FLORIDA HOSPITAL
HUMAN RESEARCH
PROTECTION PROGRAM (HRPP)
ACCREDITATION
IRB Administration
Outreach, Training, and Education
OBJECTIVES
 AAHRPP
 Benefits of Accreditation
 Where Are We In The Process
 Investigator Preparation
An independent, non-profit accrediting body, that
ensures the HRPPs meet rigorous standards for quality
and protection.
BENEFITS OF AAHRPP
Respect
Competitive Edge
Reduce Risk
Enhance Standing
Where Are We In The Process
FH INVESTIGATOR PREPARATION
IRB Website - P/P’s, Guidances,
Investigator Manual, etc
IRBNet – Forms, Templates
Interview Prep - FAQs
MAIN COMPONENTS OF
FLORIDA HOSPITAL
HUMAN RESEARCH PROTECTION
PROGRAM (HRP-010)
 Investigators & research teams
 Sponsor
 Organizational Official (OO)
 Institutional Review Board (IRB)
 Office of Research Administration (ORA) – Contracts,
budgets, COI, compliance & education visits (audits)
 Legal – for interpretation of law i.e. who is considered
a minor or who can be an LAR (HRP-021)
 Grants
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ORGANIZATIONAL
OFFICIAL
The person who is
ultimately
responsible for
Human Research
Protection Program
at Florida Hospital.
Chief Scientific Officer,
Steven Smith, M.D.
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WHAT TRAINING IS REQUIRED FOR
RESEARCHERS AT FH?
 CITI - Every 3 Years
•
•
•
Basic Training Modules
Good Clinical Practice (GCP)
HIPAA
 ORA COI Training
 Investigator Forum
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What ethical standards or guides
do you follow?
PER HRP-010 – HRPP
BELMONT REPORT
HERE AT FH - Regardless of support or geographical
location
CLINICAL TRIALS – conducted in accordance with
ethical principles that have origin in the declaration of
Helsinki and are consistent with Good Clinical Practice
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What are the three ethical
principles of the Belmont Report?
RESPECT FOR PERSONS –
AUTONOMY
BENEFICENCE – DO NO HARM
JUSTICE – DISTRIBUTION OF
RISKS AND BURDENS
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What Rules are You Expected to Follow?
FDA / HHS Definitions
HUMAN SUBJECT Defined
RESEARCH Defined
FDA
<Research as Defined by FDA>: Any
experiment that involves a test article and
one or more <Human Subjects as Defined by
FDA>, and that either must meet the
requirements for prior submission to the
Food and Drug Administration under section
505(i) or 520(g) of the Act, or need not meet the
requirements for prior submission to the Food
and Drug Administration under these sections of
the act, but the results of which are intended
to be later submitted to, or held for
inspection by, the Food and Drug
Administration as part of an application for a
research or marketing permit.
HHS
<Research as Defined by HHS>: A systematic
investigation designed to develop or
contribute to generalizable knowledge
FDA
<Human Subject as Defined by FDA>:
An individual who is or becomes a
participant in <Research as Defined by
FDA>, either as a recipient of the test
article or as a control, or an individual
on whose specimen an investigational
device is used.
HHS
<Human Subject as Defined by HHS>:
A living individual about whom an
investigator conducting <Research as
Defined by HHS> obtains (1) data
through <Intervention> or <Interaction>
with the individual, or (2) information
that is both <Identifiable Information>
and <Private Information>.
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What Rules are You Expected to Follow?
CONT…
 State Laws pertaining to Research
 Local Laws pertaining to Research
 HIPAA pertaining to Research
 International as appropriate
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FH FWA
(FEDERALWIDE ASSURANCE)
The Florida Hospital Institutional Review Board (FHIRB) is duly constituted by the Adventist
Health System, dba Florida Hospital, and is organized and operates in compliance 45 CFR §46
when research involves human subjects as defined by 45 CFR 46, 21 CFR §50 and §56 when
research involves human subjects as defined by 21 CFR 56, International Conference on
Harmonisation – Good Clinical Practice E6 (ICH-GCP) for clinical trials, Florida State law, and
Florida Hospital policies for the conduct of human subject research. The institute holds a
Federalwide Assurance (FWA) from the Office of Human Research Protection (OHRP), under
DHHS, and is registered as follows:
Florida Hospital Institutional Review Board
(IORG #0000516),
Federalwide Assurance (FWA) #2060
(Expires 10/18/2018),
FHIRB 1/Panel A (IRB #0842)
FHIRB 2/Panel B (IRB #8071)
What does it mean when we
say FH is “engaged” in human
subject research?
NIH
FH
UF
HRP-010 Worksheet for Rules of
Engagement
1.If FH is the federal grant recipient;
2. If for purposes of human subject research:
(a) Data about subjects through
intervention or interaction;
(b) Identifiable private information
(c) Informed consent from a research
subject
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WHAT IS FH STANCE ON PAYMENTS
FOR REFERRALS OR ACCELERATED ENROLLMENT?
HRP-010
Legal Requirements – Page 3
Bullet 7
“7. This Florida Hospital prohibits
payments to professionals in
exchange for referrals of potential
subjects (“finder’s fees.”)”
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HOW DOES THE HRPP HANDLE INVESTIGATOR
SIGNIFICANT FINANCIAL INTERESTS?
• Research Personnel Log identifies financial interest.
• IRB works with ORA
Visit ORA Website for Policies/Procedures/Training on Conflicts of Interest
The IRB will verify that a management plan is in place with the Florida Hospital (FH)
Conflict of Interest (COI) Official. If the FH COI Official does not have an approved
management plan in place for this research, they will contact the individual(s) indicating
the Significant Financial Interest (SFI).
Final IRB approval cannot be granted until all SFI matters are settled. When an SFI
requires disclosure to subjects, the IRB receives a recommendation from the FH COI
Official regarding consent form language. The IRB reserves the right to determine what
disclosure language should be in the consent form.
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Concerns, Complaints, Suggestions
Report To:
IRB Chair
IRB Administration
Organizational Official
Legal Counsel
Department Heads
 Contact info on HRP-010, IRB & ORA
Websites, consent forms
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WHO PERFORMS THE ASSESSMENT OF THE
SCIENTIFIC DESIGN OF A STUDY?
Sponsors
FH Scientific Review Committees – Children’s / Nursing & Allied
Health
IRB members / Consultants as needed
WHAT DOES IRB TAKE INTO CONSIDERATION?
WORKSHEET HRP-401 such as:
• Does application accurately describe risks and benefits;
• Is research likely to yield the knowledge proposed to result;
• Is there a safer way to perform the research that will still accomplish the
aims;
• Are there any other procedures not described that my reduce risks to21
subjects with negatively affecting the research
WHAT ARE
DECISIONS THE
IRB
COMMITTEE
MAY MAKE
WHEN
CONDUCTING A
REVIEW?
Approve
Modification
required to secure
approval
Deferred
Tabled
Disapprove
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Reportable New Information (RNI) –
•
•
•
•
New Risk
Severe Harm
DSMB Reports
and the rest……
HRP-801 Prompt Reporting
Requirements
HRP-204 FORM
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OTHER QUESTIONS
 What are the requirements for data safety plans?
Answer: Required for research involving more than minimal risk.
The IRB considers the following: What safety information will be collected; how it will be
collected; the frequency of collection, when collection starts; the frequency or periodicity of
review; whether a data monitoring committee is needed; statistical tests for analyzing the
data to detect harm; provisions for the oversight of safety data; stopping conditions
 When designing/conducting a study, what do you think about to minimize risks to
participants? Answer: Utilizing procedures already performed on subjects for other
purposes; properly trained staff, proper consent administration with feedback
regarding subject comprehension, steps to ensure confidentiality, privacy
 Describe the processes you use to obtain consent. Answer: Ensure those delegated
are properly trained; utilize IRB Investigator Guidance and ORA Guidance
 What do you do if a prospective participant is unable to make a decision or does not
understand the research study? Answer: STOP. Do not enroll unless the protocol has
outlined and the IRB has approved procedures to utilize a legally authorized
representative to consent the participant for research.
OTHER QUESTIONS
 What are you expected to do to ensure equitable selection of participants?
Answer: PI should be particularly cognizant of the special problems of
research involving vulnerable populations, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons. Equitable selection flows from the
ethical principle of justice and does not mean that all groups are represented
in proportion to the population. It means that selection criteria should be
both fair and appropriate to the research question.
Common Justifications for Excluding Non-English Speakers from Participation
 Studies without a prospect for direct benefit and with procedures that are greater than minimal risk;
 Assessment tools, surveys, questionnaires or psychological tests that are only available in English;
 Enrollment required in situations where translators will not be readily available (satellite clinics, after regular
working hours, emergencies, etc.)
 Expectation based on experience that non-English speakers will rarely present to the clinic where enrollment will
take place.
OTHER QUESTIONS
What is the difference between Privacy & Confidentiality?
What is Privacy?
What is Confidentiality?
Privacy is the control over the extent, timing, and
circumstances of sharing oneself (physically, behaviorally,
or intellectually) with others. For example, persons may
not want to be seen entering a place that might stigmatize
them, such as a pregnancy counseling center clearly
identified by signs on the front of the building. The
evaluation of privacy also involves consideration of how
the researcher accesses information from or about
potential participants (e.g., recruitment process). IRB
members consider strategies to protect privacy interests
relating to contact with potential participants, and access
to private information.
Confidentiality pertains to the treatment of information
that an individual has disclosed in a relationship of trust
and with the expectation that it will not be divulged to
others without permission in ways that are inconsistent with
the understanding of the original disclosure.
During the informed consent process, if applicable, subjects
must be informed of the precautions that will be taken to
protect the confidentiality of the data and be informed of
the parties who will or may have access (e.g., research
team, FDA, OHRP). This will allow subjects to decide about
the adequacy of the protections and the acceptability of
the possible release of private information to the
interested parties.
Privacy is...
About people
A sense of being in control of access that others have to
ourselves
A right to be protected
Is in the eye of the participant, not the researcher or the
IRB
Confidentiality...
Is about identifiable data
Is an extension of privacy
Is an agreement about maintenance and who has access to
identifiable data
In regards to HIPAA, protects patients from inappropriate
disclosures of "Protected Health Information" (PHI)
OTHER QUESTIONS

 What if you just simply don’t know an answer to a question? Or
Who do you go to when you have questions about conducting research?
You can refer to policies/worksheets/checklists and/or that you would
contact IRB Office, IRB Chair, IRB Manager, ORA Office, Coordinators, IRB /
ORA Policy and Procedure on Websites and IRBNet.
 No need to offer more information than necessary to answer the question.
Questions?
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