Getting Through
The Approval Process
Objectives
• Discuss why it is necessary to get informal and
formal approvals
• Describe the documents that DUHS IRB requires for
approval
• Describe definitions of IRB and IRB approval
• Discuss Human Subject Protection (HSP)
• Describe DUHS IRB reviewing process
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What Are Types Of Approval?
• Informal approval, or “buy in”
– Support and participation of peers and
unit leadership
• Formal approval
– Institutional Review Board (IRB)
– Site-Based Research (SBR) Units Review
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Why Is It Important To Obtain Informal
Approval?
• The support and participation of peers and unit
leadership will be invaluable to the success of
your study.
• Peer support serves to speed the project’s
completion and also contributes to enthusiasm
and general buy-in for the study.
• Administrative support is equally valuable and
may impact the degree to which the study
ultimately influences practice in your institution.
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How To Obtain Informal Approval
• Identify key stakeholders
– An individual or a group who will be affected by
the study but possibly not directly involved in the
development or data collection for the study
•
•
•
•
Share a patient population
Staffing pool that will be involved in data collection
Interest in the outcome of the patients being studied
Vested interest in the question
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How To Obtain Informal Approval
• Get feedback from stakeholders early in the proposal
process
– Leadership buy-in
– Physician participation - particularly regarding access to
patients
– Staff participation
• Clarify the commitment of stakeholder
– Level of commitment will vary among the stakeholders
– Level of commitment should be clarified from the start
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What Is DUHS Process for Nursing
Research/Projects Approval?
• Fill out a Nursing Research/Project Organizational
Feasibility Form
• Obtain these signatures in the following order:
1.
2.
3.
4.
5.
6.
The PI
Nurse manager
Clinical Operations Director
Associate Chief Nursing Officer
Nursing Research Scientist
DUHS Chief Nursing Officer
• Keep the completed Feasibility Form in the study
regulatory binder
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What Is Nursing
Research/Project
Organizational
Feasibility Form?
• A form required
to obtain DUHS
administrative
approval for staff
research/projects
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DUHS Training Requirements
• Training to be completed prior to eIRB submission
• IRB Human Subjects Protection (HSP) Certification via
CITI modules which are self paced online modules.
General information is
available: http://medschool.duke.edu/research/hsp-certification
• Clinical Research Support Office (CRSO) New Investigator
workshop. When you register for the class, you will be
required to complete on on-line pre-assessment. This
course is offered only once a month.
http://crso.som.duke.edu/modules/crso_resrch/index.php?id=14
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What Is Formal Approval Process?
• IRB: an Institutional Review Board established in accord with
and for the purposes expressed in Code of Federal Regulations
(CFR) TITLE 45 PUBLIC WELFARE, Department of Health
and Human Services, PART 46, PROTECTION OF HUMAN
SUBJECTS
• IRB approval: the determination of the IRB that the research
has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other
institutional and federal requirements.
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What Does IRB Do?
• Institutional Review Board (IRB)
– To protect the rights of human subjects
who will be enrolled in the study
– To evaluate and resolve any ethical issues
which may arise in the course of the study
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What Needs IRB Approval?
• The IRB must review and approve all
research on human subjects, both
patient and staff research, conducted
in the institution prior to beginning
data collection
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Site Based Research Review
• A component of the IRB process is review by a specified
Site Based Research (SBR) Unit.
• The SBR serves as the operating business unit and is
responsible for the integrity, financial accountability,
regulatory compliance, quality and academic productivity
of clinical research studies
• You will need to specify an SBR as part of the eIRB
submission process
• Learn about SBR at Duke:
http://crso.som.duke.edu/modules/crso_sbrg/index.php?id=62
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What Does a SBR Review?
• Site Based Research Units (SBR) review
– A review of your proposal by other experts within your
institution
– The purpose of this review is to ensure content validity as
well as legal, ethical, and scientific standards.
– After the protocol is submitted to the DUHS IRB, SBR
reviewer is assigned by the director of the specified SBR
– When the SBR review is complete the study automatically
progresses to the next step, IRB review
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IRB Process
Types of Submissions
• Regular Study Application
– Most common
– IRB will determine is study is eligible for expedited review
or requires full board review
– Expedited
• Application for Exemption from IRB review
– Only IRB can make a declaration of exemption from RIB
review (includes Exempt (45 CFR 46.101(b)), Not Human
Subject Research (45 CFR 46.102 (f)), & Not Research (45
CFR 46.102 (d)).
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QI as Research
• DUHS IRB has set an expectation that Quality
Improvement projects which are externally
disseminated are to be submitted for an IRB
determination
• http://irb.duhs.duke.edu/wysiwyg/downloads/QI_Acti
vities_vs_Research_03-09-2009.pdf
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IRB Process
• Expedited vs. Exempt ?
• Human Subject Regulations Decision Charts
– A guide for institutional review boards (IRBs),
investigators, and others who decide if an activity is
research involving human subjects that must be reviewed
by an IRB under the requirements of the U.S. Department
of Health and Human Services (HHS) regulations in CFR
45 part 46.
http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
– Also see the lecture given by the DUHS IRB Senior Chair,
Dr. Falletta on January 2010: Find the ppt presentation in
“Past Things You Need To Know” at CRSO website http://crso.som.duke.edu/modules/crso_resrch/index.php?id=2
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IRB Process
• Expedited vs. Exempt
– If a protocol is not ‘exempt’ and does require
review, it may still be able to qualify for
expedited review
– To undergo expedited review the protocol
must involve no more than minimal risk
– Additional information on this subject is
available https://www.dtmi.duke.edu/aboutus/organization/duke-translational-nursinginstitute/education
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IRB Requirements
• Must have:
–
–
–
–
Protocol
Consent form and HIPAA waiver if applicable
Study summary
Research Data Security Plan
• Others may be required and the information can
be found at DUHS eIRB website:
https://eirb.mc.duke.edu/
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IRB Requirements Resource
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IRB Requirements Resource
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Most Common eIRB Submission Errors
• Same information in multiples places does not match (e.g. accrual
number on application vs. in informed consent and summary)
• Not referring to updated summary instructions
• Use of obscure acronyms on summary
• What a waiver of Consent/HIPAA is and when it is required (8590% of the time)
• Lack of required signoffs on “Sub-committee” page
• Standard language needs to be updated (e.g. HIPAA,
contraception, injury statement)
• Accrual: IRB approves # of consented subjects, not number
enrolled. Expected screen failures should be included in accrual
numbers
• Forgetting to mark exclusion of pregnant woman
• Errors in Conflict of Interest (COI) section
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Strategies To Speed The Approval Process
• Follow the guidelines as exactly as possible
• Include all appendices
– Tools
– Surveys/questionnaires
– Consent
• Enlist the help of expert
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Enlist the Help of Expert
• DTNI: email dtni@mc.duke.edu
919-668-2344
• DUSON ORA:
919-684-5376
• DUHS Research Nurse Scientist:
919-613 6406
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