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Leslie Howes, MPH, CIP
Alyssa Speier, MS, CIP
September 24, 2014
Investigator Manual: http://www.hsph.harvard.edu/ohra/investigator-manual/
OHRA’s Investigator Manual and Updates: The Investigator’s Best Friend
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Agenda
I.M. Table of Contents Human Research Protection Program (HRPP) Human Research Training Online Submission (ESTR) Research Protocol Reporting Financial Interests Classifications of Review and Determinations Investigator’s Responsibilities Informed Consent Continuing Review Considerations Services Available to Assist Investigators: QIP Study Closure Questions?
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I.M. Table of Contents
What is the purpose of this manual? What is the Human Research
Protection Program? What is Human Research? Exempt Human Research Who can be Principal Investigator
(PI)? What training do investigators and
study staff need to conduct Human Research?
How to submit a new Human Research Application Online
Who has access to my ESTR record and submission to the IRB?
How to write a Research Protocol What financial interests have to be
reported to the IRB?
How to create a consent/assent document?
What are the different regulatory classifications that research activities may fall under?
How does the IRB decide whether to approve Human Research?
Review Using the Expedited Procedures
Review by the Convened IRB What will happen after IRB office
receives a submission? What are the decisions the IRB can
make when reviewing proposed research?
What are the Investigator's obligations after IRB approval?
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I.M. Table of Contents (continued)
How to document consent? How to submit a modification? How to submit continuing review? How to get help for an IRB
submission? Are there any services available to
assist investigators with ensuring regulatory compliance?
How to close out a study? How long should records be kept? How to get additional information and
answers to questions? Appendix A: Prompt Reporting
Requirements Additional Requirements for DHHS-
Regulated Research Additional Requirements for FDA-
Regulated Research
Additional Requirements for Clinical Trials (ICH-GCP)
Additional Requirements for Department of Defense (DOD) Research
Additional Requirements for Department of Energy (DOE) Research
Additional Requirements for Department of Justice (DOJ) Research
Additional Requirements for Department of Education (ED) Research
Additional Requirements for Environmental Protection Agency (EPA) Research
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Human Research Protection Program (HRPP)
Not just the IRBComprised of :
– Institutional leadership– Institutional Review Board (IRB)– Quality Improvement Program (QIP)– Investigators and Study Staff– Relevant Departments and Units
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Human Research Training
Read HRPP Plan IRB approval may not be granted for proposed
research in which investigators have not completed human research protections training
– CITI Training– Check with ORARC Coordinator to find out if OHRA has current
training on file Staci Landis at [email protected] or 617-432-2157
Additional Training Available for staff– For training offerings visit:
http://www.hsph.harvard.edu/ohra/education-2/
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Online Submission (ESTR)
Electronic, Submission, Tracking and Reporting (ESTR) - http://irb.harvard.edu – University-wide system– Dedicated support available at
Study Submission Guide– Provides step-by-step instructions
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Research Protocol
Every section’s requirements are explained in detail Some highlights:
– Inclusion and Exclusion Criteria– Procedures involved in the Human Research
Include ALL HS Research vs. Standard of Care HLMA staff vs. others Describe what data will be collected and duration of research
– Privacy It involves consideration of whether the participants will be comfortable with the research
procedures– Confidentiality of Data
Describe where data will be stored, who will have access to the data, measures taken to secure the data, how long data will be stored, and, when applicable, how data will be archived and/or destroyed
Data security plans must comply with protection requirements described in the Harvard Research Data Security Policy (HRDSP)
Data Management and monitoring
Reporting Financial Interests
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Who “All individuals involved in the design, conduct, or reporting of the research” and their immediate family (anyone on the personnel information form and some not on it, too)
“Immediate family” means spouse, domestic partner, children, and dependents.
What Any amount over $0 must be reportedE.g., Ownership interest, Compensation of any amount, Proprietary interest of any value, Board or executive relationship regardless of compensation
When Initial and Continuing ReviewReport any change to the IRB within 30 business days
How Upload Financial Interest Disclosure Form in ESTR
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Classifications of Review & Determinations
Types of Review– Not Human Research– Exempt– Expedited– Convened IRB
Determinations – Approval– Requires Modification(s)– Deferral/Disapproval
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Investigator’s Responsibilities
Secure IRB approval prior to implementation Conduct study according to IRB approved protocol
– Submit Continuing Review, Modifications (including study staff changes) to IRB
Ensure adequate facilitates, equipment on site Ensure study staff are qualified Report “new information” (see Appendix A) Do not accept or provide “finder’s fees” or “bonus
payments”
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Informed Consent
Consent Templates available online with signature blocks and check boxes, e.g., written long form vs. child assent
If alternative format, submit justification Include all required elements Other considerations, e.g., HIPAA
authorization Documentation, e.g., signature and date fields
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Continuing Review Considerations
If involves modifications submit a separate modification request
If not received by submission deadline, will be restricted from submitting new Human Research until the completed application has been received
If expires, all HR Study procedures must stop– If stopping will harm participants, provide these on a clinical basis– If such procedures not available on a clinical basis, contact IRB
Administrative Chair, Julie Kaberry ([email protected] or 617-432-2149) and provide a written list of enrolled participants and explanation as to why they would be harmed if procedures were stopped
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Services Available to Assist Investigators: QIP
IRB Submission Assistance Routine On-site Reviews Education/Additional Training
– IRB Clinic– In-Service– New Investigator/Research Coordinator Orientation– Scheduled Education Series
Floating Research Coordinator/Assistant Study Management Tools
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Study Closure
Retain all records for seven years after study completion, i.e., closure of the Human Research protocol, or longer if required by the sponsor Including signed and dated consent documents
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Questions?
Leslie Howes, OHRA Director ([email protected])
Julie Kaberry, IRB Administrative Chair ([email protected])
QA/QI Specialists
Alyssa Speier ([email protected]) Stanley Estime ([email protected]) Lisa Gabel ([email protected])
OHRA: www.hsph.harvard.edu/ohra
See OHRA web site for department-assigned IRB Review Specialist and contact information
