irb overview 101414 - ut agresearch | ut agresearch
TRANSCRIPT
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IRB Overview
An Introduction to our HSPP
Presented by: Robert Nobles, DrPH, MPH, CIP
Sonya Sullivan, MBA
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Objectives
• Help you succeed by exploring the IRB – Basic Review Criteria – Historical Context – Submission Forms – Internal Processes
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HUMAN SUBJECTS PROTECTION PROGRAM
SPONSOR
UT
IRB
GRANTS AND CONTRACTS
RESEARCHER
RESEARCH STAFF
RESEARCH SUBJECT
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A closer look at two diverging needs
HSPP
• Ensure submissions are complete and coherent
• Ensure federal and UT rules/policies are upheld
• Ensure submitted protocols and research materials receive appropriate review
• Ensure informed consent document and procedures are appropriate
Research Investigators/Teams
• Develop and conduct relevant research
• Develop and perform sound research methods
• Maintain proper documentation and approvals
• Interact with subjects in an ethical manner
• Analyze and report data
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Unified Goals and Jurisdiction • IRB Primary Goal: To protect
the rights and welfare of human research participants.
• HSPP Primary Goal: serve as regulatory specialist to enhance and facilitate the review of human subjects research.
• Human Subject: Individual from which an investigator conducting research obtains data through intervention/interaction or private information from some other source.
• Basic Ethical Principles: 1) Respect for persons, 2) Beneficence, and 3) Justice
• Jurisdiction: Research being conducted by an employee of the university, on our facilities, or with our UT student/employee population.
• Submissions that Require Review: 1) Initial Reviews, 2) Change Requests, 3) Continuing Reviews, 4) Protocol Deviations, 5) Data and Safety Monitoring Reports, 6) Adverse Events, 7) Miscellaneous Submissions, and 8) Study Closures.
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SUBMISSION DEVELOPMENT
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The Ultimate Study Submission Balance
• Is the study scientifically sound?
• Are all of the activities ethical and meet regulatory requirements?
• Are all of the logistics explicit?
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Scientific Assessment Criteria
• Rationale is clear and scientifically sound. • Study design is adequate & aims are measurable. • Research relies on the least risky procedures that
are clinically/scientifically sound. • Literature review is adequate. • Statistical considerations (sample size, accrual,
analysis) are adequate for objectives. • Investigators are qualified to conduct the study. • Proposed subject population is appropriate. • Data collected is needed to meet study objectives.
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Protocol Elements
• Literature review/current state of knowledge
• Justification for the study
• Potential use of study findings
• Study design and locations
• Hypothesis
• Methodology • Description and
source of study population
• Inclusion and exclusion criteria
• Number of participants
• Sampling and participant selection
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Protocol Elements (2)
• Recruitment/enrollment activities
• Consenting process • Confidentiality/privacy • Data monitoring • Explanation of study
instruments • Data analysis plan
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Recruitment/Screening • Recruitment: – Process that is implemented to identify or inform
prospective individuals about the research study. • Direct contact in a medical or non-medical setting;
solicitation letters; flyers/brochures; media outlets; etc.
• Screening: – To select, reject, or consider persons by examining
either their desire and/or the appropriateness for inclusion into a study. • This can occur before or after obtaining informed consent
with the proper IRB approval.
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Enrollment/Consent • Enrollment: – Point at which research data is collected on
individuals • Can be retrospective or prospective • If prospective, informed consent is obtained (unless
otherwise waived by the IRB
• Informed Consent: – The process by which a study participant provides
prospective agreement to participate in a research study once he/she has gathered enough essential information to independently make that decision.
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Subject Recruitment • Recruiting subjects from the general public – Use of patient brochures – Use of recruitment flyers – Use of media outlets, including the internet, radio, etc.
• Basic guidelines include: research indicating, eligibility, title, purpose, contact information, and institution.
• What should not be stated: – emphasize on monetary compensation; – amount of compensation; – catchy words such as “exciting”, “cutting-edge”, etc.; – statements that recruit children directly; – or misstatements of information contained within the protocol.
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Informed Consent Overview • All modern codes of ethics concerning research with
human subjects affirm the moral importance of a principle of informed consent.
• “The voluntary consent of the human subject is absolutely essential”
• Obtaining consent is an ongoing process of communication and mutual understanding
• The process is misrepresented as: • A piece of paper • A moment in time • A legal contract
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Informed Consent Overview (2)
• Must be obtained for each research subject • Must be obtained prior to initiation of
screening procedures or receipt of personal information
• Must be tailored to the level of understanding
• If a medical term is used, a lay definition is needed
• Sufficient opportunity must be given for consideration, without coercion
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Four Tenets for Effective Consenting
1. Accurate Information
2. Understanding
3. Voluntariness
4. Decision Making Capacity
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IRB Overview
• Mission: – To protect the rights and
welfare of human research participants.
• Definition of Research: – Systematic investigation,
including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
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Key Features Of Research
• Intent: generate new knowledge, principles, or theories that revises or improves existing knowledge, programs or processes.
• Systematic collection and/or analysis of data.
• Anticipated results that are valid
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HUMAN SUBJECTS
• Individuals from which an investigator, whether professional or student, conducting research obtains: – data through
intervention or interaction with the individual, or
– identifiable private information
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Assessment Criteria
• Reviewing research to ensure: – Risks are minimized – Risks are reasonable vs. benefits – Selection is equitable – Informed Consent is obtained – Data and Safety are protected/monitored – Privacy and confidentiality are upheld – Vulnerable population protections are enhanced
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Phy
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Lega
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Psy
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Soci
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Eco
nom
ic
Discomfort
Inconvenience
Harm
TYPES OF RISKS
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EXEMPT
• No risk • Case Study • Existing
data
EXPEDITED
• Minimal risk
• Prospective data
• MRI, blood, Ultrasound
FULL BOARD
• Greater than minimal risk
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• IRB leadership • IRB Membership • IRB Compliance Officer • iMedRIS implementation • Process enhancements – Continuing Review Cycle – Link to Sponsored Programs – Oversight through data analysis
Recent Changes
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Discussion/Questions