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Clinical Research in Pediatrics at McMaster:
Types, Resources & Support Facilities
Stephanie A. Atkinson, PhD, FCAHS
Professor & Associate Chair, Pediatrics
Associate Member, Dept. Biochemistry & Biomedical Sciences
Professional Staff, McMaster Children’s Hospital
Clinical Research
• Definition
• Funding
• Ethics
• Clinical research at McMaster
– Areas of research
– Facilities
Research Approaches
Hypothesis based scholarly investigation
Basic science
Clinical study
Health services
Epidemiological
Systematic Review
Quality Assurance, Review of Practice
Case reports
Clinical Research Designs
Common Design Objective of Research
Randomized clinical trial Treatment effect
Cohort Prognosis
Cohort, case control,
cross-sectional
Cause
Cohort Incidence
Cross-sectional Prevalence
J. HollandOctober 2009
Clinical Research: Process, Policy, Procedures
PRINCIPAL
INVESTIGATOR
STUDY
MANAGEMENTOVERSIGHT DISSEMINATIONAPPROVALSSCIENCE
CLINICAL RESEARCH
Integrated
Research Services
Health Research
Services
Clinical Department
Research Directors
Peer Scientific
Reviews
Grants
Contracts
Division / Dept
Clinical Services
Clinical Program
HEALTH CANADA
( & / or FDA )
RESEARCH
ETHICS BOARD
Patients
Patient Care policy
Safe Location
Education
Study Audit
& Monitoring
Clinical Research
Site (Nursing,
Beds, Exercise Lab)
Staff Education
Template SOPs
Study Budgets
Data Management
& Biostatistics
Health Care Team:
- Clinical Practice
- Rounds
Research Subjects
Patients:
- Individual Results
- Summary Results
Colleagues:
- Conferences
- Peer review journals
Public:
- Advocacy Groups
- Granting Agencies
- Media
Medical Advisory
Committee
Clinical
Departments
Study Design
(Sponsor; PI)
RESEARCH
ETHICS BOARD
RESEARCH
ETHICS BOARD
5
J Holland 2007
Funding for Research
or Graduate/Postgrad Training
• Tri-Council Federal Agencies
- CIHR/NSERC/SSHRC
• Disease-specific Agencies
• Provincial Agencies
Institute of Health Services &
Policy (IHSP): Example of Special Funding
Opportunities from an Institute
• Funding Opportunities launched Jun 24 – 09
• Masters, PhD and Fellowship capacity building
grants in PRIMARY HEALTHCARE
• National and international Catalyst Research
Grants in PRIMARY HEALTHCARE
• Methods and Tools grant to support research
that enables the development and refinement of
research methods and tools
Funding for Research
• Disease-specific agencies
– Heart and Stroke Foundation
– National Cancer Institute
– Canadian Cystic Fibrosis Foundation
– MS Society of Canada
– Juvenile Diabetes Research Foundation International – PDF and early career awards
– Many others……..just google the disease of interest
Funding for Research
• Provincial Agencies
– Ontario Graduate Scholarship
– Center of Excellence for Child & Youth Mental Health at CHEO
– Physician Services Inc – Ontario only
– Alberta Heritage Fdn Medical Research – AB
– Michael Smith Fdn for Health Research – BC
– FRSQ – Quebec only
– Min Health Long-term Care, ON only
Funding Beyond CIHR
• Hospital Foundations, e.g. HHS – most target young investigators – fellows/early career – and only local
• Hospital for Sick Children Foundation – national competition – www.sickkidsfoundation.com
• PSI – www.psifoundation.org
• HSF – www.hsf.ca
• NCE for Child and Youth Mental Health –www.onthepoint.ca
• Michael Smith Foundation for Health Research
Hamilton Health Sciences/Faculty of
Health Sciences
Research Ethics Board (REB)
http://fhs.mcmaster.ca/healthresearch/reb/fo
rms.html
ETHICS in RESEARCH
Mandate of the REB
To protect the rights, safety and well-
being of any patient or healthy
volunteer who participates in research
conducted by a member of the staff of
HHS/Faculty of Health Sciences
Research Ethics Board
Online Documents
• Chart Review Research Application
• General Research Application (Revised: Oct 1, 2009)
• Prospective Database Research Application
• Human Tissue Research Application
• Information and Consent
– General Consent template
– Genetic Consent Template
– Assent Template
– Consent Checklist
ETHICS OF RESEARCH INVOLVING
HUMAN SUBJECTS
AN EDUCATIONAL SEMINAR FOR GRADUATE STUDENTS
CIBC Hall 308/309, Student Centre, McMaster
Thursday October 28, 2010
8:30 a.m. to 1:30 p.m.*
• to introduce graduate students across all faculties and disciplines to ethical issues surrounding
research involving human participants.
FREE - Register online before Oct 27th
http://iserv.mcmaster.ca/ethics/mreb/register/registration.cfm
Tri-Council Policy Statement
• REBs
• Privacy
• Conflict of Interest
• Inclusion
• Aboriginal Research
• Clinical Trials
• Fetus
• Tissues
• Mechanism of Disease & Disability
• Innovative Management of Childhood Disease
• Health and Quality of Life Outcomes
• Knowledge Translation and Education
http://fhs.mcmaster.ca/pediatrics_research/index.html
Research in Department of Pediatrics
McMaster Child Health Research
• Wet labs for measurement of biomarkers,
tracer studies etc - 5+
• Measurement of nutrition, growth and body
composition in children
• questionnaires, Case Report Forms
• database management
• measurement tools
• knowledge translation
McMaster Child Health Research
ANTHROMPOMETRY – Length/Height
Nutrition, Physical Activity & Health
Length Boards – for use on
flat counter tops
- Premature infant
- Term infant
- Child to 2 years
Stationary Wall-mounted Stadiometer
Anthropometric Equipment for Pediatric
Clinical Research Unit
Body Composition in Children
• Bioelectrical Impedence
• Calipers for skin fold thickness
• DXA –- Dr. Atkinson - located in HSC 4U18 with specialized infant software
Anthropometric Equipment for Pediatric
Clinical Research Unit
Pea Pod by Life
Measurement, Inc
• Will be available by
Dr. Fusch for use both
within the NICU and
outside of it for
measures in infants
up to 6 months of age