Transcript IRB Overview and eProst Redesigned (presented by Joey Casanova)

Joey Casanova, Education Coordinator
Human Subject Research Office
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Respect: individuals must be autonomous in
their decisions of whether to participate in
research (making informed decisions)
Beneficence: securing well-being of
participants by reducing risks
Justice: considerations appropriate
to avoid injustices that arise from
social, racial, sexual, and cultural
biases
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The mission of the OHRP is to monitor and
promote compliance with regulations set forth
from the Department of Health and Human
Services (DHHS) that relate to the ethical
standards of research involving human subjects
(45 CFR 46).
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Any research involving a drug, a biologic, or a
medical device is subject to Food & Drug
Administration (FDA) regulation (21 CFR 50, 56,
respectively).
UM
Policies
& Procedures
State and Local
Laws
Federal Regulations
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HHS:
A living individual about
whom an investigator…
conducting research obtains
1. Data through intervention or interaction
with the individual, or
2. Identifiable private information
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FDA:
Recipient of test article or control
HHS:
A systematic investigation designed to
develop or contribute to generalizeable
knowledge
 FDA:
Clinical Investigations of FDA Regulated
Products – any experiment in which a
drug, biologic or significant risk device is
administered or dispensed to or used
involving one or more human subjects
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Human
Research
Subjects
Exempt
Expedited
Full
Low
Minimal
Higher
*Level of risk helps determine route of review
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DHHS 45 CFR 46.102(i) & FDA 21 CFR 56:
 The probability and magnitude of harm or
discomfort anticipated in the research are
not greater in and of themselves than those
ordinarily encountered in daily life or during
routine physical or psychological exams or tests
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OHRP Guidance:
 Minimal risk is relative to the daily life of a normal,
healthy person. The risk threshold cannot increase
because the person is sick and faces greater risk due
to illness
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Six categories defined by 45 CFR 46
Research must fall into one or more of the
categories to be exempt
IRB has the responsibility to determine
exemption, PI cannot make determination
May still require consent or other safeguards
How is data being collected?
 Is there a code that links data to subjects
(easily identifiable)?
(1) Educational research
(2-3) Tests, surveys, interviews or public
observation
(4) Research on existing public or anonymous
data or specimens
(5) Federal demonstration projects
(6) Taste and food evaluation
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Expedited does not mean quicker
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Rigor of review is the same, number of
reviewers different
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Review carried out by IRB chair or by one or
more experienced reviewers
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Reviewers may approve or modify, but may
not disapprove
An IRB may use the expedited review
procedure to review either of the
following:
 Some or all of the research appearing on
the list and found by the reviewer(s) to
involve no more than minimal risk
 Minor changes in previously approved
research during the period (of one year or
less) for which approval is authorized
(1) Clinical studies: IND/IDE not required
(2) Blood sample collection (routine methods –
small amounts)
(3) Prospective collection of biological samples –
noninvasive means
(4) Data collected through noninvasive means
(routinely practiced in clinical settings)
(5) Materials (data, documents, specimens) have
been collected or will be collected for nonresearch purposes
(6) Collection of voice, video or digital data for
research purposes
(7) Individual or group behavior, surveys,
interviews, oral histories
This is not correct. The IRB must
consider the risk of criminal/civil liability,
financial risk, employment risk, risk of
stigmatization, risk to insurability, and
risk of embarrassment in addition to
physical risk when deciding if risk is truly
minimal.
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A full quorum is assembled (at least half of
the members plus one, includes nonscientist)
All members participate in discussion and
make comments (plenary review)
Decision is rendered by a majority of the
assembled quorum
No member with a conflict of interest
participates in the decision
Numerical vote is taken and recorded
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Minimized risks (not eliminated)
Reasonable risk/benefit assessment
Equitable subject selection
Informed consent process
Informed consent documentation
Data monitored for safety
Confidentiality/privacy maintained
Vulnerable populations protected
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Unless waived by the IRB, the investigator
must obtain the legally effective informed
consent of the subject or the subject’s legally
authorized representative
Must provide the subject sufficient
opportunity to consider participation and
minimize undue influence
Information must be in language
understandable to the subject
May not include exculpatory language
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Consent is a Process in which:
 You disclose relevant information
 The potential subject has the opportunity to ask
questions
 You answer questions
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The consent form is a permanent record of…
 The information you conveyed
 The fact that the process occurred
 The subject’s willingness to participate
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Research acknowledgement
Purpose of the study
Description of procedures
Description of potential risks
Description of potential benefits
Alternatives
Confidentiality
Compensation for Injury
Who will answer questions
Participation is voluntary
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The fact there may be unforeseeable risks
Involuntary termination of participation
Additional research costs
Consequences of subject withdrawal
Significant new finding will be reported to
subject
Approximate number of subjects
Payments/Reimbursement
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Applies to children 7 through 17 years of age.
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Failure to object is not assent
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IRB determines whether and how it is
documented
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Assent is required except:
 when child not capable: age, maturity, or
psychological state;
 Research presents direct benefit; important to the
child’s well-being, and available only in context of
research
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Assent can be waived if:
 Research involves no more than minimal risk
 Waiver will not adversely affect the rights
and welfare
 Research could not be practicably carried out
without the waiver
 Whenever appropriate the participants will be
provided with additional pertinent
information
http://hsro.miami.edu
Electronic PROtocol
Submission & Tracking system
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Assists the HSRO in supporting and managing
all biomedical and social behavioral research
Access via standard internet browser
 Internet Explorer (PC Users)
 Safari (Apple Users)
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Captures information capture as required by
federal regulations, state laws, and
institutional policies
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Full Re-deployment of the electronic workflow
will be completed in February 2008
Study teams will continue to complete protocol
forms in eProst
All members of the Protocol Team need to
Submit their Conflict of Interest disclosures
individually
Principal Investigator will then be able to
Submit Protocol
Study will now be traveling through the
workflow
Accessible anywhere you have internet access
Faster turnaround time for submissions to the
HSRO
 Easier tracking of studies through review process
 Incorporated audit trail
 Improved interaction between study teams and
Institutional Review Board staff
 Back-ups performed regularly by both the HSRO
and Med-IT
 IRB-approved and watermarked documents
available online
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 No new studies are being reviewed at WIRB
 Many existing studies currently at WIRB are being
reacquired at continuing review
 WIRB submissions will still need to be printed for
submission to the HSRO and subsequently WIRB
 Only WIRB forms required for continuing report or
amendment
◦ Investigators asked to update smart form for
amendments when necessary
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eProst User Guide available at
http://hsro.miami.edu
Up-to-date information relayed via eProst
and HSRO eNews
Pre-Submission
Originating
Department
Review
Ancillary
Committee Review
Withdrawn
Changes Required
by Originating
Department
Changes Required
by Ancillary
Reviewer
Disapproved
Disapproved
Pre-Board
Review
Pre-Board Review
Regulatory Review
Awaiting Meeting
Assignment
Changes Required by
Pre-Board Staff
Changes Required by
Regulatory Staff
IRB Meeting
Assigned
Approved
Ancillary Committee
Review
Expedited Review in
Progress
Deferred to
Full Board
Protocol at WIRB
Exempt Review in
Process
Approved
Deferred to
Full Board
IRB Meeting
Assigned
Meeting
Complete: PostBoard Review
Approved
Deferred to Chair
Deferred to Full
Board
Board
Disapproval
Average time for completion
of review process/IRB
determination = 4-6 weeks
Study cannot begin until PI
has received approval
notification from the IRB.
IRB Regulatory
Specialist
(Exempt & Expedited
Review)
Submission
arrives
At HSRO
IRB Regulatory
Analyst
(Full Board Review)
Post-Board Review
(Determination Letter)
IRB Full Board
IRB Chair/Designee
(Exempt/Expedited)
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Educational Initiatives
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Marisabel Davalos, M.S.Ed., C.I.P.
Assistant Director for Educational
Initiatives
[email protected]
305-243-9769
 Joey Casanova
Education Coordinator
[email protected]
305-243-3476
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Amanda Coltes-Rojas, M.P.H., C.I.P.
Associate Director for Regulatory Affairs and
Educational Initiatives
[email protected]
305-243-6494
eProst Help Desk
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HSRO IT Group
Stella Uyeno
Sr. Systems Administrator
[email protected]
305-243-3196
 Leandro Guzman
Software Specialist II
[email protected]
305-243-8554
Regulatory Guidance/
Participant Complaints
Daniel Auguste
IRB Senior Staff Assistant
[email protected]
305-243-9662
eProst General Technical Assistance
Via email: [email protected]
305-243-3195