2021 Research Boot Camp Series
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2021 Research Boot Camp Series
As we are waiting to start our session please enter
one topic or question that you are hoping we
address during today’s presentation entitled:
“Designing your Study & Protocol and IRB”
Presented by:
Research in Outcomes for Children’s Surgery (ROCS)
Center for Children’s Surgery
2021 Research Boot Camp Series Presented by: Research in Outcomes for Children’s Surgery (ROCS) Center for Children’s Surgery
CONTRIBUTORS Maxie Meier, MS Kaci Pickett, MS Jill Kaar, PhD Additional Thanks: Claudia Mata, MPH
General Housekeeping • Welcome! • Timeline • Evaluations • Goal for today
Series Schedule
❑Day 1, Friday, August 6th : “Designing Your Study and Protocol and IRB”
֍ Study Design
֍ Research Questions and Aims
֍ IRB Overview
❑Day 2, Friday, August 13th : “Data Collection Practices and REDCap Overview”
֍ Data Variable Types
֍ Collecting Data and Database Building: REDCap
❑Day 3, Friday, August 20th : “Data Analysis and Manuscript Writing”
֍ Working with a Statistician
֍ Preparing Data for Analysis
֍ Presenting Your Results
Day 1:
Study Design & Protocol Development
Jill Landsbaugh Kaar, PhD
Associate Professor | Dept Pediatrics | Endocrinology
Director of Research Outcomes | ROCS
Director of Postdoctoral Research Education | Endocrinology
Editorial Board | Sleep Health
Steps to
Complete a STUDY DESIGNS PROTOCOL AND DATA
Scholarly IRB APPLICATION COLLECTION
Project
DATA ENTRY & ANALYZE & PUBLICATIONS
CLEANING INTERPRETATION
OF RESULTS
Steps to
Complete a STUDY DESIGNS PROTOCOL AND DATA
Scholarly IRB APPLICATION COLLECTION
Project
DATA ENTRY & ANALYZE & PUBLICATIONS
CLEANING INTERPRETATION
OF RESULTS
Overview of Study Design
Details of Study Designs
How to Choose Study Design
RETROSPECTIVE:
Disease has long induction &
latent period
COHORT;
Historical exposure
Little known about exposure
Want to save time & money
Evaluate many effects of an
exposure
PROSPECTIVE:
Exposure is rare
OBSERVATIONAL: Disease has short induction &
Underlying population is fixed latent period
Research question involves a
prevention, treatment, or Current exposure
causal factor CASE-CONTROL: Want high-quality data
Moderate or large effect Little know about disease
GOAL: expected Evaluate many exposures
Valid and precise Trial not ethical or feasible Disease is rare
information Trial too expensive Disease has long induction &
Association between latent period
exposure and disease EXPERIMENTAL: Exposure & data are
Using minimum resources expensive
Research question involves a
prevention or treatment Underlying population is
dynamic
Small effect expected
Ethical & feasible
Money is availableSteps to
Complete a STUDY DESIGNS PROTOCOL AND DATA
Scholarly IRB APPLICATION COLLECTION
Project
DATA ENTRY & ANALYZE & PUBLICATIONS
CLEANING INTERPRETATION
OF RESULTSLevel of Experience in the Group Today…
Protocol Development
Hypotheses and Specific Aims
Protocol
Background and Significance
Components
Preliminary Studies/Progress Report
Research Methods
• Outcome Measures
• Description of Population to be Enrolled
• Study Design and Research Methods
• Description, Risks, and Justification of Procedures
& Data Collection Tools
• Potential Scientific Problems
• Data Analysis Plan
• Summarize Knowledge to be Gained
• ReferencesExample Specific Aims
Example Protocol A Example Protocol B
Aim 1: To determine if children are Aim 1: To quantify the number of
susceptible to COVID-19. children who are diagnosed with
COVID-19.
Aim 2: To quantify the number of
children who are diagnosed with Aim 2: To examine predictors (i.e.,
COVID-19. age, sex, existing comorbidities) that
may be associated with children who
are diagnosed with COVID-19.Hypothesis and Specific Aims
Preliminary Studies VS
Pilot StudiesPreliminary Studies
Terms preliminary data and pilot data can’t be used interchangeably.
Outcome Measures
Study Design and Research Methods
Risks & Procedures
Data Caution!
Consult your
Analysis Statistician!
PlanWhat variable is used to “POWER” your study?
NOT NECESSARY FOR CHART REVIEW
P
I
L
O
T
S
T
U
D
Y
Consult your
Statistician!!Grant Proposals the “Aims Page”
• Aims Page
• Find examples relevant to your research project (i.e., previous fellows)
• Ask for “funded research proposals ( typically, first page is aims page) from
colleagues that are more senior to you or if at your level, have secured the
funding you want
• Ultimate goal, an example of a successful proposal formatted exactly for
where it is going (i.e., retrospective chart review conducted at Children’s
Hospital Colorado, NIH K23 NHLBI, American Heart Association Scientists
Development Grant, etc)
• Examples I am sharing include
• Research Institute Pilot Award – pilot & feasibility study
• COMIRB approved retrospective chart reviewExamine the Hidden Formula
Opening Sentence
• Need to immediately capture the reviewer’s attention by
highlighting the relevance of your topic
– Consider the mission of the funder and include key words that
highlight that missionCurrent Knowledge
• In 3-4 sentences what is known on the subject
– Keep in mind you are setting up the reviewer for the “gap in
knowledge” you are proposing to fill with your proposalResearch Gap
• Define the subject of your proposal
– Keep in simple, direct, and relate it to the preceding sentencesLong-Term Goal
• State to the reviewers where this project will go next
– They want to see that the results from this project will continue into
the next logical stepPart 1: Importance - Identify Gap in Literature
Part 2: Preliminary Data
Part 3: Rationale, Aims, & Hypotheses
Example Timeline 6-8 Months
Human Subject Research Protections
Human Subject Protections
• IRB is not meant to be difficult or the enemy
• The purpose of the IRB is to ensure that research upholds
the following…
Belmont Principle Application
Respect for Persons Informed Consent
Beneficence Risk/Benefit Assessment
Justice Subject SelectionIRB Process
Before submission Submission process
• Complete CITI training • Submit through the Human
• COI disclosure Subject Research Portal
• Feasibility Review
(CHCO/RI)
• COMIRB
• OnCore protocol creation
(may or may not use it)
More Info…. https://research.cuanschutz.edu/comirb/home/submissionsCITI Training COI Disclosure For all research personnel involved in Complete your COI Disclosure Form on the study the eRA website. Select Anschutz as Required courses: your campus and login with your CU • Biomedical or Social Behavior credentials investigators • Step by step guide on how to complete • Health Information Privacy and Security the COI Disclosure Form (HIPS) for Clinical Investigators Complete COI once a year, unless your If you need help creating an account, status changes during the year email ROCS@childrenscolorado.org
Human Subject Research Portal
HSR Portal Submission
• Complete Clinical Research Protocol
Assessment Form
– https://research.cuanschutz.edu/crs/c
linical-research-support/clinical-
research-administration/human-
subjects-research-portals/hsr-new-
protocol-portal
• Clearance letter
– Receive clearance letter via email
from CHCO Research Start-Up
– Need letter for COMIRB submissionPersonnel
Colorado Multiple
Institutional
Sites
Review Board
(COMIRB) Data and Specimen Collection
Application
Components Data Management and Security
All IRB forms and templates can be found
on the COMIRB website Consent/Waiver of
Consent/AuthorizationReferences • COMIRB website https://research.cuanschutz.edu/comirb • Clinical Research Support Center https://research.cuanschutz.edu/crs • ROCS Support Intake Form https://form.jotform.com/CCS_ROCS/rocs-intake • ROCS contact info ROCS@childrenscolorado.org
Thank you!
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