subjects are elected or appointed public
officials or candidates for public office or
federal statute(s) require(s) without exception
that the confidentiality of the personally
identifiable information will be maintained
throughout the research and thereafter.
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Exempt Protocols
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.
What is existing?
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Exempt Protocols
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 (a) public benefit or service programs
(b) procedures for obtaining benefits or services
under these programs (c) possible changes in or
alternatives to those programs or procedures or
(d) possible changes in methods or levels of
payment for benefits or services under those
programs.
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Exempt Protocols
6. Taste and food quality evaluation and
consumer acceptance studies (a) if wholesome
foods without additives are consumed, or (b) 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 chemicals or environmental
contaminant at or below the level found to be
safe, by the Food Drug Administration, or
approved by the Environmental Protection Agency,
or the Food Safety and Inspection Service of the
United States Department of Agriculture.
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Exempt Protocols
What is submitted?
Introductory Questionnaire Short Form
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Expedited Protocols
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Expedited Protocols

• Considered no more than minimal risk

Risks are those encountered through every-day
life events

• Reviewed by a member of the Executive Committee

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Expedited Protocols
1. Clinical studies of drugs and medical devices
only when condition (a) or (b) is met (a)
Research on drugs for which an investigational
new drug application (21 CFR part 312) is not
required. Note Research on a marketed drug is
not eligible if the research significantly
increases the risks or decreases the
acceptability of the risks associated with the
use of the drug. (b) Research on medical devices
for which (1) an investigational device exemption
application (21 CFR part 812) is not required, or
(2) The medical device is both cleared/approved
for marketing and being used in accordance with
its cleared/approved labeling.
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Expedited Protocols
2. Collection of blood samples by finger stick,
heel stick, ear stick, or venipuncture as
follows (a) Subjects are healthy, non-pregnant
adults who weigh at least 110 pounds amount
drawn may not exceed 550 ml over 8 weeks and
collection may not occur more frequently than 2
times per week, or (b) Subjects are other adults
and children (defined in 45 CFR 46.402(a) as
persons who have not attained the legal age for
consent to treatments or procedures involved in
research, under the applicable law of the
jurisdiction in which the research will be
conducted), considering the age, weight, and
health of the subjects the collection procedure
the amount of blood to be collected and the
frequency with which it will be collected. For
these subjects, the amount collected may not
exceed the lesser of 50 ml or 3 ml/kg over 8
weeks, and collection may not occur more
frequently than 2 times per week.
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Expedited Protocols
3. Prospective collection of biological
specimens for research purposes by noninvasive
means. Examples hair and nail clippings, if
collected in a non-disfiguring manner deciduous
teeth at time of exfoliation or if routine
patient care indicates a need for extraction
permanent teeth, if routine patient care
indicates a need for extraction excreta and
external secretions (including sweat)
uncannulated saliva collected either in an
unstimulated fashion or stimulated by chewing
gumbase or wax or by applying a dilute citric
solution to the tongue placenta removed at
delivery amniotic fluid obtained at the time of
rupture of the membrane before or during labor
supra- and subgingival dental plaque and
calculus, provided the collection procedure is
not more invasive than routine prophylactic
scaling of the teeth and the process is
accomplished in accordance with accepted
prophylactic techniques mucosal and skin cells
collected by buccal scraping or swab, skin swab,
or mouth washings sputum collected after saline
mist nebulization.
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Expedited Protocols
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. Where medical devices are
employed, they must be cleared/approved for
marketing. (Studies intended to evaluate the
safety and effectiveness of the medical device
are generally not eligible for expedited review,
including studies of cleared medical devises for
new indications.) Examples physical sensors
that are applied either to the surface of the
body or at a distance and do not involve input of
significant amounts of energy into the subject or
an invasion of the subjects privacy weighing or
testing sensory acuity magnetic resonance
imaging electrocardiography, electroencephalograp
hy, thermography, detection of naturally
occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, Doppler
blood flow, and echocardiography moderate
exercise, muscular strength testing, body
composition assessment, and flexibility testing,
where appropriate to the age, weight and health
of the individual.
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Expedited Protocols
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). Note Some research in this
category may be exempt from the regulations for
the protection of human subjects as noted in 45
CFR 46.101(b)(4). This listing refers only to
research that is not exempt.
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Expedited Protocols
6. Collection of data from voice, video, digital
or image recordings made for research purposes.
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Expedited Protocols
7. Research on individual or group
characteristics or behavior (including, but not
limited to, research on perception, cognition,
motivation, identity, language, communication,
cultural beliefs or practices and social
behaviors) or research employing survey,
interview, oral history, focus group, program
evaluation, human factors evaluation or quality
assurance methodologies. Note Some research in
this category may be exempt from the regulations
for the protection of human subjects as noted in
45 CFR 46.101(b)(2) and (b)(3). This listing
refers only to research that is not exempt.
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Expedited Protocols
What is submitted?
Introductory Questionnaire
Protocol
Informed Consent Form
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Full Board Submissions
Greater than minimal risk
Perceived as greater than minimal risk
Deadlines apply
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Full Board Submissions
What is submitted?
Introductory Questionnaire
Protocol
Informed Consent Form
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Perfect Protocols
Do you have a sponsors protocol?
You do not need to write a new protocol you can
submit the sponsors protocol instead.
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Perfect Protocols
Do you intend to participate in all portions of
the sponsors protocol?
Yes. Provide the sponsors protocol.
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Perfect Protocols
Do you intend to participate in all portions of
the sponsors protocol?
No. Provide the sponsors protocol AND delineate
everything you will NOT be doing in Item 6
Research Plan.
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Perfect Protocols
 6.      Research Plan    Provide a
description of what you will NOT do.    Be
specific about what you will not be doing by
citing the relevant sections of the sponsors
protocol.
A simple addendum will be sufficient.
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What does the IRB want to see in a Protocol?
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Title
Be sure the title of your project is the same on
ALL of your submission materials.
Introductory Questionnaire
Informed Consent Form
Protocol
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Title
Be sure the title of your project is the same on
ALL of your submission materials.
GRANT APPLICATION!
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Investigators
List the name of the Principal Investigator and
all sub-Investigators.
Students must list the names of their supervisory
chair and committee members.
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Abstract
The abstract must be clear, concise, and include
the following information
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Abstract
Objectives
Identify the primary and secondary objectives of
the research project.
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Abstract
Design
Describe the basic design of your research
project, including study interventions.
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Abstract
Setting
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Abstract
Study Participants
Identify the subjects you intend to study.
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Abstract
Outcome Measures
Describe the data you will collect and the
statistical measures you will use.
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Abstract
Follow-up
If you intend to collect longitudinal data,
identify your follow-up measures.
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Specific Aims
Identify the hypothesis or the objectives of the
research project.
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Background Significance
Provide a literature review, including background
information
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Background Significance
Discuss why your project is a logical step toward
solving the problem and why this next step is
important.
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Research Plan
Include a discussion of the expected results and
how these results may be important.
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Research Plan
Provide a thorough description of what you intend
to do.
Include a study visit schedule.
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Research Plan
Discuss dosing regimens, blood draws, and other
study parameters.
How were these parameters determined? Provide a
justification.
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Research Plan
Describe the inclusion and exclusion criteria.
You may wish to design inclusion and exclusion
criteria with flexible parameters to avoid
protocol deviations at some future date.
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Research Plan
Discuss how research interventions differ from
standard therapies.
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Research Plan
A word or eighteen about HIPAA
The Protocol is the most important document when
assessing HIPAA information provided to subjects
on the consent document.
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Research Plan
Procedures for recruiting and consenting study
participants should be identified
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Research Plan
If you intend to use a vulnerable population,
include information describing how you intend to
protect them.
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Research Plan
What are the procedures should a study
participant decide to withdraw from the research
project?
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Research Plan
Under what conditions will you withdraw a study
participant from the research project?
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Research Plan
Identify the statistical methods you used to
determine the total number of study participants
you intend to recruit.
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Research Plan
Be sure you over-estimate your anticipated
subject accrual.
For example
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Research Plan
If you are screening 100 study participants to
obtain data on a total of 30, you must state this
here as well as on the Introductory Questionnaire.
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Research Plan
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Research Plan
Protected Health Information
Collect the minimum necessary to conduct the
study.
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Research Plan
HIPAA De-Identification Criteria

• Name

• Geographic subdivision smaller than a state or
  the first three digits of a zip code.

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Research Plan

• Dates

• Telephone numbers

• Facsimile numbers

• Email addresses

• Social Security Numbers

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Research Plan

• Medical Record Numbers

• Health Plan Numbers

• Account Numbers

• Certificate/License Numbers

• Vehicle Identifiers

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Research Plan

• Device Identifiers

• Web URLs

• IP Address Numbers

• Biometric Identifiers

• Full Face Photographic Images

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Research Plan

• Any other unique identifying number,
  characteristic, or code.

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Research Plan
If you intend to follow study participants, you
must indicate this in the research plan and
describe your follow-up activities.
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Research Plan
What types of statistical analyses will you use
for your data?
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Research Plan
Is there a Data Safety Monitoring Board (DSMB) or
an oversight committee for this research project?
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Research Plan
Provide information about the DSMB or oversight
committee including
Who is on the committee?
How frequently will the committee meet?
When will you get information from the committee?
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Research Plan
The use of flow charts, diagrams, and tables in
this section is encouraged.
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Discomforts Risks
Identify all discomforts and risks study
participants may encounter or experience.
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Discomforts Risks
List more common risks and discomforts first.
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Discomforts Risks
Less common risks should be identified separately.
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Discomforts Risks
Describe how you intend to minimize discomforts
and risks.
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Discomforts Risks
Discomforts and risks may include psychological
trauma and social stigma.
Discuss possible psychological and social risks
and how you intend to mitigate them.
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Benefits
Are there direct benefits to study participants?
If there is no potential for direct benefit, you
must state this in the Informed Consent Form.
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Benefits
What are the potential benefits to future
populations?
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Financial Risks
Identify potential financial risks study
participants may incur.
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Financial Risks
Indicate any procedures, medications, tests, or
therapies that study participants (or their
insurer) will have to pay for.
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Financial Risks
Are these considered standard care or are these
procedures required for the research project?
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Financial Benefits
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Financial Benefits
If so, discuss how compensation will be provided
and how it will be pro-rated for your research
project.
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Financial Benefits
Identify any laboratory tests, study medications,
or other procedures that will be provided at no
cost to study participants.
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Financial Benefits
If there are no direct financial benefits, you
must state this in the Informed Consent Form.
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Conflict of Interest
Describe any conflict of interest you or other
investigators may have concerning the funding of
this research project.
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Conflict of Interest
If the project is sponsored, how are you
affiliated with the sponsor?
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Conflict of Interest
Do you receive speakers fees?
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Conflict of Interest
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Conflict of Interest
Do you own stock in the company?
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Conflict of Interest
Will the sponsor pay the University of Florida or
the Veterans Administration for conducting the
study?
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Conflict of Interest
Are patent applications being developed based on
the results of this study?
Michael Scian, Asst Director of
Compliance 352-846-3533
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Review
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Protocol Review
Title
Investigators
Abstract
Specific Aims
Background Significance
Research Plan
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Protocol Review
Discomforts Risks
Benefits
Financial Risks
Financial Benefits
Conflict of Interest
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Any Questions?
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http//irb.ufl.edu/irb01
http//www.hscj.ufl.edu/irb/
Presentation by LKFallon