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Primary Care and Community Outreach Research
VCOM Institutional Review Board
Jim Mahaney, PhD
Associate Dean for Biomedical Affairs, Virginia Campus
Past Chair, VCOM IRB
The VCOM IRB
The role of the VCOM IRB is to oversee and foster the ethical treatment of human research
participants in VCOM research studies – including Primary Care and Community Medicine
research.
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Governed by the Department of Health and Human Services: OHRP
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45.CFR.46 – the “Common Rule”
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Specific guidance given for education applications
Also governed by the Food and Drug Administration
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21.CFR.50 and 21.CFR.56 – FDA Regulations
The VCOM IRB is also service oriented, seeking to help new and experienced investigators
develop human subjects research projects and navigate the application process. At all times,
the IRB’s goal is to foster research.
VCOM IRB Essentials
http://www.vcom.edu/research/irb/index.html
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Key Personnel:
– Dr. Dixie Tooke-Rawlins: Institutional Official
– Dr. Gunnar Brolinson: IRB Chair
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[email protected]
– Ms. Eryn Perry: IRB Director
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Help and guidance on IRB applications, reviews, general questions
[email protected]
– Ms. Stephanie Hurt: IRB Coordinator
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All correspondence with the IRB, submission of applications, inquiries about pending
reviews
[email protected]
The VCOM IRB Website
http://www.vcom.edu/research/irb/index.html
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Information about the Application Submission Process (PLEASE start here!)
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Forms and instructions
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Required training
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Policies and Procedures
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Contact information for help and guidance
– Ms. Eryn Perry: project design, application guidance and help
– Ms. Stephanie Hurt: application submission and compliance with requirements
Research at VCOM
and VCOM-Affiliated Sites
• Oversight of human subjects research is dependent on several
factors:
– Research onsite at VCOM by Faculty / Students
• Direct oversight by the VCOM IRB
– Research at a VCOM Clinical Partner Training Site
• Depends on agreement and whether site has its own IRB
• Usually written into agreement or a relationship exists between IRBs
– Research by VCOM Faculty / Students at other sites
• Requires interaction with other site IRB, or creation of IRB relationship
Important Rule!
Absolutely NO HUMAN SUBJECT RESEARCH may be done at
VCOM or by VCOM personnel at other sites prior to approval by the
VCOM IRB.
Any human subject data collected prior to approval…or during a
“lapsed” protocol…is void and cannot be used or published in any
way.
NO RETROACTIVE APPROVAL OF RESEARCH PROTOCOLS
Getting Started with Human
Subject Research
• First, a researcher develops his/her idea for a study
– Develop a research proposal first!
• Work out your ideas
• Plan your study
• Enlist your co-investigators and students.
• Next, one must determine if this is human subject research…and
what level of review is needed for this project
– Exempt: not human subject research
– Expedited: only minimal risk
– Full Board: more than minimal risk, special populations
Decision Charts
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
The Office for Human Research Protections (OHRP) under the Department of Health & Human
Services (HHS) provides decision charts as a guide for institutional review boards (IRBs),
investigators, and others who need to decide if an activity is research involving human subjects
that must be reviewed by an IRB under at 45 Code of Federal Regulations part 46.
The decision charts address decisions on the following:
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whether an activity is research that must be reviewed by an IRB
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whether the review may be performed by expedited procedures, and
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whether informed consent or its documentation may be altered or waived.
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Specific help with these decisions can be obtained from Eryn Perry:
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Ask for help and guidance early in the process for maximum benefit and time savings.
Is it Human
Subjects
Research?
Is the study
Exempt?
Expedited
Review
Who Decides?
The IRB (usually the IRB Chair) is the decision maker as to whether any proposed study
is human subject research and what level of IRB review is needed.
Many institutions require even exempt human subject research to be reviewed on an
annual basis as it is easy for a study to morph into one that needs IRB review without
a research team realizing it.
General Rule: it is far better to seek IRB approval…even
for an exemption…than risk being wrong.
Next: Get the Required Training
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IRBs, institutions, and sponsors generally require key research personnel to complete
formal training in the protection of human research subjects.
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VCOM uses the CITI Training System
http://www.vcom.edu/research/irb/required_education.html
https://www.citiprogram.org/
https://phrp.nihtraining.com/users/login.php
Other equivalent training will be accepted
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This training must be completed prior to submission of a protocol to an IRB. Proof of
certification required! It is the investigator’s responsibility to complete his / her training and
receive proof of certification, and to keep a record of this certification for use with IRB
applications.
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Absolutely NO human subjects research may be conducted without certification of IRB
training. Investigators, students, primary project persons.
Forms, forms and more forms!
http://www.vcom.edu/research/irb/forms.html
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IRB Application Form (required)
– This is a SUMMARY of the overall research proposal. It is NOT the proposal.
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IRB Form A, B or C (one of these is required)
– Each one corresponds to a level of IRB Review (Exempt, Expedited, Full Board)
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IRB Form F (Optional based on design of study)
– Waiver of Informed Consent or Documentation of Informed Consent
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Informed Consent Documents (Required unless waived)
Informed Consent
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http://www.vcom.edu/research/irb/forms.html
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Most adult subjects: Consent Document
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They can agree (assent) to be part of study
Parents CANNOT consent for the child
Parents CANNOT force child to participate
Parent(s) / Guardian(s) Permission Form:
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The informed consent document may be
modified depending on the type of study
and risk involved with the study
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Documenting informed consent can be
waived by the IRB under special
circumstances
18 years old and up
Minors: Assent Document
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Provide permission for their child to
participate
Is not the same thing as consent or assent
Child may refuse even if parent says yes
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Most commonly for anonymous surveys
where the informed consent would be the
only link between the participant and the
survey.
HIPAA and Research
http://privacyruleandresearch.nih.gov/
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The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the comprehensive
Federal protection for the privacy of protected health information (PHI).
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PHI relates to any data or information about a patient or subject that is personally identifiable and/or link
the information directly and uniquely to the patient/subject.
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HIPAA focuses mostly on health care delivery rather than research, but if research activities access PHI
or generate new PHI, HIPAA is a consideration for that research.
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Example of HIPAA requirement: direct examination of patient medical records without the consent of the patient.
Contrast: Physician with regular access to medical records may provide de-identified data from records
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Note: even in this case, many hospitals / clinics still require HIPAA waiver or consent from patient.
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So human subjects research may or may not be subject to the HIPAA Privacy Rule.
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The IRB will help make this determination and to facilitate getting the proper permissions / waiver as
needed.
Submit your Application
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Stephanie Hurt, IRB Coordinator
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[email protected]
Will check submission to ensure all is in order
Copy of Research Proposal required!
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Details of study not always clear from the application
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Documentation of IRB Training Certificate: Investigator’s responsibility
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IRB Application and all related forms
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Informed Consent, Assent, Permissions
Surveys, tests, teaching instruments, plans
Mission research with non-English speaking subjects? Documents in subject’s language must be
submitted, and they must be certified translations of the English version.
The VCOM IRB is Here to Help
How can we help you today?